One Health: Insights from Organizational & Social, Technology Assessment and Human Factors Perspectives.

OBJECTIVES: To offer diverse but complementary perspectives on how biomedical and health informatics can be informed by and help to achieve the vision of One Health. METHODS: Overview of key considerations and critical discussion of common themes, barriers and opportunities, based on collaborative review by International Medical Informatics Association (IMIA) working group members active in related fields. RESULTS: Health and care systems are complex sociotechnical systems that need explicit design and implementation strategies to align with the goals of One Health. The evidence-based health informatics paradigm and associated frameworks for evaluation of digital health technologies need to broaden their scope to take full account of the One Health approach. Informatics has specific contributions to make to One Health, for example by improved user experience reducing energy consumption and effective app design enhancing medication adherence. CONCLUSIONS: One Health is inherently intertwined with ergonomic, sociotechnical and evaluation perspectives in biomedical and health informatics. Health is a planetary issue that requires interdisciplinary collaborative action. The theories and principles of biomedical and health informatics offer many opportunities to transform digital health technology to better serve the One Health agenda.

Modelling clinical narrative as computable knowledge: The NICE computable implementation guidance project.

Introduction: Translating narrative clinical guidelines to computable knowledge is a long-standing challenge that has seen a diverse range of approaches. The UK National Institute for Health and Care Excellence (NICE) Content Advisory Board (CAB) aims ultimately to (1) guide clinical decision support and other software developers to increase traceability, fidelity and consistency in supporting clinical use of NICE recommendations, (2) guide local practice audit and intervention to reduce unwarranted variation, (3) provide feedback to NICE on how future recommendations should be developed. Objectives: The first phase of work was to explore a range of technical approaches to transition NICE toward the production of natively digital content. Methods: Following an initial 'collaborathon' in November 2022, the NICE Computable Implementation Guidance project (NCIG) was established. We held a series of workstream calls approximately fortnightly, focusing on (1) user stories and trigger events, (2) information model and definitions, (3) horizon-scanning and output format. A second collaborathon was held in March 2023 to consolidate progress across the workstreams and agree residual actions to complete. Results: While we initially focussed on technical implementation standards, we decided that an intermediate logical model was a more achievable first step in the journey from narrative to fully computable representation. NCIG adopted the WHO Digital Adaptation Kit (DAK) as a technology-agnostic method to model user scenarios, personae, processes and workflow, core data elements and decision-support logic. Further work will address indicators, such as prescribing compliance, and implementation in document templates for primary care patient record systems. Conclusions: The project has shown that the WHO DAK, with some modification, is a promising approach to build technology-neutral logical specifications of NICE recommendations. Implementation of concurrent computable modelling by multidisciplinary teams during guideline development poses methodological and cultural questions that are complex but tractable given suitable will and leadership.

Which computable biomedical knowledge objects will be regulated? Results of a UK workshop discussing the regulation of knowledge libraries and software as a medical device.

Introduction: To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom. Methods: A briefing paper was circulated to a multi-disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1-day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions. Results: This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level. Conclusions: If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as "software as a medical device." However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries.

Digital health and care: emerging from pandemic times.

In 2020, we published an editorial about the massive disruption of health and care services caused by the COVID-19 pandemic and the rapid changes in digital service delivery, artificial intelligence and data sharing that were taking place at the time. Now, 3 years later, we describe how these developments have progressed since, reflect on lessons learnt and consider key challenges and opportunities ahead by reviewing significant developments reported in the literature. As before, the three key areas we consider are digital transformation of services, realising the potential of artificial intelligence and wise data sharing to facilitate learning health systems. We conclude that the field of digital health has rapidly matured during the pandemic, but there are still major sociotechnical, evaluation and trust challenges in the development and deployment of new digital services.

The need to strengthen the evaluation of the impact of Artificial Intelligence-based decision support systems on healthcare provision.

