FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Active subperiosteal versus passive subdural 24-hour drainage following single burr hole evacuation of chronic subdural haematoma (the SUPERDURA trial): protocol for a multicentre, randomised non-inferiority trial

Por: Miscov · R. · Gronhoj · M. · Ronn Jensen · T. S. · Schack · A. E. · Korshoej · A. R. · Haldrup · M. · Olsen · M. H. · Holmen Terkelsen · J. · Poulsen · F. R. · Fugleholm · K. · Bjarkam · C.
Introduction

The main treatment of chronic subdural haematoma (CSDH) is neurosurgical evacuation with subsequent drainage. However, consensus on optimal drain modality and placement is lacking.

Aim

To examine whether 24-hour active subperiosteal drainage is non-inferior to 24-hour passive subdural drainage after a single burr hole evacuation of a symptomatic CSDH.

Methods and analysis

SUPERDURA is a multicentre randomised non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical haematoma evacuation, patients will be randomised to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score, 90-day serious adverse events and complications related to surgery or occurring during admission, including intracerebral haemorrhage due to misplaced drains, acute subdural haematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal haematoma, thromboembolic events, infections and seizures.

A detailed statistical analysis plan is published separately. Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years.

Ethics and dissemination

Ethics approval for the inclusion of competent patients has been obtained from the North Denmark Region Committee on Health Research Ethics. Results of the primary and secondary outcomes will be submitted for publication in an international peer-reviewed journal and presented at relevant neurosurgical meetings.

Trial registration number at ethics committee

N-20240009, accepted 13 May 2024 and 13 December 2024.

Trial registration number

NCT06621407.

Generative artificial intelligence-driven chatbots and medical misinformation: an accuracy, referencing and readability audit

Por: Tiller · N. B. · Marcon · A. R. · Zenone · M. · Kidd · K. E. · Jeukendrup · A. E. · Master · Z. · Caulfield · T.
Objectives

Artificial intelligence (AI)-driven chatbots have been rapidly adopted across research, education, business, marketing and medicine. Most interactions, however, come from non-experts using chatbots like search engines, including for everyday health and medical queries.

Design

We conducted an original study to audit chatbot responses in health and medical fields prone to misinformation.

Methods

Five popular chatbots were assessed: Gemini (Google), DeepSeek (High-Flyer), Meta AI (Meta), ChatGPT (OpenAI) and Grok (xAI). In February 2025, each chatbot was prompted with 10 questions from five categories: cancer, vaccines, stem cells, nutrition and athletic performance. We deployed an adversarial-like framework, using open- and closed-ended prompts designed to strain models toward misinformation or contraindicated advice. Two experts from each category rated responses as ‘non-problematic’, ‘somewhat problematic’ or highly problematic’ using a coding matrix based on objective, predefined criteria. Citations were scored for accuracy and completeness, and each response was given a Flesch Reading Ease score.

Results

Nearly half (49.6%) of responses were problematic: 30% somewhat problematic and 19.6% highly problematic. Response quality did not differ significantly among chatbots (p=0.566) but Grok generated significantly more highly problematic responses than would be expected under a random distribution (z-score +2.07, p=0.038). Performance was strongest in vaccines (mean z-score –2.57) and cancer (–2.12), and weakest in stem cells (+1.25), athletic performance (+3.74) and nutrition (+4.35). Chatbot outputs were consistently expressed with confidence and certainty; from 250 total questions, there were only two refusals to answer (0.8%), both from Meta AI. Reference quality was poor, with a median completeness score of 40% (Q1–Q3: 20–67%). Chatbot hallucinations and fabricated citations precluded any chatbot from producing a fully accurate reference list. All readability scores were graded as ‘Difficult’ (30–50), equivalent to college sophomore–senior level.

Conclusions

The audited chatbots performed poorly when answering questions in misinformation-prone health and medical fields. Continued deployment without public education and oversight risks amplifying misinformation.

Process evaluation of a basic life support educational intervention (FirstCPR cluster randomised study) delivered at community organisations in New South Wales, Australia

Por: Munot · S. · Bauman · A. · Bray · J. · Redfern · J. · Angell · B. · Kancijanic · D. · Rock · Z. · Semsarian · C. · Jennings · G. · Coggins · A. · Denniss · A. R. · Chow · C.
Background

The FirstCPR cluster randomised trial delivered multimodal basic life support (BLS) learning opportunities to community organisations. An a priori process evaluation examined intervention implementation, including participation, reach, uptake and member engagement.

Methods

The study used a multimethod process evaluation. Data were collected via semistructured interviews, focus group discussions, participant surveys, study records, web analytics and in-field observations. These sources captured participation patterns and implementation measures (delivery, reach, uptake and engagement: opt-in to digital messages and attendance at training sessions), as well as reasons for refusals and withdrawals. Qualitative data were analysed thematically and organised using the UK Medical Research Council process-evaluation framework. Qualitative and quantitative data were analysed separately and subsequently interpreted collectively to contextualise implementation patterns and identify barriers and enablers that influenced trial successes and failures.

