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☐ ☆ ✇ BMJ Open

Comparative Efficacy and Safety of Pharmacological Agents for Chronic Low Back Pain: A Systematic Review and Bivariate Bayesian Network Meta-analysis Protocol

Por: Aremu · O. · Ogunlade · O. · Mata · T. — Septiembre 29th 2025 at 07:52
Introduction

Non-specific chronic low back pain is a leading cause of disability-adjusted life-years (DALYs) with a lifetime prevalence of 80%–85%. Although many modalities of treating chronic low back pain are available, pharmacotherapy remains a very important treatment modality, according to many recognised guidelines. Each of these pharmacological agents has evidence supporting its efficacy in treating chronic low back pain, and each of them is associated with side effects. At present, no study has unified these two outcomes or ranked them from the most effective to the least effective. Thus, this study aims to identify pharmacological agents that rank best by conducting multivariate bivariate network meta-analysis.

Methods

Four databases (Medline/Pubmed, Cochrane Central Register for Controlled Trials, Cochrane Database for Systematic Reviews and CINAHL) will be systematically searched from their inception to 31 July 2024 for randomised control trials that meet the inclusion criteria. Appropriate data will be extracted from the relevant studies, including the two outcomes of interest: the pain intensity score and the proportion of patients who withdrew from the study because of adverse events. A bivariate Bayesian network meta-analysis will be used to combine the two outcomes of interest to form a single probability that will rank the pharmacotherapy agents from the most effective and safe to the least. The studies will be assessed for risk of bias, and their evidence will be graded using the Grading of Recommendations Assessment, Development, and Evaluation assessment tool. Inconsistency, which is a key assumption of network meta-analysis, will be assessed using both local and global methods.

Ethics and Dissemination

This systematic review is based on already published data, so it does not require ethical approval. The findings from the review, after completion, will be disseminated via peer-reviewed publications.

PROSPERO registration number

CRD42024569192.

☐ ☆ ✇ BMJ Open

Cohort profile: trajectory of knee health in runners with and without heightened osteoarthritis risk (TRAIL) in Australia--prospective cohort study

Por: De Oliveira Silva · D. · Mentiplay · B. F. · Girdwood · M. · Haberfield · M. J. · Bruder · A. M. · Culvenor · A. G. · West · T. J. · Hill · J. P. · Carey · D. L. · Johnston · R. T. R. · Crossley · K. M. — Septiembre 29th 2025 at 07:52
Purpose

The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.

Participants

Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.

Findings to date

Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).

Future plans

Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.

☐ ☆ ✇ BMJ Open

Swallowing prehabilitation for people with head and neck cancer: a pilot cluster-randomised feasibility trial of the SIP SMART intervention

Por: Govender · R. · Wang · J. · Marston · L. · Pizzo · E. · Taylor · S. · Nazareth · I. — Septiembre 25th 2025 at 11:09
Objectives

To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.

Design

Two-arm cluster-randomised pilot trial: SIP SMART2 trial.

Setting and participants

Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.

Interventions

Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.

Outcomes

Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.

Results

12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.

Conclusions

It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.

Trial registration number

ISRCTN12377415.

☐ ☆ ✇ BMJ Open

Prevalence of workplace bullying among healthcare workers in hospitals in Greater Beirut: effects on psychological well-being, burnout and sick leaves

Por: Makarem · N. N. · Tavitian-Elmadjian · L. R. · Brome · D. · Soubra · N. A. — Septiembre 23rd 2025 at 03:05
Introduction

Interest in workplace bullying (WPB) has been steadily growing with a focus on understanding its consequences as well as prevalence rates in different occupations and across different countries with varying cultural contexts. Research in the Middle East remains limited, especially in Lebanon. The scarcity of data from the Lebanese healthcare sector underscores the need to better understand WPB in this unique sociocultural and organisational environment.

Objectives

The primary aim of this study is to investigate the prevalence of WPB among healthcare providers and hospital staff in Greater Beirut. The secondary aim is to investigate the relationship between WPB, psychological well-being, burnout and sick leaves in the Lebanese cultural context.

Design

A cross-sectional study design was conducted.

