Poverty can have profound negative impacts on parent, child and family health. Primary care providers are in a unique position to address child poverty. Some team-based models have integrated community support workers (CSWs) for social service system navigation assistance. The overall aim of this study is to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care. The primary objective is to compare parenting stress between CSW-supported, structured review of financial supports and social system navigation (intervention) and receipt of written summary of local resources (usual care).
This is a multisite pragmatic superiority randomised controlled trial with a 1:1 allocation to the CSW-supported social system navigation versus no navigation. Parent–child dyads (80 parents of children aged Do you ever have difficulty making ends meet at the end of the month?’) will be recruited during a scheduled health supervision visit from primary care practices in Kingston, Ontario. Intervention group participants will have a structured review of financial supports with a trained CSW and will meet up to 6 times over 6 months. Outcomes are measured at baseline, 6 months and 12 months after randomisation. The primary outcome is the Parenting Stress Index Fourth Edition Short Form (PSI-4-SF) total score at 6 months. Secondary outcomes include household income, food insecurity, parent mental health (depression and anxiety) and child health. An internal pilot study was used to obtain more reliable estimates of the SD of PSI-4-SF at 6 months to recalculate the sample size (if needed) and assess randomisation and completion rates. Qualitative interviews conducted 9 months after enrolment explore parent experiences with the CSW intervention.
Research ethics approval by Queen’s University Health Sciences REB. Results will be shared with the College of Family Physicians of Canada, the Ontario SPOR SUPPORT Unit and academic forums.
Connecting Families (Registered 12 October 2021 at www.clinicaltrials.gov;
by Natalia Mach, Julien Polleux, Lea Heinrich, Lukas Lechner, Iryna Levytska, Cornelia Lass-Flörl, Susanne Perkhofer
Aspergillus terreus is an opportunistic fungal pathogen associated with high mortality rates and intrinsic resistance to amphotericin B. Its ability to persist within host tissues without inducing strong immune responses was suggested to contribute to poor clinical outcomes. The cellular mechanisms underlying A. terreus interactions with host cells remain largely unexplored. In this study, we have used a micropattern-based infection model to investigate the early interactions between A. terreus conidia and alveolar epithelial cells, focusing on the role of Arp2/3-dependent actin remodeling. This system allows quantitative analysis of conidia-cell interactions under defined spatial conditions. We show that A. terreus conidia rapidly bind to micropatterned A549 cell islands, with conidial numbers increasing over time. Conidia were found in actin- and Lamp1-positive vesicles already after one hour of infection. Inhibition of the Arp2/3 complex significantly impaired conidial binding and disrupted the formation of actin-positive vesicles, confirming the essential role of Arp2/3-mediated actin remodeling in early stages of conidial uptake. A subset of conidia was localized to Lamp1-positive phagolysosomes and accumulated over time. Interestingly, we have identified a small but consistent population of Lamp1-positive vesicles decorated with actin structures, potentially resembling actin flashes. These structures were entirely abolished upon Arp2/3 inhibition, indicating active cytoskeletal remodeling at the phagolysosomal interface. Our findings provide the first mechanistic insights into A. terreus internalization by alveolar epithelial cells and establish Arp2/3-mediated actin dynamics as a key process in early host-pathogen interactions. This cellular pathway may further contribute to intracellular trafficking and help understand the delayed onset of A. terreus infections.The commercial determinants of health (CDoH) are a rapidly growing field of research and global health priority. Despite being disproportionately affected, Indigenous Peoples’ voices and perspectives are conspicuously absent from CDoH research and policy. This article outlines the protocol for Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE), an Aboriginal and Torres Strait Islander-led project in Australia.
ACHIEVE integrates four research streams, using a novel combination of methods. The first three streams will (i) conceptualise the CDoH using Indigenous yarning methodology, (ii) evaluate the effectiveness and cost-effectiveness of policies to reduce exposure to harmful marketing and (iii) assess the impacts of specific commercial entities on Aboriginal and Torres Strait Islander health using case studies. The final stream will consolidate findings from streams 1–3 and work with Aboriginal Community Controlled Health Organisations (ACCHOs) to co-create strategies for addressing the commercial determinants of Aboriginal and Torres Strait Islander health.
