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Hoy — Diciembre 16th 2025Tus fuentes RSS

Emerging importance of psychological flexibility mediating psychotic symptom severity to depression as an innovative intervention tool for people with schizophrenia

Por: Chang · C.-K.

Commentary on: Yıldız E, Yıldırım Ö. The mediating role of psychological flexibility in the relationship between psychotic symptom severity and depression in individuals diagnosed with schizophrenia. J Psychiatr Ment Health Nurs. 2024. (in press) doi: 10.1111/jpm.13040.

Implications for practice and research

  • Mental health nurses’ training could be more focused on clinical skills and knowledge in enhancing psychological flexibility to minimize the impact of psychotic symptoms on comorbid depression in people with schizophrenia.

  • Further development of the intervention of building psychological flexibility is of research interest for the clinical management of people with schizophrenia.

  • Context

    Schizophrenia is a mental disorder affecting approximately 23.9 million people worldwide, significantly contributing to the global disease burden, revealing 14.8 (10.9–19.1) million years lived with disability in 2021.1 The lifetime prevalence of schizophrenia was estimated at 0.72%,2 noteworthy for its severe functional impairments and considerable physical and...

    Parental experiences of congenital heart disease transition care highlight the need for family-centered approaches

    Por: Fox · K. R. · Garg · V.

    Commentary on: Lykkeberg B, Noergaard MW, Bjerrum M. Experiences and expectations of parents when young people with congenital heart disease transfer from pediatric to adult care: A qualitative systematic review. J Child Health Care. doi:10.1177/13674935241231024

    Implications for practice and research

  • To inform family-centred transition programmes, more high-quality qualitative research describing parental experiences should be conducted, particularly in non-European and low- and middle-income countries.

  • Congenital heart disease transition programmes should consider adopting a family-centred approach that incorporates informational and psychosocial support resources for parents.

  • Context

    A growing number of individuals born with congenital heart disease (CHD) are surviving well into adulthood, and a successful transition from paediatric to adult healthcare is essential for their long-term health. However, discontinuity in care is prevalent.1 Parents play an important role in the transition process and may impact transition-related outcomes,2 but their experiences and...

    Examining tobacco consumption: prevalence and associated factors among Cambodians aged 15-49 from the 2021-2022 Demographic and Health Survey

    Por: Oo · M. Z. · Tint · S. S. · Rerkasem · A. · Leakhena · P. · Wiwatkunupakarn · N. · Angkurawaranon · C. · Rerkasem · K.
    Objectives

    Tobacco consumption is a significant preventable cause of death worldwide. This study aimed to assess the prevalence and associated factors of tobacco consumption among Cambodian individuals aged 15–49, utilising data from the 2021–2022 Cambodia Demographic and Health Survey (CDHS).

    Design

    Cross-sectional study based on secondary analysis of the 2021–2022 CDHS.

    Setting

    Nationwide household survey conducted across urban and rural areas of Cambodia.

    Participants

    A total of 28 321 respondents aged 15–49 years were included in the analysis.

    Outcome measures

    Tobacco consumption categorised as no use, smoking tobacco, smokeless tobacco and dual use. Descriptive statistics, 2 tests and multinomial logistic regression were used to assess associations between background characteristics and tobacco consumption, with ‘no consumption’ as the reference category. Statistical significance was set at p

    Results

    Among the 28 321 respondents (68.8% female), 91.8% were non-users of tobacco (reference group), while 6.9% reported smoking (predominantly males; adjusted relative risk ratios (ARRR)=39.29, 95% CI 29.70 to 51.96, p

    Conclusions

    While Cambodia has made notable progress in reducing tobacco consumption, the persistent challenges highlighted by the prevalence of smoking, particularly among specific demographics, indicate the need for targeted public health interventions.