Despite the renewed interest in Artificial Intelligence-based clinical decision support systems (AI-CDS), there is still a lack of empirical evidence supporting their effectiveness. This underscores the need for rigorous and continuous evaluation and monitoring of processes and outcomes associated with the introduction of health information technology. We illustrate how the emergence of AI-CDS has helped to bring to the fore the critical importance of evaluation principles and action regarding all health information technology applications, as these hitherto have received limited attention. Key aspects include assessment of design, implementation and adoption contexts; ensuring systems support and optimise human performance (which in turn requires understanding clinical and system logics); and ensuring that design of systems prioritises ethics, equity, effectiveness, and outcomes. Going forward, information technology strategy, implementation and assessment need to actively incorporate these dimensions. International policy makers, regulators and strategic decision makers in implementing organisations therefore need to be cognisant of these aspects and incorporate them in decision-making and in prioritising investment. In particular, the emphasis needs to be on stronger and more evidence-based evaluation surrounding system limitations and risks as well as optimisation of outcomes, whilst ensuring learning and contextual review. Otherwise, there is a risk that applications will be sub-optimally embodied in health systems with unintended consequences and without yielding intended benefits.

One Health in a Digital World: Technology, Data, Information and Knowledge.

OBJECTIVES: To describe the origins and growth of the One Health concept and its recent application in One Digital Health. METHODS: Bibliometric review and critical discussion of emergent themes derived from co-occurrence of MeSH keywords. RESULTS: The fundamental interrelationship between human health, animal health and the wider environment has been recognized since ancient times. One Health as a distinct term originated in 2004 and has been a rapidly growing concept of interest in the biomedical literature since 2017. One Digital Health has quickly established itself as a unifying construct that highlights the critical role of technology, data, information and knowledge to facilitate the interdisciplinary collaboration that One Health requires. The principal application domains of One Digital Health to date are in FAIR data integration and analysis, disease surveillance, antimicrobial stewardship and environmental monitoring. CONCLUSIONS: One Health and One Digital Health offer powerful lenses to examine and address crises in our living world. We propose thinking in terms of Learning One Health Systems that can dynamically capture, integrate, analyse and monitor application of data across the biosphere.

Barriers, Priorities and Lessons Learned in Achieving Electronic Health Records Interoperability in Low- and Middle-Income Countries: Workshop Findings.

Electronic health records (EHR) interoperability is a complex topic that continues to gain traction in the digital health landscape. We facilitated a qualitative workshop consisting of domain experts in EHR implementation and health IT managers. The workshop aimed to identify critical barriers to achieving interoperability, priorities for new EHR implementations and lessons learned from managing existing implementations. The workshop highlighted that data modelling and interoperability standards are vital priorities for maternal and child health data services in low- and middle-income countries (LMICs).

Automating Electronic Health Record Data Quality Assessment.

Information systems such as Electronic Health Record (EHR) systems are susceptible to data quality (DQ) issues. Given the growing importance of EHR data, there is an increasing demand for strategies and tools to help ensure that available data are fit for use. However, developing reliable data quality assessment (DQA) tools necessary for guiding and evaluating improvement efforts has remained a fundamental challenge. This review examines the state of research on operationalising EHR DQA, mainly automated tooling, and highlights necessary considerations for future implementations. We reviewed 1841 articles from PubMed, Web of Science, and Scopus published between 2011 and 2021. 23 DQA programs deployed in real-world settings to assess EHR data quality (n = 14), and a few experimental prototypes (n = 9), were identified. Many of these programs investigate completeness (n = 15) and value conformance (n = 12) quality dimensions and are backed by knowledge items gathered from domain experts (n = 9), literature reviews and existing DQ measurements (n = 3). A few DQA programs also explore the feasibility of using data-driven techniques to assess EHR data quality automatically. Overall, the automation of EHR DQA is gaining traction, but current efforts are fragmented and not backed by relevant theory. Existing programs also vary in scope, type of data supported, and how measurements are sourced. There is a need to standardise programs for assessing EHR data quality, as current evidence suggests their quality may be unknown.

