Publications
133 results found
Meinert E, Milne-Ives M, Surodina S, et al., 2020, Agile Requirements Engineering and Software Planning for a Digital Health Platform to Engage the Effects of Isolation Caused by Social Distancing: Case Study (Preprint)
<sec> <title>BACKGROUND</title> <p>Social distancing and shielding measures have been put in place to reduce social interaction and slow the transmission of the coronavirus disease (COVID-19). For older people, self-isolation presents particular challenges for mental health and social relationships. As time progresses, continued social distancing could have a compounding impact on these concerns.</p> </sec> <sec> <title>OBJECTIVE</title> <p>This project aims to provide a tool for older people and their families and peers to improve their well-being and health during and after regulated social distancing. First, we will evaluate the tool’s feasibility, acceptability, and usability to encourage positive nutrition, enhance physical activity, and enable virtual interaction while social distancing. Second, we will be implementing the app to provide an online community to assist families and peer groups in maintaining contact with older people using goal setting. Anonymized data from the app will be aggregated with other real-world data sources to develop a machine learning algorithm to improve the identification of patients with COVID-19 and track for real time use by health systems.</p> </sec> <sec> <title>METHODS</title> <p>Development of this project is occurring at the time of publication, and therefore, a case study design was selected to provide a systematic means of capturing software engineering in progress. The app development framework for software design was based on agile methods. The evaluation of the app’s feasibility, acceptability and usability shall be conducted using Public Health England's guidance on evaluating digital health produ
Lam C, van Velthoven M, Meinert E, 2020, Application of “Internet of Things” in cell-based therapy delivery: a systematic review protocol, JMIR Research Protocols, Vol: 9, Pages: 1-6, ISSN: 1929-0748
Internet of Things (IoT) or Industry 4.0, represents a ‘smart’ shift to more interconnected manufacturing processes where individual entities within the supply chain communicate with each other in order to achieve greater flexibility and responsiveness in manufacturing and leaner manufacturing to reduce cost of production. IoT has proven itself instrumental in driving leaner manufacturing and more efficient systems in other industries such as transportation and logistics. While cell-based therapeutic products hold the promise of transforming various diseases, the delivery of these products is complex and challenging. This review aims to understand the applicability of IoT in cell-based product supply chain and delivery.
Lam C, Milne-Ives M, van Velthoven M, et al., 2020, IoT-enabled technologies for weight management in children and young people: a systematic review protocol, JMIR Research Protocols, Vol: 9, Pages: 1-7, ISSN: 1929-0748
Background:Childhood obesity is a serious global issue, leading to greater medical spending in obesity-related diseases such as cardiovascular diseases and diabetes. There is a need for healthcare services that link health behaviour, such as diet and physical activity, to risk factors and provides better advice and feedback to users, which Internet of Things-enabled technologies could facilitate.Objective:The objective of the systematic review will be to identify available Internet of Things-enabled technologies for weight management of children and young people (users below the age of 18). Also it will aim to understand the use, effectiveness and feasibility of these technologies.Methods:We will search Medline, PubMed, Web of Science, Scopus, ProQuest Central and the IEEE Xplore Digital Library for studies published after 2010 using a combination of keywords and subject headings related to health activity tracking, youth and Internet of Things. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria. Any discrepancies will then be discussed and resolved. The quality of the included studies will be assessed using the Critical Appraisal Skills Programme (CASP) checklists. Data from included studies will be extracted into a predesigned form to identify the types of devices or apps, Internet of Things applications and health outcomes related to weight management.Results:A preliminary search on Medline returned 484 results. The full systematic review will be conducted within the next 12 months and the publication of the final review and meta-analysis is expected at the beginning of the year 2020.Conclusions:The effectiveness and feasibility of physical activity trackers and consumer wearables for different patient groups have been well reviewed but there are currently no published reviews
Milne-Ives M, Lam C, De Cock C, et al., 2020, Mobile apps for health behaviour change in physical activity, diet, drug and alcohol use, and mental health: a systematic review, JMIR mHealth and uHealth, Vol: 8, Pages: 1-16, ISSN: 2291-5222
Background: With a growing focus on patient interaction with health management, mobile apps are increasingly used to deliver behavioural health interventions. The large variation in these mobile health apps - their target patient group, health behaviour, and behavioural change strategies - has resulted in a large but incohesive body of literature.Objective: The purpose of this systematic review was to assess the effectiveness of mobile apps at improving health behaviours and outcomes, and to examine the inclusion and effectiveness of Behaviour Change Techniques in mobile health apps.Methods: Medline, EMBASE, CINAHL, and Web of Science were systematically searched for articles published between 2014 and 2019 that evaluated mobile apps for health behaviour change. Two authors independently screened and selected studies according to the eligibility criteria. Data was extracted and risk of bias assessed by one reviewer and validated by a second reviewer.Results: 52 randomized controlled trials met the inclusion criteria and were included in analysis - 37 studies focused on physical activity, diet, or a combination of both, 11 on drug and alcohol use, and 4 on mental health. Participant perceptions were generally positive - only one app was rated as less helpful and satisfactory than the control - and the studies that measured engagement and usability found relatively high study completion rates (mean = 83.3%, n = 18) and ease of use ratings (3 significantly better than control, 9/15 rated >70%) . However, there was little evidence of changed behaviour or health outcomes.Conclusions: There was not strong evidence found to support the effectiveness of mobile apps at improving health behaviours or outcomes because few studies found significant differences between the app and control groups. Further research is needed to identify the behaviour change techniques that are most effective at promoting behaviour change. Improved reporting is necessary to accurately evaluate t
