Weighing benefits and risks in aspects of security, privacy and adoption of technology in a value-based healthcare system.

BACKGROUND: Technology can potentially enable the implementation of a value-based healthcare system, where the impact of quality of care is offered at optimised cost for maximised patient benefit. Technology can deliver value by aiding in data collection to evaluate outcomes and measure costs on a patient and population level. Healthcare organisations, however, face several challenges and risks that result almost exclusively from the use of these technologies. DISCUSSION: Some challenges associated with healthcare technology include their unsustainability, due to lack of scale-up plans and timely evaluations. Other risks include noncompliance with data protection policies, inadequate data governance, and overestimated expectations resulting from the rapid introduction of new technologies. CONCLUSION: Organisations need to consider the risks and challenges associated with the use of technology and develop comprehensive strategies that mitigate factors leading to non-adoption and to realise benefits for achieving a value-based healthcare system.

Improving accountability through alignment: the role of academic health science centres and networks in England.

BACKGROUND: As in many countries around the world, there are high expectations on academic health science centres and networks in England to provide high-quality care, innovative research, and world-class education, while also supporting wealth creation and economic growth. Meeting these expectations increasingly depends on partnership working between university medical schools and teaching hospitals, as well as other healthcare providers. However, academic-clinical relationships in England are still characterised by the "unlinked partners" model, whereby universities and their partner teaching hospitals are neither fiscally nor structurally linked, creating bifurcating accountabilities to various government and public agencies. DISCUSSION: This article focuses on accountability relationships in universities and teaching hospitals, as well as other healthcare providers that form core constituent parts of academic health science centres and networks. The authors analyse accountability for the tripartite mission of patient care, research, and education, using a four-fold typology of accountability relationships, which distinguishes between hierarchical (bureaucratic) accountability, legal accountability, professional accountability, and political accountability. Examples from North West London suggest that a number of mechanisms can be used to improve accountability for the tripartite mission through alignment, but that the simple creation of academic health science centres and networks is probably not sufficient. SUMMARY: At the heart of the challenge for academic health science centres and networks is the separation of accountabilities for patient care, research, and education in different government departments. Given that a fundamental top-down system redesign is now extremely unlikely, local academic and clinical leaders face the challenge of aligning their institutions as a matter of priority in order to improve accountability for the tripartite mission from the bottom up. It remains to be seen which alignment mechanisms are most effective, and whether they are strong enough to counter the separation of accountabilities for the tripartite mission at the national level, the on-going structural fragmentation of the health system in England, and the unprecedented financial challenges that it faces. Future research should focus on determining the comparative effectiveness of different alignment mechanisms, developing standardised metrics and key performance indicators, evaluating and assessing academic health science centres and networks, and empirically addressing leadership issues.

How COVID-19 has changed medical research funding.

Here, we consider how the lessons we learned in 2020 from funding COVID-19 research could have a long-term impact on the way that we fund medical research. We look back at how UK government funding for COVID-19 medical research evolved, beginning with the early calls for proposals in February that pump-primed funding for vaccines and therapeutics, and culminating in the launch of the government's National Core Studies programme in October. We discuss how the research community mobilized to submit and review grants more rapidly than ever before, against a background of laboratory and office closures. We also highlight the challenges of running clinical trials as the number of hospitalized patients fluctuated with different waves of the disease.

Cell tracking and therapy evaluation of bone marrow monocytes and stromal cells using SPECT and CMR in a canine model of myocardial infarction.

