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Preoperative anaemia and its impact on immediate surgical outcomes in elderly patients: a multicentre prospective cohort study in Ethiopia

Por: Wubet · H. B. · Gobezie · N. Z. · Deress · G. M. · Mekuriaw · B. Y. · Abuhay · A. G. · Afework · W. A. · Siyoum · T. M. · Gedefaw · G. D. · Abate · A. T. · Demissie · B. · Demtie · D. G. · Asmare · T. B.
Objective

To assess how preoperative anaemia affects surgical outcomes in elderly patients within a resource-limited setting.

Design

Prospective cohort study.

Setting

Two comprehensive specialised hospitals in Ethiopia.

Participants

Participants consisted of 224 patients aged 65 years and older who underwent surgery between 1 December 2024 and 29 March 2025.

Primary and secondary outcome measures

Perioperative blood transfusions were the primary outcome. Secondary outcomes included intensive care unit (ICU) admission, risk of postoperative complications, prolonged hospitalisation, poor recovery quality and in-hospital mortality.

Results

The anaemic group required transfusions of three or more units more frequently than the non-anaemic group (10.5% vs 2.6%; absolute risk difference 8.0%). Their perioperative transfusion rates were significantly higher (42.3% vs 18.4%; p

Conclusion and recommendation

Preoperative anaemia significantly increases the risk of transfusion, poor recovery, ICU admission, prolonged hospitalisation and in-hospital mortality in older patients who underwent surgery. In resource-limited settings, improving perioperative outcomes should prioritise the early detection and treatment of anaemia.

Diagnosing deep vein thrombosis early in critically ill patients (DETECT) trial: a protocol for a randomised controlled trial

Por: Arabi · Y. M. · Alenezi · F. · Al-Hameed · F. · al Humedi · H. I. · Kharaba · A. · Alhazzani · W. · Alshahrani · M. S. S. · Algethamy · H. · Maghrabi · K. · Chalabi · J. · Ardah · H. I. · Alahmari · A. M. · AlQahtani · R. M. · Ababtain · A. A. · Al-Filfil · W. A. M. · Al-Fares · A. A.
Introduction

Deep vein thrombosis (DVT) in critically ill patients is often undetected. However, it is unclear whether ultrasound surveillance for early detection of DVT in high-risk medical-surgical intensive care unit (ICU) patients improves patients’ outcomes. The DETECT trial (Diagnosing deep-vein thrombosis early in critically ill patients) evaluates the effect of twice-weekly bilateral lower limb ultrasound compared to usual care on 90-day mortality of critically ill adult patients admitted to medical, surgical and trauma ICUs.

Methods and analysis

The DETECT trial is an international, parallel-group, open-label, randomised trial, which will recruit 1800 critically ill adults from over 14 hospitals in Saudi Arabia and Kuwait. Eligible patients will be allocated to twice-weekly bilateral lower limb ultrasound or usual care. The primary outcome is 90-day mortality. Secondary outcomes include lower limb proximal DVT, pulmonary embolism and clinically important bleeding. The first patient was enrolled on 21 March 2023. As of 8 April 2025, 711 patients have been enrolled from 14 centres in Saudi Arabia and Kuwait. The first interim analysis was conducted on 14 May 2025. We expect to complete recruitment by December 2026.

Ethics and dissemination

Institutional review boards (IRBs) of each participating institution approved the study. We plan to publish the results in peer-reviewed journals and present the findings at international critical care conferences.

Trial registration number

Clinicaltrials.gov: NCT05112705, registered on 9-11-2021.

Understanding internet-supported self-management for low back pain in primary care: a qualitative process evaluation of the SupportBack 2 randomised controlled trial

Por: Geraghty · A. W. A. · Hughes · S. · Roberts · L. · Hill · J. C. · Foster · N. E. · Hay · E. · Mansell · G. · White · M. · Davies · F. · Steele · M. · Little · P. · Yardley · L.
Objective

The SupportBack 2 randomised controlled trial (RCT) compared the clinical and cost-effectiveness of an internet intervention supporting self-management versus usual primary care in reducing low back pain (LBP)-related disability. In this study, we aimed to identify and understand key processes and potential mechanisms underlying the impact of the intervention.

Design

This was a nested qualitative process evaluation of the SupportBack 2 RCT (ISRCTN: 14736486 pre-results).

Setting

Primary care in the UK (England).

