Artificial intelligence (AI) is increasingly being used in cancer care across the Asia-Pacific region.However, AI tools that work well in one country or hospital can fail in another because of differences in patients, equipment, language, and clinical practice.This commentary explains why three different checks-validation (does it work for our patients?),verification (is it built correctly?), and auditing (is it safe and fair over time?)-are all needed to ensure AI is used safely.We argue that oncology nurses, who spend the most time with patients, are essential partners in these checks but are usually left out.To address this, we propose the Integrated Clinical AI Audit Principles (ICAAP): seven evidence-based principles that combine the best parts of existing AI governance frameworks.Embedding nurses as formal AI auditors can help ensure that AI-enabled cancer care is safer and more patient-centered.
Background: Burnout negatively impacts healthcare professionals' well-being, leading to an increased risk of human errors and patient harm. There are limited assessments of burnout and associated stressors among acute care and trauma surgery teams. Methods: Acute care and trauma surgery team members at a US academic medical center were administered a survey that included a 2-item Maslach Burnout Inventory and 21 workplace stressors based on the National Academy of Medicine's systems model of clinician burnout and professional well-being. Stressors were summarized and presented to participants in focus groups. Contextual inquiries (CIs) were conducted to gather additional information about key stressors. Qualitative data were used to generate an affinity model, which participants then validated and used to prioritize top stressors. Participants rated stressors by level of impact and level of effort, and improvement recommendations were made based on these results. Results: 74% (n=14/19) acute care and trauma surgery team members reported high burnout. Key stressors included inadequate staffing, organizational culture, excessive workload, and inefficient workflows. Attending faculty (surgeons) classified the following key priorities for improvement: (i) improve throughput and patient flow, (ii) provide better information technology support, and (iii) improve rewards and support. Non-faculty (advanced practice providers (APPs), nurses, staff) classified the following for improvement: (i) align APP job responsibilities, (ii) improve lack of recognition from leadership, and (iii) robust and consistent APP training. Conclusions: A contextual design approach to studying burnout using surveys, focus groups, CIs, modeling, and validation and prioritization is a feasible method for identifying key stressors and improvements that may enable more impactful and appropriately targeted interventions. Results indicate high levels of burnout among acute care and trauma surgery team members, requiring prioritized attention to operational and relationship issues necessary to care for patients. Efforts to improve surgery teams' workflows, auxiliary support, compensation, and relationships with leadership may address burnout. Level of evidence: Level V.
BACKGROUND: Clinician well-being is crucial to the healthcare system, particularly during the COVID-19 pandemic, which intensified psychological distress among clinicians. This study examines well-being disparities between rural and urban clinicians using the NIOSH Worker Well-Being Questionnaire (WellBQ). METHODS: A cross-sectional survey was conducted with 222 clinicians from one urban and three rural hospitals in North Carolina between September and December 2022. The WellBQ assessed well-being across five domains. Data analysis identified concerning thresholds based on positive and negative responses, with discrepancies resolved through independent reviews and focus group validation. FINDINGS: In the work evaluation and experience domain, rural hospitals reported concerns with time paucity and work overload, while urban hospitals focused on work-related fatigue and job engagement. Rural hospitals noted issues with job benefits, health programs, and schedule flexibility, whereas urban hospitals emphasized the lack of supportive work culture and management trust. Both settings reported concerns in the physical environment and safety climate domain, including sexual harassment, physical violence, and bullying. Health status concerns in rural hospitals included overall stress and poor mental health, while urban hospitals highlighted chronic health conditions and risky drinking. CONCLUSION: This study identified significant well-being disparities between rural and urban clinicians, with urban hospitals showing higher concerning thresholds. Future research should refine these thresholds, explore workplace violence causes, and assess long-term impacts on clinician well-being.Applications to Practice:This study reveals significant well-being disparities between rural and urban clinicians, emphasizing the need for tailored occupational health interventions.