Ethical approval for streams 1–3 has been granted by Deakin University Human Research Ethics Committee. ACHIEVE is guided by a governance model that prioritises Indigenous data sovereignty, community and ACCHO partnerships, capacity building and knowledge translation. Findings will be shared with participants, ACCHOs and policymakers to maximise research impact.
by Ploy Khongrungjarat, Chonnikan Tothong, Chanyanut Pankaew, Suchada Phimsen, Nopawit Khamto, Nutthamon Kijchalao, Warissara Wongkham, Piyathida Wongkham, Wipaporn Chuaymaung, Adsadayu Thonnondang, Apinun Limmongkon
Prenylated stilbenoids, particularly trans-arachidin-1 (Ara-1) and trans-arachidin-3 (Ara-3), have gained attention for their notable bioactivities and potential health-promoting properties. This study presents the first comprehensive investigation into the stability and biological efficacy of these compounds in both peanut hairy root culture crude extracts (PCE) and partially purified fractions derived from elicited peanut hairy root cultures. PCE stored at –20 °C and 4 °C maintained higher antioxidant capacity, total phenolic content compared to samples stored at room temperature. In cytotoxicity assays using SW480 colon cancer cells, the extract stored at –20 °C retained bioactivity with only minor changes in IC₅₀ values over three months, demonstrating superior stability under frozen conditions. Over a six-month period, partially purified fractions of Ara-1 and Ara-3 showed a time-dependent decline in compound content. However, Ara-3 maintained strong cytotoxicity against KKU-100 cholangiocarcinoma cells, while Ara-1 exhibited a significant loss in activity. These findings demonstrate that low-temperature storage, particularly at –20 °C, is crucial for preserving the chemical integrity and bioactivity of stilbenoid-rich extracts. The study underscores the importance of optimizing storage conditions to ensure consistent bioactivity, supporting the potential application of these compounds in the development of stable and effective pharmaceutical or nutraceutical products.A new surgical technique for ray amputation of the diabetic foot is described. The procedure provides soft tissue reconstruction using a local flap in combination with negative pressure wound therapy to close these wounds safely and effectively. This article reports on 12 patients treated with this technique in a Tertiary Hospital/General Hospital in Singapore and compares their outcomes to those of 12 comparative cases from neighbouring institutions under the same health group who received conventional dressings. The new technique led to a higher number of healed wounds (12 vs. 4) and a shorter median time to healing (46.5 vs. 196.5 days). No major amputation or further minor amputation of the target limb occurred in the group treated with the new technique, whereas one major amputation and two further minor amputations took place in the comparison group. Our results suggest that the new technique is promising in this diabetic population with concurrent comorbidities.
Patients with combat wounds and injuries, presented as extensive infected and purulent defects with antibiotic-resistant microflora, were treated in a surgical inpatient setting. Closure of extensive soft tissue defects of the limbs is possible using methods of plastic and reconstructive surgery and requires preoperative infection control. The lack of effect from preoperative treatment for purulent limb defects with antibiotic-resistant microflora leads to limb amputation. This clinical study proposes a method of treatment by hyperbaric oxygenation with an ozone-containing steam–water mixture as an anti-bacterial agent. Eighteen male patients, aged between 20 and 60 years, were categorised into three groups based on the time elapsed since the injury. All patients were treated using the proposed method. The high effectiveness of the proposed method was demonstrated in all groups and resulted in saving limbs from amputation, establishing suitable conditions for closing the soft tissue defects of the limbs and achieving significant progress in the recovery.
