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BackgroundPrehospital delay contributes to treatment delay in acute stroke. Numerous prehospital stroke scales exist for stroke identification, but they lack the diagnostic accuracy of the in-hospital National Institutes of Health Stroke Scale (NIHSS). We have developed a mobile application to aid paramedics assessing prehospital NIHSS. This study explores agreement between NIHSS scores obtained using the Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) application compared with conventional assessment.Methods25 physicians working with stroke were randomised to an application group or control. 20 unique videos portraying acute stroke symptoms were scored by both groups. 95% limits of agreement (LoA) were calculated using Bland-Altman’s method, comparing the groups to predefined scores, and each other. LoAs within ±3 NIHSS points were considered acceptable. Cohen’s kappa was calculated on dichotomised NIHSS scores.ResultsThe ParaNASPP application group had 95% LoA of −2.33 to 2.71. The control group had LoA of −2.60 to 2.55. Direct comparison between the groups gave LoA of −3.12 to 3.55. When compared with the dichotomised predefined scores kappa was 0.93 in the application group and 0.89 in the control group. Kappa was 0.84 for direct comparison between the groups.DiscussionThere was very good agreement between the application and both the predefined score and the control group. Scores from the ParaNASPP application differ slightly more than our predefined goal when compared with the control group, but is well within when compared with the predefined NIHSS scores. We consider this acceptable and the ParaNASPP application validated for further clinical studies.

Communicable disease outbreaks can spread rapidly, causing enormous losses to individual health, national economies and social well-being. Therefore, communicable disease surveillance is essential for protecting public health. In Qatar, electronic reporting from primary health centres was proposed as a means of improving disease notification, replacing a paper-based method of reporting (via internal mail, facsimile, email or telephone), which has disadvantages and requires active cooperation and engagement of staff. This study is a predescriptive and postdescriptive analysis, which compared disease notifications received from electronic and paper-based systems during 3-month evaluation periods (quarter 2 in 2016 and quarter 2 in 2018 for paper-based and electronic reporting, respectively) in terms of comprehensiveness, timeliness and completeness. For the 23 notifiable diseases included in this study, approximately twice as many notifications were received through the electronic reporting system as from the paper-based reporting system, demonstrating it is more comprehensive. An overall increase in notifications is likely to have a positive public health impact in Qatar. 100% of electronic notifications were received in a timely manner, compared with 28% for paper-based notifications. Findings of the study show that electronic reporting presents a revolutionary opportunity to advance public health surveillance. It is recommended that electronic reporting be rolled out more widely to improve the completeness, stability and representativeness of the national public health surveillance system in Qatar as well as other countries.

ObjectiveTo describe recommendations applicable to new diagnostic and screening tests brought to market in the UK as of 01 June 2023; and extract agreements, disagreements and gaps.DesignExtant regulations, recommendations and guidelines for new diagnostic and screening tests applicable to new products placed in the UK market as of 01 June 2023. Non-English and references not applicable to new tests seeking market access in the UK on 01 June 2023 were excluded.Data sourcesPubMed, Web of Science Core Collection and Scopus; grey literature via EuropePMC and Google, government regulations and guidelines, and relevant professional societies. References of relevant included data were scanned for includable articles. Resultant data were thematically analysed and presented as a narrative scoping review.Eligibility for selecting studiesPubMed, Web of Science Core Collection and Scopus were searched from 1/1/2018 for regulations, guidelines or recommendations for in vitro diagnositic tests as applied to the UK on 1/6/23. Relevant papers also had references searched.Results943 items were initially identified with 892 excluded. Reference searching located a further 31 papers and 82 items were analysed. Seven themes were identified: regulation, companion diagnostics and lab developed tests, safety and evidence, test specific recommendations, data, innovation and recommendations for patients/the public. Wide agreement included the need to reduce bureaucracy and duplication; to mitigate to avoid unintended consequences of In Vitro Diagnostic Regulation. Disagreement over whether high-quality evidence should precede regulatory approval, or could be gathered as part of postmarketing surveillance emerged.ConclusionsIndustry, regulators, academics, patients representing a variety of views, should collaborate to work through areas of disagreement.