    Association between the continuum of maternal healthcare services and child immunisation in East Africa: a propensity score matching analysis

    Por: Gebrehana · A. K. · Abrham Asnake · A. · Seifu · B. L. · Fente · B. M. · Bezie · M. M. · Asmare · Z. A. · Tsega · S. S. · Negussie · Y. M. · Asebe · H. A. · Melkam · M.
    Objective

    To assess the association between the maternal continuum of healthcare and child immunisation in East Africa using propensity score matching (PSM).

    Design

    Cross-sectional study using Demographic and Health Survey data.

    Setting

    This study was conducted in East African countries.

    Participants

    This study included a weighted sample of 13 488 women with children aged 12–23 months.

    Outcome measure

    Child immunisation was the outcome variable of this study.

    Results

    The PSM estimates indicate that the average treatment effect on the treated for complete child immunisation was 0.0583, meaning that children of mothers who received a complete maternal continuum of care had a 5.83% higher probability of being fully immunised compared with children of mothers with incomplete care. Expressed relative to the treated group’s mean, this corresponds to a 7.48% increase. Additionally, our results indicated that the population average treatment effect was 0.0629. This means that, on average, a complete continuum of maternal healthcare increases the probability of full child immunisation by approximately 6.29% across the entire population.

    Conclusion

    The study highlights that children whose mothers receive comprehensive maternal healthcare are more likely to complete their childhood immunisations. This finding underscores the need to integrate immunisation services into maternal healthcare programmes to enhance vaccination coverage and promote better child health. To maximise this connection, improving access to maternal healthcare, especially in underserved regions, is crucial, along with ensuring that immunisation is a regular part of maternal care.

    Optimising time-limited trials in acute respiratory failure: a multicentre focused ethnography protocol

    Por: Kruser · J. M. · Wiegmann · D. A. · Nadig · N. R. · Secunda · K. E. · Hanlon · B. M. · Moy · J. X. · Ahmad · A. · Campbell · E. G. · Donnelly · H. K. · Martinez · F. J. · Polley · M. · Orhan · C. · Korth · E. · Stalter · L. N. · Rowe · T. J. · Wu · A. L. · Viglianti · E. M. · Eisinger · E
    Introduction

    The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

    Methods and analysis

    We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

    Ethics and dissemination

    This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

    Trial registration number

    NCT06042621.

    Development and validation of a case identification algorithm for hand trauma patients using health administrative data and the epidemiology of hand trauma in a universal healthcare system

    Por: Wong · C. R. · Tu · K. · Hernandez · A. · Urbach · D. R. · Witiw · C. · Hansen · B. · Ko · A. · Tsai · P. · Baltzer · H.
    Objectives

    Our primary objectives were (1) to develop and validate an administrative data algorithm for the identification of hand trauma cases using clinical diagnoses documented in medical records as the reference standard and (2) to estimate the incidence of hand trauma in a universal public healthcare system from 1993 to 2023 using a population-based research cohort constructed using a validated case identification algorithm.

    Design

    A population-based retrospective validation study.

    Setting

    Ontario, Canada, from 2022 to 2023 (validation) and from 1993 to 2023 (estimation).

    Participants

    Our reference standard was the known hand trauma status of 301 patients (N=147 with hand trauma) who presented to an urban tertiary-care hand trauma centre in Toronto, Ontario.

    Primary and secondary outcome measures

    (1) The sensitivity, specificity, positive and negative predictive values of the optimal algorithm to identify hand trauma using provincial health administrative data and (2) age-standardised and sex-standardised incidence rates of hand trauma among men and women, by age, and by area of patient residence.

    Results

    The optimal algorithm had a sensitivity of 73.8% (95% CI 66.6% to 81.0%), specificity of 80.1% (95% CI 73.8% to 86.5%), positive predictive value of 78.1% (95% CI 71.2% to 85.0%) and negative predictive value of 76.1% (95% CI 69.5% to 82.7%). Over the study period, the age-standardised and sex-standardised incidence of hand trauma increased from 384 to 530 per 100 000. The greatest increase was observed in males and individuals aged 0–19 and 80+, with higher incidence rates in Southern compared with Northern Ontario.