Results

Intervention uptake and engagement varied significantly across organisations, with greater success observed in social and faith-based groups. Of the 82 intervention clusters, 78 (95%) received intervention materials; 74 (90%) engaged in at least one activity and 15 (18%) engaged in all activities. Participation was primarily driven by the organisation’s leadership interest and support in providing BLS training to members, and by the time available to facilitate intervention activities. The presence of a dedicated liaison/champion emerged as the most critical enabler of member engagement and implementation. Feedback recommended concise, simple and culturally tailored modules, with practical components delivered in shorter, convenient sessions. Intervention delivery was affected by contextual challenges, including COVID-19 disruptions that limited in-field recruitment and group activities.

Conclusions

Process evaluation can strengthen community-based interventions by identifying mechanisms and contextual factors that shape implementation and engagement. Partnering with social and faith-based organisations may be an effective approach to disseminating educational programmes such as life-saving skills to lay communities. Minimising research burden and ensuring organisational leadership support may improve participation while brief, practical and culturally tailored training may enhance engagement.

Trial registration number

ACTRN12621000367842.

Development and acceptability of a patient decision aid for people with degenerative cervical myelopathy: an international mixed-methods study

Por: Gamble · A. R. · Anderson · D. B. · McKay · M. J. · Davies · B. · Macpherson · S. · Van Gelder · J. · Hoffmann · T. · McCaffery · K. · Stevens · S. X. · Ammendolia · C. · Chauhan · R. V. · Zipser · C. M. · Boerger · T. F. · Tetreault · L. A. · Fehlings · M. G. · Dustan · E. · Nugent · C
Objectives

To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.

Design

Mixed-methods study describing the development of a patient decision aid.

Setting

A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.

Participants

Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.

Results

We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).

Conclusion

Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

Vitamin D supplementation to reduce maternal adverse events: the jury is still out

Por: Martineau · A. R. · Iliodromiti · S.

Commentary on: Borumandnia et al. The impact of vitamin D changes during pregnancy on the development of maternal adverse events: a random forest analysis. BMC Pregnancy and Childbirth 2024;24:125.

Implications for practice and research

  • Data presented in this paper do not demonstrate a cause-effect relationship between maternal vitamin D deficiency during pregnancy and increased risk of maternal adverse events.

  • Randomised controlled trials are needed to resolve uncertainty regarding the effects of vitamin D supplementation in pregnancy on maternal and fetal outcomes.

  • Context

    Sustainable Development Goal Target 3.1 is to reduce maternal mortality to less than 70 maternal deaths per 100 000 live births by 2030. This remains elusive, with 223 maternal deaths per 100 000 live births reported worldwide in 2020.1 Vitamin D plays pleiotropic physiological roles in maintaining calcium homeostasis, modulating the renin-angiotensin axis and regulating insulin secretion.2 Deficiency in...

    Microsimulation model to identify suboptimal recurrence detection in patients with colorectal cancer following the current standard of care

    Por: Samur · S. · Gursel · E. · Gu · N. Y. · Carter · G. C. · Sahinkoc · M. · Ayer · T. · Chhatwal · J. · Subramaniam · S. · Palomares · M. · Parikh · A. R. · Neugut · A. I.
    Objectives

    Colorectal cancer (CRC) is one of the most common cancers worldwide. Stage II/III patients undergo curative-intent surgery yet still face the recurrence risk. Detecting recurrences early provides the best opportunity for optimal treatment. We aimed to develop a microsimulation model to evaluate CRC management-associated outcomes based on current guidelines, including the performance of guideline-recommended surveillance in detecting recurrences.

    Design

    Two separate individual-level state transition (microsimulation) models for colon and rectal cancer were built with a lifetime horizon using monthly cycles. The models integrated treatment and surveillance strategies per current guidelines.

    Setting

    The currently recommended surveillance modalities by National Comprehensive Cancer Network guidelines for surveilling patients with CRC after curative-intent surgery.

    Participants

    65-year-old patients with stage II and stage III CRC who underwent curative-intent surgery in the USA.

    Outcome measures

    Cumulative recurrences, detected recurrences, detection rate, overall survival and recurrence-free survival in a 5-year horizon, as well as average life expectancy, were the outcome measures used.

    Results

    Over 5 years, disease recurrence was observed in 9.5% of patients with stage II–III colon cancer and in 38.0% of patients with stage II–III rectal cancer. Of these, 82.5% and 85.5% were detected via surveillance, respectively, within 5 years. The predicted 5-year overall survival was 86.0% for colon cancer and 69.3% for rectal cancer, with corresponding recurrence-free survival rates of 78.9% and 53.8%. Based on current guidelines-recommended surveillance, detecting one colon cancer recurrence requires 148 carcinoembryonic antigen (CEA) tests, 37 CT scans and 21 colonoscopies. In contrast, detecting one rectal cancer recurrence requires 31 CEA tests, 8 CT scans and 4 colonoscopies.