Mental health services across the globe are overburdened due to increased patient need for psychological therapies and a shortage of qualified mental health practitioners. This is unlikely to change in the short-to-medium term. Digital support is urgently needed to facilitate access to mental healthcare while creating efficiencies in service delivery. In this paper, we evaluate the use of a conversational artificial intelligence (AI) solution (Limbic Access) to assist both patients and mental health practitioners with referral, triage, and clinical assessment of mild-to-moderate adult mental illness. Assessing this solution in the context of England’s National Health Service (NHS) Talking Therapies services, we demonstrate in a cohort study design that deploying such an AI solution is associated with improved recovery rates. We find that those NHS Talking Therapies services that introduced the conversational AI solution improved their recovery rates, while comparable NHS Talking Therapies services across the country reported deteriorating recovery rates during the same time period. Further, we provide an economic analysis indicating that the usage of this AI solution can be highly cost-effective relative to other methods of improving recovery rates. Together, these results highlight the potential of AI solutions to support mental health services in the delivery of quality care in the context of worsening workforce supply and system overburdening. For transparency, the authors of this paper declare our conflict of interest as employees and shareholders of Limbic Access, the AI solution referred to in this paper.

Medical devices risk reinforcing societal inequalities unless we rethink how they are designed, developed and deployed. The UK government’s recent independent review on Equity in Medical Devices highlights how biases in the design and use of medical devices can lead to solutions that fail to equitably distribute benefits or can further exacerbate health inequalities. In this paper, we draw attention to how wider social, cultural, political and economic factors can also shape the way medical devices are designed, developed and deployed, and how individuals can access or come to be excluded from the associated benefits. Using the example of continuous glucose monitoring devices, we show the potential for medical devices to undermine patient well-being, to occlude patient expertise, and to reflect the priorities of politics rather than patients. These systemic failures highlight the urgent need to reconsider innovation and to develop processes where equity is a fundamental goal and moral responsibility. Here, we suggest a framework for equitable innovation that combines a process of co-design that accounts for knowledge, power and social differences among stakeholders, with considerations of technical needs alongside the institutional arrangements that mediate how devices are deployed in different social contexts.

In this paper, we make a distinction between spreading and scaling innovations and spreading and scaling good practices for improvement, as many healthcare change practitioners often feel there is a “muddle” between them. We argue there are multiple factors where the spread and scale factors are similar for innovation and improvement, such as enabling leadership, the capacity and capability for spread and scale, a process of behaviour change, use of data and evidence and system alignment. However, there are multiple characteristics that may be different, including the level of complexity, the nature of the intervention, the approach to fidelity and adaptability, the source of the innovation or improvement and the outcome metrics. These insights enable us to be better equipped to design and deliver successful spread and scale strategies tailored to the specific intervention and situation and realise the full benefits of our change initiatives.

The healthcare sector is among the most rapidly expanding sectors. Drones are increasingly being used to reach the unreached in healthcare. Drones exhibit profound significance by overcoming accessibility challenges and offering versatile solutions. The future of healthcare is in the air, and new government initiatives uncover the country’s rapid market growth. Investments in drone technologies are rising, with research predicting significant drone expansion in the upcoming decade. Since this sector is still in its nascent stage, the time is ripe for stakeholders to collectively work for the effective implementation of drone technology in India. In this context, the paper seeks to bridge existing knowledge gaps by analysing the global regulatory landscape, the evolution of drones in India, used cases in healthcare, and the barriers that constrain their deployment in the healthcare domain. It explores the obstacles that hinder the widespread adoption of drones. Addressing these challenges becomes essential in unlocking the full potential of drone technology in revolutionising healthcare delivery, enhancing patient outcomes and overcoming logistical constraints. The report argues about the potential shift drones can bring to healthcare delivery while underlining the necessity of addressing regulatory concerns and fostering public trust.

Technological advancements are vital for improving the capacity of the health system to deliver health and well-being benefits to individuals. Despite significant financial investments in technological innovations in healthcare, patients reported benefiting from only 30%–60% of new healthcare technologies. We argue that failed adoption can be attributed to the underprioritisation of the human aspect of innovation development and uptake. In this paper, we elaborate on the psychological experience of being introduced to new technology at work through the perspective of a healthcare employee. We then present a psychology-based practical framework called ‘Tech-ISM’ for healthcare decision-makers to encourage more human-centric technology implementation processes, resources and leadership. The framework identifies the key individuals and relationships within a healthcare delivery context that can influence individual attitudes towards adoption, before offering recommendations for how decision-makers can socialise new technology into the workplace (ie, types of organisational resources and processes to provide), and manage these social dynamics over time (ie, types of work cultures to cultivate through leadership). While Tech-ISM is written for a healthcare decision-maker, any individuals involved with healthcare technology implementation can benefit from a holistic understanding of how social and organisational factors of a workplace inter-relate with the human experience of novelty and change.