    Conclusions

    Our algorithm enabled identification of hand trauma cases using health administrative data suitable for population-level surveillance and health services research, revealing a rising burden of hand trauma from 1993 to 2023. These findings can support improved surveillance, resource allocation and care delivery for this public health problem.

    Multilayer low-stretch bandage combined with conventional rehabilitation to promote functional recovery after knee surgery: study protocol for a prospective, single-blind, randomised controlled trial

    Por: Han · X. · Cao · W. · Jin · W. · Hu · K. · Xu · R. · Sun · C.
    Introduction

    Patients undergoing anterior cruciate ligament reconstruction (ACLR) and patellar fracture frequently present with substantial pain, swelling and inflammation. These pathophysiological changes not only intensify postoperative pain but also compromise the intra-articular environment via mechanical compression and localised microcirculatory deficits, thereby impeding recovery. Conventional interventions for postoperative swelling, such as cryotherapy and physical agent modalities, are commonly applied yet exhibit limited efficacy. Multilayer low-stretch bandage (MLB), with its gradient compression properties, has recently demonstrated superior swelling control and functional restoration; however, existing research primarily assesses short-term outcomes and lacks a systematic analysis across the postoperative continuum—acute, subacute and chronic phases—as well as long-term follow-up. This study therefore employs a multi-temporal intervention design and extended follow-up to evaluate the effectiveness of MLB in managing swelling, modulating pain and enhancing long-term knee function and activities of daily living across different recovery stages. The findings aim to furnish high-level evidence for knee rehabilitation protocols, refine clinical practice and ultimately improve patient quality of life.

    Methods and analysis

    This prospective, single-blind, randomised controlled trial will enrol 36 patients following ACLR and patellar fracture. Participants will be allocated at a 1:1 ratio through computerised randomisation to either an experimental group receiving MLB plus conventional rehabilitation, or a control group receiving conventional rehabilitation alone. The study spans 12 weeks, with follow-up assessments scheduled at baseline (T0), 4 weeks (T1), 8 weeks (T2) and 12 weeks (T3). Outcome measures comprise the Hospital for Special Surgery (HSS) Knee Rating Score, affected limb oedema regression rate, Visual Analogue Scale (VAS) pain score, knee range of motion, quadriceps and hamstring muscle strength, centre of pressure (COP) displacement parameters, proprioceptive testing, the 36-Item Short Form Health Survey (SF-36) and the Holden Walking Function Classification. A subsequent 1-year follow-up will assess long-term efficacy and patient satisfaction, while adverse events are strictly monitored throughout the entire study period. Adherence to Consolidated Standards of Reporting Trials guidelines is maintained, and a single-blind design ensures that both participants and assessors remain unaware of group assignments. This trial aims to establish an evidence-based foundation for optimising postoperative rehabilitation in this patient population.

    Ethics and dissemination

    Ethical approval for the study was obtained from the Medical Ethics Committee of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School (2025-0141-01). The results of the study will be published in a peer-reviewed medical journal.

    Trial registration number

    ClinicalTrials.gov chiCTR2500100566. Registration date is 10 April 2025.

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

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

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

    Methods and analysis

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

    Ethics and dissemination

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

    PROSPERO registration number

    CRD42025644244.

    High-dose intermittent theta burst stimulation targeting the individualised frontoparietal cognitive network for post-stroke cognitive impairment: protocol for a randomised sham-controlled trial in China

    Por: Han · K. · Zhou · Y. · Huang · J. · Ren · J. · Lu · H. · Liao · X. · Zhu · Y. · Zhang · H. · Liu · H.
    Introduction

    Cognitive impairment is a common consequence after stroke. Intermittent theta burst stimulation (iTBS) has emerged as a promising cognitive therapy. However, traditional iTBS typically employs lower doses and one-size-fits-all stimulation targets, which may not fully capitalise on the potential of this therapy and warrants further evaluation for both efficacy and safety. This study aims to evaluate the efficacy and safety of high-dose iTBS targeting the individualised frontoparietal cognitive network (FCN) identified by precision functional neuroimaging for post-stroke cognitive impairment (PSCI).