    Conclusions

    Our validated model suggests that relative to an optimal benchmark in which all recurrences are detected, recurrence detection under current guidelines may be suboptimal, indicating room for improvement. As new tests emerge, this model could be a valuable tool for evaluating existing clinical practices and the potential of new tests to enhance patient outcomes.

    MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS): protocol for a mixed-methods randomised controlled trial at two US medical centres

    Por: Rodgers-Melnick · S. N. · Gorthi · V. · Foss · A. · Erande · A. · DiFrancesco · K. · Owusu-Ansah · A. · Anim · S. · Bretz · S. · Ketter · P. · Fuqua · T. · Anderson · A. R. · Karasz · A. · Bailey · L. · Ezenwa · M. · Jenerette · C. · Dusek · J. A.
    Introduction

    Accessible, person-centred, non-pharmacologic modalities are needed to address chronic pain and health-related quality of life (HRQoL) among individuals with sickle cell disease (SCD). Building off prior single-site pilot studies of music therapy (MT) in SCD, the purpose of this study is to (1) examine the data collection processes and intervention implementation overall and across two sites and (2) evaluate the implementation of the MT and health education interventions using quantitative and qualitative data.

    Methods and analysis

    This three-arm, two-site, feasibility randomised controlled trial will include 90 individuals ≥14 years who have SCD, chronic pain and access to a mobile device who are not currently engaged in mind-body pain management interventions under the supervision of a healthcare professional. Participants will be randomised to six sessions over 8 weeks of either: (1) in-person MT, (2) hybrid (one in-person, five virtual) MT or (3) hybrid health education. Patient-reported outcome measures of HRQoL and self-efficacy will be assessed at baseline, post-intervention and 6 weeks post-intervention. 24 participants (eight per arm) and 20 stakeholders (eg, haematologists, music therapists, nurses) will be invited to complete semi-structured interviews to further examine intervention acceptability, perceived benefits and implementation. Sessions will be monitored for fidelity, and participants lacking access to home internet or videoconferencing technology will be provided tablets to engage in virtual sessions. Feasibility will be determined by rates of data completion, recruitment, retention, session attendance and home practice.

    Ethics and dissemination

    This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board (STUDY20231055). The dissemination plan includes presenting findings at national and international scientific conferences and publishing in peer-reviewed journals. All activities will be conducted in collaboration with SCD community stakeholders.

    Trial registration number

    NCT06853158.

    Psychometric properties and cultural validity of mental health assessment tools for refugees and asylum seekers: a systematic review and meta-analysis protocol

    Por: Tempia Valenta · S. · Conti · A. · Porru · F. · Giovannardi · G. · Andersen · I. · Bramer · W. M. · Atti · A. R. · De Ronchi · D. · Panella · M. · Hubloue · I.
    Introduction

    Migration is a complex global phenomenon, with millions of people relocating each year driven by various social or personal reasons. Among them, refugees and asylum seekers form a particularly vulnerable subgroup, often forced to escape conflicts, persecution or life-threatening conditions. Most mental health assessment tools, originally developed in high-income countries and validated primarily in Western populations, may lack the cultural validity needed for this demographic. The primary objective is to systematically review and synthesise the psychometric properties and cultural validity of mental health assessment tools validated for refugees and asylum seekers. Secondary objectives are to (a) identify the range of mental health symptoms these tools assess and (b) describe the geographical coverage in terms of the regions of origin and host countries where tools have been validated.

    Methods and analysis

    Reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines, the review will conduct searches across different databases (ie, MEDLINE, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, PsycINFO, Global Index Medicus, CINAHL and Scopus), from inception to January 2025, with no restrictions on language. We will include validation, adaptation or diagnostic accuracy studies, as well as any other study design that reports at least one psychometric property of a mental health assessment tool. Two pairs of reviewers will screen, extract and appraise each study independently. Methodological quality will be assessed with the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) Risk-of-Bias checklist for measurement studies and QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2) for diagnostic accuracy studies; the certainty of the evidence per property will be graded using the COSMIN-GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Narrative synthesis will be performed for all properties; where appropriate, meta-analyses will pool Cronbach’s α (Fisher-Z), intraclass correlations and sensitivity/specificity estimates using random-effects models. Inconsistency will be explored with subgroup analyses and meta-regressions; publication bias will be investigated with funnel plots and Egger’s test when ≥10 studies are available.

    Ethics and dissemination

    Ethical approval is not required for this systematic review, as no empirical data will be collected. Results will be disseminated through a peer-reviewed publication in a scientific journal and presented at relevant conferences.

    PROSPERO registration number

    CRD42024510901.

    Exploring stress and coping among black women in early midlife with elevated blood pressure in a safety-net health system: a qualitative focus group protocol

    Por: Sprague · B. N. · Beverly · A. R.
    Introduction

    Black women in early midlife experience disproportionate exposure to stress and elevated cardiovascular risk, including hypertension. Despite this, few stress management interventions are designed with and for this population. This study aims to explore the lived experiences of stress and coping among black women in early midlife with elevated blood pressure to inform the codesign of a culturally relevant, multilevel stress management intervention.