van Velthoven M, Lam C, de Cock C, et al., 2020, Development of an innovative real world evidence registry for the herpes simplex Virus: a case study, JMIR Dermatology, Vol: 3, Pages: 1-10, ISSN: 2562-0959
Background: Infection with the Herpes Simplex Virus is common but is not well understood and stigmatised. Whilst a considerable number of people experience mild to severe physical symptoms after infection, only one sub-effective drug is available for treatment. A registry collecting real world data reported by people with the Herpes Simplex Virus could help them manage their condition, facilitate research into a vaccine, better treatment, and the impact of herpes on other conditions.Objective: This paper reports on the development a registry to collect real world data reported by people with the Herpes Simplex Virus.Methods: A case study design was selected to support a systematic means of observing the subject of investigation. The case study followed seven stages: plan, design, prepare, collect, analyse, create and share. We carried out semi-structured interviews with experts, thematically analysed the findings and built use cases. These will be used to generate detailed models of how a real world evidence registry might look, feel, and operate for different users.Results: We found the following key themes in the interviews: 1) stigma and anonymity; 2) selection bias; 3) understanding treatment and outcome gaps; 4) lifestyle factors; 5) individualised vs population-level; and 6) severe complications of herpes simplex virus. We developed use cases for different types of patients, members of the public, researchers and clinicians for a herpes simplex virus registry.Conclusions: This case study showed insights for the development of an appropriate registry to collect real world data reported by people with the Herpes Simplex Virus. Further research is needed on developing and testing the registry with different users and evaluate its feasibility and effectiveness of collecting data to support symptom management, and the development of vaccines and better treatment.
Fawcett E, van Velthoven M, Brindley D, et al., 2020, Long-term weight management using wearable technology in overweight and obese adults: A systematic review, JMIR mHealth and uHealth, Vol: 8, Pages: 1-10, ISSN: 2291-5222
Background:Whilst there are many wearable devices available to help people losing weight and decrease the rising obesity prevalence, their effectiveness in long-term weight management has not been established.Objective:To systematically review the literature on using wearable technology for long-term weight loss in overweight and obese adults.Methods:We searched the following databases: Medline, Embase, Compendex - ScienceDirect, Cochrane Central, and Scopus. Studies were included that took measurements over a period of ≥1 year (long-term) and had adult participants with a BMI > 24. Two reviewers screened titles and abstracts and assessed selected full text papers for eligibility. Risk of bias assessment was done through the following tools appropriate for different study types: The Cochrane Risk of Bias Tool, ROBINS-I, AMSTAR, ‘6 Questions to Trigger Critical Thinking’. The results of the studies are provided in a narrative summary. Results: We included five intervention studies: four randomised controlled trials, and one non-randomized study. Also, we used insights from six systematic reviews, four commentary papers and a dissertation. The interventions delivered by wearable devices did not show a benefit over comparator interventions, but overweight and obese participants still lost weight over time. The included intervention studies were likely to suffer from bias. There was a range of conclusions between the included studies, due to differences in their objectives, methods, and results. Therefore, it was not possible to conduct a meta-analysis. Conclusions:This review showed some evidence that wearable devices can improve long-term physical activity and weight loss outcomes, but there was not enough evidence to show a benefit over comparator methods. A major issue is the challenge to separate the effect of decreasing use of wearable devices over time from the effect of the wearable devices on outcomes. Consistency in study methods is needed i
de Cock C, Milne-Ives M, van Velthoven M, et al., 2020, Effectiveness of conversational agents (virtual assistants) in healthcare: protocol for a systematic review, JMIR Research Protocols, Vol: 9, Pages: 1-6, ISSN: 1929-0748
Background:Conversational agents have evolved in recent decades to become multimodal, multifunctional platforms that have the 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 healthcare. However, there is little focus on the effectiveness of these systems, thus the viability and applicability of these systems is unclear.Objective:The objective of this systematic review is to assess the effectiveness of conversational agents in healthcare 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 PubMed (Medline), EMBASE, CINAHL, and Web of Science will be conducted. Two authors will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. Two reviewers will extract and validate data, respectively, from included studies into a standardised form and conduct quality appraisal.Results:At the time of writing, 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 healthcare. Our findings may be used to inform future development of conversational agents and further the personalisation of care.
