An age-old problem or an old-age problem? A UK survey of attitudes, historical use and recommendations by healthcare professionals to use healthcare apps.

BACKGROUND: The coronavirus pandemic has exacerbated barriers to accessing face-to-face care. Consequently, the potential for digital health technologies (DHTs) to address unmet needs has gained traction. DHTs may circumvent several barriers to healthy independent living, resulting in both socioeconomic and clinical benefits. However, previous studies have demonstrated these benefits may be disproportionately realised among younger populations while excluding older people. METHODS: We performed a prospective survey using the One Poll market research platform among 2000 adults from the United Kingdom. To mitigate against self-selection bias, participants were not informed of the topic of the survey until they had completed recruitment. We compared willingness to use and historical use of health-apps, in addition to recommendations to use health-apps from healthcare professionals; comparing outcomes across all age groups, including a reference group (n = 222) of those aged 18-24. Outcomes were analysed using multivariate logistic regression and reported as odds ratios (OR) with respondent age, ethnicity, gender, and location as covariates. RESULTS: Willingness to use health-apps decreased significantly with age, reaching a minimum (OR = 0.39) among those aged 65 and over compared to the reference group of 18-24 year olds. Despite this, more than 52% of those aged 65 and over were willing to use health-apps. Functions and features most cited as useful by older populations included symptom self-monitoring and surgery recovery assistance. The likelihood of never having used a health-app also increased consistently with age, reaching a maximum among those aged 65 and over (OR = 18.3). Finally, the likelihood of being recommended health-apps by a healthcare professional decreased significantly with age, (OR = 0.09) for those aged 65 and over. In absolute terms, 33.8% of those aged 18-24, and 3.9% of those aged 65 and over were recommended health-apps by their healthcare professionals. CONCLUSION: Although absolute utilisation of health-apps decreases with age, the findings of this study suggest that the gap between those willing to use health-apps, and those being recommended health-apps by healthcare professionals increases with age. Given the increasing availability of evidence-based health-apps designed for older populations, this may result in entirely avoidable unmet needs, suggesting that more should be done by healthcare professionals to recommend health-apps to older persons who are generally positive about their use. This may result in considerable improvements in healthy and independent ageing.

Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders.

BACKGROUND: Medical device certification has undergone significant changes in recent years. However, exploration of stakeholder experiences remains relatively limited, particularly in the context of software as a medical device. This study sought to explore stakeholder experiences of medical device certification across both the UK and EU. METHODS: Semi-structured interviews (n = 22) analysed using inductive-thematic analysis, synthesised using activity theory. RESULTS: Innovators, consultants and notified bodies share more similarities than differences when discussing barriers and enablers to achieving medical device certification. Systemic tensions between existing rules, tools, community understanding and division of labour currently undermine the intended aim of certification processes. Existing rules are considered complex, with small and medium-sized enterprises considered disproportionality affected, resulting in several unintended outcomes including the perceived 'killing' of innovation. Existing certification processes are described as unfit for purpose, unethical and unsustainable. CONCLUSION: Stakeholder experiences suggest that the intention of establishing a robust and sustainable regulatory framework capable of ensuring a high level of safety whilst also supporting innovation is not yet being realised. Failure to enact desired changes may further jeopardise future innovations, outcomes and care quality.

System Usability Scale Benchmarking for Digital Health Apps: Meta-analysis.

BACKGROUND: The System Usability Scale (SUS) is a widely used scale that has been used to quantify the usability of many software and hardware products. However, the SUS was not specifically designed to evaluate mobile apps, or in particular digital health apps (DHAs). OBJECTIVE: The aim of this study was to examine whether the widely used SUS distribution for benchmarking (mean 68, SD 12.5) can be used to reliably assess the usability of DHAs. METHODS: A search of the literature was performed using the ACM Digital Library, IEEE Xplore, CORE, PubMed, and Google Scholar databases to identify SUS scores related to the usability of DHAs for meta-analysis. This study included papers that published the SUS scores of the evaluated DHAs from 2011 to 2021 to get a 10-year representation. In total, 117 SUS scores for 114 DHAs were identified. R Studio and the R programming language were used to model the DHA SUS distribution, with a 1-sample, 2-tailed t test used to compare this distribution with the standard SUS distribution. RESULTS: The mean SUS score when all the collected apps were included was 76.64 (SD 15.12); however, this distribution exhibited asymmetrical skewness (-0.52) and was not normally distributed according to Shapiro-Wilk test (P=.002). The mean SUS score for "physical activity" apps was 83.28 (SD 12.39) and drove the skewness. Hence, the mean SUS score for all collected apps excluding "physical activity" apps was 68.05 (SD 14.05). A 1-sample, 2-tailed t test indicated that this health app SUS distribution was not statistically significantly different from the standard SUS distribution (P=.98). CONCLUSIONS: This study concludes that the SUS and the widely accepted benchmark of a mean SUS score of 68 (SD 12.5) are suitable for evaluating the usability of DHAs. We speculate as to why physical activity apps received higher SUS scores than expected. A template for reporting mean SUS scores to facilitate meta-analysis is proposed, together with future work that could be done to further examine the SUS benchmark scores for DHAs.

