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Hoy — Diciembre 16th 2025Tus fuentes RSS

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.

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Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+

Por: Daneman · N. · Johnstone · J. · Lee · T. C. · MacFadden · D. R. · McDonald · E. G. · Morpeth · S. C. · Ong · S. W. X. · Paterson · D. L. · Pinto · R. L. · Rishu · A. · Rogers · B. A. · Yahav · D. · Coburn · B. · Daley · P. · Das · P. · Fiest · K. · Findlater · A. · Fralick · M. · George · M
Objectives

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Design

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Setting

Ten hospitals across four Canadian provinces.

Participants

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

Interventions

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Primary outcome measures

Domain-specific recruitment rates and protocol adherence.

Results

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

Conclusions

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

Trial registration number

NCT05893147.

Effectiveness of rapid verbal persuasion in promoting herpes zoster vaccination among older adults in China: study protocol of a two-arm randomised controlled trial

Por: Huang · Z. · Li · Q.-Q. · Tang · Z. · Liu · S. · Zhong · D. · Sun · Q. · Wang · J. · Huang · X. · Qiu · Y. · Zhu · J. · Zhu · X. · Wang · R. · He · W. · Zhao · R. · Zhang · M. · Luo · H. · Luo · C. · Xu · D. R.
Introduction

Herpes zoster (HZ) vaccinations effectively prevent HZ and may decrease dementia, but HZ vaccine uptake remains poor in China. Rapid verbal persuasion is an innovative intervention, in which physicians offered brief advice to encourage individuals to accept vaccination. This study aims to tailor this intervention to promote HZ vaccination among older adults.

Methods and analysis

The proposed study will be a two-arm randomised controlled trial and conducted across four community health centres in Shenzhen, China. A total of 388 participants aged 50 and above will be recruited and assigned to either the intervention arm or the standard-care arm. The primary outcome will be first-dose uptake, recorded within 3 weeks after intervention. The primary outcome will be calculated for each arm and compared using 2 test.

Ethics and dissemination

This trial has been approved by the Ethics Committee of Southern Medical University (Ethical Approval (2024) No. 90). Our findings will be disseminated to patients, healthcare providers and stakeholders through outreach activities and published in peer-reviewed journals, as well as presented in scientific conferences to inform future research or evidence-based practices for public health promotion.

Trial registration number

Chinese Clinical Trial Registry (No. ChiCTR2500100798). Registered on 15 April 2025.

Public health assistance for people with haemophilia in Brazil (PATCH study): a cross-sectional study protocol

Por: Roberti · M. d. R. F. · Gea · Y. R. e. A. · Marinho · I. A. · Inacio · P. P. · Camelo · R. M. · de Castro · T. F. · Batista · S. R. R.
Introduction

Haemophilia is a rare inherited bleeding disorder with complex support and costly treatment. Comprehensive care for people with haemophilia (PwH) must take place in structured and continuously evaluated treatment centres. The aim of the Public Assistance for People with Haemophilia in Brazil Project (PATCH Project) is to assess the infrastructure, human resources and healthcare delivery processes of Brazilian Blood Centres (BC) involved in the provision of haemophilia care.

Methods and analysis

This is a nationwide cross-sectional study involving 98 BC across Brazil’s 26 states and the Federal District, focusing on the care provided to PwH. A self-administered structured questionnaire was prepared, based on national and international recommendations for management, treatment and outcomes assessment in PwH. The criteria of the World Federation of Haemophilia and the European Association for Haemophilia and Allied Disorders will be used to define standards of quality.

Ethics and dissemination

Ethical approval for this study was granted by the Human Research Ethics Committee of the Federal University of Goiás, the coordinating centre (protocol CAAE 53863221.8.0000.5078), and subsequently by all participating institutions. Written informed consent is obtained from all participants prior to enrolment. Study findings will be disseminated through publication in peer-reviewed journals and presentation at international scientific conferences. Research data will be managed in accordance with ethical and legal standards and will be made available on reasonable request to support future investigations.

Protocol registration

Not applicable

Examining the care priorities, service needs and lived experiences of rural people with cognitive impairment and dementia in Canada: a scoping review protocol

Por: Bacsu · J.-D. R. · Berlinguette · C. · Smith · M. · Stone · C. · Vazquez · C. · Singer · J. · Rahemi · Z. · Funk · M. · Abudu-Birresborn · D. · Chai · H. W.
Introduction

Older age is one of the greatest risk factors of dementia, and the rural demographic is ageing in Canada. Compared with their urban counterparts, rural older adults often face unique challenges in accessing cognitive healthcare, which is exacerbated by a shortage of healthcare specialists, public transportation, finances, education, services and dispersed geography. This scoping review protocol outlines the methodology that will be used to examine the literature about the care priorities, service needs and lived experiences from the perspectives of rural older adults living with cognitive impairment and dementia in Canada.