by Thanh Luan Nguyen, Thanh Khoi Tu, Thien-Vy Phan, Chanh M. Nguyen, Khoa D. Nguyen, Minh Quan Pham, Hai Ha Pham Thi
Cyperus amuricus (Cyperaceae) has exhibited potential anticancer activity against hepatocellular carcinoma (HCC), yet its molecular mechanisms and phytoconstituent interactions with oncogenic pathways remain underexplored. This study integrates in vitro cytotoxicity assays and molecular docking to evaluate the effects of C. amuricus fractionated extracts on HCC, focusing on PI3K/AKT/mTOR signaling axis. The ethyl acetate (EA) fraction selectively inhibited HepG2 cell proliferation (IC50 = 159.76 µg/mL) with minimal toxicity to normal fibroblasts. Apoptotic features—cell shrinkage, membrane blebbing, nuclear condensation, and DNA fragmentation—were confirmed through DAPI staining and gel electrophoresis. Western blot analysis revealed dose-dependent suppression of phosphorylated Akt and p70S6K, indicating pathway inhibition. Molecular docking identified strong binding affinities between Cyperaceae-derived compounds and PI3K/AKT/mTOR targets, with luteolin 7-O-β-D-glucuronopyranoside-6″-methyl ester blocked PI3K activation, vitexin bound AKT’s allosteric site, and digitoxin targeted mTOR’s ATP-binding pocket, showing comparable binding energies to reference ligands. These findings suggest C. amuricus as a promising candidate for natural product-based HCC therapy.by Tatiana Petukhova, Maria Spinato, Tanya Rossi, Michele T. Guerin, Cathy A. Bauman, Pauline Nelson-Smikle, Davor Ojkic, Zvonimir Poljak
Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) is endemic in many pig-producing countries and poses significant health and economic challenges. Enhanced surveillance strategies are essential for effective disease management. This study aimed to evaluate and compare the performance of different time-series modeling techniques to predict weekly PRRSV-positive laboratory submissions in Ontario, Canada. Ten years of PRRSV diagnostic data were obtained from the Animal Health Laboratory at the University of Guelph and were processed into a weekly time series. The dataset was analyzed with autoregressive integrated moving average (ARIMA), exponential smoothing (ETS), random forest (RF), and recurrent neural network (RNN) models. Two validation strategies were employed: a traditional train-test split and a simulated prospective rolling forecast. Model accuracy was evaluated using common predictive error metrics. Descriptive analysis indicated a gradual increase in PRRSV positive submissions over time, with no consistent seasonal pattern. ARIMA and ETS models generally overpredict case counts, while RF and RNN tended to underpredict them. Among the evaluated models, the RF regression model most accurately captured the underlying time-series dynamics and produced the lowest prediction errors across both validation approaches. Despite outperforming other models, the RF model’s high relative prediction errors limit its suitability for accurate forecasting of PRRSV-positive submissions in Ontario’s routine surveillance system. Further data refinement and algorithm improvements are warranted.This study assessed whether a previously developed Monte Carlo simulation model can be reused for evaluating various strategies to minimise time-to-treatment in southwest Netherlands for endovascular thrombectomy (EVT) in patients who had an ischaemic stroke.
Reuse of a previously developed simulation model to simulate various strategies in another region, using prospectively collected data from stroke centres and retrospective data from emergency medical services.
Data from 509 patients who had an ischaemic stroke (≥18 years) treated with EVT (2014–2018) were used.
Input for the simulation model reuse included distributions of observed time delays along the acute stroke pathway. Validation of the baseline models was based on face validity and statistical measures (patient data vs model output) using the Assessment of the Validation Status of Health Economic decision models tool. We simulated strategies for a subregion: interhospital patient transfer by helicopter, transport of the neurointerventionalist to the primary stroke centre (‘drive-the-doctor’), interhospital patient transfer to a thrombectomy-capable stroke centre (TSC) outside the region and prehospital triage using the Rapid Arterial Occlusion Evaluation (RACE) scale.
Onset-to-groin time was the outcome.
Reuse of the original simulation model was obtained by minimal effort, implying limited adaptation. Compared with the baseline model, interhospital patient transfer by helicopter or to a TSC outside the region and prehospital routing using the RACE scale reduced mean onset-to-groin time by 16, 13 and 39 min, respectively (95% CrI for all: equal to the point estimate). ‘Drive the doctor’ reduced mean onset-to-groin time by 27 (car), 49 (ambulance) or 58 min (helicopter), each with a 95% CrI equal to the point estimate.
The original simulation model can be applied to different regions in the Netherlands. Strategies tested within the subregion resulted in promising results of ‘drive the doctor’ and prehospital patient routing using the RACE scale.