This article argues that plastics ought to be included under the category of ‘hazardous’ healthcare waste and suggests that health professionals should strive for alternatives as part of their mission to improve health. The focus of this paper is on replacing, rather than recycling, plastics. The rationale for this stance stems from the unbridled escalation of plastics use, the fact that few countries have significant recycling capacity, and because the process of recycling as well as the end products of recycled plastics remain hazardous to health and the environment.Issues related to incinerated plastic, plastics in single-use items, plastic blister packs and containers for medicines, as well as plastics which are unrelated to healthcare but which nevertheless make up a substantial part of general healthcare waste are discussed. Suggestions are put forward to dramatically reduce plastics in all such cases.To support needed reforms and to guide best practice for single-use plastics in particular, a call for a reliable reference source is made—similar to the Essential Medicines Lists, which would share updated information on the most problematic items in use and environmentally friendly alternatives in each case.It is argued that concerted action by health professionals to improve healthcare waste, beginning with plastics, would send much needed market signals to industry to produce environmentally-friendly products for healthcare and would likely lead to solutions for domestic waste, too.

The regulatory framework around medical devices in the European Union has always focused on upholding patient safety. However, over the years, certain scandals have come to light in which patient safety has been compromised considerably. As a consequence, the overwhelming opprobrium was the cause for a radical change. The new Medical Device Regulation (MDR) has now been introduced (but yet to be fully implemented) to primarily combat the issues that have arisen as a result of these scandals. The MDR has been subject to significant commentary, particularly the effect it will have on relevant stakeholders. The stakeholders in the context of the MDR are the manufacturers, distributors, authorised representatives and importers. There is a general consensus among various professionals that the new requirements are far more onerous than the obligations contained in the previous regulatory framework. Moreover, there has been a lengthy delay in the date of application for the MDR. In particular, the approval of the notified bodies is raising a great concern. This paper will provide a critical analysis of the new requirements that stakeholders must comply with and, in addition, will review the postponement of the MDR.

IntroductionContact tracing is an integral component of the overall public health strategy for controlling the outbreak of infectious diseases such as COVID-19. In addition to the conventional contact tracing, Qatar has implemented Ehteraz, a proximity-tracing mobile phone App using global positioning system and Bluetooth technologies. In this paper, we aim to evaluate the accuracy of Ehteraz as a contact tracing App based on the WHO contact tracing criteria and compare its effectiveness to the traditional human led case investigation.MethodsA cross-sectional study was conducted using two databases, including Ehteraz proximity data and swab collection and case investigations reports for the same period.Results46.9% of contacts identified by the Ehteraz app did not meet WHO duration and distance criteria. Among the 5650 contacts flagged by Ehteraz during the period, 4973 (88.0%) of contacts did not share any known relation with the index case they are linked to.ConclusionThe study highlighted the inaccuracy of the Ehteraz tool as its technology enables signals passing through walls, so people in different rooms could be unnecessarily flagged as having had contact. Big segments of the population (eg, Children) do not necessarily use smartphones and are not, therefore, flagged by Ehteraz digital contact tracing App. Similarly, Ehteraz rarely flags close contacts identified by human investigation as Bluetooth is usually turned off in a household or at a workplace. These findings highlight that digital contact tracing would be an efficient public health strategy when integrated to and complementing human investigation.

IntroductionThe delay in seeking emergency obstetric care leads to significant maternal morbidity and mortality and can worsen during pandemics, especially in humanitarian conflict settings with low uptake of obstetric services. To mitigate the challenges related to the second delay caused by lack of transport in the COVID-19 pandemic, the organisation United Nations Population Fund implements a community-based referral project called Referral Hub in the Rohingya refugee population in Bangladesh. The objective of the paper is to describe the implementation process of the Referral hub and present clients’ utilisation and perception of the service.MethodsFindings from part of a larger mixed-method study, the analysis of the standard operating protocol of the intervention, secondary data of routine utilisation of the 12 referral hubs between January and August 2020, 21 key informant interviews and a community survey among 100 pregnant women are presented in this paper.ResultsThe findings show an increasing trend in the referral hub utilisation and a strong recommendation of the service.ConclusionDue to a robust referral mechanism by collaborating with the community and engaging accessible and free of cost transport service, the intervention has high potential to improve access to facility care in low-resource and humanitarian contexts, especially during pandemics.