    Methods and analysis

    This is a prospective, double-blind, sham-controlled, parallel-group randomised controlled trial. 60 eligible participants with PSCI will be randomly assigned (1:1) to an active iTBS or a sham-controlled group. The active group will receive high-dose iTBS (3600 pulses/day) at 80% resting motor threshold targeting the left individualised FCN, guided by a real-time neuronavigation system. The sham group will follow identical procedures using a sham coil. Both groups will also undergo conventional computerised cognitive training. The intervention will be administered on workdays over a period of 3 weeks, totalling 15 workdays. The primary outcome is the change in Montreal Cognitive Assessment scores from baseline to immediately post-treatment. Secondary outcomes include long-term change in global cognition, activities of daily living and specific cognitive domains (assessed by a comprehensive neuropsychological battery covering memory, attention, executive function and language), as well as mood. Assessments occur at baseline, post-treatment and 3-month follow-up. Safety outcomes, specifically the number of adverse events related to iTBS, will be monitored and recorded throughout the trial.

    Ethics and dissemination

    This study has been approved by the Medical Ethics Committee of the China Rehabilitation Research Center. The results of this study will be published in peer-reviewed scientific journals and disseminated at academic conferences.

    Trial registration number

    NCT05953415.

    Patient satisfaction with infection prevention and control interventions in acute hospitals: a systematic review and meta-analysis

    Por: Skally · M. · Kearney · A. · Strawbridge · J. · Heritage · J. · Cox · C. · Bennett · K. E. · Humpreys · H. · Fitzpatrick · F.
    Introduction

    Infection prevention and control (IPC) interventions are multifactorial and are used to prevent healthcare-associated infections in healthcare facilities. However, patient views and enabling patient and public involvement (PPI) in their development has been minimal.

    Objectives

    This systematic review aims to identify peer-reviewed publications reporting patient satisfaction outcomes in the context of IPC interventions, to document the methods used to assess patient satisfaction and to conduct a meta-analysis on reported satisfaction outcomes.

    Design

    Systematic review and meta-analysis following the Joanna Briggs Institute (JBI) methodology and the PRISMA statement, with oversight from a steering group including PPI partners. Studies in peer-reviewed journals were included based on eligibility criteria.

    Data sources

    MEDLINE, Scopus, Web of Science, EMBASE, Cochrane Library, CINAHL and PsycINFO were searched in June 2024.

    Eligibility criteria

    Included studies investigated satisfaction among hospitalised patients in acute care settings following IPC measures, including isolation, cohorting, screening, hand hygiene, antimicrobial stewardship, patient flagging, education, personal protective equipment use, visiting restrictions and treatment delays

    Data extraction and synthesis

    Titles and abstracts were screened independently by two reviewers; disagreements were resolved by a third. Study quality was assessed using the JBI manual for evidence synthesis. A meta-analysis was conducted where four or more studies used comparable designs and methods within the same areas of IPC, with heterogeneity evaluated using Cochran’s Q statistic and I2 and pooled estimates calculated with 95% CIs using the Wilson (score) method.

    Results

    Twenty-nine studies were identified. Among IPC measures, isolation precautions were the most commonly reported intervention (11 studies, 38%). The Likert scale was the predominant assessment method (13 studies, 45%). Patient satisfaction with IPC interventions ranged from 58.3% to 97.2%. Meta-analysis of four studies using the Hospital Consumer Assessment of Healthcare Providers and Systems survey showed substantial heterogeneity (I2, 55%, p=0.08) and a pooled patient satisfaction level of 69% (95% CI 63.6% to 74.4%) for isolation precautions.

    Conclusion

    Sixty-nine percent of isolated patients reported satisfaction with their care. Patient satisfaction with IPC interventions varies widely, highlighting limitations in current measurement approaches. Strengthening PPI in the design and evaluation of satisfaction measures is essential to capture meaningful data and improvements in IPC programmes.