    Methods and analysis

    We will conduct one-time, semistructured focus groups with black women aged 35–50 who have elevated blood pressure, recruited from a large safety-net health system. Data will be analysed using a constructivist grounded theory approach, with inductive theme development supported by line-by-line, focused and theoretical coding. The Social Determinants of Cardiovascular Disease framework will serve as a sensitising guide to multilevel contextual factors rather than a prescriptive coding structure. An artificial intelligence (AI)-assisted analytic component will complement human-led analysis by supporting preliminary theme exploration and enhancing transparency.

    Ethics and dissemination

    Approved by the Indiana University Institutional Review Board (Protocol #21785). All participants will provide written informed consent. Findings will be shared via peer-reviewed publications, conference presentations and lay summaries for stakeholders.

    Knowledge, attitudes and practices toward skin cancer prevention among Malaysian adults: a cross-sectional online survey

    Por: Mohammed · A. H. · Hassan · B. A. R. · Wong · Y. J. · Ying · L. H. · Hong · M. L. B. · Nee · A. W. S. · Ying · L. S. · Ramachandram · D. S. · Hassan · H. S. · Jia · L. J. · Dujaili · J. · Blebil · A.
    Objectives

    To assess the levels of knowledge, attitudes and practices (KAP) toward skin cancer prevention among Malaysian adults and to examine differences in KAP across socio-demographic groups.

    Design

    Cross-sectional online survey.

    Setting

    Community-based study conducted in Malaysia using social media recruitment.

    Participants

    A total of 386 adults aged ≥18 years residing in Malaysia. Most participants were young adults (86.3%), female (55.4%) and of Chinese ethnicity (65.5%). Healthcare professionals were excluded.

    Primary and secondary outcome measures

    Primary outcomes were levels of knowledge, attitude and preventive practices toward skin cancer, measured using the validated KAP-SC-Q (Knowledge, Attitude and Practice of Skin Cancer Questionnaire) and categorised as poor, moderate or good. Secondary outcomes included differences in KAP across socio-demographic and clinical characteristics, analysed using independent t-tests and 2 tests.

    Results

    Over half of participants demonstrated poor knowledge of skin cancer (56.0%) and the vast majority showed inadequate preventive practices (84.2%), while attitudes toward skin cancer were predominantly positive (62.4%). Significant differences in mean KAP scores and categorical levels were observed across several socio-demographic variables. Participants with tertiary education had higher knowledge (14.32 vs 12.61) and attitude scores (20.01 vs 15.95; p

    Conclusions

    Malaysian adults exhibited limited knowledge and very poor preventive practices toward skin cancer despite generally positive attitudes. These findings highlight substantial gaps between awareness and behaviour and support the need for targeted public health interventions to correct misconceptions, improve risk perception especially in high-risk groups and promote effective ultraviolet protection behaviours.

    Organ donation and transplantation education in UK medical schools: a protocol for parallel national cross-sectional surveys of students and educators

    Por: Prigg · A. R. · Smith · O. A. · Lipkin · G. · Ong · A. · Patel · K. · Dabare · D.
    Introduction

    Solid organ transplantation is a cornerstone of care for end-stage organ disease and a critical consideration for all doctors managing chronic conditions such as chronic kidney disease. Transplantation is wholly dependent on organ donation (both living and deceased), with shortages directly limiting access to life-saving therapy and resulting in preventable mortality for patients on waiting lists. Yet undergraduate exposure to organ donation and transplantation (ODT) across UK medical schools is anecdotally poor and not mapped nationally. The most substantive UK evidence is more than two decades old and demonstrates limited exposure and significant knowledge gaps among final-year medical students.

    We here describe a protocol for two coordinated national surveys: U-KNOW-RT (Understanding and Knowledge of Renal Transplantation; final-year students) and U-TEACH-ODT (Undergraduate Teaching in ODT; educator leads). Together, these will provide the first UK-wide mapping of undergraduate ODT education, generating contemporary evidence on teaching provision, student exposure, knowledge, attitudes and career intentions. This work will directly inform the design of a standardised national ODT teaching module to ensure that all UK medical graduates attain a core level of literacy in ODT. Survey distribution is scheduled for January 2026, with completion expected by summer 2026.

    Methods and analysis

    We will conduct two parallel cross-sectional online surveys. U-KNOW-RT will recruit final-year medical students from all 44 UK medical schools via social media, institutional channels and student societies. U-TEACH-ODT will invite deans and senior curriculum leads. The student target is ~1200 responses (≥10 per school) to enable national mapping and triangulation with educator reports. Analyses will follow the Consensus-Based Checklist for Reporting of Survey Studies and the Checklist for Reporting Results of Internet E-Surveys reporting frameworks. Prespecified outcomes include student knowledge, exposure and attitudes alongside educator-reported curricular provision. Primary analyses will use mixed-effects regression with school-level clustering, agreement between student and educator reports will be quantified and selected items will be readministered to allow 20-year comparisons with legacy surveys.