Van Velthoven M, Milne-Ives M, de Cock C, et al., 2020, Use of apps to promote childhood vaccination: a systematic review protocol, JMIR Research Protocols, Vol: 9, Pages: 1-6, ISSN: 1929-0748
Background:The decline in the uptake of routine childhood vaccinations has resulted in outbreaks of vaccine-preventable diseases. Vaccination apps can be used as a tool to promote immunization through the provision of reminders, dissemination of information, peer-support and feedback.Objective:The aim of this review is to systematically review the evidence on the use of apps to support childhood vaccination uptake, information storage and record sharing. Methods:We will identify relevant papers by searching electronic databases: PubMed, EMBASE (Ovid), Cochrane Central Register of Controlled Trials, ERIC and ClinicalTrials.gov. We will review the reference lists of those studies that we include to identify relevant additional papers not initially identified using our search strategy. In addition to the use of electronic databases, we will search for grey literature on the topic. The search strategy will include only terms relating to or describing the intervention, which is app use. As almost all titles and abstracts are in English, 100% of these will be reviewed, but retrieval will be confined to those in the English language. We will record the search outcome on a specifically designed record sheet. Two reviewers will select observational and intervention studies, appraise the quality of the studies and extract the relevant data.
Meinert E, Rahman E, Potter A, et al., 2020, Acceptability and Usability of the Mobile Digital Health App NoObesity for Families and Health Care Professionals: Protocol for a Feasibility Study (Preprint)
<sec> <title>BACKGROUND</title> <p>Almost a quarter or more than a fifth of children in the United Kingdom are overweight or obese by the time they start school. The UK Department of Health and Social Care’s national policy for combating childhood obesity has critical outcomes centered on sugar and caloric consumption reduction. Health Education England has developed two digital apps for families with children up to 15 years and for their associated health care professionals to provide a digital learning resource and tool aimed at encouraging healthy lifestyles to prevent obesity.</p> </sec> <sec> <title>OBJECTIVE</title> <p>This feasibility study assesses the usability and acceptability of Health Education England’s NoObesity app for undertaking activities to improve families’ diet and physical activity. The purpose of the study is to evaluate the app’s influence on self-efficacy and goal setting and to determine what can be learnt to improve its design for future studies, if there is evidence of adoption and sustainability.</p> </sec> <sec> <title>METHODS</title> <p>The study population will include 20 to 40 families and their linked health care professionals. Considering issues related to digital access associated with socioeconomic status and the impact on information technology use, study recruitment will be regionally focused in a low socioeconomic status area. The study will last for 9 months (3-month intervention period and 6-month follow-up). The evaluations of feasibility, acceptability, and usability will be conducted using the following scales and theoretical frameworks: (1) system usability scale; (2) Reach Effectiveness
Lam C, van Velthoven M, Chaudhury H, et al., 2020, Teaching real world evidence: a systematic review protocol, JMIR Research Protocols, Vol: 9, Pages: 1-5, ISSN: 1929-0748
Background: Real world evidence refers to observational healthcare data beyond clinical trial data. It holds promise of transforming healthcare as a new form of evidence to support decision-makers in making decisions in developing and regulating medicines. As the importance of real world evidence is recognized by industry and regulatory bodies, teaching real world evidence becomes an important matter to evaluate and refine in order to develop future researchers and stakeholders who can better integrate RWE into the routine development of medicine.Objective: The aim of this review is to understand how real world evidence is currently being taught. From this landscape study, the insufficiencies of current education of real world evidence can be identified and subsequently inform future education policies around RWE and its sub-facets.Methods: We will search Medline, Embase, PsycINFO, HMIC, Cochrane and Web of Science for published studies using a combination of keywords and subject headings related to real world evidence and education. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria, and any discrepancies will then be discussed and resolved. The quality of the included literature will be assessed using the CASP Systematic Review checklist. Results: Data from eligible publications will be abstracted into a predesigned form in order to better understand the current state of education of RWE and inform future real world evidence education directions and policies.Conclusions: The subsequent systematic review will be published in a peer-reviewed journal.
Milne-Ives M, Lam C, van Velthoven M, et al., 2020, Mobile apps for health behaviour change: a systematic review protocol, JMIR Research Protocols, Vol: 9, Pages: 1-7, ISSN: 1929-0748
The popularity and ubiquity of mobile apps has rapidly expanded in the past decade. With a growing focus on patient interaction with health management, mobile apps are increasingly used to monitor health and deliver behavioural interventions. The large variation in these mobile health apps - their target patient group, health behaviour, and behavioural change strategy - has resulted in a large but incohesive body of literature.