OBJECTIVE: There is growing evidence that hypertensive pregnancy complications and other adverse pregnancy outcomes are associated with the presence of inherited or acquired thrombophilias. As hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome is one of the most severe forms of pre-eclampsia we aimed to assess the prevalence of the factor V Leiden, the prothrombin 20210G >A mutation and the methylenetetrahydrofolate reductase (MTHFR) 677C >T polymorphism in women with HELLP syndrome and in their fetuses from the same index pregnancy. DESIGN: The study was performed retrospectively in a case-control design. SAMPLE: Seventy-one mother-child pairs with HELLP syndrome and 79 control mother-child pairs with uncomplicated pregnancies were included in the study. METHODS: Genotyping of the three thrombophilic mutations was performed using the LightCycler technology. The chi-squared test was used for statistical analysis. Main outcome measures were maternal and fetal genotypes and their correlation with clinical parameters. RESULTS: Maternal heterozygosity for factor V Leiden was significantly more prevalent in the HELLP group than in controls (OR 4.45, 95% CI 1.31-15.31). No significant association was observed for maternal prothrombin mutation or MTHFR polymorphism (p=0.894, p=0.189, respectively). The fetal genotype was not associated with HELLP syndrome for any of the three mutations investigated. Analysis of gene-gene interactions and genotype-phenotype correlation with respect to clinical parameters and perinatal outcome revealed no further differences. CONCLUSIONS: Our study confirms that women heterozygous for factor V Leiden have an increased risk of developing HELLP syndrome, while the most frequent mutations of the prothrombin and MTHFR gene do not play a major role in the pathogenesis of HELLP syndrome.
INTRODUCTION: The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques to prevent agitation. Time pressure, fluctuating work demands, and other systems-related factors pose challenges to efficient decision-making and adoption of best practice recommendations during an unfolding behavioural crisis. As such, we propose to design, develop and evaluate a computerised clinical decision support (CDS) system, Early Detection and Treatment to Reduce Events with Agitation Tool (ED-TREAT). We aim to identify patients at risk of agitation and guide ED clinicians through appropriate risk assessment and timely interventions to prevent agitation with a goal of minimising restraint use and improving patient experience and outcomes. METHODS AND ANALYSIS: This study describes the formative evaluation of the health record embedded CDS tool. Under aim 1, the study will collect qualitative data to design and develop ED-TREAT using a contextual design approach and an iterative user-centred design process. Participants will include potential CDS users, that is, ED physicians, nurses, technicians, as well as patients with lived experience of restraint use for behavioural crisis management during an ED visit. We will use purposive sampling to ensure the full spectrum of perspectives until we reach thematic saturation. Next, under aim 2, the study will conduct a pilot, randomised controlled trial of ED-TREAT at two adult ED sites in a regional health system in the Northeast USA to evaluate the feasibility, fidelity and bedside acceptability of ED-TREAT. We aim to recruit a total of at least 26 eligible subjects under the pilot trial. ETHICS AND DISSEMINATION: Ethical approval by the Yale University Human Investigation Committee was obtained in 2021 (HIC# 2000030893 and 2000030906). All participants will provide informed verbal consent prior to being enrolled in the study. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations or through direct email notifications. TRIAL REGISTRATION NUMBER: NCT04959279; Pre-results.
In resource-constrained countries like India, mammography-based breast screening is challenging to implement. This state-wide study, funded by the Government of Punjab, evaluated the use of Thermalytix, a low-cost, radiation-free AI tool, for breast cancer screening. Community health workers, trained to raise awareness, mobilized women aged 30 and above for screening. Thermalytix triaged women into five risk categories based on thermal images, with high-risk women recalled for diagnostic imaging. Over 18 months, 15,069 women were screened across 183 locations in Punjab. The median age was 41 years, and 69.9% were asymptomatic. Of 460 women testing positive (recall rate 3.1%), 268 underwent follow-up imaging, and 27 were confirmed with breast cancer, yielding a detection rate of 0.18%. The positive predictive value of biopsy performed was 81.81%, and the median diagnostic interval was 21 days, with therapy initiation within 30 days. The study demonstrates the potential of Thermalytix for effective population-level breast cancer screening in low-resource settings.