Setting

Seven hospitals in Greater Beirut took part in the study, including six private hospitals and one public hospital.

Participants

A total of 958 participants aged 18–64 were recruited using stratified proportionate non-random sampling. Stratification by hospital size and department aimed to ensure broad representation of nursing and support staff across institutions. The participants included nursing and supporting staff, of which 26.3% were males and 73.7% were females. Those employed for less than 6 months were excluded.

Primary and secondary outcome measures

The Arabic versions of each of the Negative Acts Questionnaire-Revised (NAQ-R), the General Health Questionnaire (GHQ-12) and the Copenhagen Burnout Inventory (CBI) were administered. These instruments were selected for their established reliability and widespread use in cross-cultural occupational health research. Surveys were administered via paper-and-pencil (six hospitals) and online (one hospital). Prevalence of bullying using the NAQ-R cut-off scores was first calculated and then their respective thresholds identified using receiver operating characteristic analysis. Pearson’s correlation coefficient was used to evaluate the relationship between the NAQ-R and the GHQ-12, CBI and number of sick leaves.

Results

Using the lower threshold as a cut-off on the NAQ-R, 35.1% of participants were classified as bullied. When applying the higher threshold as a cut-off, the percentage was slightly lower but remained comparable at 32.4%. Results showed that across the two outcomes, those who were bullied both when using a lower threshold and upper threshold were significantly more distressed and burnt out (pt(df) = –8.43, p±1.96; Upper threshold: ² (4, N=902)=9.963, p=0.019, Standardised residual for 6–10 days=2.2>±1.96).

Conclusion

Findings yielded lower prevalence rates of WPB among nurses and the entire sample as compared with research carried out in the Arab region. Our study further supports the impact of culture on the perpetuation of WPB and the uniqueness of Lebanon’s culture on influencing this prevalence. Results indicated that participants who were bullied were significantly more distressed, more burnt out and reported taking up more sick leaves. These findings highlight the need to consider local workplace culture when addressing bullying and reinforce the significant psychological and occupational toll bullying takes on affected individuals. Healthcare institutions are encouraged to implement and reinforce clear antibullying policies, WPB prevention strategies and confidential reporting mechanisms. Future research should explore longitudinal patterns of bullying, obtain a more nationally representative sample and examine the effectiveness of targeted interventions to create safer, more supportive work environments.

☐ ☆ ✇ BMJ Open

Changes in prescription patterns of antidiabetic medication in patients newly diagnosed with type 2 diabetes in Spain: an observational study

Por: Cea-Soriano · L. · Moreno · A. · Calonge · M. · Rivas · A. · Pulido-Manzanero · J. · Colchero · M. C. · Artola · S. · Serrano · R. · Franch-Nadal · J. · Regidor · E. · the PRECOZIN Study Group · Adan · Almanzar · Alonso · Alonso · Alonso · Alvarez · Alvarez · Amoros · Araujo · Arbide — Septiembre 23rd 2025 at 03:05
Objective

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Design

Observational study.

Participants

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

Primary and secondary outcomes

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

Results

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Conclusion

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

☐ ☆ ✇ BMJ Open

Progression from uncomplicated to severe malaria among children in settings receiving different malaria control interventions in sub-Saharan Africa: a systematic review protocol

Por: Okek · E. J. · Lutwama · J. · Kinengyere · A. A. · Asio · J. · Awor · S. · Le Doare · K. · Musinguzi · B. · Sande · J. O. · Ocan · M. · Kayondo · J. — Septiembre 17th 2025 at 06:57
Background

Different malaria control measures are deployed simultaneously in endemic settings globally, with varying impacts on malaria burden. In sub-Saharan Africa, which bears the greatest burden of malaria, evidence on the impact of implementing various control interventions on malaria immunity remains unknown. This systematic review seeks to collate evidence on the extent of progression from uncomplicated to severe malaria among populations in sub-Saharan Africa settings receiving concurrent deployment of various malaria control measures.

