Patient portal registration and healthcare utilisation in general practices in England: a longitudinal cohort study.

BACKGROUND: Patient portals introduced in most of England's general practices since 2015 have the potential to improve healthcare efficiency. There is a paucity of information on the use of patient portals within the NHS general practices and the potential impact on healthcare utilisation. AIM: To investigate the association between patient portal registration and care utilisation (measured by the number of general practice consultations) among general practice patients. DESIGN & SETTING: A longitudinal analysis using electronic health record data from the Clinical Practice Research Datalink (CPRD). METHOD: We analysed patients registered for patient portals (n = 284 666), aggregating their consultations 1 year before and 1 year after registration. We ran a multilevel negative binomial regression model to examine patient portal registration's association with face-to-face and remote consultations. RESULTS: Patients who registered to the portal had a small decrease in the total number of face-to-face consultations after registering to the patient portal (incidence rate ratio = 0.93, 95% confidence interval [CI] = 0.93 to 0.94). Patients who registered to the portal had an increase in the total number of remote consultations after registering to the portal (incidence rate ratio = 1.16, 95% CI = 1.15 to 1.18). CONCLUSION: The study found minor changes in consultation numbers post-patient portal registration, notably with an increase in remote consultations. While causality between portal registration and consultation number remains unclear, the potential link between patient portal use and healthcare utilisation warrants further investigation, especially within the NHS, where portal impacts are not well-studied. Detailed portal utilisation data could clarify this relationship.

Cross-sectional analyses of online appointment booking and repeat prescription ordering user characteristics in general practices of England in the years 2018-2020.

OBJECTIVES: To explore the characteristics of the General Practice Patient Survey (GPPS) respondents using the different functionalities of the online services in the context of England's National Health Service General Practices. We hypothesised that respondents who are older, with lower socioeconomic status and non-white ethnicity would be less likely to use online services, while long-term conditions might increase their usage. DESIGN: Cross-sectional study using respondent-level data from the GPPS in England of the years 2018, 2019 and 2020. We assessed the association between online services use and respondent characteristics using two-level mixed-effects logistic regression. PARTICIPANTS: Survey respondents of the GPPS 2018-2020. PRIMARY OUTCOME MEASURES: Online appointment booking and online repeat prescription ordering. RESULTS: 1 807 049 survey respondents were included in this study. 15% (n=263 938) used online appointment booking in the previous 12 months, and 19% (n=339 449) had ordered a repeat prescription in the previous 12 months. Respondents with a long-term condition, on regular multiple medications, who have deafness or hearing loss and who are from the lowest deprivation quintile were more likely to have used online services. Male respondents (compared with females) and respondents with black and other ethnicity compared with white ethnicity were less likely to use online services. Respondents over 85 years old were less likely to use online appointment booking and online repeat prescription ordering compared with the younger age groups. CONCLUSIONS: Specific groups of respondents were more likely to use online services such as patients with long-term conditions or those with deafness or hearing loss. While online services could provide efficiency to patients and practices it is essential that alternatives continue to be provided to those that cannot use or choose not to use online services. Understanding the different patients' needs could inform solutions to increase the uptake and use of the services.

Patient Portal Functionalities and Patient Outcomes Among Patients With Diabetes: Systematic Review.

BACKGROUND: Patient portal use could help improve the care and health outcomes of patients with diabetes owing to functionalities, such as appointment booking, electronic messaging (e-messaging), and repeat prescription ordering, which enable patient-centered care and improve patient self-management of the disease. OBJECTIVE: This review aimed to summarize the evidence regarding patient portal use (portals that are connected to electronic health care records) or patient portal functionality use (eg, appointment booking and e-messaging) and their reported associations with health and health care quality outcomes among adult patients with diabetes. METHODS: We searched the MEDLINE, Embase, and Scopus databases and reported the review methodology using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Three independent reviewers screened titles and abstracts, and two reviewers assessed the full texts of relevant studies and performed data extraction and quality assessments of the included studies. We used the Cochrane Collaboration Risk of Bias Tool and the National Heart, Lung and Blood Institute (NHLBI) Study Quality Assessment Tool to assess the risk of bias of the included studies. Data were summarized through narrative synthesis. RESULTS: Twelve studies were included in this review. Five studies reported overall patient portal use and its association with diabetes health and health care quality outcomes. Six studies reported e-messaging or email use-associated outcomes, and two studies reported prescription refill-associated outcomes. The reported health outcomes included the associations of patient portal use with blood pressure, low-density lipoprotein cholesterol, and BMI. Few studies reported health care utilization outcomes such as office visits, emergency department visits, and hospitalizations. A limited number of studies reported overall quality of care for patients with diabetes who used patient portals. CONCLUSIONS: The included studies mostly reported improved glycemic control outcomes for patients with diabetes who used patient portals. However, limitations of studying the effects of patient portals exist, which do not guarantee whether the outcomes reported are completely the result of patient portal use or if confounding factors exist. Randomized controlled trials and mixed-methods studies could help understand the mechanisms involved in health outcome improvements and patient portal use among patients with diabetes. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019141131; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019141131. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14975.