    PROSPERO registration number

    IS 2024 CRD42024558385.

    Sleep problems and associated risk factors among physicians in Bangladesh: a protocol for systematic review and meta-analysis of observational cross-sectional studies

    Por: Rahman · M. · Islam Zahid · M. · Kabir · H. · Abdullah · I. · Saha · T. · Alam · U. K. · Shimu · A. T. · Uddin · M. N. · Ghimire · R.
    Introduction

    Sleep problems are an escalating global health concern, with prevalence estimates ranging from 8.3% to 45%. Physicians are disproportionately affected, with rates around 44% compared with 36% in the general population. In Bangladesh, reported rates range from 32% to 58%, with physicians being particularly vulnerable. Poor sleep among physicians is strongly linked to burnout, medical errors and increased mental health risks. Despite these serious implications, existing evidence from Bangladesh remains fragmented and inconsistent, limiting its utility for health policy and workforce interventions. This review therefore seeks to generate reliable pooled prevalence estimates and identify key determinants of sleep problems among Bangladeshi physicians.

    Methods and analysis

    The research team will search the PubMed, Scopus, Web of Science, EMBASE, PsycInfo, ProQuest Medical, CINAHL, Google Scholar and BanglaJOL electronic and regional databases following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines for published studies from inception until 1 August 2025, using truncated and phrase-searched keywords, relevant medical subject headings and citation chaining from grey literature. Observational cross-sectional studies published within the predefined timeframe, using validated assessment tools, and published in English or other major international languages will be prioritised for inclusion. Review papers, case reports, case series, intervention studies, commentaries, preprints, meeting abstracts, protocols, unpublished articles and letters will be excluded. Two independent reviewers will screen the retrieved papers using the Rayyan web-based application, with any disagreements resolved by a third reviewer. Quantitative estimates of sleep problems, including prevalence, duration, quality and associated risk factors among Bangladeshi physicians will be extracted. A narrative synthesis and meta-analysis will be performed to assess the pooled prevalence using a random effects meta-analysis model. Forest and funnel plots will be generated for visualisation. Heterogeneity will be assessed using the I2 statistic, with sensitivity or subgroup analysis conducted as required. The quality of included studies will be evaluated using Joanna Briggs Institute critical appraisal tools for observational study designs. All statistical analysis will be conducted using Jamovi V2.7.6, R V4.3.2 ‘meta’ packages and GraphPad Prism V9.0.2.

    Ethics and dissemination

    This review will synthesise evidence from existing published literature. While completing the findings, the findings will be submitted to an international peer-reviewed journal and disseminated through conferences, policy forums and stakeholders’ networks to inform future research and interventions.

    PROSPERO registration number

    CRD420251123294.

    Perspectives and experiences related to caring for older people among nursing students in a state university in Sri Lanka: a qualitative study

    Por: Madhushani · C. K. · Rathnayake · S.
    Objectives

    To explore the perspectives and experiences related to caring for older people during clinical placement among undergraduate nursing students.

    Design

    A qualitative exploratory study analysing individual interview data.

    Setting

    Department of Nursing, Faculty of Allied Health Sciences, University of Peradeniya, Sri Lanka.

    Participants: A purposive sample of 14 undergraduate nursing students.

    Method

    Semi-structured in-depth interviews were conducted, audio-recorded and transcribed. Data were analysed using Braun and Clarke’s reflexive thematic analysis framework.

    Results

    Five themes emerged: (1) understanding ageing: The concept of ‘Age’, (2) Complexity of care: navigating challenges, (3) Care provision: rewards, growth and fulfilment, (4) Addressing challenges: barriers to support and (5) Reaching the horizon: enhancing geriatric education. Nursing students encountered both positive and negative experiences related to caring for older people. Positive experiences included increased self-awareness, learning opportunities, skill development and personal satisfaction. Negative experiences involved student-related and patient-related challenges, initial difficulties in providing care and inadequate support and mentoring during clinical placements.