Experiences of Creating Computable Knowledge Tutorials Using HL7 Clinical Quality Language.

Computable knowledge artefact development is challenging and often culminates in the development of unique single usage solutions. Libraries of computable knowledge artefacts have the possibility to enhance the Learning Health System in order to improve the benefits of innovation and the decision making of clinicians. This paper aims to discuss the process of creating the use cases and the tutorial material that would enable students to both understand how the interaction between the dataset and the outcome occurs as well as how HL7 Clinical Quality Language can be used to create artefacts of re-usable code.

Theory of Change: A Tool for Engaging the Health and Care Workforce in Developing Digital Skills.

The health and social care sector has experienced an optimistic turn in the last decade. There has been substantial growth in recent years due to the COVID-19 pandemic that forced the entire sector to identify digital methods of delivering a better level of care than before the pandemic. This paper used the Theory to Change (ToC) approach to demonstrate how the digital skills development of the health and care workforce can be achieved in specific contexts. The paper offers background on digital technologies used in healthcare and outlines the steps and methods used in developing a ToC map. The impact of the proposed ToC approach provides a measurable and predictable way to onboard the health and social care workforce into digital technologies, providing a more digitally skilled and literate workforce.

Implementing Electronic Health Records in Primary Care Using the Theory of Change: Nigerian Case Study.

BACKGROUND: Digital health has been a tool of transformation for the delivery of health care services globally. An electronic health record (EHR) system can solve the bottleneck of paper documentation in health service delivery if it is successfully implemented, but poor implementation can lead to a waste of resources. The study of EHR system implementation in low- and middle-income countries (LMICs) is of particular interest to health stakeholders such as policy makers, funders, and care providers because of the efficiencies and evidence base that could result from the appropriate evaluation of such systems. OBJECTIVE: We aimed to develop a theory of change (ToC) for the implementation of EHRs for maternal and child health care delivery in LMICs. The ToC is an outcomes-based approach that starts with the long-term goals and works backward to the inputs and mediating components required to achieve these goals for complex programs. METHODS: We used the ToC approach for the whole implementation's life cycle to guide the pilot study and identify the preconditions needed to realize the study's long-term goal at Festac Primary Health Centre in Lagos, Nigeria. To evaluate the maturity of the implementation, we adapted previously defined success factors to supplement the ToC approach. RESULTS: The initial ToC map showed that the long-term goal was an improved service delivery in primary care with the introduction of EHRs. The revised ToC revealed that the long-term change was the improved maternal and child health care delivery at Festac Primary Health Center using EHRs. We proposed a generic ToC map that implementers in LMICs can use to introduce an optimized EHR system, with assumptions about sustainability and other relevant factors. The outcomes from the critical success factors were sustainability: the sustained improvements included trained health care professionals, a change in mindset from using paper systems toward digital health transformation, and using the project's laptops to collect aggregate data for the District Health Information System 2-based national health information management system; financial: we secured funding to procure IT equipment, including servers, laptops, and networking, but the initial cost of implementation was high, and funds mainly came from the funding partner; and organizational: the health professionals, especially the head of nursing and health information officers, showed significant commitment to adopting the EHR system, but certain physicians and midwives were unwilling to use the EHR system initially until they were persuaded or incentivized by the management. CONCLUSIONS: This study shows that the ToC is a rewarding approach to framing dialogue with stakeholders and serves as a framework for planning, evaluation, learning, and reflection. We hypothesized that any future health IT implementation in primary care could adapt our ToC approach to their contexts with necessary modifications based on inherent characteristics.

Efficacy of high-throughput transthoracic ultrasonographic screening for on-farm detection of ovine pulmonary adenocarcinoma.