Patient Portal Functionalities and Uptake: Systematic Review Protocol.

BACKGROUND: Patient portals are digital health tools adopted by health care organizations. The portals are generally connected to the electronic health record of the health care organization and offer patients functionalities such as access to the medical record, ability to order repeat prescriptions, make appointments, or message the health care provider. Patient portals may be beneficial for both patients and the health care system. Patient portals can widely differ from one context to another due to the differences in the portal functionalities and capabilities and it is anticipated that outcomes associated with the functionalities also differ. Current systematic reviews report outcomes associated with patient portal uptake but do not explicitly specify the patient portal functionalities. OBJECTIVE: The aim of this systematic review is to synthesize the evidence on health and health care quality outcomes associated with patient portal use among adult (18 years or older) patients. The review research questions are as follows: What kind of health outcomes do tethered patient portals and patient portal functionalities contribute to in adult patients (18 years or older)? and What kind of health care quality outcomes, including health care utilization outcomes, do tethered patient portals and patient portal functionalities contribute to in adult patients (18 years or older)? METHODS: The systematic review will be conducted by searching the MEDLINE, EMBASE, and Scopus databases for relevant literature. The review inclusion criteria will be studies about adult patients (18 years or older), studies only about tethered patient portals, and studies with or without a comparator. We will report patient portal-associated health and health care quality outcomes based on the patient portal functionalities. All quantitative primary study types will be included. Risk of bias of included studies will be assessed using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials and the National Heart, Lung, and Blood Institute's quality assessment tools. Data will be synthesized using narrative synthesis and will be reported according to the patient portal functionalities, country, disease, and health care system model. RESULTS: Searches will be conducted in September 2019, and the review is anticipated to be completed by the end of June 2020. CONCLUSIONS: This systematic review will provide an overview of health and health care quality outcomes associated with patient portal use among adult patients, providing detailed information about the functionalities of the portals and their associations with the outcomes. The review could potentially help patient portal evaluation studies by providing insights into outcomes associated with the different functionalities of patient portals. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019141131; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=141131. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14975.

Massive Open Online Course Evaluation Methods: Systematic Review.

BACKGROUND: Massive open online courses (MOOCs) have the potential to make a broader educational impact because many learners undertake these courses. Despite their reach, there is a lack of knowledge about which methods are used for evaluating these courses. OBJECTIVE: The aim of this review was to identify current MOOC evaluation methods to inform future study designs. METHODS: We systematically searched the following databases for studies published from January 2008 to October 2018: (1) Scopus, (2) Education Resources Information Center, (3) IEEE (Institute of Electrical and Electronic Engineers) Xplore, (4) PubMed, (5) Web of Science, (6) British Education Index, and (7) Google Scholar search engine. Two reviewers independently screened the abstracts and titles of the studies. Published studies in the English language that evaluated MOOCs were included. The study design of the evaluations, the underlying motivation for the evaluation studies, data collection, and data analysis methods were quantitatively and qualitatively analyzed. The quality of the included studies was appraised using the Cochrane Collaboration Risk of Bias Tool for randomized controlled trials (RCTs) and the National Institutes of Health-National Heart, Lung, and Blood Institute quality assessment tool for cohort observational studies and for before-after (pre-post) studies with no control group. RESULTS: The initial search resulted in 3275 studies, and 33 eligible studies were included in this review. In total, 16 studies used a quantitative study design, 11 used a qualitative design, and 6 used a mixed methods study design. In all, 16 studies evaluated learner characteristics and behavior, and 20 studies evaluated learning outcomes and experiences. A total of 12 studies used 1 data source, 11 used 2 data sources, 7 used 3 data sources, 4 used 2 data sources, and 1 used 5 data sources. Overall, 3 studies used more than 3 data sources in their evaluation. In terms of the data analysis methods, quantitative methods were most prominent with descriptive and inferential statistics, which were the top 2 preferred methods. In all, 26 studies with a cross-sectional design had a low-quality assessment, whereas RCTs and quasi-experimental studies received a high-quality assessment. CONCLUSIONS: The MOOC evaluation data collection and data analysis methods should be determined carefully on the basis of the aim of the evaluation. The MOOC evaluations are subject to bias, which could be reduced using pre-MOOC measures for comparison or by controlling for confounding variables. Future MOOC evaluations should consider using more diverse data sources and data analysis methods. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12087.