To Tweet or Not to Tweet: A Longitudinal Analysis of Social Media Use by Global Diabetes Researchers.

BACKGROUND: Engaging influential stakeholders in meaningful exchange is essential for pharmaceutical companies aiming to improve care. At a time where opportunities for face-to-face engagement are limited, the ability to interact, learn and generate actionable insights through digital channels such as Twitter, is of considerable value. AIM: The aim of this study was to evaluate digital engagement among global diabetes mellitus researchers. MATERIALS AND METHODS: We identified every global tweet (20,614,515) and scientific publication (44,135) regarding diabetes mellitus from 1 August 2018 to 1 August 2020. Through author matching we combined datasets, resulting in a list of digitally active scientific authors. Generalised linear modelling identified factors predicting their digital engagement. FINDINGS: Globally, 2686 diabetes researchers used Twitter to discuss the management of diabetes mellitus, posting 110,346 diabetes-related tweets. As Twitter followers increased, so did tweet frequency (p < 0.001), retweets (p < 0.001) and replies (p < 0.001) to their content. Publication count (overall/per month) and proportion of first/last authorships were unrelated to tweet frequency and the likelihood of being retweeted or replied to (p > 0.05). Those with the most  academic co-authors were significantly less likely to tweet than those with smaller networks (< 50; p = 0.001). Finally, those publishing most frequently on specific themes, including insulin (p = 0.041) and paediatrics (p < 0.001), were significantly more likely to tweet about these themes. CONCLUSION: Academic expertise and seniority cannot be assumed as proxies for digital influence. Those aiming to promote science and obtain digital insights regarding condition management should consider looking beyond well-known 'key opinion leaders' to perhaps lesser known 'digital opinion leaders' with smaller academic networks, who are likely to specialise in the delivery of highly specific content to captive audiences.

Traditionally, research scientists and clinical experts in any field make their opinions and expertise known by writing academic journal papers. After successful peer review, they are accepted and made publicly available. However, during the coronavirus disease 2019 (COVID-19) pandemic, more scientific information has been shared and discussed using digital platforms such as Twitter than ever before, setting the stage for their greater role in scientific discussions in the future. It is important that the pharmaceutical industry is aware of this shift as it may offer up new insights and opportunities. Using diabetes as a test case, we compared researchers' publishing activity with their Twitter activity over a 2-year period. We found that less established researchers who are less well-known in their fields, and with less publications to their name, are far more likely to be active in sharing valuable scientific content to large Twitter audiences. This makes them 'opinion leaders' even if they would not be thought of as such in a traditional, academic sense, suggesting that those who look only to high-ranking academic journals, and those who publish within them, may be missing an important and ever-increasing part of the conversation. This is the first ever study to compare digital and traditional publishing activities and highlights the potential of this approach to gain novel and valuable knowledge about specific topics.

Oral Misoprostol alone versus oral misoprostol followed by oxytocin for labour induction in women with hypertension in pregnancy (MOLI): protocol for a randomised controlled trial.

BACKGROUND: Every year approximately 30,000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion if ongoing stimulation is required. However, some studies have shown that oral misoprostol can be continued into active labour, a simpler and potentially more acceptable protocol for women. To date, these two protocols have never been directly compared. METHODS: This pragmatic, open-label, randomised trial will compare a misoprostol alone labour induction protocol with the standard misoprostol plus oxytocin protocol in three Indian hospitals. The study will recruit 520 pregnant women being induced for hypertensive disease in pregnancy and requiring augmentation after membrane rupture. Participants will be randomised to receive either further oral misoprostol 25mcg every 2 h, or titrated intravenous oxytocin. The primary outcome will be caesarean birth. Secondary outcomes will assess the efficacy of the induction process, maternal and fetal/neonatal complications and patient acceptability. This protocol (version 1.04) adheres to the SPIRIT checklist. A cost-effectiveness analysis, situational analysis and formal qualitative assessment of women's experience are also planned. DISCUSSION: Avoiding oxytocin and continuing low dose misoprostol into active labour may have a number of benefits for both women and the health care system. Misoprostol is heat stable, oral medication and thus easy to store, transport and administer; qualities particularly desirable in low resource settings. An oral medication protocol requires less equipment (e.g. electronic infusion pumps) and may free up health care providers to assist with other aspects of the woman's care. The simplicity of the protocol may also help to reduce human errors associated with the delivery of intravenous infusions. Finally, women may prefer to be mobile during labour and not restricted by an intravenous infusion. There is a need, therefore, to assess whether augmentation using oral misoprostol is superior clinically and economically to the standard protocol of intravenous oxytocin. TRIAL REGISTRATION: Clinical Trials.gov, NCT03749902 , registered on 21st Nov 2018.