    Ethics and dissemination

    This study involves human participants and was granted ethical approval by the University of Sheffield Ethics Department (reference 070914) on 25 November 2025. Participants provided informed consent before taking part. This manuscript reports a study protocol only; no results will be reported. Findings will be disseminated through peer-reviewed publications, conferences and feedback to medical schools and national bodies. De-identified data, questionnaires and analysis code will be shared openly on Open science framework.

    Trial registration number

    OSF preregistration (DOI 10.17605/OSF.IO/38W5N).

    Research waste in total knee arthroplasty studies: an observational study on registered trials

    Por: Iken · A. R. · Schaap · M. · Poolman · R. W. · Gademan · M. G. J.
    Background

    Timely publication of preregistered study outcomes is not self-evident. Discrepancies can lead to significant research waste.

    Objectives

    To assess timely (within 7 years) and consistent publication of preregistered primary outcomes and associated factors of total knee arthroplasty (TKA) studies registered between 2000 and 2017 over time.

    Design

    An observational study.

    Data sources

    ClinicalTrials.Gov, MEDLINE, Embase, Cochrane Library, Web of Science, PubMed and Google Scholar.

    Participants

    Registered TKA trials at ClinicalTrials.Gov between 2000 and 2017.

    Data extraction and synthesis

    ClinicalTrials.Gov’s required and optional data elements for registering a study and the preregistered and published primary outcome, defined as the outcome stated in the primary outcome field on ClinicalTrials.Gov. We used descriptive statistics, Kaplan-Meier curves and Cox regression analyses.

    Results

    1352 registered TKA (1072 interventional; 280 observational) studies were included, with 967 (811 interventional; 156 observational) unique references. Regarding the publication of preregistered primary outcomes within 7 years, the results for interventional trials were 0% (2000), which increased to 59.6% (2017). Observational studies were timely published in 0% (2000) and 37.5% (2017). Interventional trials and observational studies not funded by industry were more likely to have timely and consistent publication of their primary outcomes. Drug intervention trials were more likely to be timely and consistently published than procedure-focused trials. Phase 3 interventional trials were more likely, while phase 1 trials were less likely to be consistently published on time.

    Conclusion

    Despite ongoing efforts to improve publication rates, over a third of interventional trials remain unpublished within 7 years. For observational studies, the rate is even lower, with only two-fifths published on time, contributing to significant research waste.

    PROSPERO registration number

    CRD42021246599.

    Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE)

    Por: Al Alawi · A. M. · Al Busaidi · S. · Al Rasbi · S. K. · Al Farsi · R. S. · Al Zeedy · K. · Al Huraizi · A. R. · Al-Maqbali · J. S.
    Objectives

    To evaluate the efficacy of melatonin, a neurohormone regulating the sleep–wake cycle, in preventing delirium within 5 days of hospitalisation among older adult patients (≥65 years) admitted to general medical wards.

    Design

    Single-centre, double-blinded, randomised, placebo-controlled trial.

    Setting

    General medical wards of a tertiary hospital in Oman.

    Participants

    Patients aged ≥65 years admitted within 24 hours to general medical wards were screened. Key exclusion criteria included prevalent delirium, use of vasopressors, non-invasive ventilation, intensive or high-dependency unit admission and aphasia.

    Interventions

    Participants were randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days during hospitalisation or until discharge, whichever occurred first.

    Primary and secondary outcome measures

    The primary outcome was the incidence of delirium within 5 days, assessed using the 3-Minute Diagnostic Confusion Assessment Method. Secondary outcomes included delirium treatment, average sleep duration or sleep maintained, 28-day mortality and 28-day readmission. Analyses followed the intention-to-treat (ITT) principle, with per-protocol (PP) analyses conducted for robustness.

    Results

    The study was terminated early due to futility. At termination, a total of 115 participants were recruited, 109 of whom were included in the ITT analyses: 55 in the melatonin group (5 mg or 8 mg) and 54 in the placebo group. The overall incidence of delirium by day 5 was 2.75%, 3.64% in the melatonin group and 1.85% in the placebo group (p=1.000). No statistically significant differences were found in the average sleep duration (p=0.136), 28-day mortality (3.64% vs 1.85%, p=1.000) or 28-day readmission (21.82% vs 20.37%, p=0.853). PP analyses and subgroup sensitivity yielded similar findings.

    Conclusions

    In this trial, melatonin did not significantly reduce the incidence of delirium. The lower-than-expected numbers of outcome events and resultant early termination for futility limited the study’s power. As a result, the study findings should be interpreted with caution, and further research is necessary before definitive recommendations can be made.

    Trial registration number

    NCT06509191.