    Conclusion

    Despite the complexities of caring for older people, nursing students are motivated to learn and provide the necessary care. This study highlights the need for quality care for older people, the importance of early geriatric education and the need for enhancing clinical supervision and mentoring.

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    Buccal fat applied to transoral robotic lateral oropharyngectomy defects to lessen radical tonsillectomy pain (BOLT): a single-centre, phase II, parallel, randomised control trial study protocol

    Por: Xie · M. · de Almeida · J. · Goldstein · D. · Martino · R. · Liu · Y. F. · Allen · B. · Xu · W. · Hueniken · K. · Yao · C. M.
    Introduction

    Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

    Methods and analysis

    This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

    Ethics and dissemination

    The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

    Trial registration number

    NCT06965738.

    Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol

    Por: Negishi · H. · Hirata · K. · Aiyama · H. · Fujita · K. · Komatsu · Y. · Kato · N. · Shibata · Y. · Tsuda · K. · Yamazaki · T. · Sato · M. · Watanabe · S. · Sugii · N. · Konishi · T. · Mathis · B. J. · Ohigashi · T. · Endo · M. · Ishikawa · E. · Matsumaru · Y. · The Triple Study Investigato
    Introduction

    Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

    Methods and analysis

    This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

    Ethics and dissemination

    Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

    Trial registration number

    jRCTs031240007.

    Determining the longitudinal associations between suicidal ideation and biopsychosocial factors in early to mid-adolescence: a prospective cohort study

    Por: Crethar · M. · Boyes · A. · Schwenn · P. · Mills · L. · Prince · T. · Bromley · K. · Kennedy · M. · Driver · C. · Hermens · D. F.
    Objectives

    To determine whether a biopsychosocial model of suicidality, specifically sleep, nutrition, physical exercise, mindfulness, social connectedness, lower socioeconomic status (SES) and sex are uniquely associated with increased suicidal ideation, longitudinally over adolescence.

    Design

    Longitudinal, prospective cohort study.

    Setting

    A structured self-report questionnaire was collected as part of the Longitudinal Adolescent Brain Study at the University of the Sunshine Coast’s Thompson Institute (Queensland, Australia) from July 2018 to January 2024.

    Participants

    159 Australian adolescents (n=91 female; 68 male) aged 12 to 17 years.

    Outcome measures

    Self-reported suicidal ideation was measured longitudinally. Data were also collected on self-reported lifestyle factors (sleep, nutrition, physical exercise, mindfulness and social connectedness), psychological distress, SES and sex. All measures were collected at 4-monthly intervals for each participant for up to 5 years (maximum of 15 time points).

    Results

    Significant relationships were identified between increased suicidal ideation and poor sleep (OR 2.6, 95% CI 1.4 to 4.6, p=0.002), socioeconomic disadvantage (SES quintile 1: OR 6.3, 95% CI, 1.8 to 21.8, p=0.004; SES quintile 2: OR 8.7, 95% CI 1.4 to 56.2, p=0.022), psychological distress (OR 5.7, 95% CI 2.1 to 15.6, p≤0.001) and eating habits (β –0.08, 95% CI –0.2 to –0.0).

    Conclusions

    Poor sleep, socioeconomic disadvantage, psychological distress and eating habits were all found to be significantly associated with increased adolescent suicidal ideation over time. These biopsychosocial factors should be considered in targeted interventions and policies for reducing adolescent suicidality. Further research should employ multilevel modelling to examine factor interactions and rigorously evaluate interventions targeting lifestyle factors and socioeconomic inequalities through randomised controlled trials and quasi-experimental designs.

    DIVINE-pilot trial: a phase 2 multicentre, randomised pilot trial of pharmacotherapy and physical activity monitoring conducted in women with recent gestational diabetes and increased risk of type 2 diabetes recruited from tertiary referral hospitals in A

    Por: Chen · A. X.-N. · Lee · V. Y. · Donges · K. · Giancas · C. · Angell · B. · Parmenter · B. · Barrett · H. L. · Henry · A. · Patel · A. · Arnott · C.
    Introduction

    Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.