BACKGROUND: The clinical application of stem cell therapy for myocardial infarction will require the development of methods to monitor treatment and pre-clinical assessment in a large animal model, to determine its effectiveness and the optimum cell population, route of delivery, timing, and flow milieu. OBJECTIVES: To establish a model for a) in vivo tracking to monitor cell engraftment after autologous transplantation and b) concurrent measurement of infarct evolution and remodeling. METHODS: We evaluated 22 dogs (8 sham controls, 7 treated with autologous bone marrow monocytes, and 7 with stromal cells) using both imaging of 111Indium-tropolone labeled cells and late gadolinium enhancement CMR for up to12 weeks after a 3 hour coronary occlusion. Hearts were also examined using immunohistochemistry for capillary density and presence of PKH26 labeled cells. RESULTS: In vivo Indium imaging demonstrated an effective biological clearance half-life from the injection site of ~5 days. CMR demonstrated a pattern of progressive infarct shrinkage over 12 weeks, ranging from 67-88% of baseline values with monocytes producing a significant treatment effect. Relative infarct shrinkage was similar through to 6 weeks in all groups, following which the treatment effect was manifest. There was a trend towards an increase in capillary density with cell treatment. CONCLUSION: This multi-modality approach will allow determination of the success and persistence of engraftment, and a correlation of this with infarct size shrinkage, regional function, and left ventricular remodeling. There were overall no major treatment effects with this particular model of transplantation immediately post-infarct.

ChroniSense National Early Warning Score Study (CHESS): a wearable wrist device to measure vital signs in hospitalised patients-protocol and study design.

INTRODUCTION: The National Early Warning Score is used as standard clinical practice in the UK as a track and trigger system to monitor hospitalised patients. Currently, nurses are tasked to take routine vital signs measurements and manually record these on a clinical chart. Wearable devices could provide an easier, reliable, more convenient and cost-effective method of monitoring. Our aim is to evaluate the clinical validity of Polso (ChroniSense Medical, Yokneam Illit, Israel), a wrist-based device, to provide National Early Warning Scores. METHODS AND ANALYSIS: We will compare Polso National Early Warning Score measurements to the currently used manual measurements in a UK Teaching District General Hospital. Patients aged 18 years or above who require recordings of observations of vital signs at least every 6 hours will be enrolled after consenting. The sample size for the study was calculated to be 300 participants based on the assumption that the final dataset will include four pairs of measurements per-patient and per-vital sign, resulting in a total of 1200 pairs of data points per vital sign. The primary outcome is the agreement on the individual parameter scores and values of the National Early Warning Score: (1) respiratory rate, (2) oxygen saturation, (3) body temperature, (4) systolic blood pressure and (5) heart rate. Secondary outcomes are the agreement on the aggregate National Early Warning Score. The incidence of adverse events will be recorded. The measurements by the device will not be used for the clinical decision-making in this study. ETHICS AND DISSEMINATION: We obtained ethical approval, reference number 18/LO/0123 from London-Hampstead Research Ethics Committee, through the Integrated Research Application System, (reference number: 235 034. The study received no objection from the Medicine and Health Regulatory Authority, reference number: CI/20018/005 and has National Institute for Health Research portfolio adoption status CPMS number: 32 532. TRIAL REGISTRATION NUMBER: NCT03448861; Pre-results.

Data Collection Approaches to Enable Evaluation of a Massive Open Online Course About Data Science for Continuing Education in Health Care: Case Study.

BACKGROUND: This study presents learner perceptions of a pilot massive open online course (MOOC). OBJECTIVE: The objective of this study was to explore data collection approaches to help inform future MOOC evaluations on the use of semistructured interviews and the Kirkpatrick evaluation model. METHODS: A total of 191 learners joined 2 course runs of a limited trial of the MOOC. Moreover, 7 learners volunteered to be interviewed for the study. The study design drew on semistructured interviews of 2 learners transcribed and analyzed using Braun and Clark's method for thematic coding. This limited participant set was used to identify how the Kirkpatrick evaluation model could be used to evaluate further implementations of the course at scale. RESULTS: The study identified several themes that could be used for further analysis. The themes and subthemes include learner background (educational, professional, and topic significance), MOOC learning (learning achievement and MOOC application), and MOOC features (MOOC positives, MOOC negatives, and networking). There were insufficient data points to perform a Kirkpatrick evaluation. CONCLUSIONS: Semistructured interviews for MOOC evaluation can provide a valuable in-depth analysis of learners' experience of the course. However, there must be sufficient data sources to complete a Kirkpatrick evaluation to provide for data triangulation. For example, data from precourse and postcourse surveys, quizzes, and test results could be used to improve the evaluation methodology.