Read moreB1MG WP1 organises the stakeholder engagement in the field of genomics-based health that have the expertise and capacities to play a role in the European 1+MG Initiative. Priority is to engage key stakeholders in the essential workstreams organised as part of the B1MG Work Packages (and their corresponding 1+MG Working Groups). Stakeholders are organisations of a variable nature and scope, and B1MG chooses to organise their involvement at multiple levels. Stakeholders are here defined as European, national and regional organisations and individuals active in and/or interested in the development and implementation of genomics-based health in national and regional healthcare systems. In particular, B1MG addresses stakeholders active in and/or interested in realising the key goal of the 1+MG initiative: the ability to make genomics and related health data accessible across borders for trans-national use in research, diagnostics and/or innovation of healthcare. The B1MG stakeholder organisation targets stakeholders at the follow level, and in the following manner: General public: B1MG has opened a website to inform the general public on issues related to genomics-based health and data access. All stakeholders with an active role in 1+MG: B1MG arranges for a Stakeholder Forum and Stakeholder Portal to inform and engage the broad range of key European, national and regional organisations that play an active role in implementation of genomics-based health and help create the conditions to facilitate cross-border data access. Selection of key European stakeholders to drive and help realise the1+MG initiative: B1MG arranges for a Stakeholder Coordination Group bringing together experts from a selected range of key organisations and projects crucial for the realisation of the 1+MG Roadmap until and beyond 2022. Stakeholder Forum The B1MG Stakeholder Forum (SF) acts as a key platform of interaction and consultation between all active stakeholders from B1MG, including stakeholders in signatory countries of the 1+MG initiative and at the European level. Collecting input and discussing viewpoints from patient organisations, clinicians, medical specialists, regulators, industry and HTA bodies and others will be crucial to shape the work of B1MG, especially in its thematic Work Packages WP2 (ELSI), WP3 (data standards and quality), WP4 (technical infrastructure) and WP5 (implementation in healthcare), alongside the implementation of the B1MG project. The role of the SF will be to provide methods to coordinate between stakeholders at the EU, country and regional level and to actively inform the stakeholders and involve them in the B1MG Work Packages. Stakeholder Coordination Group The B1MG Stakeholder Coordination Group (SCG) acts as a strategic council to the 1+MG initiative, and includes a selection of experts of key European initiatives, umbrella-organisations and major projects derived from the Stakeholder Coordination Forum. Additionally, B1MG SCG members are selected to help advance the field and align agenda’s along the thematic B1MG Work Packages WP2-5.
Read moreThe introduction of personalized medicine, through the increasing multi-omics characterization of disease, brings new challenges to disease modeling. The scope of this review was a broad evaluation of the relevance, validity, and predictive value of the current preclinical methodologies applied in stratified medicine approaches. Two case models were chosen: oncology and brain disorders. We conducted a scoping review, following the Joanna Briggs Institute guidelines, and searched PubMed, EMBASE, and relevant databases for reports describing preclinical models applied in personalized medicine approaches. A total of 1292 and 1516 records were identified from the oncology and brain disorders search, respectively. Quantitative and qualitative synthesis was performed on a final total of 63 oncology and 94 brain disorder studies. The complexity of personalized approaches highlights the need for more sophisticated biological systems to assess the integrated mechanisms of response. Despite the progress in developing innovative and complex preclinical model systems, the currently available methods need to be further developed and validated before their potential in personalized medicine endeavors can be realized. More importantly, we identified underlying gaps in preclinical research relating to the relevance of experimental models, quality assessment practices, reporting, regulation, and a gap between preclinical and clinical research. To achieve a broad implementation of predictive translational models in personalized medicine, these fundamental deficits must be addressed.
Read moreThis dataset provides the data extracted for the scoping review of the literature on preclinical models for personalised medicine, as part of the EU project on “Personalised Medicine Trials” (PERMIT). It covers the references for all articles selected as part of the scoping review of the two case models chosen, oncology and brain disorders.