Participants

46 trial participants experiencing LBP without indicators of serious spinal pathologies (eg, fractures, infection) took part in telephone interviews at either 3 (n=15), 6 (n=14) or 12 months (n=17) post randomisation. Five physiotherapists who provided telephone support for the internet intervention also took part in telephone interviews.

Intervention

An internet intervention ‘SupportBack’ supporting self-management of LBP primarily through physical activity and exercise delivered in addition to usual care, with and without physiotherapist telephone support.

Analysis

Data were analysed thematically, applying a realist logic to develop context-mechanism-outcome configurations.

Results

Four explanatory themes were developed, with five context-mechanism-outcome configurations. Where benefit was reported, SupportBack appeared to work by facilitating a central associative process where participants linked increases in physical activity or exercise with improvements in LBP, then continued to use physical activity or exercise as key regulatory strategies. Participants who reported little or no benefit from the intervention appeared to experience several barriers to this associative process, including negative expectations, prohibitive beliefs about the cause of LBP or functional limitations preventing engagement. Physiotherapists appeared to provide accountability and validation for some; however, the remote telephone support that lacked physical assessment was viewed as limiting its potential value.

Conclusions

Digital interventions targeting physical activity and exercise to support LBP self-management may rely on mechanisms that are easily inhibited in complex, heterogeneous populations. Future research should focus on identifying and removing barriers that may limit the effectiveness of digital self-management support for LBP.

Evaluating diabetes-specific meal replacements for glycaemic control in overweight and obese patients with T2DM: a protocol for a randomised controlled trial

Por: Che Wan Mansor · W. A. N. · Shahar · S. · Mohd Tohit · N. · Rajikan · R. · Ismail · M.
Introduction

Uncontrolled type 2 diabetes mellitus (T2DM) causes microvascular and macrovascular issues that hike healthcare costs and threaten global health. Previous studies have suggested meal replacement (MR) therapy for T2DM, but there were inconsistencies in the results. Thus, a randomised controlled trial is proposed to determine the efficacy of a diabetes-specific MR product on weight loss, glycaemic control, satiety, quality of life, metabolic gene expression and cost benefit in overweight and obese patients with T2DM.

Methods and analysis

164 overweight and obese participants with T2DM will be randomly assigned to either an intervention group (n=82) or a control group (n=82). All participants will receive dietary counselling; however, only the intervention group will receive MR for 12 weeks. Glycaemic control and obesity indicators are the study’s main outcomes. Secondary outcomes include cardiovascular disease risk markers, metabolic risk, metabolic gene profile analysis, dietary data, physical activity, satiety level, quality of life and cost analysis. Baseline data will include sociodemographics, anthropometry, blood pressure, diet, physical activity, satiety level, quality of life, blood profile, metabolic gene expression profile and cost-benefit analysis. A follow-up is planned at intervention weeks 6 and 12. Week 6 will assess only anthropometry, blood pressure, diet, physical activity and satiety level. For compliance assessment, intervention group participants will bring their MR container. Week 12 will measure the same baseline parameter, except sociodemographic data. Individuals who consume less than 80% of the MR will be deemed non-compliant. All parameter modifications will be documented and analysed for comparison. All statistical analyses will be conducted using IBM SPSS V.29.0 software, with a significance level of p

Ethics and dissemination

This research protocol was approved by the Ethical Committee of the National University of Malaysia (JEP-2024-695) and registered on International Standard Randomised Controlled Trial Number. Study findings will be disseminated in peer-reviewed journals, conference presentations and social media.

Trial registration number

ISRCTN57040303).

The impact of working conditions on breast cancer outcomes: a study protocol for a population-based cohort study using UK Biobank data

Por: van der Linden · B. W. A. · Carmeli · C. · Duijts · S. F. A. · Guseva Canu · I. · Rohrmann · S. · Chiolero · A.
Introduction

Breast cancer is the most common cancer among women globally. While the impact of lifestyle factors like smoking and obesity on breast cancer risk and survival is well documented, the effect of working conditions is not fully understood. Moreover, breast cancer can reduce employability, making it crucial to identify factors that facilitate return to work and improve life satisfaction. Since breast cancer is affected by sleep and lifestyle, which are related to working conditions, understanding how they affect breast cancer outcomes is key. This study aims to explore the relationship between working conditions and breast cancer outcomes, including incidence, mortality and survival within a causal framework. Our specific aims are to understand the relationship between (1) working conditions and occupational groups and breast cancer outcomes, including the extent to which sleep, lifestyle and breast cancer screening uptake explain these relationships and (2) prediagnosis working conditions, sleep and lifestyle and their effect on return to work and life satisfaction among breast cancer survivors.