Methods

The review will use a priori criteria contained in the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. An experienced librarian (AAK) will independently search for articles from the following databases: PubMed, Web of Science, Embase, Scopus and Google Scholar. Boolean operators ‘AND’ and ‘OR’ will be used in the article search. Identified articles will be managed using EndNote. Article screening for inclusion and data extraction will be done in duplicate by two reviewers (EJO, and BM). Data extraction tools will be developed and customised in Excel. Data will be analysed using both narrative and quantitative synthesis. The level of heterogeneity between study outcomes will be measured using the I2 statistic. Subgroup analysis will be conducted to explore heterogeneity and establish the impact of different control interventions on progression from uncomplicated to severe malaria. A full systematic review and meta-analysis is expected to be ready for dissemination by the end of December 2025.

Ethical consideration and dissemination of findings

This study did not involve human participants and so ethical approval was not sought. A full review and a meta-analysis will be published in a peer-reviewed journal and presented at national and international conferences.

PROSPERO registration number

CRD 42024619945.

☐ ☆ ✇ BMJ Open

Lived experiences of women with pelvic organ prolapse at Gurage zone, Central Regional State, Ethiopia: an interpretive phenomenological analysis

Por: Tega · A. · Desalegn · M. · Asmare · E. · Addis · Z. · Bantie · H. W. · Demelash · R. — Septiembre 15th 2025 at 05:56
Introduction

Pelvic organ prolapse (POP) is the descent of one or more pelvic organs through the vaginal canal, including the vagina, uterus, rectum, bladder, cervix, posthysterectomy vaginal cuff, and small or large bowel, which compromises a woman’s physical, mental and social well-being.

Objective

This study aimed to explore how women with POP experience their living and its impact on their quality of life (QoL).

Design

This was a qualitative study using interpretive phenomenological analysis, following in-depth structured interviews. Analysis was undertaken to identify superordinate themes relating to how women are living with POP.

Setting

3 public hospitals and 3 woredas in Gurage zone, Central Regional State, Ethiopia.

Participants

A purposive sample of 12 women who were diagnosed with POP was recruited.

Results

Five core themes with subthemes were identified; general health judgement, POP symptom, life situation related to POP, feeling about POP and limitation in daily life/activity. The majority of respondents expressed concern that the prolapse had negatively impacted their general health and voiced hope that pelvic floor reconstruction would improve their general well-being. The majority of the informants stated that disclosing to others might significantly lower their QoL and that having the condition was extremely embarrassing. The women were most affected by the actual physical symptoms of prolapse (bulge, back pain, heaviness, bowel problems, urinary incontinence) as well as by the impact prolapse has on their sexual function.

Conclusion

Women with POP should be offered psychosocial support, early care and counselling because they have physical, personal, emotional, social and sleep/energy problems. Healthcare providers should take the initiative in educating women regarding prolapse and to make them aware that it is a treatable condition which can improve their QoL.

☐ ☆ ✇ BMJ Open

Factors influencing HPV vaccine acceptance in immunosuppressed patient populations: a protocol for a systematic review

Por: Soares · L. M. C. · Carvalho · A. V. · Azevedo da Silva · C. H. · Maximo · G. M. · Medeiros · K. S. d. · de Souza · D. L. B. · Nogueira-Rodrigues · A. · Oliveira de Mendonca · A. E. — Septiembre 15th 2025 at 05:56
Introduction

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

Methods and analysis

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

Ethics and dissemination

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023452537.

☐ ☆ ✇ BMJ Open

Factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 in primary healthcare settings in Nepal: a cross-sectional study

Por: Timalsena · D. · Nakarmi · C. S. · Mali · S. · Dhakal · A. · Bharati · A. · Bishwokarma · A. · Adhikari · A. · Poudel · B. · Rai · B. K. · Baral · P. P. · Bhattarai · S. · Dixit · L. · Pokharel · Y. · Rhodes · E. · Xu · D. R. · Spiegelman · D. · Shrestha · A. — Septiembre 11th 2025 at 06:34
Objective

To assess factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 at primary healthcare (PHC) facilities in Nepal after healthcare workers received training.

Design

Cross-sectional study.

Setting

PHC facilities across various provinces in Nepal.

Participants

A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.