Methods and analysis

Our scoping review protocol will follow the guidance of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extensions for Scoping Reviews checklist. Our search strategy will identify relevant peer-reviewed literature in databases including Cumulated Index in Nursing and Allied Health Literature (CINAHL), EMBASE, PsycINFO, PubMed, Web of Science and Scopus. The database search dates for this scoping review will be from 1 January 2015 to 1 January 2025. The data will be charted by two reviewers using a standardised data extraction table. Inductive content analysis will be performed using a three-step process.

Ethics and dissemination

Given this scoping review will be an examination of the published literature, human subjects will not be included in this research. Therefore, ethics approval is not required. Knowledge mobilisation and dissemination strategies will include peer-reviewed journal articles, conference presentations, community workshops, newsletter articles and webinars. This study may provide valuable information for healthcare practitioners, community leaders and policymakers working to support people living with cognitive impairment and dementia in rural communities.

Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol

Por: Cirisola · R. W. C. · Moya · L. E. P. · Olazabal · M. V. G. · Wagmann · D. A. A. · Suarez · G. P. · Wince · C. · Bruno · M. L. H. · Salaberry · D. R. · Sobral · A. P. T. · Longo · P. L. · Motta · L. J. · Bussadori · S. K. · Duran · C. C. G. · Fernandes · K. P. S. · Mesquita-Ferrari
Introduction

Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.

Methods and analysis

A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.

Trial registration number

NCT05935306.

School-based strategies to increase physical activity and reduce sedentary behaviour in students with disability: protocol of the TransformUs All Abilities hybrid type II implementation-effectiveness trial

Por: Mazzoli · E. · Contardo Ayala · A. M. · Koorts · H. · Timperio · A. · Lander · N. · Lubans · D. R. · Ridgers · N. D. · Anderson · K. L. M. · Cairney · J. · Barnett · L. M. · Salmon · J.
Introduction

TransformUs is a multicomponent school-based programme that offers teachers professional learning and resources aligned with the Australian curriculum to promote physically active teaching and learning, a supportive environment and physical activity opportunities during recess and lunch. The programme was originally developed for students in mainstream primary schools and has been proven efficacious for increasing physical activity and reducing sedentary behaviour in children without disability. The programme has been adapted for delivery with students with disabilities in primary and secondary schools (TransformUs All Abilities). This project aims to determine the implementation at scale and effectiveness of the TransformUs All Abilities programme to increase physical activity among primary and secondary school children and adolescents with disability. This protocol describes the hybrid implementation-effectiveness trial that will be used for this evaluation.

Methods and analysis

This study employs a hybrid type II implementation-effectiveness trial to evaluate the TransformUs All Abilities programme, targeting all government and independent, primary and secondary schools in Victoria, as well as special and mainstream secondary schools in Queensland and South Australia (n=2173 eligible schools). The effectiveness trial will focus on a subgroup of government/independent special schools for students with mild to moderate intellectual disability in Victoria, involving up to three intervention and three waitlist control schools (n=61 eligible schools). In both trials, outcomes will be guided by the RE-AIM framework focusing on reach, adoption and implementation (implementation trial) and effectiveness (effectiveness trial), with data collected at baseline and 6 months. The effectiveness trial will focus on students’ device-measured physical activity and sedentary behaviour—primary outcomes—and sleep, physical literacy and cognitive functions—secondary outcomes. Teacher feedback on the programme’s adaptation and their experience with programme implementation will also be collected, alongside qualitative feedback from a subsample of students regarding engagement/enjoyment and suggestions for improvements. Implementation data will be analysed descriptively and using linear mixed models to test changes over time. Effectiveness outcomes will be analysed using linear mixed models to compare intervention and waitlist control, accounting for confounding and school/classroom clustering. Interview data will be thematically analysed.

Ethics and dissemination

Ethical approval for this trial was obtained from the Deakin University Human Research Ethics Committee (2021-368). Clearance to conduct research in schools was also obtained from the Education Departments of Victoria (2023-004726), Queensland (550/27/2592) and South Australia (2022-0020). Informed consent is required for participation in the study. School staff can enrol in the implementation trial via the TransformUs website, while the effectiveness trial requires organisational, staff, parental/carer consent and student assent. Results will be disseminated through academic publications, scientific conference presentations and summary reports to schools, parents and partner organisations.