Alturkistani A, Lam C, Foley K, et al., 2020, Massive open online course evaluation methods: systematic review (Preprint), Publisher: JMIR Publications
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
Hu R, Velthoven M, Brindley D, et al., 2020, Perspectives of overweight and obese people on using wearable technology for weight management: a systematic review, JMIR mHealth and uHealth, Vol: 8, Pages: 1-10, ISSN: 2291-5222
Background: Obesity is a large contributor to preventable chronic diseases and healthcare costs. The efficacy of wearable devices for weight management has been researched, however, there is limited knowledge on how these devices are perceived by users. Objective: To review user perspectives on wearable technology for weight management in overweight and obese people. Methods: We searched the online databases Pubmed, Scopus, Embase and the Cochrane library for literature published from 2008 onwards. We included all types of studies using a wearable device for delivering weight-loss interventions in overweight or obese adults when qualitative data were collected about participant’s perspectives on the device. We performed a quality assessment using criteria relevant to different study types. The Cochrane risk of bias tool was used for randomized controlled trials. The Risk of Bias in Non-randomised Studies – of Interventions (ROBINS-I) was used for non-randomised studies. The Oxman and Guyatt Criteria was used for systematic reviews. We used the Critical appraisal checklist for qualitative studies. Data were extracted into a data extraction sheet and thematically analyzed. Results: We included 19 studies: 5 randomized controlled trials, 6 non-randomised studies, 5 qualitative studies, and 3 reviews. Mixed perceptions existed for different constructs of wearable technologies, which reflects on differences in the suitability of wearable technology interventions for different individuals in different contexts. This also indicates that interventions were not often tailored to participant’s motivations. In addition, very few wearable technology interventions included a thorough qualitative analysis of the participant’s view on important features of the intervention that made it successful. Conclusions: This study highlighted the importance of determining the type of intervention most suitable for an individual before the intervention is used. This c
Vazirani AA, O'Donoghue O, Brindley D, et al., 2020, Blockchain vehicles for efficient Medical Record management., NPJ Digit Med, Vol: 3
The lack of interoperability in Britain's medical records systems precludes the realisation of benefits generated by increased spending elsewhere in healthcare. Growing concerns regarding the security of online medical data following breaches, and regarding regulations governing data ownership, mandate strict parameters in the development of efficient methods to administrate medical records. Furthermore, consideration must be placed on the rise of connected devices, which vastly increase the amount of data that can be collected in order to improve a patient's long-term health outcomes. Increasing numbers of healthcare systems are developing Blockchain-based systems to manage medical data. A Blockchain is a decentralised, continuously growing online ledger of records, validated by members of the network. Traditionally used to manage cryptocurrency records, distributed ledger technology can be applied to various aspects of healthcare. In this manuscript, we focus on how Electronic Medical Records in particular can be managed by Blockchain, and how the introduction of this novel technology can create a more efficient and interoperable infrastructure to manage records that leads to improved healthcare outcomes, while maintaining patient data ownership and without compromising privacy or security of sensitive data.
Vazirani A, ODonoghue O, Brindley D, et al., 2020, Blockchain vehicles for efficient Medical Record management, npj Digital Medicine, Vol: 3, Pages: 1-5, ISSN: 2398-6352
The lack of interoperability in Britain’s medical records systems precludes the realisation of benefits generated by increased spending elsewhere in healthcare. Growing concerns regarding the security of online medical data following breaches, and regarding regulations governing data ownership, mandate strict parameters in the development of efficient methods to administrate medical records. Furthermore, consideration must be placed on the rise of connected devices, which vastly increase the amount of data that can be collected in order to improve a patient’s long-term health outcomes. Increasing numbers of healthcare systems are developing Blockchain-based systems to manage medical data. A Blockchain is a decentralised, continuously growing online ledger of records, validated by members of the network. Traditionally used to manage cryptocurrency records, distributed ledger technology can be applied to various aspects of healthcare. In this manuscript, we focus on how Electronic Medical Records in particular can be managed by Blockchain, and how the introduction of this novel technology can create a more efficient and interoperable infrastructure to manage records that leads to improved healthcare outcomes, while maintaining patient data ownership and without compromising privacy or security of sensitive data.