Main outcome measures

The adoption of PEN Protocol 1 components: blood pressure measurement, blood glucose screening, 10-year cardiovascular disease (CVD) risk assessment using WHO/International Society of Hypertension risk charts and body mass index (BMI) assessment. Factors associated with protocol adoption were assessed using generalised estimating equations for ORs.

Results

Among participants, 100% reported measuring blood pressure, while 56% measured blood sugar, 28% assessed CVD risk and 27% assessed BMI. The adoption of the CVD risk prediction chart was positively associated with the availability of amlodipine (adjusted OR (aOR) 3.00; 95% CI 1.09 to 8.27). The adoption of BMI assessment was positively associated with access to a stadiometer (aOR 3.23; 95% CI 1.26 to 8.30) and a glucometer (aOR 3.07; 95% CI 1.12 to 8.40), and negatively associated with lack of motivation/inertia of previous practice (aOR 0.60; 95% CI 0.42 to 0.87) and environmental factors such as lack of time and resources (aOR 0.57; 95% CI 0.37 to 0.89). Blood glucose level measurements were positively associated with being at a PHC centre (aOR 7.34; 95% CI 2.79 to 19.3) and the availability of metformin (OR 2.40; 95% CI 1.08 to 5.29).

Conclusion

Adoption of PEN Protocol 1 varied by component and was influenced by resource availability, provider motivation and system barriers. Addressing these factors is key to optimising implementation in low-resource settings.

☐ ☆ ✇ BMJ Open

Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya

Por: Kwach · B. · Odoyo · J. B. · Lauff · A. R. · Omollo · V. · Rono · B. · Ogello · V. · Mann · V. · Kwena · Z. · Thomas · K. · Sharma · M. · Morton · J. F. · Ngure · K. · Bukusi · E. · Mugwanya · K. K. · PrEP Care Team · O.-S. — Septiembre 8th 2025 at 18:11
Introduction

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

Methods and analysis

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethics and dissemination

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Protocol amendments

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

Protocol version

V. 2.0 dated 21 May 2024.

Trial registration number

NCT03194308.

☐ ☆ ✇ BMJ Open

Pragmatic trial evaluating a randomly allocated Supplemental Nutrition Assistance Program outreach and enrolment assistance programme in Michigan: study protocol

Por: Samuel · L. · Stuart · E. A. · Liu · Y. · Szanton · S. L. · Clark · A. L. · Miguel · M. · Schneider · M. · Mashrah · A. · Laretz · M. · Swenor · B. — Septiembre 5th 2025 at 13:49
Introduction

Low-income adults with disabilities experience disproportionately high rates of food insecurity and preventable healthcare utilisation. The Supplemental Nutrition Assistance Program (SNAP) can reduce food insecurity and improve health, but there are accessibility gaps in the SNAP enrolment process. Existing outreach and enrolment assistance programmes have been shown to boost SNAP enrolment, but their health effects are understudied. This study estimates the effects of a SNAP outreach and enrolment assistance programme on health outcomes among low-income adults with disabilities.

Methods and analysis

The study pragmatically evaluates a programme that provided outreach and SNAP enrolment assistance for low-income households. The study leverages a random process that selected households for one of two types of outreach, including an information-only arm and an information plus enrolment assistance arm, which formed a control group by default. The study will estimate the effect of this programme among low-income adults with disabilities using Medicaid and SNAP administrative data. Study outcomes include emergency department, hospital and long-term nursing home utilisation. SNAP enrolment and benefit amounts are secondary study outcomes and will be tested as a mediating mechanism of action. The study will test effect heterogeneity based on race, ethnicity, age and chronic conditions.

Ethics and dissemination

The study, which relies on deidentified data, was determined to be exempt as human subjects research by the Institutional Review Boards at Johns Hopkins Medicine and the Michigan Department of Health and Human Services. The study is being conducted in ongoing consultation with an Advisory Group of experts in food advocacy and disability advocacy. In addition to disseminating findings in peer-reviewed publications, findings will be disseminated to state decision-makers and the community in partnership with an advisory group.