Trial registration

ACTRN12622001082796; Universal Trial Number: U1111-1281-1103; ACTRN12622001050741: U1111-1280-8828.

Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial: protocol for a batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness-implementation trial

Por: Prendergast · N. T. · Kahn · J. M. · Angus · D. C. · Argote · L. · Barnes · B. · Chang · C.-C. H. · Graff · S. · Hess · D. R. · Onyemekwu · C. A. · Rak · K. J. · Russell · J. L. · Seaman · J. B. · Toth · K. M. · Girard · T. D.
Introduction

Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.

Methods and analysis

This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.

Ethics and dissemination

This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.

Trial registration number

NCT05523479.

Development and validation of the musculoskeletal health climate questionnaire

Por: Nielsen · K. J. · Jensen · S. H. J. · Andersen · D. R. · Andersen · J. H. · Christiansen · D. H.
Objective

To develop, evaluate and validate the musculoskeletal health climate questionnaire (MHCQ), a multidimensional questionnaire for measuring musculoskeletal health climate.

Design

Cross-sectional test–retest study including systematic scale development and psychometric validation.

Setting and participants

The questionnaire was developed following the best practice recommendations for scale development outlined by Boateng et al (2017), including item development, scale development and scale evaluation with input from experts, stakeholders and the target population. Validation was conducted among employees in three physically demanding occupations in Denmark (care workers, slaughterhouse workers and residential painters), where a total of 1420 participants were recruited through labour unions. Of these, 796 completed the retest survey 30 days later. Exploratory and confirmatory factor analyses (EFA and CFA, respectively), internal consistency (Cronbach’s α), test–retest reliability (intraclass correlation coefficients (ICC)) and SEM were used to assess the psychometric properties. Criterion validity was examined via associations with pain points, pain medication use and sickness absence. Construct validity was assessed using correlations with the prevent for work questionnaire (P4Wq).

Results

EFA and CFA supported a four-factor model (supervisor’s practices, workplace practices, worker involvement practices and workers’ pain practices) with good to excellent fit (comparative fit index, 0.96–0.99; root mean square error of approximation, 0.04–0.06). All scales showed high internal consistency (α=0.80–0.88) and excellent test–retest reliability (ICC=0.86–0.92). Associations with musculoskeletal outcomes supported criterion validity. Weak to moderate correlations with the P4Wq subscales (rho

Conclusions

The MHCQ provides a validated, multidimensional tool to assess workplace climate related to musculoskeletal health. It can support workplace assessments and prevention efforts by capturing shared perceptions of leadership, support, involvement and pain-related norms. Further longitudinal research and the use of objective outcome data are needed to assess predictive validity and strengthen the instrument’s applicability across settings.

Systematic protocol to identify 'clinical controls for paediatric neuroimaging research from clinically acquired brain MRIs

Por: Zimmerman · D. · Mandal · A. S. · Jung · B. · Buczek · M. J. · Schabdach · J. M. · Karandikar · S. · Kafadar · E. · Gardner · M. · Daniali · M. · Mercedes · L. · Kohler · S. · Abdel-Qader · L. · Gur · R. E. · Roalf · D. R. · Satterthwaite · T. D. · Williams · R. · Padmanabhan · V. · Seid
Introduction

Progress at the intersection of artificial intelligence and paediatric neuroimaging necessitates large, heterogeneous datasets to generate robust and generalisable models. Retrospective analysis of clinical brain MRI scans offers a promising avenue to augment prospective research datasets, leveraging the extensive repositories of scans routinely acquired by hospital systems in the course of clinical care. Here, we present a systematic protocol for identifying ‘scans with limited imaging pathology’ through machine-assisted manual review of radiology reports.

Methods and analysis

The protocol employs a standardised grading scheme developed with expert neuroradiologists and implemented by non-clinician graders. Categorising scans based on the presence or absence of significant pathology and image quality concerns facilitates the repurposing of clinical brain MRI data for brain research. Such an approach has the potential to harness vast clinical imaging archives—exemplified by over 250 000 brain MRIs at the Children’s Hospital of Philadelphia—to address demographic biases in research participation, to increase sample size and to improve replicability in neurodevelopmental imaging research. Ultimately, this protocol aims to enable scalable, reliable identification of clinical control brain MRIs, supporting large-scale, generalisable neuroimaging studies of typical brain development and neurogenetic conditions.

Ethics and dissemination

Studies using datasets generated from this protocol will be disseminated in peer-reviewed journals and at academic conferences.

