Edward Meinert

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.

Data and Corporate Governance in Pharma and Digital Health: A Necessary Regulatory Convergence

Data and Corporate Governance in Pharma and Digital Health: A Necessary Regulatory Convergence.

Biotechnology Governance 2.0: A Proposal for Minimum Standards in Biotechnology Corporate Governance.

Based on experience and the existing limited research literature in biotechnology corporate governance, the authors propose potential attributes of minimum corporate governance standards for biotechnology companies, as a basis for further quantitative and qualitative research. The authors assert that the recent proliferation of biotechnology start-up organizations is substantively changing inter- and intraorganizational cultures throughout the health care sector via a cascade of governance. Therefore, governance decisions and actions-both positive and negative-that are instituted in start-up biotech companies may set new norms for other start-up biotech companies, the larger (bio)pharmaceutical companies by which they are acquired and the range of health care subsector actors that interact with biotechnology companies. The authors stress the importance of appropriate, proportionate, and consistent biotech corporate governance throughout company lifecycles, not simply to support value inflection or as a response to a crisis. Fail to govern, fail to succeed-for investors and, most importantly, for patients.

Digital technology in somatic and gene therapy trials of paediatric patients with ocular diseases: a systematic scoping review protocol (Preprint)

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

The Internet of Things in Healthcare: Proof of Concept Opportunities in Oxford (Preprint)

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

Implementation of blockchains in healthcare: A Systematic Review Protocol (Preprint)

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

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.

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.

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.

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.