Methods and analysis

We will use data from the UK Biobank, a large-scale cohort study with data on 273 825 women between 40 and 69 years old at baseline, followed from 2006 to 2022. The data has been linked with death and cancer registries and includes 8309 incident breast cancer cases. To quantify the effect of working conditions on breast cancer outcomes (aim 1) and their effect on return to work and life satisfaction (aim 2), we will implement g-methods to estimate the average causal effect and employ counterfactual-based mediation analysis to quantify how much mediating factors, such as sleep and lifestyle, explain this effect.

Ethics and dissemination

UK Biobank received ethical approval from the North West Multi-Centre Research Ethics Committee. No further ethical approval was required for the proposed research project. In line with the two aims, four original research manuscripts will be published in open-access peer-reviewed journals to disseminate the findings. In addition, findings will be disseminated at international conferences and scientific meetings.

Experiences of using a physical activity and exercise digital intervention to reduce respiratory tract infections: a qualitative process evaluation

Por: Dennis · A. · Joseph · J. · Greenwell · K. · Miller · S. · Vennik · J. · Dennison · L. · Holt · S. · Bradbury · K. · Ainsworth · B. · Yardley · L. · Little · P. · Geraghty · A. W. A.
Objectives

Increasing physical activity and effectively managing stress can positively impact immunity and may reduce the duration of respiratory tract infections (RTIs). As part of a larger trial, participants accessed a digital behavioural change intervention that encouraged physical activity and stress management to reduce RTIs. We aimed to understand the barriers and facilitators to engaging in physical activity and stress reduction.

Design

A qualitative process analysis from semistructured interviews of the behavioural intervention in a randomised control trial.

Setting

Primary care in the UK.

Participants

34 participants (aged 18–82 years) in the behavioural intervention arm.

Interventions

The larger trial involved four interventions: a gel-based antiviral nasal spray; a saline water-based nasal spray; a behavioural intervention; usual care. In this study, we focused on participants allocated to the behavioural intervention. The behavioural intervention included two components: one to increase physical activity (getting active) and another for stress management techniques (healthy paths) to reduce RTIs.

Results

We analysed the interviews using thematic analysis with a critical realist perspective (focusing on). We developed five themes: digital intervention engagement, views on intervention allocation, the role of getting active, the role of healthy paths and benefits reinforcing behaviour. Participants’ views on the relevance and benefit of the behavioural intervention shaped their engagement with the intervention website and behaviour. Facilitators of intervention engagement included awareness of inactivity, goal setting, increasing immunity, positive outcome expectations and benefits from changing behaviour. Barriers to engagement included negative outcome expectations, such as around efficacy of the behaviours.

Conclusions

Overall, the results highlighted the importance of positive expectations for a digital intervention promoting physical activity and stress management for RTI reduction. Future interventions should consider how to clearly communicate a broad range of perceived benefits to users.

Trial registrations

The trial was prospectively registered with International Standard Randomized Controlled Trial Number (ISRCTN) registry (17936080).

Incidence and predictors of delirium in patients admitted to intensive care unit at comprehensive specialised hospitals in Amhara region, northwest Ethiopia: a multicentre prospective observational study

Por: Asmare · T. B. · Wubet · H. B. · Gobezie · N. Z. · Deress · G. M. · Belete · K. G. · Tadesse · M. A. · Abuhay · A. G. · Demissie · B. · Melesew · A. A. · Afework · W. A. · Alle · Y. F. · Demite · D. G. · Teshome · D. · Mossie · K. D. · Kassa · B. D. · Gedefaw · G. D.
Objective

To assess the incidence of delirium and its predictors among adult patients admitted to the intensive care units of comprehensive specialised hospitals in the Amhara region of northwest Ethiopia from 18 October 2024 to 20 February 2025.

Design

A multicentre prospective observational study was conducted.

Setting

Four comprehensive specialised hospitals in the Amhara region of northwest Ethiopia, from 18 October 2024 to 20 February 2025.

Participants

A total of 351 patients were included in the final analysis during the study period.

Outcome measures

The primary outcome measure of this study was the incidence of delirium. Additionally, the study investigated the factors associated with delirium incidence among adult patients admitted to intensive care units.

Results

The incidence of delirium among adult patients in intensive care units was 42.17% (95% CI: 37.08 to 47.42). Pain (adjusted HR (AHR) = 4.74; 95% CI: 2.38 to 9.44), mechanical ventilation (AHR = 2.96; 95% CI: 1.56 to 5.63), age 65 years or older (AHR = 2.18; 95% CI: 1.48 to 3.21) and agitation (Richmond Agitation-Sedation Scale (RASS) ≥1) (AHR = 3.26; 95% CI: 2.09 to 5.09) were statistically significant factors associated with delirium.