IntroductionYouth engagement has the potential to enhance the design, implementation and relevance of research. Without strategies to capacitate young people with research skills, youth engagement in research is often tokenistic and ineffective. In this paper, we detail the implementation and evaluation of an innovative research training programme for youth (aged 18–24 years) in Zimbabwe called the Youth Researchers Academy (YRA).MethodsQuantitative programme data and qualitative interviews and focus group discussions assessed acceptability of the YRA, youth researcher and mentor experiences, and impact of the YRA over time.ResultsWe received 60 applications in 2019 and 89 applications in 2021. Ongoing feedback led to changes in the second programme (including longer training and certification). Youth researcher experiences included being motivated by learning new skills and valuing the relationship with mentors and peer networks. Many described long-term impact, including facilitation of higher education, setting up of new businesses through the stipends received, and, for some, opportunities to work in research.DiscussionOverall, the programme was acceptable, facilitated meaningful youth-led research and trained a cohort of empowered youth researchers. Young people were eager to learn and capable of both learning and implementing critical research skills in a professional working environment. Implementation challenges included limited freedom in the co-design of research projects and the additional burden of work for YRA mentors.ConclusionThe YRA provides a template for other academics to support similar training to facilitate capacity building and meaningful youth engagement for research with and for youth.

‘Design with the user’ is a guiding principle for creating digital solutions to solve systemic developmental challenges. According to this principle, digital solutions are more likely to be effective if the intended users are involved in the design process, thereby rooting design thinking in a human-centric approach that seeks to understand their characteristics, needs and challenges. However, few examples exist for human-centred design (HCD) processes being successfully applied in low-and-middle-income countries to create digital health interventions that achieve both scale and sustainability. This paper describes the application of a five-stage HCD process to develop a suite of mobile solutions to improve reproductive, maternal, neonatal and child health in Bihar, India, and discusses lessons learnt. Two of the solutions were later adopted by the government and scaled to 10 million subscribers and more than 300 000 front-line health workers (FLHWs) in 13 states. The socio-ecological model, which considers the interplay between individual, interpersonal, organisational, community and public policy factors, provides a conceptual framework for understanding key learnings from the HCD process. At the organisational level, we found that demand generation was constrained by deficiencies in the public health system, while at the community level, gender norms were a barrier to changing health practices. At the interpersonal level, mobile health solutions for mothers also had to address fathers, because they controlled women’s access to mobile phones. At the individual level, FLHWs had limited time to build their skills and needed more flexible, home-based learning opportunities; most FLHWs had access to mobile phones, but devices were overwhelmingly basic and digital skills limited; voice technology was required to maximise reach among low literate women and an authoritative yet empathetic narrator was required to humanise the digital experience, lend credibility and create engagement.

ObjectivesThe primary objective of this paper was to independently evaluate the currently available web-based software options for virtual consultations in a secondary care setting.DesignComparative study.SettingUK.ParticipantsWeb-based software options for virtual consultations in a secondary care setting.Main outcome measuresEight predetermined measures of functionality were assessed including time to setup, availability of a diary system, ability to book appointments in advance, ability to send patient reminders, ability to add a second caller, text messaging functionality, need for the patient to download an app and web browser compatibility.ResultsNine platforms met the inclusion criteria for web-based standalone video consultation solutions. Four offered immediate access via an nhs.net email address. Six platforms used an appointment diary system, with five allowing clinicians to see which patients were ready and waiting for consultation at any particular time. Four of the platforms had the facility to book appointments in advance and send appointment details via text message or email. Five of the platforms had the ability to add a second caller. One platform required the patient to download a mobile phone app. All platforms were compatible with Google Chrome, Safari, Firefox and Microsoft Edge (Chromium or Blink versions).ConclusionsThe uptake of virtual online consultations has been accelerated by the COVID-19 pandemic and the National Health Service (NHS) has become a forced ‘early-adopter’. Many of the solutions do well to address the demand; however, more work is required for it to be embedded into routine service and fulfil the aims of the NHS Long Term Plan: allow patients more choice and flexibility in their care. It is vital that once normality resumes, research focuses on the outcomes of virtual online consultations, with focus on factors such as patient satisfaction, length of appointment, time to diagnosis and initiation of management.