BACKGROUND: The aim of this study was to evaluate the efficacy of high-throughput on-farm transthoracic ultrasound (TUS) to screen for ovine pulmonary adenocarcinoma (OPA), an infectious ovine disease of increasing concern. No other routine diagnosis of preclinical OPA is available, or any vaccine or treatment. METHODS: More than 80,000 rapid TUS scans were applied on farms with a history of OPA. The TUS results from a convenience sample of 171 TUS-negative and 269 TUS-positive sheep were compared with postmortem histology/immunohistochemistry results, the 'gold standard' reference test for OPA diagnosis. These results, together with new data on within-flock prevalence, allowed estimation of the efficacy of rapid TUS screening to identify OPA (defined as tumours of larger than 1 cm) on-farm. RESULTS: The TUS screening had an estimated specificity of 0.998 (95% confidence interval [CI]: 0.998-0.999) and an estimated sensitivity of between 0.76 (95% CI: 0.72-0.79) and 0.99 (95% CI: 0.97-0.99) depending on the presumed false-negative rate applied to the calculation. CONCLUSION: High-throughput TUS should be considered for screening to identify individual sheep with OPA and has potential application to indicate flocks at low risk of OPA. However, lower efficacy is likely if conducted by less experienced persons.

The Role of Formative Evaluation in Promoting Digitally-based Health Equity and Reducing Bias for Resilient Health Systems: The Case of Patient Portals.

OBJECTIVES: Patient portals are increasingly implemented to improve patient involvement and engagement. We here seek to provide an overview of ways to mitigate existing concerns that these technologies increase inequity and bias and do not reach those who could benefit most from them. METHODS: Based on the current literature, we review the limitations of existing evaluations of patient portals in relation to addressing health equity, literacy and bias; outline challenges evaluators face when conducting such evaluations; and suggest methodological approaches that may address existing shortcomings. RESULTS: Various stakeholder needs should be addressed before deploying patient portals, involving vulnerable groups in user-centred design, and studying unanticipated consequences and impacts of information systems in use over time. CONCLUSIONS: Formative approaches to evaluation can help to address existing shortcomings and facilitate the development and implementation of patient portals in an equitable way thereby promoting the creation of resilient health systems.

Personal Health Records an Approach to Answer: What Works for Whom in What Circumstances?

National Health Service (NHS) policy suggests that increasing usage of electronic personal health records (PHR) by patients will result in cost savings and improved public health, especially for people with long-term conditions. PHR design features are inevitably important, since a good PHR design should make the users achieve their health goals effortlessly, which is understandable and usable. Three original theoretical models were developed using realist evaluation, one per long-term condition cohort, describing the interaction between the PHR design features and the patient and disease specific factors, to help determine what works for whom in what circumstances.

Vat Photopolymerization of Reinforced Styrene-Butadiene Elastomers: A Degradable Scaffold Approach.

Vat photopolymerization (VP) is a high-throughput additive manufacturing modality that also offers exceptional feature resolution and surface finish; however, the process is constrained by a limited selection of processable photocurable resins. Low resin viscosity (<10 Pa·s) is one of the most stringent process-induced constraints on resin processability, which in turn limits the mechanical performance of printed resin systems. Recently, the authors created a VP-processable photosensitive latex resin, where compartmentalization of the high molecular weight polymer chains into discrete particles resulted in the decoupling of viscosity from molecular weight. However, the monomers used to form the hydrogel green body resulted in decreased ultimate material properties due to the high cross-link density. Herein, we report a novel scaffold that allows for facile UV-based AM and simultaneously enhances the final part's material properties. This is achieved with a chemically labile acetal-containing cross-linker in conjunction with N-vinylpyrrolidone, which forms a glassy polymer after photocuring. Subsequent reactive extraction cleaves the cross-links and liberates the glassy polymer, which provides mechanical reinforcement of the geometrically complex VP-printed elastomer. With only a 0.1 wt % loading of photoinitiator, G'/G'' crossover times of less than 1 s and green body plateau moduli nearing 105 Pa are obtained. In addition, removal of the hydrophilic and thermally labile scaffold results in decreased water uptake and increased thermal stability of the final printed part. Ultimate strain and stress values of over 650% and 8.5 MPa, respectively, are achieved, setting a new benchmark for styrene-butadiene VP elastomers.