Conclusion and recommendation

In the present study, more than one-third of patients developed delirium. Pain, mechanical ventilation, age 65 or older and agitation (RASS≥1) were significantly associated with delirium occurrence. To reduce the incidence of delirium, the current study recommends treating or preventing pain and agitation. Additionally, special attention should be given to patients receiving mechanical ventilation and those aged 65 or older during care.

Mental health disorders among people living with HIV in sub-Saharan Africa: a scoping review protocol

Por: Adedeji · W. A. · Ishola · A. G. · Elugbadebo · O. · Oladepo · O. M. · Mudzviti · T. · Kaiyo-Utete · M. · Willis · N. · Adebayo · D. A. · Mtisi · T. J. · Chokuona · K. F. V. · Ma · Q. · Cha · R. · Hutson · A. · Charurat · M. E. · Yusuf · O. B. · Maponga · C. · Fehintola · F. A. · Gureje
Background

The mental health of people living with HIV (PLWH) is a growing concern globally, particularly in sub-Saharan Africa (SSA), where there is limited access to mental healthcare, with evidence showing high levels of depression, anxiety and neurocognitive disorders among this population. While Mental Health Disorders (MHDs) can impede HIV care and promote adverse health outcomes, there is limited literature on MHDs among PLWH. This scoping review will explore the existing literature on the burden and factors associated with MHDs among adults living with HIV in SSA.

Methods and analysis

Arksey and O’Malley’s methodological framework will guide the search of this scoping review. Relevant original research articles published in English from 1 January 2000 to 31 May 2025 on MHDs among PLWH in SSA will be identified through searches in the African Index Medicus, African Journal Online, PubMed and Embase databases. Four independent reviewers, working in pairs (one reviewer and one verifier), will screen the titles, abstracts and later the full texts, adopting the population, concept and context framework. Other coauthors will serve as tiebreakers whenever there is disagreement on the eligibility. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews flowchart will be presented. We will perform a narrative synthesis to report our findings.

Ethics and dissemination

This scoping review protocol does not require ethical approval, as it relies solely on publicly available existing data and does not involve human participants. We will disseminate the findings from this review through peer-reviewed publications and presentations at local and international conferences.

Trial registration

The protocol was registered in the Open Science Framework (https://osf.io/8ymqu).

Stress reactivity and maternal health (STRIVE): protocol for a multisite observational cohort study

Por: Kershaw · K. N. · Hoffer · L. · Achepohl · G. D. · Alexandria · S. J. · Bartholomew · A. · Brindle · S. · Frey · H. · Williams · B. · Yee · L. M. · Grobman · W. A.
Introduction

Black adults are generally exposed to more stressors over the life course and, due to the intersections of racism and economic and social resources, they tend to have more limited resources to cope with social stressors than white adults. This mismatch between stress exposures and resources may lead to dysregulated responses or reactivity to stressors and contribute to persistent racial disparities seen in adverse pregnancy outcomes (APOs). Prior studies examining stress exposures have been hampered by the challenge of capturing stress exposures comprehensively, given they are manifold, dynamic and accumulate over time. The Stress Reactivity and Maternal Health Study seeks to overcome this limitation by examining the impact of physiological and psychological stress reactivity to everyday stressors on APOs.

Methods and analysis

We are recruiting 700 nulliparous self-identified non-Hispanic black and white pregnant individuals from academic medical centres in the USA. We use ecological momentary assessments administered via smartphones to collect repeated measurements of exposure to everyday stressors throughout the day over the course of seven consecutive days at two different time points mid-pregnancy (14–22 weeks and 22–28 weeks). At the same time, we collect intensive measurements of heart rate variability, blood pressure, salivary cortisol and positive and negative affect. We will use mixed-effects models to estimate personalised indicators of cardiovascular, neuroendocrine and affective reactivity to everyday stressors. We will then use linear and logistic regression modelling to examine associations of these personalised indicators of stress reactivity with placental histological lesions and the occurrence of APOs. Finally, we will use the gap-closing estimand method to quantify the extent to which racial disparities in adverse placental and pregnancy outcomes are explained by differences in prenatal stress exposure and prenatal stress reactivity.