BackgroundChildren’s health and healthcare use are impacted by both medical conditions and social factors, such as their home and community environment. As healthcare systems manage a pediatric population, information about these factors is crucial to providing quality care coordination.MethodsThe authors developed a novel methodology combining medical complexity (using the Pediatric Medical Complexity Algorithm) and social complexity (using available family social factors known to impact a child’s health and healthcare use) to create a new health complexity model at both the population-level and individual-level. System-level data from Oregon’s Medicaid Management Information Systems and Integrated Client Services database was analysed, examining claims data and service utilization, to calculate the health complexity of children enrolled in Medicaid/Child Health Insurance Program (CHIP) across Oregon.ResultsOf the 390 582 children ages 0 to 17 enrolled in Medicaid/CHIP in Oregon from July 2015 to June 2016, 83.4% (n=325 900) had some level of medical and/or social complexity and 22.1% (n=85 839) had health complexity (both medical and social complexity). Statistically significant (p<0.05) differences in health complexity were observed among attributed patients by Oregon’s 16 Coordinated Care Organizations, as well as by a child’s age, county of residence and race/ethnicity.ConclusionsGiven the high proportion of children with health complexity, these findings demonstrate that a large number of Medicaid/CHIP-insured children could benefit from targeted care coordination and differential resource allocation. Reports have been shared with state, county and health system leaders to drive work across the state. This paper describes the collaborative process necessary for other states considering similar work.

BackgroundGene therapies have the potential to be a curative approach to a large number of genetic diseases. However, granting of a positive marketing authorisation does not equal patient access to therapy.ObjectivesThe purpose of this paper is to identify a full set of hurdles potentially preventing patient access to gene therapies based on the available literature.MethodsA review of the literature using systematic approach in two distinct databases was performed by identifying relevant, peer-reviewed publications, between 2012 and 2018.ResultsSeven major topics were identified as potential patient access hurdles, namely affordability, assessment of value, development of therapy, ethical/social factors, evidence generation, operational implementation and regulatory hurdles. From these, 25 additional subthemes were further identified. The most frequently mentioned obstacle in the literature is related to the affordability aspect especially focusing on high cost of therapy (84%) and therapy payment/reimbursement (51%). Importantly, the evidence generation focusing on limited trial outcomes (81%) seems as a strong obstacle in patient access to these therapies.ConclusionsA growing number of gene therapies are expected to be developed and made available to patients and healthcare professionals. Improvement of patient access to gene therapies can only be achieved by understanding all hurdles, in a complete and integrated fashion, so that strategies are timely established to ensure gene therapies’ benefits are provided to patients and to the society.

With a considerably high level of poverty, high population density and relatively fragile health systems, most African countries have a predominance of factors that could contribute to the rapid spread of the COVID-19 pandemic. Despite these challenges, the continent has shown capacity in its response to the pandemic. This may be related to the continent’s experience in responding to several infectious disease outbreaks such as Ebola disease, Lassa fever and cholera. Since the beginning of the COVID-19 pandemic, several local innovations have been developed and implemented. These innovations take into consideration unique circumstances in countries such as multiple government levels, belief in traditional medicine, limited access to medical supplies and others. This paper describes the various strategies developed in African countries across leadership and coordination, surveillance, laboratory capacity, case management, infection, prevention and control, risk communications, points of entry, research, logistics and supply chain, partnership, food security and education. We highlight the impact of these strategies on the response so far, and lessons that other regions across the world can learn from Africa’s response to COVID-19. Finally, we recommend the urgent need for increased investment in African health and social institutions to enable the development of African-owned and led strategies in response to disease outbreaks.

Design thinking has been increasingly adopted as an approach to support innovation in healthcare. Recent publications report design thinking application to various innovation projects, across medical specialties, including paediatrics, psychiatry, radiology, gastroenterology, oncology, orthopaedics and surgery, as well as to innovation in hospital operations and healthcare management. Current literature in the area typically focuses on single case descriptions. With the recent increase in the number of cases, there is an opportunity to assess multiple cases to identify patterns and avenues for further research. This study provides a systematic review of published design thinking projects in healthcare. The aim of the study is to provide an overview of how design thinking has been applied in the healthcare sector. Data collection was based on Institute of Scientific Information (ISI) Web of Science, PubMed and Scopus databases. The systematic review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 32 original pieces of research was selected for analysis, being classified and assessed. The paper presents current status of research and practice from various perspectives, including the design thinking progression phase—inspiration, ideation, implementation—and the prevalence of design thinking tools. Avenues for further research include the need to increase focus on the inspiration phase, the opportunity for platforms for leveraging the integration of individuals in innovation projects, and the opportunity to enhance the role of lead users in healthcare innovation.