☐ ☆ ✇ BMJ Open

Outcomes of pulmonary embolism in patients with psychiatric disorders: a nationwide analysis

Por: Gatuz · M. · Abu Fanne · R. · Abramov · D. · Mamas · M. · Ebert · T. · Barel · M. · Roguin · A. · Kobo · O. — Septiembre 5th 2025 at 13:49
Background

Pulmonary embolism (PE) is a life-threatening condition with significant morbidity and mortality. The relationship between psychiatric disorders and PE outcomes is complex and not well understood. This study aimed to determine the impact of psychiatric disorders on PE outcomes by comparing patients with and without these conditions.

Methods

Using the National Inpatient Sample database, we analysed 725 725 adult patients hospitalised with PE between 2016 and 2019. Patients were stratified based on the presence or absence of psychiatric disorders. Multivariable logistic regression models were used to examine associations between psychiatric disorders and in-hospital outcomes, adjusting for baseline differences.

Results

Of the patients studied, 26.6% had psychiatric disorders. These patients were younger (59.80 vs 63.91 years, p

Conclusions

Psychiatric disorders are associated with distinct management and outcomes in PE. Recognising these unique characteristics may help optimise care for this population; further research is needed to clarify the best management strategies.

☐ ☆ ✇ BMJ Open

Better Living with Non-memory-led Dementia: study protocol for a randomised controlled trial of a web-based caregiver educational programme (BELIDE trial)

Por: Suarez-Gonzalez · A. · Brotherhood · E. · John · A. · Hayes · O. · Rossi-Harries · S. · Zimmermann · N. · Mansfield · V. · Brand · A. · Hoare · Z. · Fitzsimmons · D. · Cullen · K. · Crutch · S. · Stott · J. — Septiembre 5th 2025 at 13:49
Introduction

Carers of people with non-memory-led dementias such as posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural variant frontotemporal dementia (bvFTD) face unique challenges. Yet, little evidence-based support and guidance are available for this population. To address this gap in services, we have developed a novel, web-based educational programme: the Better Living with Non-memory-led Dementia programme (BELIDE). BELIDE was co-designed with people with lived experience of non-memory-led dementia and a previous pilot study confirmed its feasibility as an online intervention. This protocol outlines the randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of BELIDE.

Methods and analysis

This is a parallel-group, single-blind, RCT of 238 unpaid caregivers of people diagnosed with PCA, PPA or bvFTD recruited internationally among members of the UK-based organisation Rare Dementia Support. The intervention (BELIDE programme) consists of six structured online educational modules tailored to each phenotype, a virtual onboarding session, real-life practice tasks and up to two follow-up facilitation sessions. The group receiving the intervention will be given access to the programme, while the control group will receive treatment as usual and be placed on a wait-list to receive access to the programme once they complete their participation in the trial. The allocation ratio will be 1:1 stratified by dementia diagnosis and gender. The primary outcome is reduction in caregiver depressive symptoms. Secondary outcomes include stress, anxiety, self-efficacy, quality of life and caregiver-patient relationship quality. Data will be collected online via Qualtrics surveys at baseline, 8 weeks and 6 months post-randomisation. A mixed-method process evaluation with a subgroup of intervention participants will explore barriers and facilitators for engagement. A health economics evaluation will also be conducted to assess cost-effectiveness. If effective, this programme could improve access to caregiver support for non-memory-led dementias by providing scalable, tailored education.

Ethics and dissemination

Ethical approval has been granted by University College London Research Ethics Committee (8545/007). The results will be disseminated via peer-reviewed publications, conferences, stakeholder events and open-access resources.

Trial registration

This trial has been registered prospectively on the Clinical Trials registry, first posted on 5 February 2024 under registration number NCT06241287.

☐ ☆ ✇ BMJ Open

Predictive modelling of clinically significant depressive symptoms after coronary artery bypass graft surgery: protocol for a multicentre observational study in two Swiss hospitals (the PsyCor study)

Por: Lazaridou · A. · Sivakumar · S. · Rodriguez Cetina Biefer · H. · Weilenmann · S. · Princip · M. · Zuccarella-Hackl · C. · Petzschner · F. H. · Heinzle · J. · Stephan · K. E. · Dzemali · O. · von Känel · R. — Septiembre 5th 2025 at 13:49
Introduction

Coronary artery bypass grafting (CABG) remains one of the most commonly performed cardiac surgeries worldwide. Despite surgical advancements, a significant proportion of patients experience psychological distress following surgery, with depression being particularly common. Current evidence regarding the effectiveness of preoperative psychological interventions in improving postoperative mental health outcomes remains inconclusive. There is a critical need for predictive models that can identify patients at risk of developing clinically significant depressive symptoms (CSDSs) and related psychological conditions after CABG. This multicentre observational study aims to develop and validate prognostic models for predicting CSDSs and other psychological outcomes, including anxiety, post-traumatic stress symptoms and quality of life, 6 weeks after elective CABG surgery.