Parkinson’s disease (PD) is a neurodegenerative disorder characterised by heterogeneous motor symptoms, non-motor symptoms and rates of disease progression; phenotype and prognosis vary by individual. Although researchers have attempted to predict clinical outcomes using biomarkers and other variables, there are limited data on the development, validation and clinical utility of multivariable prediction models for individual prognostication in PD. In this protocol, we will develop a method for identifying, reviewing and appraising existing PD prognostic models in order to summarise the current literature, identify knowledge gaps and inform future research.
This scoping review will be guided by the methodological principles outlined in the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews. We will include all multivariable models that predict disease progression in individuals with PD using traditional statistical methods or machine learning. We will exclude models that only report performance measures for one variable (ie, univariable models) or only provide effect estimates (eg, OR, HR). A detailed search of peer-reviewed research publications will be performed through 2025 using the following electronic databases: PubMed, EMBASE, Web of Science and Scopus. Article data will be extracted using Covidence. Two independent reviewers will screen articles by title and abstract for relevance, and a third reviewer will resolve any discrepancies. The remaining full-text articles will also be screened by two independent reviewers, and a third reviewer will resolve any discrepancies. Results from multivariable prediction models meeting inclusion criteria will be summarised using narrative synthesis and organised by clinical outcome. Models will also be appraised using Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis + Artificial Intelligence (TRIPOD+AI) and Prediction model Risk Of Bias ASsessment Tool (PROBAST) guidelines to identify deficiencies and areas of future study.
Ethical approval is not required for this scoping review. Findings will help clinicians make evidence-based decisions to improve prognostication in PD. Findings can also be used to inform the development and validation of additional multivariable clinical prediction models in PD. The results of this scoping review will be disseminated through peer-reviewed publications, research reports and presentations at relevant conferences.
Interstitial lung diseases (ILD) associated with an underlying connective tissue disease (CTD), also known as a systemic autoimmune rheumatic disease or SARD, are chronic conditions with a tendency to progress. CTD-ILDs are increasingly diagnosed and pose an important global health challenge. This systematic review aims to provide an overarching evaluation of their epidemiology and disease burden in Asia. In this review, the term CTD-ILD will be used to denote all major forms of ILD arising in the context of a SARD.
This systematic review will adhere to the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a flow diagram to depict the process by four independent reviewers that will assess titles and abstracts against the following predetermined criteria. A systematic review of the literature search published from 2000 to 2024 will be conducted using five electronic databases including PubMed/MEDLINE, Scopus, EMBASE, Cochrane Library and Web of Science. Publications that meet the inclusion criteria of this review will be subjected to a full-text review to extract relevant data. Collated data will be analysed and organised into categories based on the expected outcome and objectives. The quality of published evidence, including heterogeneity across studies, will be checked against PRISMA checklists and assessed by Newcastle-Ottawa Scale.
Ethics approval is not applicable for this study since no original data will be collected. The findings of this review will be disseminated through a peer-reviewed publication in a scientific journal and conference communications, with the aim of contributing insights to the field by identifying research gaps and informing clinical practice.
The protocol of this systematic review is registered with the National Medical & Research Register (ID-24–03600-GUB) and International Prospective Register of Systematic Reviews PROSPERO (CRD420251037095).
Randomised controlled trials (RCTs) are central to generating high-quality evidence in the surgical field but face unique methodological and practical challenges, including recruitment, follow-up, blinding and ensuring patient-centred outcomes. Patient and public involvement (PPI) has emerged as a promising strategy to enhance the relevance, quality and impact of surgical research by actively involving patients throughout the whole research process. Despite growing recognition of its value, the integration and reporting of PPI in surgical RCTs remain inconsistent, and no systematic evaluation has yet addressed its application within general and abdominal surgery.
RCTs in general and abdominal surgery published since 2014 will be identified through systematic searches of the databases MEDLINE, Web of Science and CENTRAL. This systematic review and primary (meta-epidemiological) statistical analysis will assess the reporting prevalence, implementation extent and quality of PPI over time. The Guidance for Reporting Involvement of Patients and the Public 2 (GRIPP2)-SF checklist and Cochrane Risk of Bias V.2.0 tool will be used to evaluate PPI reporting and study quality. To enable a comparison between studies reporting PPI and those that do not, propensity score matching will be performed to identify non-PPI studies with similar population and design characteristics. Subsequently, regression analyses will be employed to investigate potential associations between PPI reporting and various trial characteristics, including patient recruitment and retention, outcome selection and methodological quality. The Patient Advisory Board of the Study Centre of the German Society of Surgery is actively engaged in all phases of the systematic review.