The Health and Family Welfare Department, Government of Gujarat, is implementing a program named Technology for Community Health Operation or TeCHO+ addressing state’s priority health issues. This program envisages replacing the existing mother and child tracking system or e-Mamta application in the state. This program is based on ImTeCHO—Innovative Mobile Technology for Community Health Operations—which was piloted in Jhagadia, Bharuch district of Gujarat in 2013. The program showed improvements not only in terms of coverage of maternal and newborn care packages averting malnutrition but also was cost-effective. This paper details the protocol for health technology assessment to assess the impact of TeCHO+ program on data quality, improvement in service delivery coverage, reduction in morbidity and mortality as well as assess the cost-effectiveness. The study will be conducted in five districts of the state. A mixed-method approach will be adopted. Data will be validated in a phased manner over a period of 3 years along with an assessment of key outcome indicators. Additionally, key informant interviews will be conducted and cost data will be gathered to perform cost-effectiveness analysis. The study will inform policymakers about the impact of TeCHO+ program on quality, access and cost-effectiveness of healthcare services.

This paper presents the design, development and testing of a novel neck chamber device for non-invasive stimulation of an individual carotid baroreceptor in a graded manner. The proposed neck chamber device is a strap-free design that avoids discomfort during testing due to tight seal generated by the neck collar design, and facilitates unilateral testing and targeted assessment without stimulating other neck baroreceptors. The device consists of two independent components to achieve these requirements: an outer suction mechanism and an inner chamber. The outer mechanism consists of multiple suction cups to grip the device over the human neck, while the inner chamber creates controlled positive and negative pressure for stimulation of baroreceptors using a pump. The indigenously developed device was employed for the testing by providing neck chamber stimulation in discrete steps of –20 mm Hg, –40 mm Hg, −60 mm Hg, 0 mm Hg, 20 mm Hg, 40 mm Hg and 60 mm Hg with the gap of 60 s between each stimulation as per the standard test protocol of autonomic function test. The changes in heart rate and RR interval were recorded to determine the baroreceptor gain using the logistic equation derivative and gain curve plot. The results of the present study show that the estimated baroreceptor gain is –0.109±0.04, which is consistent with the previous studies conducted using neck collar devices. The testing results showed that the desired objectives are achieved successfully by the prototype device, opening up the possibility of its use for the treatment of resistant hypertension.

BackgroundUp to 70% of medical devices in low-income and middle-income countries are partially or completely non-functional, impairing service provision and patient outcomes. In Sub-Saharan Africa, medical devices not designed for local conditions, lack of well-trained biomedical engineers and diverse donated equipment have led to poor maintenance and non-repair. The Maker Project’s aim was to test the effectiveness of an innovative partnership ecosystem network, the ‘Maker Hub’, in reducing gaps in the supply of essential medical devices for maternal, newborn and child health. This paper describes the first phase of the project, the building of the Maker Hub.MethodsKey activities in setting up the Maker Hub—a collaborative partnership between the University of Nairobi (UoN) and the Kenyatta National Hospital (KNH), catalysed by Concern Worldwide Kenya—are described using a product development partnership approach. Using a health systems approach, a needs assessment identified a medical equipment shortlist. Design thinking with a capacity building component was used by the UoN (innovators, public health specialists, engineers) working closely and with KNH nurses, physicians and biomedical engineers to develop the prototypes.ResultsTo date, four medical device prototypes have been developed. Two have been evaluated by the National Bureau of Standards and one has undergone clinical testing.ConclusionsWe have demonstrated an innovative partnership ecosystem that has developed medical devices that have undergone national standards evaluation and clinical testing, a first in Sub-Saharan Africa. Promoting a robust innovation ecosystem for medical equipment requires investment in building trust in the innovation ecosystem.