Methods and analysis

The study will recruit 300 adult patients undergoing elective CABG (with or without valve intervention) across two Swiss hospitals. Data collected will include demographic, clinical, psychometric, inflammation-related and interoceptive variables. A training set (n=200) will be used to develop predictive models using machine learning, while a held-out test set (n=100) will be used for model validation. The primary outcome prediction will focus on CSDSs, assessed using the Patient Health Questionnaire-9 (PHQ-9), with analyses conducted both categorically (PHQ-9 total score ≥10) and continuously as complementary approaches. Secondary models will address anxiety, using the General Anxiety Disorder Scale-7, post-traumatic stress, using the post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Disorders-5 and health-related quality of life, using the 12-item Short Form Survey. A simplified ‘light solution’ model with fewer predictors will also be developed for broader applicability. This study will address an important gap in perioperative mental healthcare by identifying key predictors of psychological morbidity following CABG, particularly CSDSs. The resulting models may inform future screening and preventive strategies and improve postsurgical outcomes through early identification and intervention in high-risk individuals.

Ethics and dissemination

The responsible ethics committee has reviewed and approved this project (Kantonale Ethikkommission Zürich, BASEC number: 2023-02040). The study minimises participant burden by integrating brief validated instruments and limiting psychiatric interviews to relevant outcomes, while ensuring ethical safeguards and respect for participant rights (including written consent). Results will be shared through peer-reviewed publications, conference presentations and stakeholder meetings involving clinicians and mental health professionals. Findings will also be communicated to participating centres and patient communities in accessible formats.

☐ ☆ ✇ BMJ Open

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. — Septiembre 5th 2025 at 13:49
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.

☐ ☆ ✇ BMJ Open

Quality and efficiency of integrating customised large language model-generated summaries versus physician-written summaries: a validation study

Objectives

To compare the quality and time efficiency of physician-written summaries with customised large language model (LLM)-generated medical summaries integrated into the electronic health record (EHR) in a non-English clinical environment.

Design

Cross-sectional non-inferiority validation study.

Setting

Tertiary academic hospital.

Participants

52 physicians from 8 specialties at a large Dutch academic hospital participated, either in writing summaries (n=42) or evaluating them (n=10).

Interventions

Physician writers wrote summaries of 50 patient records. LLM-generated summaries were created for the same records using an EHR-integrated LLM. An independent, blinded panel of physician evaluators compared physician-written summaries to LLM-generated summaries.

Primary and secondary outcome measures

Primary outcome measures were completeness, correctness and conciseness (on a 5-point Likert scale). Secondary outcomes were preference and trust, and time to generate either the physician-written or LLM-generated summary.

Results

The completeness and correctness of LLM-generated summaries did not differ significantly from physician-written summaries. However, LLM summaries were less concise (3.0 vs 3.5, p=0.001). Overall evaluation scores were similar (3.4 vs 3.3, p=0.373), with 57% of evaluators preferring LLM-generated summaries. Trust in both summary types was comparable, and interobserver variability showed excellent reliability (intraclass correlation coefficient 0.975). Physicians took an average of 7 min per summary, while LLMs completed the same task in just 15.7 s.

Conclusions

LLM-generated summaries are comparable to physician-written summaries in completeness and correctness, although slightly less concise. With a clear time-saving benefit, LLMs could help reduce clinicians’ administrative burden without compromising summary quality.