Read moreClinical and experimental studies have demonstrated that connective-tissue growth factor (CTGF) expression is increased in fibrotic human liver and experimental animal models of liver fibrogenesis. CTGF has been linked to transforming growth factor-beta (TGF-beta) pathways in fibroproliferative diseases and specific polymorphisms within the CTGF gene may predispose for fibrosis in systemic sclerosis. As CTGF is detectable in various human fluids (serum, plasma and urine), it may provide information about fibrotic remodelling processes and reflect hepatic TGF-beta bioactivity. We established a novel ELISA for the measurement of serum CTGF and tested its clinical value in patients with chronic hepatitis C virus (HCV) infection and chronic liver disease (CLD). HCV infected patients (n = 138) had significantly higher serum CTGF levels than healthy controls. CTGF was linked to the histological degree of liver fibrosis. To expand the results to other aetiologies, a separate cohort of CLD patients (n = 129) was evaluated, showing higher serum CTGF than healthy controls and again an association with advanced stages of liver cirrhosis (Child B and C). Although independent of the underlying aetiology, serum CTGF was most powerful in indicating fibrosis/advanced disease states in HCV-related disorders. The genotyping of six polymorphisms (rs6917644, rs9399005, rs6918698, rs9493150, rs2151532 and rs11966728) covering the CTGF locus in 365 patients suffering from chronic hepatitis C revealed that none of these polymorphisms showed a genotypic or allelic association with the severity of hepatic fibrosis. Taken together, serum CTGF is suitable for determination of hepatic fibrosis and most powerful in patients with chronic HCV infection.
Read moreAbstract Introduction The rapid growth of digital health initiatives has heightened dependence on frontline health workers (FLHWs) to deliver, document, and manage services via digital tools, especially in low- and middle-income countries. In India, widespread adoption of platforms under the Ayushman Bharat Digital Mission (ABDM) lacks a standardized digital health competency framework for FLHWs, hindering systematic skill development, assessment, and integration. This study designed, developed, and evaluated a theory-driven, evidence-based, scalable Digital Health Competency Framework (DHCF) for India’s health workforce, framed as a feasibility and proof-of-concept study, piloted among FLHWs in Uttar Pradesh. Methods We used a three-stage approach: design, implementation, and evaluation. Development drew from a systematic literature review and the Government of India’s Framework for Roles, Activities, and Competencies (FRAC). A cadre-agnostic competency dictionary was created, covering functional, behavioral, domain-specific, and intervention-specific skills at graded proficiency levels. Competencies were mapped to FLHW roles, with aligned training materials and assessments developed. The framework was piloted via in-person, instructor-led sessions for Auxiliary Nurse Midwives (ANMs) in two districts (n=70), plus baseline evaluations for Accredited Social Health Activists (ASHAs; n=32). Results The DHCF comprises a three-component package: (i) a cadre-agnostic competency dictionary with progressive proficiency levels, (ii) systematic role-to-competency mapping via the FRAC methodology, and (iii) integrated training content and assessment scaffolding designed for institutional embedding. The DHCF defined ten core competencies, enabling role-specific mapping across cadres. Feasibility testing showed significant gains in ANMs’ knowledge and digital skills (Wilcoxon signed-rank test showed significant gains in two of four competency levels (C1L1 and C2L1, both p<0.001), with the largest effect in data collection basics (r=0.84)); ASHA baselines exposed major foundational literacy gaps (mean total score 11.97/30, 39.9%; data collection competency weakest at 32.5%, with no ASHA scoring above 60% on C2L1). Stakeholders affirmed the framework’s relevance, feasibility, and adaptability, but noted needs for hybrid training and better institutional embedding. Conclusion The DHCF offers a structured, scalable method to standardize digital health training for FLHWs, enhancing workforce preparedness in resource-limited settings during India’s digital health evolution. This feasibility study demonstrates the framework’s relevance and applicability, with future work needed to assess effectiveness at scale, long-term competency retention, and linkage to service delivery outcomes. Parallel attention to digital tool design and usability is essential to complement competency-building efforts.