Early detection of physiological deterioration has been shown to improve patient outcomes. Due to recent improvements in technology, comprehensive outpatient vital signs monitoring is now possible. This is the first review to collate information on all wearable devices on the market for outpatient physiological monitoring.A scoping review was undertaken. The monitors reviewed were limited to those that can function in the outpatient setting with minimal restrictions on the patient’s normal lifestyle, while measuring any or all of the vital signs: heart rate, ECG, oxygen saturation, respiration rate, blood pressure and temperature.A total of 270 papers were included in the review. Thirty wearable monitors were examined: 6 patches, 3 clothing-based monitors, 4 chest straps, 2 upper arm bands and 15 wristbands. The monitoring of vital signs in the outpatient setting is a developing field with differing levels of evidence for each monitor. The most common clinical application was heart rate monitoring. Blood pressure and oxygen saturation measurements were the least common applications. There is a need for clinical validation studies in the outpatient setting to prove the potential of many of the monitors identified.Research in this area is in its infancy. Future research should look at aggregating the results of validity and reliability and patient outcome studies for each monitor and between different devices. This would provide a more holistic overview of the potential for the clinical use of each device.

BackgroundStroke events often result in long-term negative health outcomes. People who experience a first stroke event are 30%–40% more likely to experience a second stroke event within 5 years. An online secondary prevention programme for stroke survivors may help stroke survivors improve their health risk behaviours and lower their risk of a second stroke.ObjectivesThis paper describes the development and early iteration testing of the usability and acceptability of an online secondary prevention programme for stroke survivors (Prevent 2nd Stroke, P2S). P2S aims to address six modifiable health risk behaviours of stroke: blood pressure, physical activity, nutrition, depression and anxiety, smoking, and alcohol consumption.MethodsP2S was developed as an eight-module online secondary prevention programme for stroke survivors. Modelled on the DoTTI (Design and development, Testing early iterations, Testing for effectiveness, Integration and implementation) framework for the development of online programmes, the following stages were followed during programme development: (1) content development and design; and (2) testing early iteration. The programme was pilot-tested with 15 stroke survivors who assessed P2S on usability and acceptability.ResultsIn stage 1, experts provided input for the content development of P2S. In stage 2, 15 stroke survivors were recruited for usability testing of P2S. They reported high ratings of usability and acceptability of P2S. P2S was generally regarded as ‘easy to use’ and ‘relevant to stroke survivors’. Participants also largely agreed that it was appropriate to offer lifestyle advice to stroke survivors through the internet.ConclusionsThe study found that an online secondary prevention programme was acceptable and easily usable by stroke survivors. The next step is to conduct a randomised controlled trial to assess the effectiveness of the programme regarding behaviour change and determine the cost-effectiveness of the intervention.

In-hospital fall incidence is a critical indicator of healthcare outcome. Predictive models for fall incidents could facilitate optimal resource planning and allocation for healthcare providers. In this paper, we proposed a tensor factorisation-based framework to capture the latent features for fall incidents prediction over time. Experiments with real-world data from local hospitals in Hong Kong demonstrated that the proposed method could predict the fall incidents reasonably well (with an area under the curve score around 0.9). As compared with the baseline time series models, the proposed tensor based models were able to successfully identify high-risk locations without records of fall incidents during the past few months.

ObjectivesHaemorrhage, hypertension, sepsis and abortion complications (often from haemorrhage or sepsis) contribute to 60% of all maternal deaths. Each is associated with vital signs (blood pressure (BP) and pulse) abnormalities, and the majority of deaths are preventable through simple and timely intervention. This paper presents the development and evaluation of the CRADLE Vital Signs Alert (VSA), an accurate, low-cost and easy-to-use device measuring BP and pulse with an integrated traffic light early warning system. The VSA was designed to be used by all cadres of healthcare providers for pregnant women in low-resource settings with the aim to prevent avoidable maternal mortality and morbidity.MethodsThe development and the mixed-methods clinical evaluation of the VSA are described.ResultsPreliminary fieldwork identified that introduction of BP devices to rural clinics improved antenatal surveillance of BP in pregnant women. The aesthetics of the integrated traffic light system were developed through iterative qualitative evaluation. The traffic lights trigger according to evidence-based vital sign thresholds in hypertension and haemodynamic compromise from haemorrhage and sepsis. The VSA can be reliably used as an auscultatory device, as well as its primary semiautomated function, and is suitable as a self-monitor used by pregnant women.ConclusionThe VSA is an accurate device incorporating an evidence-based traffic light early warning system. It is designed to ensure suitability for healthcare providers with limited training and may improve care for women in pregnancy, childbirth and in the postnatal period.