Neonatal early-onset sepsis calculator safety in an Australian tertiary perinatal centre.

AIM: To determine if any cases of culture-positive neonatal early-onset sepsis (EOS) would be missed using the neonatal EOS calculator, when compared with current guidelines and practices. METHODS: Retrospective audit of all neonates born at ≥35 weeks and admitted to Royal Brisbane and Women's Hospital with EOS from January 2014 to December 2020. A missed case was defined as antibiotic therapy not being recommended within 24 h of birth. Management recommendations according to the neonatal EOS calculator were compared with current guidelines and current practices. RESULTS: There were significantly more missed cases using the neonatal EOS calculator compared to the current guideline and current management groups. Using the neonatal EOS calculator, 11 neonates (35%, 95% confidence interval 19.2-54.6%) would not have received antibiotics by 24 h of age. In comparison, only one neonate (3%, 95% confidence interval 0.1-16.7%) would not have received antibiotics by 24 h of age using the current guidelines. In terms of the current practice in the cohort of patients, two neonates (6%) did not receive antibiotics by 24 h of age. CONCLUSIONS: The significantly higher rate of missed cases using the neonatal EOS calculator compared with current guidelines and practice supports the concerns many neonatologists have regarding safety of the neonatal EOS calculator.

BMJ HCI launches partnership programme for patients and carers as authors and peer reviewers.

BMJ Health & Care Informatics (BMJHCI) is launching a partnership programme, where patients write articles and serve as peer reviewers on both patient-written and researcher-written articles. This article outlines the programme and describes the importance of public involvement in research and implementation in digital health. We think patients and carers should be funded to participate at this stage of research as well as other stages of research. The quality of peer review can be greatly improved by recruiting patients to peer review and improve readability and understanding of scientific literature and to ensure that research and other articles appropriately include what matters most to patients. Just as real-time communication is two-way communication, both healthcare providers and patients should have a voice in the literature, and involving patients in journals is an important step toward amplifying and supporting the balance of perspectives. Patients are the whole purpose of research and practice in health and care, so this rightly includes their role in the publication and review of health informatics literature as well as the publication of their own perspectives regarding access and delivery of healthcare. Patients and carers can provide valuable insights into research articles, and they can also serve as effective peer reviewers. The BMJHCI is excited to kick off the new partnership programme and encourages all interested patients and carers to apply to participate as authors and/or reviewers.

Managing Pandemic Responses with Health Informatics - Challenges for Assessing Digital Health Technologies.

OBJECTIVES: To highlight the role of technology assessment in the management of the COVID-19 pandemic. METHOD: An overview of existing research and evaluation approaches along with expert perspectives drawn from the International Medical Informatics Association (IMIA) Working Group on Technology Assessment and Quality Development in Health Informatics and the European Federation for Medical Informatics (EFMI) Working Group for Assessment of Health Information Systems. RESULTS: Evaluation of digital health technologies for COVID-19 should be based on their technical maturity as well as the scale of implementation. For mature technologies like telehealth whose efficacy has been previously demonstrated, pragmatic, rapid evaluation using the complex systems paradigm which accounts for multiple sociotechnical factors, might be more suitable to examine their effectiveness and emerging safety concerns in new settings. New technologies, particularly those intended for use on a large scale such as digital contract tracing, will require assessment of their usability as well as performance prior to deployment, after which evaluation should shift to using a complex systems paradigm to examine the value of information provided. The success of a digital health technology is dependent on the value of information it provides relative to the sociotechnical context of the setting where it is implemented. CONCLUSION: Commitment to evaluation using the evidence-based medicine and complex systems paradigms will be critical to ensuring safe and effective use of digital health technologies for COVID-19 and future pandemics. There is an inherent tension between evaluation and the imperative to urgently deploy solutions that needs to be negotiated.