    Agreement testing of AMSTAR-PF, a tool for quality appraisal of systematic reviews of prognostic factor studies

    Por: Henry · M. L. · OConnell · N. E. · Riley · R. D. · Moons · K. G. M. · Shea · B. J. · Hooft · L. · Wallwork · S. B. · Damen · J. A. A. G. · Skoetz · N. · Appiah · R. P. · Berryman · C. · Crouch · S. M. · Ferencz · G. A. · Grant · A. R. · Henry · K. M. · Herman · A. M. · Karran · E. L. · K
    Objectives

    To test the agreement and usability of a novel quality appraisal tool: A MeaSurement Tool to Assess systematic Reviews of Prognostic Factor studies (AMSTAR-PF).

    Design

    Observational study.

    Participants

    14 appraisers of varied experience levels and backgrounds, including undergraduate, master’s and PhD students, postgraduate researchers, research fellows and clinicians.

    Study procedure

    Eight systematic reviews were rated by all reviewers using AMSTAR-PF.

    Outcome measures

    Planned measures included intrapair and inter-pair agreement using Cohen’s and Fleiss’ kappa, time of use and time to reach consensus. Interrater agreement was an added measure, and Gwet’s agreement coefficient was calculated and presented due to its greater stability across agreement levels. The percentage of intrapair agreements identical or one category apart was also presented.

    Results

    Interrater agreement averaged 0.59 (range 0.21–0.90), inter-pair agreement 0.61 (range 0.24–0.91) and intrapair agreement 0.75 (range 0.45–0.95) across the domains, with agreement for the overall rating 0.46 (95% CI 0.30 to 0.62) for interrater agreement, 0.46 (95% CI 0.17 to 0.74) for inter-pair agreement and 0.68 (range of averages 0.22–1.00) for intrapair agreement. The majority (60.7%) of intrapair ratings were identical, with 94.6% of final ratings either identical or only one category different for the overall appraisal. The time taken to appraise a study with AMSTAR-PF improved with use and averaged around 34 min after the first two appraisals.

    Conclusions

    Despite some variance in agreement for different domains and between different appraisers, the testing results suggest that AMSTAR-PF has clear utility for appraising the quality of systematic reviews of prognostic factor studies.

    Design characteristics of sequential multiple assignment randomised trials (SMARTs) for human health: a scoping review of studies between 2009 and 2024

    Por: Freeman · N. L. B. · Browder · S. E. · Rowland · B. · Jones · E. P. · Hoch · M. · Kim · A. · Zhou · C. W. · Kahkoska · A. R. · McGinigle · K. L. · Ivanova · A. · Kosorok · M. R. · Anstrom · K. J.
    Objective

    To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.

    Design

    Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.

    Background

    SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient’s response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies. A comprehensive assessment of SMART reporting practices is lacking and necessary for developing standardised SMART-specific reporting guidelines.

    Methods

    We systematically searched multiple databases for SMART-related protocol and primary analysis papers published between January 2009 and February 2024. Title, abstract and full-text screenings were performed by pairs of reviewers, with disagreements resolved by consensus. Data extraction included study characteristics, design elements and analytical approaches for embedded or tailored DTRs. Results were synthesised qualitatively and presented descriptively.

    Results

    From 5486 screened studies, 103 (59 protocol papers, 16 primary analysis papers, 14 protocol papers with corresponding primary analysis papers) met the inclusion criteria. Most studies targeted adults (62.7% protocols, 62.5% primary analyses, 42.9% protocol+primary analyses) and were primarily conducted in the USA. Behavioural and mental health constituted the most frequent therapeutic domain. While intervention descriptions and re-randomisation criteria were consistently reported, operational characteristics such as blinding (protocols: 64.4%, primary analyses: 62.5%, protocols+primary analyses: 71.4%) and randomisation details (protocols: 55.9%, primary analyses: 37.5%, protocols+primary analyses: 50.0%) were inconsistently documented. Only 46.7% of primary analyses evaluated embedded DTRs, and none explored deeply tailored DTRs.

    Conclusions

    Despite the increased adoption of SMART designs, substantial reporting variability persists. Most primary analyses underuse the capability of SMARTs to generate data for developing DTRs. SMART-specific standardised reporting guidelines can help accelerate the scientific and clinical impact of SMARTs.

    Challenges, Skills and Training Needs of Nurses in Managing Paediatric Obesity in Primary Care Settings

    ABSTRACT

    Aim

    To explore the perceptions of primary care nurses regarding their skills and the challenges they face in managing paediatric obesity.

    Design

    Qualitative descriptive study.

    Methods

    Data were collected between May 2022 and March 2024 from focus groups with primary care nurses (n = 25) and analysed using thematic analysis.

    Results

    Four themes emerged from the data. ‘Nurses’ beliefs, skills and tools to manage pediatric obesity’ highlights the skills and limitations nurses encounter in their practice, their views on the causes of this condition, and how they assess families' motivation. The second theme, ‘Nurse-family-child communication’ describes the communication strategies nurses employ when interacting with motivated and unmotivated families. The third theme, ‘The impact of nursing interventions on family behavior’ highlights the limited results behavioural changes observed in families following interventions. The fourth theme, ‘Nurses' reactions to the treatment of pediatric obesity’ reflects the negative feelings nurses experience in managing paediatric obesity.