Milne-Ives M, Lam C, van Velthoven M, et al., 2020, The Impact of Brexit on the Pharmaceutical Supply Chain of the United Kingdom: Scoping Review Protocol (Preprint)
<sec> <title>BACKGROUND</title> <p>The continuing uncertainty around Brexit has caused concern in the pharmaceutical industry and among health care professionals and patients. The exact consequences of Brexit on the pharmaceutical supply chain in the United Kingdom will depend on whether a deal is reached and what it entails, but it is likely to be affected by the withdrawal of the United Kingdom from the European Union. Regulatory issues and delays in supply have the potential to negatively affect the ability of UK residents to receive an adequate and timely supply of necessary medicines.</p> </sec> <sec> <title>OBJECTIVE</title> <p>The purpose of this protocol is to provide an overview and critical analysis of current perspectives on the effect of Brexit on the UK pharmaceutical supply chain.</p> </sec> <sec> <title>METHODS</title> <p>The PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines will be used to structure this protocol. A systematic search of MEDLINE, EMBASE, PsycINFO, Healthcare Management Information Consortium (HMIC), Cochrane, Web of Science, Business Source Complete, EconLit, and Economist Intelligence Unit will be conducted, as well as a Google and Nexis.UK search for grey literature such as reports, opinion pieces, and press releases. Two reviewers will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. One reviewer will extract data from the included studies into a standardized form, which will be validated by a second reviewer. Risk of bia
Milne-Ives M, Lam C, van Velthoven M, et al., 2020, Mobile Fitness and Weight Management Apps: Protocol for a Quality Evaluation (Preprint)
<sec> <title>BACKGROUND</title> <p>Obesity is a contributing factor for many noncommunicable diseases and a growing problem worldwide. Many mobile apps have been developed to help users improve their fitness and weight management behaviors. However, the speed at which apps are created and updated means that it is important to periodically assess their quality.</p> </sec> <sec> <title>OBJECTIVE</title> <p>The purpose of this study is to evaluate the quality of fitness and weight management mobile health apps using the Mobile Application Rating Scale (MARS). It will also describe the features of the included apps and compare the results to a previous evaluation conducted in 2015.</p> </sec> <sec> <title>METHODS</title> <p>Searches for “fitness,” “weight,” “exercise,” “physical activity,” “diet,” “eat*,” and “food” will be conducted in the Apple App Store and Google Play. Apps that have been updated over the past 5 years will be included. Two reviewers will rate the apps’ quality using the MARS objective and subjective quality subscales. Interrater reliability will also be assessed. Features included in high-quality apps will be assessed, and changes in quality, features, and behavior change techniques made during the past 5 years will be described.</p> </sec> <sec> <title>RESULTS</title> <p>The results will be included in the evaluation paper, which we aim to publish in 2020.</p> </sec> <se
Lam C, Meinert E, Yang A, et al., 2020, Decisions in the Development Lifecycle of Cell and Gene Therapies, SECOND GENERATION CELL AND GENE-BASED THERAPIES, Editors: Vertes, Smith, Qureshi, Dowden, Publisher: ACADEMIC PRESS LTD-ELSEVIER SCIENCE LTD, Pages: 597-632, ISBN: 978-0-12-812034-7
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Surodina S, Ching L, de Cock C, et al., 2019, Engineering requirements of a Herpes simplex virus patient registry: discovery phase of a real-world evidence platform to advance pharmacogenomics and personalized medicine, Biomedicines, Vol: 7, ISSN: 2227-9059
Comprehensive pharmacogenomic understanding requires both robust genomic and demographic data. Patient registries present an opportunity to collect large amounts of robust, patient-level data. Pharmacogenomic advancement in the treatment of infectious diseases is yet to be fully realised. Herpes simplex virus (HSV) is one disease for which pharmacogenomic understanding is wanting. This paper aims to understand the key factors that impact data collection quality for medical registries and suggest potential design features of an HSV medical registry to overcome current constraints and allow for this data to be used as a complement to genomic and clinical data to further the treatment of HSV. This paper outlines the discovery phase for the development of an HSV registry with the aim of learning about the users and their contexts, the technological constraints and the potential improvements that can be made. The design requirements and user stories for the HSV registry have been identified for further alpha phase development. The current landscape of HSV research and patient registry development were discussed. Through the analysis of the current state of the art and thematic user analysis, potential design features were elucidated to facilitate the collection of high-quality, robust patient-level data which could contribute to advances in pharmacogenomic understanding and personalised medicine in HSV. The user requirements specification for the development of an HSV registry has been summarised and implementation strategies for the alpha phase discussed.