Blockchain Implementation in Health Care: Protocol for a Systematic Review.

BACKGROUND: A blockchain is a digitized, decentralized, distributed public ledger that acts as a shared and synchronized database that records cryptocurrency transactions. Despite the shift toward digital platforms enabled by electronic medical records, demonstrating a will to reform the health care sector, health systems face issues including security, interoperability, data fragmentation, timely access to patient data, and silos. The application of health care blockchains could enable data interoperability, enhancement of precision medicine, and reduction in prescription frauds through implementing novel methods in access and patient consent. OBJECTIVE: To summarize the evidence on the strategies and frameworks utilized to implement blockchains for patient data in health care to ensure privacy and improve interoperability and scalability. It is anticipated this review will assist in the development of recommendations that will assist key stakeholders in health care blockchain implementation, and we predict that the evidence generated will challenge the health care status quo, moving away from more traditional approaches and facilitating decision making of patients, health care providers, and researchers. METHODS: A systematic search of MEDLINE/PubMed, Embase, Scopus, ProQuest Technology Collection and Engineering Index will be conducted. Two experienced independent reviewers will conduct titles and abstract screening followed by full-text reading to determine study eligibility. Data will then be extracted onto data extraction forms before using the Cochrane Collaboration Risk of Bias Tool to appraise the quality of included randomized studies and the Risk of Bias in nonrandomized studies of Interventions to assess the quality of nonrandomized studies. Data will then be analyzed and synthesized. RESULTS: Database searches will be initiated in September 2018. We expect to complete the review in January 2019. CONCLUSIONS: This review will summarize the strategies and frameworks used to implement blockchains in health care to increase data privacy, interoperability, and scalability. This review will also help clarify if the strategies and frameworks required for the operationalization of blockchains in health care ensure the privacy of patient data while enabling efficiency, interoperability, and scalability. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10994.

Digital Technology in Somatic and Gene Therapy Trials of Pediatric Patients With Ocular Diseases: Protocol for a Scoping Review.

BACKGROUND: Pharmacogenomics suggests that diseases with similar symptomatic presentations often have varying genetic causes, affecting an individual patient's response to a specific therapeutic strategy. Gene therapies and somatic cell therapies offer unique therapeutic pathways for ocular diseases and often depend on increased understanding of the genotype-phenotype relationship in disease presentation and progression. While demand for personalized medicine is increasing and the required molecular tools are available, its adoption within pediatric ophthalmology remains to be maximized in the postgenomic era. OBJECTIVE: The objective of our study was to address the individual hurdles encountered in the field of genomic-related clinical trials and facilitate the uptake of personalized medicine, we propose to conduct a review that will examine and identify the digital technologies used to facilitate data analysis in somatic and gene therapy trials in pediatric patients with ocular diseases. METHODS: This paper aims to present an outline for Healthcare Information Technology and Information and Communication Technology resources used in somatic and gene therapy clinical trials in children with ocular diseases. This review will enable authors to identify challenges and provide recommendations, facilitating the uptake of genetic and somatic therapies as therapeutic tools in pediatric ophthalmology. The review will also determine whether conducting a systematic review will be beneficial. RESULTS: Database searches will be initiated in September 2018. We expect to complete the review in December 2019. CONCLUSIONS: Based on review findings, the authors will summarize methods used for facilitating IT integration in personalized medicine. Additionally, it will identify further research gaps and determine whether conducting further reviews will be beneficial. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10705.

Decision Support Tools, Systems, and Artificial Intelligence in Cardiac Imaging.