    Methods and analysis

    This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.

    Ethics and dissemination

    This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).

    Trial registration number

    Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.

    Anatomic versus reverse total shoulder replacement for patients with osteoarthritis and intact rotator cuff: the RAPSODI-UK randomised controlled trial protocol

    Por: Rodrick · H. L. · Dias · J. · Watts · A. C. · Walton · M. J. · Brealey · S. · Page · R. · Foster · N. E. · Boland · K. · Cunningham · L. J. · Fairhurst · C. · Geoghegan · J. · Greenwood · W. · Hewitt · C. · Kirwan · C. · Leggett · H. · McDaid · C. · Parkes · M. · Parrott · S. · Powell · R.
    Introduction

    Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

    Methods and analysis

    RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

    Ethics and dissemination

    Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

    Trial registration number

    ISRCTN12216466.

    Spatiotemporal patterns of asthma in Bhutan: a Bayesian analysis

    Por: Tsheten · T. · Chateau · D. · Walsh · E. · Sargent · G. · Clements · A. C. A. · Gray · D. · Kelly · M. · Dorji · N. · Tenzin · P. · Adhikari · L. · Penjor · K. · Bagheri · N. · Wangdi · K.
    Introduction

    Asthma is a chronic respiratory disorder requiring ongoing medical management. This ecological study investigated the spatial and temporal patterns of notification rates for asthma from clinic visits and hospital discharges and identified demographic, meteorological and environmental factors that drive asthma in Bhutan.

    Methods

    Monthly numbers of asthma notifications from 2016 to 2022 were obtained from the Bhutan Ministry of Health. Climatic variables (rainfall, relative humidity, minimum and maximum temperature) were obtained from the National Centre for Hydrology and Meteorology, Bhutan. The Normalised Difference Vegetation Index (NDVI) and surface particulate matter (PM2.5) were extracted from open sources. A multivariable zero-inflated Poisson regression (ZIP) model was developed in a Bayesian framework to quantify the relationship between risk of asthma and sociodemographic and environmental correlates, while also identifying the underlying spatial structure of the data.

    Results

    There were 12 696 asthma notifications, with an annual average prevalence of 244/100 000 population between 2016 and 2022. In ZIP analysis, asthma notifications were 3.4 times (relative risk (RR)=3.39; 95% credible interval (CrI) 3.047 to 3.773) more likely in individuals aged >14 years than those aged ≤14 years, and 43% (RR=1.43; 95% CrI 36.5% to 49.2%) more likely for females than males. Asthma notification increased by 0.8% (RR=1.008, 95% CrI 0.2% to 1.5%) for every 10 cm increase in rainfall, and 1.7% (RR=1.017; 95% CrI 1.2% to 2.3%) for a 1°C increase in maximum temperature. An increase in one unit of NDVI and 10 µg/m3 PM2.5 was associated with 27.3% (RR=1.273; 95% CrI 8.7% to 49.2%), and 2.0% (RR=1.02; 95% CrI 1.0% to 4.0%) increase in asthma notification, respectively. The high-risk spatial clusters were identified in the south and southeastern regions of Bhutan, after accounting for covariates.

    Conclusion

    Environmental risk factors and spatial clusters of asthma notifications were identified. Identification of spatial clusters and environmental risk factors can help develop targeted interventions that maximise impact of limited public health resources for controlling asthma in Bhutan.

    Financial catastrophe and its associated factors among chronic kidney disease patients undergoing haemodialysis in Kathmandu, Nepal: a mixed-method study

    Por: Poudel · S. · Yadav · D. K. · Khanal · V. K. · Nepal Gurung · G. · Pokhrel · S. · Pudasaini · A. · Amatya · A. G.
    Objective

    The study aimed to assess the prevalence of financial catastrophe and explore patients’ perceived effectiveness of the government support programme related to chronic kidney disease.

    Design

    Cross-sectional mixed-method study.