Effectiveness of Conversational Agents (Virtual Assistants) in Health Care: Protocol for a Systematic Review.

BACKGROUND: Conversational agents (also known as chatbots) have evolved in recent decades to become multimodal, multifunctional platforms with potential to automate a diverse range of health-related activities supporting the general public, patients, and physicians. Multiple studies have reported the development of these agents, and recent systematic reviews have described the scope of use of conversational agents in health care. However, there is scarce research on the effectiveness of these systems; thus, their viability and applicability are unclear. OBJECTIVE: The objective of this systematic review is to assess the effectiveness of conversational agents in health care and to identify limitations, adverse events, and areas for future investigation of these agents. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols will be used to structure this protocol. The focus of the systematic review is guided by a population, intervention, comparator, and outcome framework. A systematic search of the PubMed (Medline), EMBASE, CINAHL, and Web of Science databases will be conducted. Two authors will independently screen the titles and abstracts of the identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. Two reviewers will independently extract and validate data from the included studies into a standardized form and conduct quality appraisal. RESULTS: As of January 2020, we have begun a preliminary literature search and piloting of the study selection process. CONCLUSIONS: This systematic review aims to clarify the effectiveness, limitations, and future applications of conversational agents in health care. Our findings may be useful to inform the future development of conversational agents and promote the personalization of patient care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16934.

Examining Cost Measurements in Production and Delivery of Three Case Studies Using E-Learning for Applied Health Sciences: Cross-Case Synthesis.

BACKGROUND: The World Health Report (2006) by the World Health Organization conveys that a significant increase is needed in global health care resourcing to meet the current and future demand for health professionals. Electronic learning (e-Learning) presents a possible opportunity to change and optimize training by providing a scalable means for instruction, thus reducing the costs for training health professionals and providing patient education. Research literature often suggests that a benefit of e-Learning is its cost-effectiveness compared with face-to-face instruction, yet there is limited evidence with respect to the comparison of design and production costs with other forms of instruction or the establishment of standards pertaining to budgeting for these costs. OBJECTIVE: To determine the potential cost favorability of e-Learning in contrast to other forms of learning, there must first be an understanding of the components and elements for building an e-Learning course. Without first taking this step, studies lack the essential financial accounting rigor for course planning and have an inconsistent basis for comparison. This study aimed to (1) establish standard ingredients for the cost of e-Learning course production and (2) determine the variance instructional design has on the production costs of e-Learning courses. METHODS: This study made use of a cross-case method among 3 case studies using mixed methods, including horizontal budget variance calculation and qualitative interpretation of responses from course designers for budget variance using total quality management themes. The different implementation-specific aspects of these cases were used to establish common principles in the composition of budgets in the production and delivery of an applied health professional e-Learning course. RESULTS: A total of 2 case studies reported significant negative budget variances caused by issues surrounding underreporting of personnel costs, inaccurate resource task estimation, lack of contingency planning, challenges in third-party resource management, and the need to update health-related materials that became outdated during course production. The third study reported a positive budget variance because of the cost efficiency derived from previous implementation, the strong working relationship of the course project team, and the use of iterative project management methods. CONCLUSIONS: This research suggests that the delivery costs of an e-Learning course could be underestimated or underreported and identifies factors that could be used to better control budgets. Through consistent management of factors affecting the cost of course production, further research could be undertaken using standard economic evaluation methods to evaluate the advantages of using e-Learning.

Tools for the Diagnosis of Herpes Simplex Virus 1/2: Systematic Review of Studies Published Between 2012 and 2018.