de Cock C, van Velthoven M, Milne-Ives M, et al., 2019, Use of Apps to Promote Childhood Vaccination: Systematic Review (Preprint)
<sec> <title>BACKGROUND</title> <p>Vaccination is a critical step in reducing child mortality; however, vaccination rates have declined in many countries in recent years. This decrease has been associated with an increase in the outbreak of vaccine-preventable diseases. The potential for leveraging mobile platforms to promote vaccination coverage has been investigated in the development of numerous mobile apps. Although many are available for public use, there is little robust evaluation of these apps.</p> </sec> <sec> <title>OBJECTIVE</title> <p>This systematic review aimed to assess the effectiveness of apps supporting childhood vaccinations in improving vaccination uptake, knowledge, and decision making as well as the usability and user perceptions of these apps.</p> </sec> <sec> <title>METHODS</title> <p>PubMed, Excerpta Medica Database (EMBASE), Web of Science, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Education Resources Information Center (ERIC) databases were systematically searched for studies published between 2008 and 2019 that evaluated childhood vaccination apps. Two authors screened and selected studies according to the inclusion and exclusion criteria. Data were extracted and analyzed, and the studies were assessed for risk of bias.</p> </sec> <sec> <title>RESULTS</title> <p>A total of 28 studies evaluating 25 apps met the inclusion criteria and were included in this analysis. Overall, 9 studies assessed vaccination uptake, of which 4 reported significant benefits (<i>P</
Milne-Ives M, Lam C, De Cock C, et al., 2019, Mobile Apps for Health Behavior Change in Physical Activity, Diet, Drug and Alcohol Use, and Mental Health: Systematic Review (Preprint)
<sec> <title>BACKGROUND</title> <p>With a growing focus on patient interaction with health management, mobile apps are increasingly used to deliver behavioral health interventions. The large variation in these mobile health apps—their target patient group, health behavior, and behavioral change strategies—has resulted in a large but incohesive body of literature.</p> </sec> <sec> <title>OBJECTIVE</title> <p>This systematic review aimed to assess the effectiveness of mobile apps in improving health behaviors and outcomes and to examine the inclusion and effectiveness of behavior change techniques (BCTs) in mobile health apps.</p> </sec> <sec> <title>METHODS</title> <p>PubMed, EMBASE, CINAHL, and Web of Science were systematically searched for articles published between 2014 and 2019 that evaluated mobile apps for health behavior change. Two authors independently screened and selected studies according to the eligibility criteria. Data were extracted and the risk of bias was assessed by one reviewer and validated by a second reviewer.</p> </sec> <sec> <title>RESULTS</title> <p>A total of 52 randomized controlled trials met the inclusion criteria and were included in the analysis—37 studies focused on physical activity, diet, or a combination of both, 11 on drug and alcohol use, and 4 on mental health. Participant perceptions were generally positive—only one app was rated as less helpful and satisfactory than the control—and the studies that measured engagement and usability found relatively high study complet
Lam C, van Velthoven MH, Meinert E, 2019, Developing a Blockchain-Based Supply Chain System for Advanced Therapies: Protocol for a Feasibility Study (Preprint)
<sec> <title>BACKGROUND</title> <p>Advanced therapies, including cell and gene therapies, have shown therapeutic promise in curing life-threatening diseases, such as leukemia and lymphoma. However, these therapies can be complicated and expensive to deliver due to their sensitivity to environment; troublesome tissue, cell, or genetic material sourcing; and complicated regulatory requirements.</p> </sec> <sec> <title>OBJECTIVE</title> <p>This study aims to create a novel connected supply chain logistics and manufacturing management platform based on blockchain, with cell and gene therapy as a use case. Objectives are to define the requirements and perform feasibility evaluations on the use of blockchain for standardized manufacturing and establishment of a chain of custody for the needle-to-needle delivery of autologous cell and gene therapies. A way of lowering overall regulatory compliance costs for running a network of facilities operating similar or parallel processes will be evaluated by lowering the monitoring costs through publishing zero-knowledge proofs and product release by exception.</p> </sec> <sec> <title>METHODS</title> <p>The study will use blockchain technologies to digitally connect and integrate supply chain with manufacturing to address the security, scheduling, and communication issues between advanced therapy treatment centers and manufacturing facilities in order to realize a transparent, secure, automated, and cost-effective solution to the delivery of these life-saving therapies. An agile software development methodology will be used to develop, implement, and evaluate the system. The system will adhere to the EU and US good manufactu
de Cock C, Milne-Ives M, van Velthoven MH, et al., 2019, Effectiveness of conversational agents (virtual assistants) in health care: protocol for a systematic review (Preprint), Publisher: JMIR Publications Inc.
Background:Conversational agents have evolved in recent decades to become multimodal, multifunctional platforms that have the 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 healthcare. However, there is little focus on the effectiveness of these systems, thus the viability and applicability of these systems is unclear.Objective:The objective of this systematic review is to assess the effectiveness of conversational agents in healthcare 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 PubMed (Medline), EMBASE, CINAHL, and Web of Science will be conducted. Two authors will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. Two reviewers will extract and validate data, respectively, from included studies into a standardised form and conduct quality appraisal.Results:At the time of writing, 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 healthcare. Our findings may be used to inform future development of conversational agents and further the personalisation of care.