☐ ☆ ✇ BMJ Open

Sexually transmitted infections self-sampling among sexually active individuals in sub-Saharan Africa: a scoping review protocol

Por: Nyamwanza · O. · Kabonga · I. · Mashanyare · T. — Agosto 22nd 2025 at 11:23
Introduction

Sexually transmitted infections (STIs) pose a huge public health challenge in sub-Saharan Africa, where prevalence rates are among the highest globally. Barriers such as limited healthcare access, stigma and inadequate diagnostic facilities impede timely detection and treatment. Self-sampling for STI testing offers a potential solution to these challenges. This scoping review will systematically map the available evidence on self-sampling for STIs in sub-Saharan Africa, focusing on its feasibility, acceptability, implementation and outcomes.

Methods and analysis

The scoping review will be guided by the Arksey and O’Malley framework. The review will include a comprehensive search of peer-reviewed and grey literature from various repositories and databases. The following databases will be searched: PubMed, Scopus and Global Health. Studies that will be included will meet specific criteria. The results of the review will be reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist.

Ethics and dissemination

The methodology used for this study is a scoping review of existing literature; therefore, ethical approval is not required. Findings of this study will be shared at national, regional and international conferences and published in a peer-reviewed journal.

Trial registration

We registered the protocol with the Open Science Framework.

☐ ☆ ✇ BMJ Open

Flow cytometric lyophilised reagent tube assay for peripheral blood neutrophil myeloperoxidase expression to rule out myelodysplastic neoplasms at a university hospital: a diagnostic accuracy study

Por: Planta · C. · Scheffen · L. · Jacob · M.-C. · Szymanski · G. · Chevalier · S. · Tondeur · S. · Bulabois · B. · Meunier · M. · Lefebvre · C. · Gonnet · N. · Garban · F. · Molina · L. · Paradis · C. · Seigneurin · A. · Chiriac · R. · Merle · R. · Labarere · J. · Park · S. · Raskovalova · T. — Agosto 22nd 2025 at 11:23
Objectives

Although flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression can accurately rule out myelodysplastic neoplasms (MDS), it lacks reliability and efficiency due to the practical limitations of laboratory-developed liquid reagent-based assays. This study aimed to quantify the agreement and comparative discriminatory accuracy between a single-use flow cytometric lyophilised reagent tube (BD Lyotube Stain 468) and its laboratory-developed liquid reagent counterpart.

Design

Cross-sectional diagnostic accuracy study of two index tests against a reference diagnosis.

Setting

A university hospital in France.

Participants

Consecutive adult patients with an indication for bone marrow aspiration due to suspected MDS and unexplained peripheral blood cytopenia.

Primary outcome

MDS confirmed by cytomorphological evaluation of the bone marrow aspirate performed in duplicate by experienced haematopathologists blinded to the index test.

Results

Of 103 participants enrolled between July 2020 and August 2021, 37 had MDS (prevalence, 36%). The median intra-individual robust coefficient of variation (RCV) for myeloperoxidase expression was 30.9% using the BD Lyotube Stain 468 and 31.2% using the laboratory-developed liquid reagent assay, with an intraclass correlation coefficient of 0.94 (95% CI 0.91 to 0.96). The areas under the receiver operating characteristic curves were 0.83 (95% CI 0.74 to 0.90) and 0.82 (95% CI 0.73 to 0.89), respectively. Using a prespecified threshold of 30.0%, the corresponding sensitivity estimates were 89% (95% CI 75% to 97%) and 95% (95% CI 82% to 99%).

Conclusion

BD Lyotube Stain 468 performs as well as its laboratory-developed liquid reagent counterpart for the quantification of myeloperoxidase expression by peripheral blood neutrophils. It may obviate the need for invasive bone marrow aspiration in up to 40% of patients with suspected MDS.

Trials registration number

NCT04399018.