BackgroundTobacco smoking can have negative health outcomes on recovery from surgery. Although it is recommended best practice to provide patients with advice to quit and follow-up support, provision of post-discharge support is rare. Developing an online smoking cessation program may help address this gap.ObjectivesThis paper describes the development and pretesting of an online smoking cessation program (smoke-free recovery, SFR) tailored to the orthopaedic trauma population for use while in hospital and post-discharge.MethodsDrawing on the DoTTI framework for developing an online program, the following steps were followed for program development: (1) design and development; (2) testing early iteration; (3) testing for effectiveness and (4) integration and implementation. This article describes the first two stages of SFR program development.ResultsSFR is a 10-module online smoking cessation program tailored for patients with orthopaedic trauma. Of the participants who completed testing early iterations, none reported any difficulties orientating themselves to the program or understanding program content. The main themes were that it was ‘helpful’, provision of ‘help to quit’ was low and SFR increased thoughts of ‘staying quit post-discharge’.ConclusionsThis study found that a theory and evidence-based approach as the basis for an online smoking cessation program for patients with orthopaedic trauma was acceptable to users. A randomised controlled trial will be conducted to examine whether the online smoking cessation program is effective in increasing smoking cessation and how it can be integrated and implemented into hospital practice (stages three and four of the DoTTI framework).

BackgroundGovernments, universities and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In this context we piloted the use of a novel mobile digital health platform, designed specifically for low-resource environments, to support high-quality data collection in a clinical research study.ObjectiveOur primary aim was to assess the feasibility of a using a mobile digital platform for clinical trial data collection in a low-resource setting. Secondarily, we sought to explore the potential benefits of such an approach.MethodsThe investigative site was a research institute in Nairobi, Kenya. We integrated an open-source platform for mobile data collection commonly used in the developing world with an open-source, standard platform for electronic data capture in clinical trials. The integration was developed using common data standards (Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model), maximising the potential to extend the approach to other platforms. The system was deployed in a pharmacokinetic study involving healthy human volunteers.ResultsThe electronic data collection platform successfully supported conduct of the study. Multidisciplinary users reported high levels of satisfaction with the mobile application and highlighted substantial advantages when compared with traditional paper record systems. The new system also demonstrated a potential for expediting data quality review.Discussion and ConclusionsThis pilot study demonstrated the feasibility of using a mobile digital platform for clinical research data collection in low-resource settings. Sustainable scientific capabilities and infrastructure are essential to attract and support clinical research studies. Since many research structures in Africa are being developed anew, stakeholders should consider implementing innovative technologies and approaches.

BackgroundTelemedicine holds promise for improving access to care. Telementoring—defined as mentoring by means of telecommunication and computer networks—can be used for remote education of healthcare professionals. Furthermore, it is rapidly establishing itself as a valuable asset in medicine and education. This paper aims to establish a financially and practically feasible, stable telementoring network using wearables for sterile and hands-free remote control, to be used during surgical procedures.MethodsTwo stand-alone computer systems, located at an academic hospital in the Netherlands and at a surgical research facility in Spain, were connected using TeamViewer software allowing for remote, hands-free controlling of radiological images using Myo gesture control armband. The operating surgeon consulted the remote surgeon through an audio, video and desktop sharing system during a live surgical procedure on a single porcine model. The system was analysed for feasibility and connection quality.ResultsThe sensors used were commercially available and relatively cheap, with the integrating computer system being responsible for the majority of costs. A successful connection was established without any downtime and with only a minor time lag, not interfering with the telementoring procedures. The operating surgeon effectively consulted with and was mentored by the remote surgeon, through video, audio and the desktop sharing system, using the wearable sensors.ConclusionsThis proof of principle shows the feasibility of using an internet-based remote desktop sharing system in combination with wearable sensors and TedCube technology for telementoring purposes during surgical procedures.

Randomised clinical trials are designed to determine whether a particular treatment is appropriate to make a significant difference to the health of a defined population and to aid its approval for use. For an accurate, cheap and simple assessment to see if a treatment benefits an individual person, all that is needed is a pen, paper, simple pocket calculator and daily recording of a few variables. It requires the ability to read and write and to understand addition and division. Factorial design of experiments is used to show the impact of several variables and their interaction on the person’s health status. An example of a 75-year-old man with an enlarged prostate is used here to illustrate this approach. This person was able to understand and reduce side effects, lower the costs of medication by 83% and improve measured health status by 28%. A multivariate model for this person was then created with about 450 person-days of data.