BACKGROUND: Herpes simplex virus (HSV)-1 and HSV-2 are common infections affecting the global population, with HSV-1 estimated to affect 67% of the global population. HSV can have rare but severe manifestations, such as encephalitis and neonatal herpes, necessitating the use of reliable and accurate diagnostic tools for the detection of the viruses. Currently used HSV diagnostic tools require highly specialized skills and availability of a laboratory setting but may lack sensitivity. The numerous recently developed HSV diagnostic tools need to be identified and compared in a systematic way to make the best decision about which diagnostic tool to use. The diagnosis of HSV is essential for prompt treatment with antivirals. To select the best test for a patient, knowledge of the performance and limitations of each test is critical. OBJECTIVE: This systematic review has summarized recent studies evaluating HSV-1 and HSV-2 diagnostic tools. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, selection criteria, data extraction, and data analysis were determined before the commencement of the study. Studies assessing the specificity/sensitivity of HSV-1 or HSV-2 diagnostic tools published between 2012 and 2018 were included. Quality assessment of included studies was performed using the quality assessment of diagnostic accuracy studies (QUADAS-2) tool. RESULTS: Searches of the PubMed database yielded 264 studies; 11 studies included 11 molecular assays, and 8 studies included 19 different serological assays for the detection of HSV-1, HSV-2, or both. A greater proportion of molecular assay-based tools are being developed by commercial entities. Studies that tested molecular assays mostly focused on cutaneous and mucosal HSV infections (n=13); 2 studies focused on ocular disease, whereas only 1 study focused on the central nervous system manifestations. The Simplexa HSV 1 & 2 Direct is currently the only Food and Drug Administration-approved device for use on cerebrospinal fluid. No tools focused on prenatal screening. We also present performance metrics of tests for benchmarking of future technology. Most of the included studies had a high risk of bias rating in half of the QUADAS-2 tool risk of bias domains. CONCLUSIONS: The use of serologic tests to diagnose genital lesions is inappropriate because positive results may be due to chronic infection, whereas negative results may overlook recent infection. The incidence of acute infections is rising. As these infections present the greatest risk to fetuses, work needs to be done to prevent vertical transfer. Prenatal screening for primary infection and subsequent medical intervention will assist in lowering the rate of neonatal herpes. In conclusion, HSV diagnosis is moving away from culture-based methods to serology-based or polymerase chain reaction-based methods. Sensitive, rapid, and efficient HSV diagnostic tools should be adopted for the prevention of acute infections and neonatal herpes.

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.

Massive Open Online Courses (MOOC) Evaluation Methods: Protocol for a Systematic Review.

BACKGROUND: Massive open online courses (MOOCs) have increased in popularity in recent years. They target a wide variety of learners and use novel teaching approaches, yet often exhibit low completion rates (10%). It is important to evaluate MOOCs to determine their impact and effectiveness, but little is known at this point about the methodologies that should be used for evaluation. OBJECTIVE: The purpose of this paper is to provide a protocol for a systematic review on MOOC evaluation methods. METHODS: We will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines for reporting this protocol. We developed a population, intervention, comparator, and outcome (PICO) framework to guide the search strategy, based on the overarching question, "What methods have been used to evaluate MOOCs?" The review will follow six stages: 1) literature search, 2) article selection, 3) data extraction, 4) quality appraisal, 5) data analysis, and 6) data synthesis. RESULTS: The systematic review is ongoing. We completed the data searches and data abstraction in October and November 2018. We are now analyzing the data and expect to complete the systematic review by March 2019. CONCLUSIONS: This systematic review will provide a useful summary of the methods used for evaluation of MOOCs and the strengths and limitations of each approach. It will also identify gaps in the literature and areas for future work. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12087.

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.

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.

Decision Support Tools for Regenerative Medicine: Systematic Review.

BACKGROUND: Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients. OBJECTIVE: The objective of this review was to investigate what decisional tools are available and what issues and gaps have been raised for their use in regenerative medicine. METHODS: We systematically searched MEDLINE to identify articles on decision support tools relevant to tissue engineering, and cell and gene therapy, with the aim of identifying gaps for future decisional tool development. We included published studies in English including a description of decisional tools in regenerative medicines. We extracted data using a predesigned Excel table and assessed the data both quantitatively and qualitatively. RESULTS: We identified 9 articles addressing key decisions in manufacturing and product development challenges in cell therapies. The decision objectives, parameters, assumptions, and solution methods were analyzed in detail. We found that all decisional tools focused on cell therapies, and 6 of the 9 reviews focused on allogeneic cell therapy products. We identified no available tools on tissue-engineering and gene therapy products. These studies addressed key decisions in manufacturing and product development challenges in cell therapies, such as choice of technology, through modeling. CONCLUSIONS: Our review identified a limited number of decisional tools. While the monoclonal antibodies and biologics decisional tool domain has been well developed and has shown great importance in driving more cost-effective manufacturing processes and better investment decisions, there is a lot to be learned in the regenerative medicine domain. There is ample space for expansion, especially with regard to autologous cell therapies, tissue engineering, and gene therapies. To consider the problem more comprehensively, the full needle-to-needle process should be modeled and evaluated.

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.

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.

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.