Noninvasive cardiac imaging is widely used for the diagnosis and management of cardiac patients. The increasing demand for cardiac imaging begins to exceed the number of available interpreting physicians, leaving less time to interpret studies. In addition, the busy clinician is facing the increasingly daunting task of keeping abreast of current medical advancements and the ongoing changes in disease diagnosis and therapy. Committing to memory and recalling such large volumes of information is challenging and is responsible for difficulties in adopting the rapid changes in imaging practice, and is likely partially responsible for errors in patient diagnosis and management. Diagnostic errors rank high in the cause of death in the United States, and are more common than any other medical error and are responsible for most malpractice claims. Most of these errors are related to cognitive errors. The use of artificial intelligence systems that can serve as complementary methods to assist humans with decision making can potentially prevent these errors. The past decades witnessed the development and integration of these tools, which can assist physicians with image interpretation. These tools work to optimize image quality for better visualization and accompany all imaging modalities, starting from patient selection for the appropriate test, patient preparation, image acquisition, processing, and finally interpretation. Current and future directions for technologies that support cardiac imaging physicians are discussed in this review.

Health information technology uses for primary prevention in preventive medicine: a scoping review protocol.

INTRODUCTION: The use of health information technologies (HITs) has been associated with positive benefits such as improved health outcomes and improved health services. Results from empirical studies reported potential benefits of HITs in preventive medicine measures such as primary prevention. This review will examine the broad range of HITs and their uses and effectiveness in primary prevention. METHODS AND ANALYSIS: We will conduct searches in relevant databases (MEDLINE, EMBASE, the Cochrane Methodology Register, Cochrane Database of Systematic Reviews, CINAHL, SCOPUS and Web of Science) using Arksey and O'Malley's scoping review methodology. The scoping review will include all study designs to identify the literature on HIT uses. Two reviewers will independently screen the literature following our screening criteria and using a data abstraction form. Findings will be summarised quantitatively (using numerical counts of HITs) and qualitatively (using narrative synthesis). ETHICS AND DISSEMINATION: The study will synthesise data from published literature and will not require an ethical approval. The results of the review will be disseminated through a peer-reviewed journal.

Real-world evidence for postgraduate students and professionals in healthcare: protocol for the design of a blended massive open online course.

INTRODUCTION: There is an increased need for improving data science skills of healthcare professionals. Massive open online courses (MOOCs) provide the opportunity to train professionals in a sustainable and cost-effective way. We present a protocol for the design and development of a blended MOOC on real-world evidence (RWE) aimed at improving RWE data science skills. The primary objective is to provide the opportunity to understand the fundamentals of RWE data science and to implement methods for analysing RWD. The blended format of MOOC will combine the expertise of healthcare professionals joining the course online with the on-campus students. We expect learners to take skills taught in MOOC and use them to seek new employment or to explore entpreneurship activities in these domains. METHODS AND ANALYSIS: The proposed MOOC will be developed through a blended format using the Analysis, Design, Development, Implementation and Evaluation instructional design model and following the connectivist-heutagogical learning theories (as a hybrid MOOC). The target learners will include postgraduate students and professionals working in the health-related roles with interest in data science. An evaluation of MOOC will be performed to assess MOOCs success in meeting its intended outcomes and to improve future iterations of the course. ETHICS AND DISSEMINATION: The education course design protocol was approved by EIT Health (grant 18654) as part of the EIT Health CAMPUS Deferred Call for Innovative Education 2018. Results will be published in a peer-reviewed journal.

Digital health app development standards: a systematic review protocol.

INTRODUCTION: There is currently a lack of clear and accepted standards for the development (planning, requirement analysis and research, design and application testing) of apps for medical and healthcare use which poses different risks to developers, providers, patients and the public. The aim of this work is to provide an overview of the current standards, frameworks, best practices and guidelines for the development of digital health apps. This review is a critical 'stepping stone' for further work on producing appropriate standards that can help mitigate risks (eg, clinical, privacy and economic risks). METHODS AND ANALYSIS: A systematic review identifying criteria from applicable standards, guidelines, frameworks and best practices for the development of health apps. We will draw from standards for software for medical devices, clinical information systems and medicine because of their relatedness and hope to apply lessons learnt to apps. We will exclude other types of publications, and those published in languages other than English. We will search websites of relevant regulatory and professional organisations. For health apps, we will also search electronic research databases (eg, MEDLINE, Embase, SCOPUS, ProQuest Technology Collection and Engineering Index) because relevant publications may not be found on other websites. We will hand-search reference lists of included publications. The review will focus on international, USA, European and UK standards because these are the markets of primary interest to the majority of app developers currently. We will provide a narrative overview of findings and tabular summaries of extracted data. Also, we will examine the relationship between different standards and compare USA and European Union standards. ETHICS AND DISSEMINATION: No ethics approval is required. The review will be disseminated through peer-reviewed publications, conference presentations and inform efforts that aim to improve the quality of health apps through existing links with relevant organisations.