Ethics and dissemination

The Northwestern University institutional review board (IRB) approved this study and serves as the single IRB of record (STU00218683). All participants will sign an informed consent document prior to participation, and data will be treated confidentially. Findings will be disseminated in peer-reviewed scientific journals, briefs, infographics and presentations.

Assessment of adverse childhood experiences in women: a study of reliability and predictive validity of self-reporting versus medical records abstraction in an American population

Por: Rocca · W. A. · Gazzuola Rocca · L. · Smith · C. Y. · Esterov · D. · Kapoor · E. · Geske · J. R. · Bailey · K. R. · Mielke · M. M. · Kantarci · K.
Objective

To study the reliability and validity of adverse childhood experiences (ACE) scores measured using a questionnaire versus abstraction of medical records, and to test whether the scores vary by history of bilateral oophorectomy, or by age and presence of anxiety or depressive symptoms at the time of questionnaire administration.

Design

The study involved a reliability component and a predictive validity component.

Setting

A population-based sample in Olmsted County, Minnesota, was derived from the Mayo Clinic Cohort Study of Oophorectomy and Aging-2.

Participants

We included 198 women who underwent premenopausal bilateral oophorectomy for a non-malignant indication between 1988 and 2007 and 174 referent women of the same age randomly sampled from the general population (total of 372 women). At a later time (median of 22.7 years later), the women were contacted and invited to self-administer the ACE questionnaire during an inperson visit. Independent of the visit, their medical records were abstracted for ACE by a physician.

Interventions

Questionnaire and abstraction-based ACE scores.

Main outcome measures

Agreement between the two ACE scores (reliability; weighted kappa statistics) and comparison of incidence of multimorbidity in women with ACE scores ≥1 vs 0 (predictive validity; survival analyses). Data were analysed in March and April 2024.

Results

The 372 women in the study had a median age of 65 years at the time of ACE questionnaire self-administration (IQR, 62–69). Questionnaire-based ACE scores showed moderate agreement with abstracted ACE scores (weighted kappa 0.44 (95% CI 0.34 to 0.54)). The cut-off score of ACE ≥1 showed an overall fair agreement between the two scores (kappa 0.33 (95% CI 0.24 to 0.43)). A comparison of the cumulative incidence of multimorbidity in women with an ACE score ≥1 versus women with ACE score of 0 yielded a HR of 1.13 (95% CI 1.00 to 1.27) for abstracted ACE and 1.13 (95% CI 1.01 to 1.27) for questionnaire-based ACE. The best predictive validity was for ACE measured by both methods combined (either or) with a HR of 1.29 (95% CI 1.13 to 1.46).

Conclusions and relevance

Questionnaire-based ACE scores have moderate agreement with medical records abstracted ACE scores. However, both sets of ACE scores are predictive of the accumulation of multimorbidity at older age and should be considered complementary.

Conceptualisation, operationalisation and role of identity in physical activity and smoking in individuals aged 45 and over: a systematic scoping review

Por: Penfornis · K. M. · van Vliet · M. H. M. · Von Haeseler · E. F. · Gebhardt · W. A. · Meijer · E.
Purpose

Identity is a determinant of health-promoting behaviours such as physical activity and health-compromising behaviours such as smoking. This scoping review provides a comprehensive synthesis and comparison of the relationship between physical activity- and smoking-related identity and behaviour, and how these identities are defined and measured. Study participants’ personal, physical activity-related and smoking-related characteristics were considered if data were available. The review focuses on people aged 45 and above.

Methods

A search across 9 databases yielded 5801 unique publications. Ensuing careful screening, 268 peer-reviewed empirical studies met eligibility criteria, of which 45 concerned participants of 45+ age. Experts in the field contributed to validating and structuring the narrative.

Results

Findings revealed the existence of an intricate, enduring direct and indirect relationship between identity and behaviour for physical activity and smoking. Numerous similarities and differences in this relationship, as well as in identity-related terminology and measurement tools used, were identified. In essence, endorsing an identity related to physical activity and smoking abstinence was found to be important for becoming physically active and quitting smoking successfully, respectively. Identity processes, encompassing identity formation, maintenance, change and loss, were detected as applicable to both physical activity and smoking, although differences were observed between the two behaviours. Characteristics such as gender, age and behavioural history emerged as relevant in shaping smoking-related and physical activity-related identities.

Conclusions

Despite variances, findings suggest that the relationship between identity and behaviour, including associated processes, may not fundamentally differ between health-promoting and health-compromising behaviours. Avenues for future research, including exploring causality between identity and behaviour, are proposed.

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