    Conclusion

    This study identifies significant challenges for nurses in addressing paediatric obesity, particularly in communication and engagement with unmotivated families, which might stem from a lack of tools. Furthermore, it recognises the emotional responses of nurses when tackling obesity.

    Implications for the Profession

    This study highlights the needs related to nurses' communication skills. It is recommended to implement training courses focused on this topic.

    Reporting Method

    Adherence to COREQ guidelines was maintained.

    Patient or Public Contribution

    There was no patient or public contribution.

    Do professional experience and qualification influence knowledge about law concerning informed consent and end-of-life decisions? A quantitative online survey among German intensive care physicians

    Por: Schumann · C. · Wachter · M. · Eslauer · E. · Angeli · R. · Girrbach · F. · Weiss · M. · Friedrich · S. · Simon · P. · Heller · A. R.
    Background

    Recently, legal questions have increasingly arisen in intensive care medicine (ICM), especially when it comes to end-of-life decisions. Still, for Europe, there is not much evidence about doctors’ situational legal knowledge and legal education during medical studies and further qualification. The present study was initiated to analyse these hitherto unexplored aspects in Germany.

    Design

    A quantitative online survey has been performed among German intensive care physicians. The voluntary participants of the anonymous online survey were asked to answer legal questions related to end-of-life policies, informed consent, surrogate decision making or advance directives. We tested pure factual knowledge in five questions. The other five questions tested situational knowledge using case vignettes. Every question could be answered with ‘yes’, ‘no’ or ‘do not know’. Furthermore, the participants were asked to assess their subjective certainty on a Likert scale and to provide information about their professional experience (PE) and qualification.

    Setting

    All members of the two German professional societies for anaesthesiology who work in ICM were asked to take part in the survey.

    Participants

    952 completed questionnaires were analysed. 86% of the participants were specialists, and 56% held the additional qualification in ICM. 78% had more than 10 years of general clinical experience, and 62% had more than 5 years of experience in ICM.

    Results

    On average, the participants answered the five facts–questions in 90.8% correctly. However, only 73.6% of the five case vignettes were answered correctly. Specialists, physicians with a lot of PE or physicians holding the additional qualification in ICM did not perform better than assistants or physicians with little PE.

    Conclusion

    German intensive care physicians have relevant gaps regarding situational legal knowledge, which are independent of their PE or qualification and persist. This may be due to difficulties in interpretation and implementation of law. Since these knowledge gaps can lead to liability and criminal prosecution, these gaps should be closed through awareness-raising and continuous education.

    European Registry of Next Generation Imaging in Advanced Prostate Cancer (RING): protocol for an international, prospective registry study

    Por: Chernysheva · D. · Fanti · S. · Bjartell · A. · Afferi · L. · Breda · A. · Palou · J. · Padhani · A. R. · Sanguedolce · F.
    Introduction

    Next-generation imaging (NGI), particularly with prostate-specific membrane antigen positron emission tomography (PSMA PET) tracers, enables earlier and more accurate detection of metastases. However, conventional imaging (CT and bone scan) remains more affordable and widely accessible and was the standard used in most pivotal trials that established current survival outcomes. As PSMA PET becomes more widely adopted, a stage migration effect is emerging. However, key uncertainties persist regarding the actual proportional employment of NGI in clinical practice, main indications for its use and the mid-term and long-term effects of an NGI-driven treatment pathway. Furthermore, when or whether CI alone might remain enough informative for the treatment decision-making is still unclear.

    Methods and analysis

    The European Registry of Next-Generation Imaging in Advanced Prostate Cancer is a non-profit, non-interventional, multi-centre, international, prospective, investigator-initiated registry that is intended to collect real-world data on how patients with prostate cancer at risk of harbouring metastasis (high-risk at initial diagnosis, or after primary treatment) are managed according to the type of imaging used for the systemic work-up. The registry is conducted in two phases: (1) cross-sectional analysis of imaging choices and their effect on clinical decision-making and (2) longitudinal follow-up evaluating survival outcomes such as progression-free survival (PFS), disease-specific survival (DSS) and skeletal-related events (SSEs). Statistical analyses will include descriptive analysis of demographic and clinical variables, comparative analysis between different imaging pathways, survival and prognostic analyses using Kaplan–Meier tests. The expected minimum sample size of the registry is 600 patients, and the planned follow-up duration is 24 months for the longitudinal follow-up.

    Ethics and dissemination

    The study protocol was approved by the ethics committee of Fundació Puigvert (#C2024/30), and ethics approval is required at all participating sites. All patients will provide written informed consent. The results will be disseminated widely and transparently to maximise their effect on clinical practice, research and patient care through peer-reviewed publications, presentations at international conferences as well as through patient advocacy groups and relevant patient websites.

    Trial registration number

    NCT06866782.