How standards and user involvement can improve app quality: A lifecycle approach.

Health apps have great potential to improve the quality of care and reduce costs, but this has not yet been achieved. Unfortunately, there are many low-quality, unsafe health apps, resulting in different types of risks. This Perspective addresses the current failure to adopt standards for the development and implementation of health apps. For each theoretical stage of the app development lifecycle we discuss problems, examples, reasons, and solutions. We believe that adapted versions of existing professional and technical standards and tools developed for clinical information systems, medical devices and medicines could help mitigate risks throughout the health app lifecycle. Adapted standards should bring more effective user involvement and cooperation amongst stakeholders. We argue that these efforts will ultimately provide users with a wider choice of higher-quality health apps, give healthcare providers access to better quality data, and allow developers to innovate without unnecessary time-consuming restrictions.

Protocol for a mixed-methods evaluation of a massive open online course on real world evidence.

INTRODUCTION: Increasing number of Massive Open Online Courses (MOOCs) are being used to train learners at scale in various healthcare-related skills. However, many challenges in course delivery require further understanding, for example, factors exploring the reasons for high MOOC dropout rates, recorded low social interaction between learners and the lack of understanding of the impact of a course facilitators' presence in course engagement. There is a need to generate further evidence to explore these detriments to MOOC course delivery to enable enhanced course learning design. The proposed mixed-methods evaluation of the MOOC was determined based on the MOOC's aims and objectives and the methodological approaches used to evaluate this type of a course. The MOOC evaluation will help appraise the effectiveness of the MOOC in delivering its intended objectives. This protocol aims to describe the design of a study evaluating learners knowledge, skills and attitudes in a MOOCs about data science for healthcare. METHODS AND ANALYSIS: Study participants will be recruited from learners who have registered for the MOOC. On registration, learners will be given an opportunity to opt into the study and complete informed consent. Following completion of the course, study participants will be contacted to complete semistructured interviews. Interviews will be transcribed and coded using thematic analysis, with data analysed using two evaluation models: (1) the reach, effectiveness, adoption, implementation, maintenance framework and the (2) Kirkpatrick model drawing data from pre and post-course surveys and post-MOOC semi-structured interviews. The primary goal of the evaluation is to appraise participants' knowledge, skills and attitude after taking the MOOC. ETHICS AND DISSEMINATION: Ethics approval for this study was obtained from Imperial College London through the Education Ethics Review Process (EERP) (EERP1617-030). A summary of the research findings will be reported through a peer-reviewed journal and will be presented at an international conference.

The technological imperative for value-based health care.

The overarching principle of a value-based health-care strategy is to provide higher quality care at a lower cost. To achieve the goals of a value-based healthcare system is highly dependent on the availability and the effective use of technologies. This article explores the potential for the use of technology to enable value and the key design factors associated with their implementation in a value-based health-care system.

The Internet of Things in Health Care in Oxford: Protocol for Proof-of-Concept Projects.