Lam C, van Velthoven MH, Chaudhury H, et al., 2019, Teaching Real-World Evidence: Protocol for a Systematic Review (Preprint)
<sec> <title>BACKGROUND</title> <p>Real-world evidence (RWE) refers to observational health care data beyond clinical trial data. It holds the promise of transforming health care as a new form of evidence to support decision makers in making decisions when developing and regulating medicines. As the importance of RWE is recognized by industry and regulatory bodies, teaching RWE becomes an important matter to evaluate and refine in order to develop future researchers and stakeholders who can better integrate RWE into the routine development of medicine.</p> </sec> <sec> <title>OBJECTIVE</title> <p>The aim of this review is to understand how RWE is currently being taught. From this landscape study, the insufficiencies of the current education of RWE can be identified and subsequently inform future education policies around RWE and its subfacets.</p> </sec> <sec> <title>METHODS</title> <p>We will search MEDLINE, EMBASE, PsycINFO, Healthcare Management Information Consortium, Cochrane, and Web of Science for published studies using a combination of keywords and subject headings related to RWE and education. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria; any discrepancies will be discussed and resolved. The quality of the included literature will be assessed using the Critical Appraisal Skills Programme systematic review checklist.</p> </sec> <sec> <title>RESULTS</title>
Van Velthoven MH, Milne-Ives M, de Cock C, et al., 2019, Use of Apps to Promote Childhood Vaccination: Protocol for a Systematic Review (Preprint)
<sec> <title>BACKGROUND</title> <p>The decline in the uptake of routine childhood vaccinations has resulted in outbreaks of vaccine-preventable diseases. Vaccination apps can be used as a tool to promote immunization through the provision of reminders, dissemination of information, peer support, and feedback.</p> </sec> <sec> <title>OBJECTIVE</title> <p>The aim of this review is to systematically review the evidence on the use of apps to support childhood vaccination uptake, information storage, and record sharing.</p> </sec> <sec> <title>METHODS</title> <p>We will identify relevant papers by searching the following electronic databases: PubMed, Embase by Ovid, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov, and Education Resources Information Center (ERIC). We will review the reference lists of those studies that we include to identify relevant additional papers not initially identified using our search strategy. In addition to the use of electronic databases, we will search for grey literature on the topic. The search strategy will include only terms relating to or describing the intervention, which is app use. As almost all titles and abstracts are in English, 100% of these will be reviewed, but retrieval will be confined to papers written in the English language. We will record the search outcome on a specifically designed record sheet. Two reviewers will select observational and intervention studies, appraise the quality of the studies, and extract the relevant data. All studies will involve the use of apps relating to child vaccinations. The primary outcome is the uptake of vaccinations. Secondary outcomes
van Velthoven MH, Lam C, de Cock C, et al., 2019, Development of an Innovative Real-World Evidence Registry for the Herpes Simplex Virus: Case Study (Preprint)
<sec> <title>BACKGROUND</title> <p>Infection with the herpes simplex virus (HSV) is common but not well understood. Furthermore, there remains a social stigma surrounding HSV that can have psychosocial implications for those infected. Despite many patients infected with HSV experiencing mild-to-severe physical symptoms, only one subeffective treatment is available. A registry collecting real-world data reported by individuals potentially infected with HSV could help patients to better understand and manage their condition.</p> </sec> <sec> <title>OBJECTIVE</title> <p>This study aimed to report on the development of a registry to collect real-world data reported by people who might be infected with HSV.</p> </sec> <sec> <title>METHODS</title> <p>A case study design was selected as it provides a systematic and in-depth approach to investigating the planning phase of the registry. The case study followed seven stages: plan, design, prepare, collect, analyze, create, and share. We carried out semistructured interviews with experts, which were thematically analyzed and used to build use cases for the proposed registry. These use cases will be used to generate detailed models of how a real-world evidence registry might be perceived and used by different users.</p> </sec> <sec> <title>RESULTS</title> <p>The following key themes were identified in the interviews: (1) stigma and anonymity, (2) selection bias, (3) understanding treatment and outcome gaps, (4) lifestyle factors, (5) individualized versus population-level data, and (6) severe compl
Milne-Ives M, Lam C, Van Velthoven MH, et al., 2019, Mobile Apps for Health Behavior Change: Protocol for a Systematic Review (Preprint)