    Optimising healthcare workforce training and deployment: qualitative experiences from stakeholders in Tanzania

    Por: Nyongole · O. V. · Sirili · N. · Mwakilasa · M. T. · Temba · P. · Mkoka · D. A. · Akoko · L. · August · F. · Kiwango · G. · Kaale · E. · Kamori · D. · Mbawala · H. · Sangeda · R. Z. · Mbugi · E. V. · Balandya · E. · Kamuhabwa · A. A. R. · Kakoko · D.
    Objective

    To explore the experiences of different stakeholders on the balance of package training and deployment of highly skilled Human Resources for Health for specialised services in Tanzania.

    Design

    An exploratory qualitative case study was used as part of a larger tracer study conducted by Muhimbili University of Health and Allied Sciences (MUHAS) for its postgraduate programmes being a requirement for quality assurance. Semi-structured interview guides were used for in-depth interviews (IDIs) and focus group discussions (FGDs). Qualitative content analysis was adopted to analyse the data.

    Setting

    The trace study was carried out in all seven geopolitical zones of the Tanzania mainland and Unguja in Zanzibar.

    Participants

    We conducted 14 FGDs and 301 IDIs. Participants included alumni, immediate supervisors at employment sites, MUHAS faculty, continuing students at MUHAS and management of professional councils in Tanzania.

    Results

    Key findings revealed variations in demands and recognition within the scheme of services, even after registration by professional councils. Five main themes emerged from the qualitative interviews: Package training to improve service provision, Unprofessional collegial relationships or issues related to professionalism within interdisciplinary teams, Silence of scheme services on super specialisation in the medical cadre, Silence of scheme services on specialisation in the nursing cadre, Integrated scheme of services for specialties in pharmacy.

    Conclusion

    The findings highlight the demand for specialised training, challenges with professionalism and inconsistencies in the recognition and remuneration of specialists across medical, nursing and pharmacy cadres within existing service schemes. There is a need for harmonisation between specialisation/super specialisation and the scheme of services. This harmonisation is crucial to ensure the provision of quality healthcare services. Furthermore, harmonisation requires multistakeholder engagement to realise universal health coverage strategies.

    From obstruction to ischaemia: a systematic review and meta-analysis on the diagnostic accuracy of CT scans in identifying small and large bowel obstruction, underlying causes and predicting critical complications in adults

    Por: Ahmad · S. J. S. · Drvaric · I. · Ahmed · A. R. · Jakob · D. · Kyriazidis · I. P. · Pouwels · S. · Hajibandeh · S. · Tang · A. · Cripps · P. · Yang · W. · Parmar · C. · Kermansaravi · M. · Abdelwahed · A. · Gelber · E. · Lala · A. · Whiteley · G. · Wilkinson · D. · Agarwal · A. · Pritchard
    Objectives

    To evaluate the diagnostic accuracy of CT in identifying small and large bowel obstruction and associated complications, including ischaemia and perforation, in adult patients.

    Design

    Systematic review and meta-analysis reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Diagnostic Test Accuracy reporting guidelines.

    Data sources

    Ovid MEDLINE and Embase were searched from 1946 to 20 February 2025.

    Eligibility criteria

    The study included randomised controlled trials, cohort studies and case–control studies evaluating the diagnostic accuracy of CT for bowel obstruction in adults (aged ≥18 years). Only studies published in English were included. Conversely, case reports, editorials, conference abstracts without full data and studies focusing exclusively on paediatric populations or animal models were excluded.

    Data extraction and synthesis

    Three reviewers independently extracted data on study characteristics, CT modality, diagnostic accuracy metrics (sensitivity, specificity and predictive values) and complications. Risk of bias was assessed using the QUADAS-2 tool. A random-effects meta-analysis was conducted. Heterogeneity was assessed using I² and Tau² statistics.

    Results

    Sixty-five studies with 9418 patients were included. The pooled sensitivity and specificity of CT for bowel obstruction were 90% (95% CI 78 to 96; I²=56%, Tau²=0.36) and 88.8% (95% CI 78.0 to 94.8; I²=65%, Tau²=0.35), respectively. For bowel ischaemia, CT showed a pooled sensitivity of 47.0% (95% CI 32.4 to 59.9; I²=0%, Tau²=0.00) and specificity of 85.3% (95% CI 77.9 to 89.5; I²=1%, Tau²=0.45). Multidetector CT (MDCT) outperformed older modalities across all endpoints. Ischaemia was present in 22.05% of all cases, with higher rates in small bowel obstruction. Perforation and mortality rates were 3.98% and 4.40%, respectively. No significant publication bias was detected, and the certainty of evidence was graded as moderate for most diagnostic accuracy outcomes.

    Conclusions

    CT, particularly MDCT, offers high diagnostic accuracy for bowel obstruction and is a critical tool for detecting serious complications such as ischaemia and perforation. However, sensitivity for ischaemia remains modest. Standardised protocols and prospective studies are needed to enhance early identification and optimise care pathways.

    ❌