This systematic review does not require ethical approval. Results will be published in an international peer-reviewed scientific journal, as well as distributed in a lay format to the patient community and to the broader public.
CRD42024524426.
To develop survey items for a national patient registry on Long COVID using a modified Delphi process.
This study was based on a modified Delphi process involving three rounds of anonymous, online surveys to develop consensus on and prioritise survey elements to be included in a minimum dataset for use in a national patient registry in Canada. Initial Long COVID items were identified through an environmental scan of the literature.
This study focused on healthcare systems in Canada and was conducted online.
A panel of 52 experts (patients, caregivers, clinicians and researchers) participated in all three rounds of the online survey. These participants were recruited through the Long COVID Web network and word of mouth.
In total, 243 survey elements related to care, quality of life and symptoms were included in round 1 of the survey. 200 reached consensus and moved to round 2 with two additional elements being developed based on open-ended responses. In round 2, participants ranked these survey elements and 34 advanced. In round 3, 33 survey elements met the threshold of consensus with one added a priori. The 33 survey elements were then used to develop a Long COVID minimum dataset, which consists of 48 items.
The findings affirm broad consensus for collecting data related to fatigue, post-exertional malaise, cardiovascular issues, respiratory problems and cognitive issues. This highlighted the desire for quality-of-life indicators and information related to care utilisation, quality and access.
by Areeya Madsusan, Saowaluk Krainara, Wantanasak Suksong, Kittithat Sudchoo, Nadeyah Tohmoh, Pattharaporn Jonggrijug, Chomkaeo Maipunklang, Chanitsara Chadaram, Kholeeyoh Samaeng, Piyadhida Kurdthongmee, Uratit Noosab, Arun Nakapong, Yanawut Udomsri, Suttiporn Kanaso, Natee Sakorn, Ng Yee Guan, Sukrit Sangkhano
Gross anatomy dissection is an essential component of medical and health science education, yet it presents notable occupational hazards, particularly from formaldehyde (FA) exposure and microbial contamination. These risks may be intensified in anatomy dissection halls located in tropical monsoon (Am) climates, where elevated humidity and temperature promote both chemical volatility and microbial persistence. This study assessed the combined effects of such climatic conditions on FA concentrations and microbial ecology within a naturally ventilated dissection hall in southern Thailand. FA levels were measured through personal and area air sampling across seven anatomical regions, while microbial contamination on cadaver-contact surfaces was evaluated using culture-based methods and high-throughput sequencing. Functional prediction of microbial communities was performed using PICRUSt2 to assess their metabolic adaptation to environmental stressors. The results revealed that both personal and indoor FA concentrations (mean 1.17 ± 0.39 ppm and 1.09 ± 0.45 ppm, respectively) exceeded several international occupational exposure limits, with the highest levels observed during dissections involving deep or adipose-rich anatomical regions. Microbial analyses identified stress-tolerant and potentially pathogenic genera, including Bdellovibrio, Aequorivita, and Aspergillus spp., along with enriched pathways involved in aromatic compound degradation and environmental resilience. These findings highlight the limitations of natural ventilation in controlling occupational exposures and microbial contamination in Am climate anatomy laboratories. The study supports the implementation of climate-responsive engineering controls and laboratory management strategies that address chemical safety, thermal regulation, and biosafety to promote healthier and more sustainable dissection environments in similar high-risk settings.To explore perceptions regarding the approved and actual prescribed doses of protein kinase inhibitors (PKIs) in clinical practice in the European Union among medicine regulators and healthcare professionals (HCPs).
A qualitative descriptive study was conducted using semistructured interviews, continuing until thematic saturation was reached. Thematic analysis was undertaken using a combined deductive-inductive approach. Deductive main analytical themes were derived from the theoretical framework of questioning-based policy design, namely problem sensing, problem categorisation and problem decomposition. Subthemes were generated inductively and could coherently be situated within these main analytical themes.
Interviews were held online or in person at a location convenient for the interviewee, depending on the participant’s preference.