<sec> <title>BACKGROUND</title> <p>The popularity and ubiquity of mobile apps have rapidly expanded in the past decade. With a growing focus on patient interaction with health management, mobile apps are increasingly used to monitor health and deliver behavioral interventions. The considerable variation in these mobile health apps, from their target patient group to their health behavior, and their behavioral change strategy, has resulted in a large but incohesive body of literature.</p> </sec> <sec> <title>OBJECTIVE</title> <p>The purpose of this protocol is to provide an overview of the current landscape, theories behind, and effectiveness of mobile apps for health behavior change.</p> </sec> <sec> <title>METHODS</title> <p>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 Medline, EMBASE, CINAHL, and Web of Science will be conducted. Two authors will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. One reviewer will extract data into a standardized form, which will be validated by a second reviewer. Risk of bias was assessed using the Cochrane Collaboration Risk of Bias tool, and a descriptive analysis will summarize the effectiveness of all the apps.</p> </sec> <sec> <title>RESULTS</title> <p>As of
Lam C, van Velthoven MH, Meinert E, 2019, Application of Internet of Things in Cell-Based Therapy Delivery: Protocol for a Systematic Review (Preprint)
<sec> <title>BACKGROUND</title> <p>Internet of Things (IoT), or Industry 4.0, represents a smart shift to more interconnected manufacturing processes where individual entities within the supply chain communicate with each other to achieve greater flexibility and responsiveness in general manufacturing and leaner manufacturing to reduce the cost of production. IoT has become instrumental in driving leaner manufacturing and more efficient systems in other industries such as transportation and logistics. Cell-based therapeutic products could potentially transform various diseases; however, the delivery of these products is complex and challenging.</p> </sec> <sec> <title>OBJECTIVE</title> <p>This study aims to understand the applicability of IoT in cell-based product supply chains and delivery.</p> </sec> <sec> <title>METHODS</title> <p>We will search Medline, EMBASE (OvidSP), Web of Science, Cochrane Library &amp; HEED, Scopus, ACM digital library, INSPEC, ScienceDirect, and the IEEE Xplore Digital Library for studies published after 2008 using a combination of keywords and subject headings related to IoT used in cell therapies. Additionally, a Google search to identify gray literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria. Any discrepancies will then be discussed and resolved. The quality of the selected literature will be assessed using the Critical Appraisal Skills Programme systematic review checklist.</p> </sec> <sec> <
Meinert E, Alturkistani A, Murray KA, et al., 2019, A case study examining the cost measurements in production and delivery of a massive open online course (MOOC) for teaching the relationship between human health and climate change, International Conference on e-Learning 2019, Publisher: IADIS Press, Pages: 1-1
A Massive Open Online Course (MOOC) is a form of online education that makes available learning to a large number of individuals at no charge. The impact of climate change on public health has been introduced in MOOCs in various forms, for example, examining the impact of natural disasters, the increase in temperature on work productivity, and the monitoring and evaluation of health adaptation to climate change and its implications for policy. However, despite this work completed to advance understanding in both online and postgraduate education, more effort is required to provide the tools and capabilities to analyse evidence and present findings that demonstrate its impact on specific outcomes, including health and wellbeing. Although these courses are made publicly available, understanding the costs associated with their production and delivery will provide evidence to develop sustainable models for deployment of this form of citizen engagement education.
Lam C, Meinert E, Halioua-Haubold C, et al., 2019, Systematic review protocol: An assessment of the post-approval challenges of autologous CAR-T therapy delivery, BMJ Open, Vol: 9, ISSN: 2044-6055
Introduction Following recent regulatory approvals of two chimeric antigen receptor T-cell (CAR-T) therapies, the field now faces a number of post-approval challenges. These challenges are in some respects defined and, in others, uncertain due to the nascence of the field. At present, information pertaining to such post-approval challenges are scattered in various previous reviews or raised in singular papers reporting experience in working with the therapy. This systematic review is designed to evaluate and summarise the post-approval challenges for robust delivery of CAR-T therapies to inform future work on the optimisation of CAR-T delivery to patients.Methods and analysis We will search Medline, EMBASE (OvidSP), BIOSIS & Web of Science, Cochrane Library, ICER database, NICE Evidence Search, CEA Registry, WHOLIS WHO Library and Scopus for studies published between 2014 and the present. In addition, a Google search for grey literature such as bioprocess blog posts, opinion pieces, press releases and listed companies involved in CAR-T development annual reports will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria and any discrepancies will be discussed and resolved. The quality of the selected literature will be assessed using the Critical Appraisal Skills Programme(CASP) Systematic Review checklist and grey literature will be assessed using the Authority, Accuracy, Coverage, Objectivity, Date, Significance (AACODS) checklist. Data from eligible publications will be categorised using a flowchart and extracted using a data abstraction form. Qualitative and quantitative analysis of the post-approval challenges of CAR-T therapies will be conducted based on the results attained.Ethics and dissemination The executed study will be published in a peer-reviewed journal in accordance with Preferred Reporting Items for Systematic Reviews and
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