BACKGROUND: Demands on health services across are increasing because of the combined challenges of an expanding and aging population, alongside complex comorbidities that transcend the classical boundaries of modern health care. Continuing to provide and coordinate care in the current manner is not a viable route to sustain the improvements in health outcomes observed in recent history. To ensure that there continues to be improvement in patient care, prevention of disease, and reduced burden on health systems, it is essential that we adapt our models of delivery. Providers of health and social care are evolving to face these pressures by changing the way they think about the care system and, importantly, how to involve patients in the planning and delivery of services. OBJECTIVE: The objective of this paper is to provide (1) an overview of the current state of Internet of Things (IoT) and key implementation considerations, (2) key use cases demonstrating technology capabilities, (3) an overview of the landscape for health care IoT use in Oxford, and (4) recommendations for promoting the IoT via collaborations between higher education institutions and industry proof-of-concept (PoC) projects. METHODS: This study describes the PoC projects that will be created to explore cost-effectiveness, clinical efficacy, and user adoption of Internet of Medical Things systems. The projects will focus on 3 areas: (1) bring your own device integration, (2) chronic disease management, and (3) personal health records. RESULTS: This study is funded by Research England's Connecting Capability Fund. The study started in March 2018, and results are expected by the end of 2019. CONCLUSIONS: Embracing digital solutions to support the evolution and transformation of health services is essential. Importantly, this should not simply be undertaken by providers in isolation. It must embrace and exploit the advances being seen in the consumer devices, national rollout of high-speed broadband services, and the rapidly expanding medical device industry centered on mobile and wearable technologies. Oxford University Hospitals and its partner providers, patients, and stakeholders are building on their leading position as an exemplar site for digital maturity in the National Health Service to implement and evaluate technologies and solutions that will capitalize on the IoT. Although early in the application to health, the IoT and the potential it provides to make the patient a partner at the center of decisions about care represent an exciting opportunity. If achieved, a fully connected and interoperable health care environment will enable continuous acquisition and real-time analysis of patient data, offering unprecedented ability to monitor patients, manage disease, and potentially deliver early diagnosis. The clinical benefit of this is clear, but additional patient benefit and value will be gained from being able to provide expert care at home or close to home. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12077.

Teaching the relationship between health and climate change: a systematic scoping review protocol.

INTRODUCTION: The observed and projected impacts of climate change on human health are significant. While climate change has gathered global momentum and is taught frequently, the extent to which the relationships between climate change and health are taught remains uncertain. Education provides an opportunity to create public engagement on these issues, but the extent to which historical implementation of climate health education could be leveraged is not well understood. To address this gap, we propose to conduct a scoping review of all forms of teaching that have been used to illustrate the health effects of climate change between 2005 and 2017, coinciding with a turning point in the public health and climate change agendas following the 2005 Group of 7/8 (G7/8) Summit. METHODS AND ANALYSIS: Using Arksey/O'Malley's and Levac's methodological framework, MEDLINE/PubMed, Embase, Scopus, Education Resource Information Centre, Web of Science, Global Health, Health Management Information Consortium, Georef, Ebsco and PROSPERO will be systematically searched. Predetermined inclusion and exclusion criteria will be applied by two independent reviewers to determine study eligibility. Studies published in English and after 2005 only will be examined. Following selection of studies, data will be extracted and analysed. ETHICS AND DISSEMINATION: No ethical approval is required as exclusively secondary data will be used. Our findings will be communicated to the European Institute of Innovation & Technology Health-Knowledge and Innovation Communities to assist in the development of a FutureLearn Massive Open Online Course on the health effects of climate change.

Clb6/Cdc28 and Cdc14 regulate phosphorylation status and cellular localization of Swi6.

Nuclear export of the transcription factor Swi6 during the budding yeast Saccharomyces cerevisiae cell cycle is known to require phosphorylation of the Swi6 serine 160 residue. We show that Clb6/Cdc28 kinase is required for this nuclear export. Furthermore, Cdc28 combined with the S-phase cyclin Clb6 specifically phosphorylates serine 160 of Swi6 in vitro. Nuclear import of Swi6 occurs concomitantly with dephosphorylation of serine 160 in late M phase. We show that Cdc14 phosphatase, the principal effector of the mitotic exit network, can trigger nuclear import of Swi6 in vivo and that Cdc14 dephosphorylates Swi6 at serine 160 in vitro. Taken together, these observations show how Swi6 dephosphorylation and phosphorylation are integrated into changes of Cdc28 activity governing entry and exit from the G1 phase of the cell cycle.