Seven medicine regulators involved in the regulation of cancer medicines—including PKIs—and 10 HCPs prescribing PKIs in clinical practice, from various countries within Europe, were included.
Regulators highlighted insufficient attention to optimal dose finding, yielding approved doses often based on outdated maximum tolerated dose concepts, leading to uncertainties in efficacy and safety. HCPs reported using alternative dosing strategies in clinical practice to improve tolerability and quality of life (QoL) but noted a lack of robust evidence to guide such adjustments and faced legal constraints to deviate from the approved dose. Participants emphasised the need for improved pre-approval and post-approval dose optimisation to improve safety, enhance QoL and bridge gaps between trial data and real-world patient diversity.
Collaborative efforts involving multistakeholders including HCPs, regulators, pharmaceutical companies, insurers, governments and patient representatives are essential to advance dose optimisation and improve patient-centric outcomes, with further research needed to understand these stakeholders’ perspectives.
A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.
This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).
The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.
In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.
The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.
In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.
TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.
Although there are some drugs to control Parkinson’s disease (PD), they have several side effects and cannot control the inflammation and oxidative stress, the leading causes of PD progression. On the other hand, there is a growing interest in herbal medicine as a safe and cheap adjunctive therapy to prevent PD progression. In this regard, limited human studies investigated the effect of saffron, a rich source of antioxidants, on PD. Nevertheless, due to low sample size, saffron dosage and study duration, they could not completely affirm the efficacy of saffron on PD. Therefore, this triple-blind randomised controlled clinical trial aimed to investigate this subject in human patients with a proper sample size, saffron dosage and duration study.
In this parallel, randomised, triple-blind controlled clinical trial, 92 patients with PD will be randomised into two groups to receive either (1) a daily tablet containing 100 mg/d saffron for 12 weeks or (2) placebo tablets for the same duration. The following variables will be assessed before and after the intervention, as the outcomes of interest: serum values of C-reactive protein, total antioxidant capacity, malondialdehyde, glutathione, zonulin, the activity of catalase enzyme, PD stage, symptoms of PD (motor symptoms, non-motor symptoms), quality of life, mental health, sleep quality, cognitive status, anthropometric indices, blood pressure, gastrointestinal symptoms, appetite and fatigue. The intention-to-treat approach will be used for patients who were lost to follow-up. Additionally, to adjust for the potential confounders, a one-way analysis of covariance will be performed.
This study was confirmed by the Ethics Committee of Isfahan University of Medical Sciences with the code of IR.MUI.PHANUT.REC.1402.072. Written informed consent to participate will be obtained from all participants. Final findings will be presented in future publications and scientific congresses.
IRCT20121216011763N61; Pre-results.
Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.
Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).
Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.
Diabetes mellitus is a significant global health challenge, requiring innovative strategies to improve management and mitigate complications. Digital health technologies offer promising solutions to enhance diabetes self-care by providing real-time feedback, improving communication and supporting data-driven decision-making. Despite the increasing adoption of digital self-care interventions, there is a lack of comprehensive synthesis of evidence on their impact, accessibility and integration into healthcare systems. This scoping review aims to map existing research on digital self-care solutions for diabetes management, identify knowledge gaps and highlight best practices and key factors influencing adoption.
The review will follow Arksey and O’Malley’s framework and adhere to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A systematic search will be conducted in Medline, Scopus, Embase, CINAHL and Google Scholar, focusing on studies published from January 2004 to December 2024 in English, French, Arabic, Portuguese, Spanish, Italian, Czech, Slovak and Chinese. Studies reporting on digital self-care solutions for diabetes management will be included, covering experimental and quasi-experimental study designs. Data extraction will cover study and participant characteristics, digital solution features, and barriers and facilitators to adoption. Ethical and equity considerations will also be analysed using established frameworks. Two reviewers will independently screen studies, with discrepancies resolved by a third reviewer.
This scoping review will provide a comprehensive understanding of digital self-care solutions for diabetes management, offering insights to inform future research and enhance self-care practices globally. Findings will be disseminated through peer-reviewed publications, conferences and interest holder engagements to inform clinical practice and policy development. As this study involves the review of existing literature, ethical approval is not required.