☐ ☆ ✇ BMJ Open

Association of nociceptive, neurocognitive, psychological and genetic profile on conditioned pain modulation in women with migraine: protocol for a case-control study

Por: Fernandez de las Penas · C. · Cigaran-Mendez · M. · Ambite-Quesada · S. · Gomez-Calero · C. · Fernandez-Palacios · F. G. · Pacho-Hernandez · J. C. · Tejera-Alonso · A. · Plaza-Manzano · G. · Valera-Calero · J. A. · Alvarez-Marino · B. · Ordas-Bandera · C. · Arendt-Nielsen · L. — Agosto 19th 2025 at 04:43
Introduction

Migraine is a primary headache showing a multifactorial component that includes altered pain processing, psychological/emotional problems, neurocognitive and executive function deficits, all with a possible genetic association. The aim of the current study will be to evaluate the association between sensitisation, psychological/emotional, neurocognitive and genetic profile on conditioned pain modulation (CPM) in women with migraine from a multidisciplinary perspective.

Methods and analysis

A cross-sectional observational case–control study including 90 women with chronic migraine, 90 women with episodic migraine and 90 women without migraine (as controls) will be conducted. Clinical variables (disability, pain), processing (sensitisation-associated, neuropathic-like symptoms), psychological/emotional (anxiety, depression, sleep quality, catastrophising), neurocognitive (attention), executive functions (memory, mental inhibition, speed processing) and genetics (Val158Met polymorphism rs4680 gene) will be assessed in all subjects by healthcare professionals. Subsequently, CPM will be evaluated with the cold-pressor test paradigm by assessing changes obtained in mechanical and thermal stimuli. The association of each group of variables on CPM will be analysed with multivariate analyses (OMNIBUS analysis of variance). A network model will also be created to identify those variables showing the greatest key measure of centrality with the rest of the severity indicators (strength, intermediation and closeness) to establish the potentially therapeutic targets in patients with migraine from a multidisciplinary point of view.

Ethics and dissemination

The protocol of the current study has been approved by the Ethics Committee of all involved institutions (Hospital Universitario Fundación Alcorcón 24–117, Universidad Rey Juan Carlos 010220240912024). All procedures will be conducted following the Declaration of Helsinki. Participants will be informed of the aims and procedures of the study and will receive the informed written consent which should be signed before their inclusion. Study results will be disseminated through peer-reviewed publications and presentations at scientific meetings.

☐ ☆ ✇ BMJ Open

Im Co-development of a Post-Acute Care Intervention for Frailty using Information and Communication technology (PACIFIC): a development process protocol

Por: Griffith · L. E. · Macedo · L. · Lokker · C. · Innes · A. · Leong · D. · Beauchamp · M. · Bosch · J. · Bray · S. R. · Lafortune · L. · Ma · J. · Marcucci · M. · Papaioannou · A. · Siu · H. Y.-H. · Alvarez · E. · Anderson · L. N. · Bassim · C. · Costa · A. P. · Crawshaw · J. · Dhillon · J. — Agosto 17th 2025 at 08:12
Introduction

Hospitalisation is one of the most stressful life events for older adults, particularly for those who are pre-frail or frail. Multi-component community-based interventions have the potential to address the complex needs of older adults post-acute care admission. While some available interventions have been developed with end-user engagement, fully involving older people who are pre-frail or frail in the design of interventions has been less common. Multi-component community-based interventions that address the needs of older adults and their care partners with potential implementation barriers informed by healthcare providers, community partners and health system decision makers are needed. This protocol paper describes the planned process of co-designing for older patients discharged into the community, a Post-Acute Care Intervention for Frailty using Information and Communication technology.

Methods and analysis

The development of a complex multi-component frailty intervention which meets older people’s needs involves several concurrent tasks and methodologies, each informed by co-design and conducted with consideration to eventual implementation. These tasks include: (1) establishing a Research Advisory Board, (2) assessing the feasibility and validity of using hospital administrative data to identify frail or pre-frail older adults and their needs, (3) conducting a needs assessment of patients returning to the community, (4) mapping community assets to identify existing programmes and services to help tailor the intervention, (5) co-designing a multicomponent frailty intervention, (6) selecting study outcome measures and (7) selecting and tailoring a digital health patient portal to support intervention delivery, data capture and communication.

Ethics and dissemination

Each task requiring ethics approval will be submitted to the Hamilton Integrated Research Ethics Board at McMaster University. Results will be disseminated through peer-reviewed journal articles, conferences and networks of relevant knowledge users who have the capacity to promote dissemination of the results. A toolkit will be developed to help researchers and healthcare providers replicate the methodology for other populations.

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