Read morePersonalised medicine (PM) research programmes represent the modern paradigm of complex cross-disciplinary research, integrating innovative methodologies and technologies. Methodological research is required to ensure that these programmes generate robust and reproducible evidence. The PERMIT project developed methodological recommendations for each stage of the PM research pipeline. A common methodology was applied to develop the recommendations in collaboration with relevant stakeholders. Each stage was addressed by a dedicated working group, specializing in the subject matter. A series of scoping reviews that mapped the methods used in PM research and a gap analysis were followed by working sessions and workshops where field experts analyzed the gaps and developed recommendations. Through collaborative writing and consensus building exercises, the final recommendations were defined. They provide guidance for the design, implementation and evaluation of PM research, from patient and omics data collection and sample size calculation to the selection of the most appropriate stratification approach, including machine learning modeling, the development and application of reliable preclinical models, and the selection and implementation of the most appropriate clinical trial design. The dissemination and implementation of these recommendations by all stakeholders can improve the quality of PM research, enhance the robustness of evidence, and improve patient care.
Read moreOBJECTIVE: Evidence for a role of microglia in the pathogenesis of multiple sclerosis (MS) is growing. We investigated association of microglial markers at time of diagnostic lumbar puncture (LP) with different aspects of disease activity (relapses, disability, magnetic resonance imaging parameters) up to 6 years later in a cohort of 143 patients. METHODS: In cerebrospinal fluid (CSF), we measured 3 macrophage and microglia-related proteins, chitotriosidase (CHIT1), chitinase-3-like protein 1 (CHI3L1 or YKL-40), and soluble triggering receptor expressed on myeloid cells 2 (sTREM2), as well as a marker of neuronal damage, neurofilament light chain (NfL), using enzyme-linked immunosorbent assay and electrochemiluminescence. We investigated the same microglia-related markers in publicly available RNA expression data from postmortem brain tissue. RESULTS: CHIT1 levels at diagnostic LP correlated with 2 aspects of long-term disease activity after correction for multiple testing. First, CHIT1 increased with reduced tissue integrity in lesions at a median 3 years later (p = 9.6E-04). Second, CHIT1 reflected disease severity at a median 5 years later (p = 1.2E-04). Together with known clinical covariates, CHIT1 levels explained 12% and 27% of variance in these 2 measures, respectively, and were able to distinguish slow and fast disability progression (area under the curve = 85%). CHIT1 was the best discriminator of chronic active versus chronic inactive lesions and the only marker correlated with NfL (r = 0.3, p = 0.0019). Associations with disease activity were, however, independent of NfL. INTERPRETATION: CHIT1 CSF levels measured during the diagnostic LP reflect microglial activation early on in MS and can be considered a valuable prognostic biomarker for future disease activity. ANN NEUROL 2020;87:633-645.
Read moreBackground: The importance of predicting disease progression in multiple sclerosis (MS) has increasingly been recognized, and hence reliable biomarkers are needed. Objectives: To investigate the prognostic role of cerebrospinal fluid (CSF) amyloid beta 1–42 (Aβ) levels by the determination of a cut-off value to classify patients in slow and fast progressors. To evaluate possible association with white matter (WM) and grey matter (GM) damage at early disease stages. Methods: Sixty patients were recruited and followed up for 3–5 years. Patients underwent clinical assessment, brain magnetic resonance imaging (MRI; at baseline and after 1 year), and CSF analysis to determine Aβ levels. T1-weighted volumes were calculated. T2-weighted scans were used to quantify WM lesion loads. Results: Lower CSF Aβ levels were observed in patients with a worse follow-up Expanded Disability Status Scale (EDSS; r = −0.65, p < 0.001). The multiple regression analysis confirmed CSF Aβ concentration as a predictor of patients’ EDSS increase ( r = −0.59, p < 0.0001). Generating a receiver operating characteristic curve, a cut-off value of 813 pg/mL was determined as the threshold able to identify patients with worse prognosis (95% confidence interval (CI): 0.690–0.933, p = 0.0001). No differences in CSF tau and neurofilament light chain (NfL) levels were observed ( p > 0.05). Conclusion: Low CSF Aβ levels may represent a predictive biomarker of disease progression in MS.
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