    Participants

    A total of 120 patients receiving free regular haemodialysis under the government’s Deprived Citizen Support Programme for at least 6 months were included in the quantitative study, and 9 patients participated in the qualitative study.

    Main outcome measures

    Prevalence of financial catastrophe and factors associated with financial catastrophe among chronic kidney disease patients undergoing haemodialysis.

    Methods

    A convergent parallel mixed-method approach was carried out from 15 June to 15 December 2024, among chronic kidney disease patients undergoing haemodialysis at the National Kidney Center. Quantitative data were collected through face-to-face interviews using a semi-structured questionnaire. Financial catastrophe was defined as out-of-pocket (OOP) healthcare payments ≥40% of a household’s disposable income, following the WHO-recommended threshold for severe financial burden. OOP expenditures were assessed over 6 months, and associations were tested using 2 and binary logistic regression at a 95% CI in SPSS V.25.0. For the qualitative arm, in-depth interviews were conducted with nine purposively selected patients, and inductive thematic analysis was applied to explore the perceived effectiveness of the government support programme. The quantitative and qualitative findings were then integrated to achieve convergence and divergence, allowing for a comprehensive understanding of the extent and context of financial hardship among patients.

    Results

    The prevalence of financial catastrophe was 72.5%. The factors associated with financial catastrophe were the presence of complications (adjusted OR (AOR): 3.67, 95% CI 1.019 to 13.27), patients without financial support (AOR: 2.77, 95% CI 1.016 to 7.56) and reduction in food expenses (AOR: 0.313, 95% CI 0.109 to 0.896). Qualitative findings on awareness regarding government subsidies, financial strain, barriers to receiving treatment and perceived effectiveness of the programme revealed key aspects of utilisation and effectiveness of the government support programme.

    Conclusion

    The prevalence of financial catastrophe was substantially high, which highlights the importance of addressing economic challenges in chronic kidney disease care. The study emphasised the need to strengthen financial protection through the expansion of government subsidies and improved insurance coverage.

    Associations of functional foods consumption with gastrointestinal and musculoskeletal conditions: a cross-sectional study among Bangladeshi adults

    Por: Mazumdar · S. · Shuvo · S. D. · Khuku · T. K. · Adnan · M. M. · Hossain · M. S. · Kamal · M. M. · Fardaus · F. · Zohra · F.-T. · Ahammed · T.
    Objectives

    Functional foods have demonstrated potential in preventing gastrointestinal and musculoskeletal (osteo-related) disorders; however, evidence from cross-sectional studies in adults remains limited. This study aimed to examine the relationship between the frequency of functional food consumption and the prevalence of gastrointestinal and osteo-related conditions among adults in Bangladesh.

    Design

    Cross-sectional study.

    Setting

    A face-to-face interview was conducted in Southern Bangladesh.

    Participants

    A total of 959 adults participated. Socio-demographic characteristics, lifestyle factors, health status and patterns of functional food consumption were collected using a structured questionnaire.

    Main outcome measures

    The prevalence of gastrointestinal and musculoskeletal (osteo-related) diseases, as well as their associations with the frequency of functional food consumption, were assessed using binary logistic regression.

    Results

    Gastrointestinal and musculoskeletal (osteo-related) diseases were reported by 55.4% and 44.1% of participants, respectively. Multivariate logistic regression showed that several functional foods were associated with lower odds of gastrointestinal conditions, including regular seed intake (OR=0.35, p=0.034), weekly fibre-rich foods (OR=0.48, p=0.021), weekly probiotics (OR=0.26, p=0.012), monthly probiotics (OR=0.33, p

    Conclusions

    The consumption of functional foods, particularly seeds, probiotics, fibre-rich foods, nuts, tea/coffee and natural products were associated with a lower risk of gastrointestinal and musculoskeletal diseases in adults. These findings provide robust evidence to inform future prospective studies and support public health strategies in Bangladesh aimed at promoting the consumption of functional foods to prevent diet-related health conditions.

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