A prospective protocol for remotely investigating brain-behaviour-genetics associations in adolescent patients in a paediatric health system with pre-existing clinical brain MRIs

Por: Mercedes · L. · Buczek · M. J. · Kafadar · E. · DiDomenico · G. · Jung · B. · Zimmerman · D. · Schabdach · J. M. · Himes · M. M. · Sotardi · S. · Vossough · A. · Driesbaugh · K. H. · Moore · T. · Barzilay · R. · Calkins · M. E. · Gur · R. E. · Roalf · D. R. · Satterthwaite · T. D. · Whit
Introduction

Adolescence is a critical period marked by rapid brain development and the onset of many mental health disorders. Brain MRI studies during adolescence, especially when paired with behavioural phenotypes and information about genetic risk factors, hold promise to advance early identification of mental health risk and spur the creation of targeted treatments to improve patient function, prognosis and quality of life. However, prospective neuroimaging is costly and time-intensive, and individuals who participate may not be reflective of the general population. These challenges are compounded when examining adolescents, as many families lack the time, energy or resources to participate in studies that use research-grade imaging. Repurposing clinical MRIs obviates many of the challenges of neuroimaging research. Here, we describe the brain-behaviour-genetics study protocol. This protocol describes procedures used to recruit participants with recent high-quality clinical brain MRIs and prospectively acquire genetic and sociobehavioural data, resulting in a highly cost-efficient design that harnesses a vast and underused neuroscientific resource.

Methods and analysis

The brain-behaviour-genetics protocol aims to recruit 1000 adolescents who have clinical brain MRIs contained in Children’s Hospital of Philadelphia’s electronic health record. One or both parents of the adolescent proband will be recruited when possible. Parents and adolescents will complete a series of self-report scales spanning the domains of mental health, trauma, risk and resilience. Saliva samples will be collected from the adolescent and at least one biological parent, using an at-home saliva collection kit. Subsequent analysis will examine associations between brain development, genetics and behavioural measures in adolescence.

Ethics and dissemination

Approval for the study had been obtained from the Children’s Hospital of Philadelphia’s institutional review board (IRB #23–0 20 851). Results will be published in peer-reviewed journals.

DIABASE: an automatically filled single-centre registry of diabetes mellitus in the Netherlands, combining clinical data with real-world longitudinal wearable device data-a study protocol

Por: Urgert · T. · Kappert · K. D. R. · Veldhuis · A. · Geerdink · J. · van Beijnum · B. J. F. · Laverman · G. D.
Introduction

Advancements in technology for treating diabetes mellitus (DM) are progressing rapidly. With the growing availability and use of continuous glucose monitoring (CGM) systems and continuous subcutaneous insulin infusion (CSII), glucose regulation is improved in individuals with DM, which will lead to less long-term complications and reduce the overall disease burden on patients with DM. Collecting vast amount of biomedical data, these devices combined with clinical outcome data provide more insight into the development and treatment of the disease. The objective of the DIABASE initiative is to collect and examine real-world data from medical devices and clinical practice in a registry.

Methods and analysis

The ongoing study is structured as an observational study registry. Clinical data and real-world data from diabetes wearable devices, such as CGM and CSII, are aggregated in the database. Clinical data is automatically extracted from the hospital’s electronic health record. Data from wearables is periodically collected manually from the various online data platforms for sharing and automatically added to the database.

Ethics and dissemination

This study is exempted from ethics approval by the Medical Research Ethics Committees United (MEC-U) since participants are not subject to procedures and are not required to follow rules of behaviour (approval ID: AW23.009/W20.197). The execution of this study has been approved by the board of the study site Hospital Group Twente (ZGT) (ZGT20-40). Results will be shared through scientific meetings and publications and through articles for the general public.

Trial registration number

NCT05584293; Pre-results.

Upfront surgery versus induction chemotherapy followed by surgery in oral cavity squamous cell cancers with advanced nodal disease (SurVIC Trial): a phase 3 multicentre randomised controlled trial

Por: Poonia · D. R. · Sehrawat · A. · Vishnoi · J. R. · Sharma · N. · Kumar · P. · Devnani · B. · Warriere · A. · Solanki · A. · Pareek · P. · Aggarwal · D. · Yadav · T. · Sharma · P. P. · Gadwal · A. · Goyal · A. · Elhence · P. · Khera · P. · Jakhetiya · A. · Swaim · P. · Muduly · D. · Mahajan
Introduction

Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2–N3).

Methods and analysis

The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).

The study population consists of patients with operable OSCC and advanced nodal disease (N2–N3), adequate organ function, aged 18–65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included.

Ethics and dissemination

This trial aims to establish the potential superiority of ICT or definitively determine its futility in OSCC with advanced nodal disease. A positive outcome could provide practice-changing data, particularly for Indian patients, whereas negative results could halt the use of ICT in this setting, directing research efforts towards more effective treatment strategies.

Trial registration number

CTRI/2024/03/064586; NCT06737822; Institutional Ethics Committee (IEC) number: AIIMS/IEC/2023/4622 (lead site).

Understanding structured medication reviews delivered by clinical pharmacists in primary care in England: a national cross-sectional survey

Por: Agwunobi · A. J. · Seeley · A. E. · Tucker · K. L. · Bateman · P. A. · Clark · C. E. · Clegg · A. · Ford · G. · Gadhia · S. · Hobbs · F. D. R. · Khunti · K. · Lip · G. Y. H. · de Lusignan · S. · Mant · J. · McCahon · D. · Payne · R. A. · Perera · R. · Seidu · S. · Sheppard · J. P. · Willia
Objectives

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

Design

A cross-sectional mixed methods online survey.

Setting

Primary care in England.

Participants

120 clinical pharmacists with experience in conducting SMRs in primary care.

Results

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

Conclusions

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

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

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

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

Design

Cross-sectional study.

Setting

PHC facilities across various provinces in Nepal.

Participants

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

Main outcome measures

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

Results

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

Conclusion

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

Self-directed arm-crank exercise to improve volitional control of the trunk in patients with subacute spinal cord injury: a multicentre, parallel-group, randomised controlled trial protocol

Por: Hidalgo Mas · M. d. R. · Kearney · J. · Middleton · V. · Chiu · C.-Y. · Duda · J. L. · Nightingale · T. E. · Martinez-Valdes · E. · Ahmed · Z. · Chiou · S.-Y.
Introduction

A spinal cord injury (SCI) disrupts synaptic connections between the corticospinal tract and motor neurons, impairing muscle control below the injury site. Many individuals with an SCI have impaired trunk control, affecting the performance of activities of daily living and quality of life. Work has shown improvements in trunk control after home-based, unsupervised arm-crank exercise training (ACET) in people with chronic motor-incomplete SCI. However, no studies have examined ACET’s impact on trunk control in individuals with subacute SCI. This study aims to investigate ACET’s effects on trunk control in adults with subacute incomplete SCI, and its mechanisms, and its long-term benefits on neuropathic pain, psychological well-being, physical activity levels and health-related quality of life.

Methods and analysis

This multicentre, parallel-group, randomised controlled trial will evaluate self-directed ACET in 60 individuals with subacute SCI (

Ethics and dissemination

This study was approved by The Health Research Authority and Health and Care Research Wales (22/NS/0054). Results will be published in peer-reviewed journals. Findings will be presented at National and International conferences for researchers and clinicians. Finally, results will be disseminated to the SCI community.

Trial registration number

ISRCTN17247972

Clinical outcomes and interventions related to sedentary behaviours in childhood, adolescent, and young adult cancer patients and survivors: a scoping review protocol

Por: Ivory · B. J. · Moore · K. · Dinalo · J. E. · Ness · K. K. · Orgel · E. · Dieli-Conwright · C. M. · Kadan-Lottick · N. S. · Freyer · D. R. · Belcher · B. R.
Introduction

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

Methods and analysis

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics and dissemination

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

Registration details

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

Awareness and prevalence of the symptoms of testosterone deficiency: a cross-sectional survey of community-dwelling men in the UK

Por: Liu · V. N. · Huang · D. R. · Alaa · A. · Hayhoe · B. · El-Osta · A.
Objectives

Non-specific symptoms of testosterone deficiency (TD) and lack of awareness impact diagnosis and appropriate treatment. This study aimed to characterise the awareness of key symptoms of TD in community-dwelling men and contextualise this against the reported prevalence of these symptoms.

Design

Cross-sectional survey comprising 54 questions (including assessment of symptoms as per the qADAM questionnaire and where relevant, men’s experiences while on TD treatment). The survey was distributed through online media channels, Prolific and academic networks.

Setting

Community-dwelling men in the UK.

Outcome measures

Associations between age, participant demographics and a ‘positive’ qADAM score were assessed using logistic regression. A positive qADAM score was defined as self-rated ‘poor’ or ‘terrible’ libido or erection strength or rating 3 of the other questionnaire domains as ‘poor’ or ‘terrible’.

Results

Of 973 men, 49% indicated high likelihood of TD using qADAM scores—5% were formally diagnosed. Men over 50 years of age had 1.54–2.0 times higher odds of TD compared with men aged

Conclusions

Almost half of the responders exhibited a burden of TD-associated symptoms, but under 5% had a formal diagnosis. These findings suggest significant gaps between symptom awareness and access to treatment options.

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