Web-based internet searches for digital health products in the United Kingdom before and during the COVID-19 pandemic: a time-series analysis using app libraries from the Organisation for the Review of Care and Health Applications (ORCHA).

OBJECTIVES: To explore if consumer interest in digital health products (DHPs), changed following the COVID-19 pandemic and the lockdown measures that ensued. DESIGN: Retrospective time-series analysis of web-based internet searches for DHPs in the UK, split over two periods, pre-COVID-19 lockdown (January 2019-23 March 2020) and post-COVID-19 lockdown (24 March 2020-31 December 2020). SETTING: The UK. PARTICIPANTS: Members of the UK general population using health-app libraries provided by the Organisation for the Review of Care and Health Applications. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was volume of searches for DHPs. Secondary outcomes considered search volumes for 25 different therapeutic areas. Outcomes were assessed for significance using a two-stage Poisson test. RESULTS: There were 126 640 searches for DHPs over the study period. Searches for DHPs increased by 343% from 2446 per month prior to COVID-19 lockdown measures being introduced to 8996 per month in the period following the first COVID-19 lockdown in the UK. In total, 23/25 (92%) of condition areas experienced a significant increase in searches for DHPs, with the greatest increases occurring in the first 2 months following lockdown. Musculoskeletal conditions (2.036%), allergy (1.253%) and healthy living DHPs (1.051%) experienced the greatest increases in searches compared with pre-lockdown. Increased search volumes for DHPs were sustained in the 9 months following the introduction of lockdown measures, with 21/25 (84%) of condition areas experiencing monthly search volumes at least 50% greater than pre-lockdown levels. CONCLUSIONS: The COVID-19 pandemic has profoundly disrupted the routine delivery of healthcare, making face-to-face interaction difficult, and contributing to unmet clinical needs. This study has demonstrated significant increases in internet searches for DHPs by members of the UK population since COVID-19, signifying an increased interest in this potential therapeutic medium. Future research should clarify whether this increased interest has resulted in increased acceptance and utilisation of these technologies also.

The Induction with Foley OR Misoprostol (INFORM) Study dataset. A dataset of 602 women with hypertensive disease in pregnancy, in India, randomised to either Foley catheter or oral misoprostol for induction of labour.

OBJECTIVES: Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013-15. DATA DESCRIPTION: This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare.

Management of non-urgent paediatric emergency department attendances by GPs: a retrospective observational study.

BACKGROUND: Non-urgent emergency department (ED) attendances are common among children. Primary care management may not only be more clinically appropriate, but may also improve patient experience and be more cost-effective. AIM: To determine the impact on admissions, waiting times, antibiotic prescribing, and treatment costs of integrating a GP into a paediatric ED. DESIGN AND SETTING: Retrospective cohort study explored non-urgent ED presentations in a paediatric ED in north-west England. METHOD: From 1 October 2015 to 30 September 2017, a GP was situated in the ED from 2.00 pm until 10.00 pm, 7 days a week. All children triaged as 'green' using the Manchester Triage System (non-urgent) were considered to be 'GP appropriate'. In cases of GP non-availability, children considered non-urgent were managed by ED staff. Clinical and operational outcomes, as well as the healthcare costs of children managed by GPs and ED staff across the same timeframe over a 2-year period were compared. RESULTS: Of 115 000 children attending the ED over the study period, a complete set of data were available for 13 099 categorised as 'GP appropriate'; of these, 8404 (64.2%) were managed by GPs and 4695 (35.8%) by ED staff. Median duration of ED stay was 39 min (interquartile range [IQR] 16-108 min) in the GP group and 165 min (IQR 104-222 min) in the ED group (P<0.001). Children in the GP group were less likely to be admitted as inpatients (odds ratio [OR] 0.16; 95% confidence interval [CI] = 0.13 to 0.20) and less likely to wait >4 hours before being admitted or discharged (OR 0.11; 95% CI = 0.08 to 0.13), but were more likely to receive antibiotics (OR 1.42; 95% CI = 1.27 to 1.58). Treatment costs were 18.4% lower in the group managed by the GP (P<0.0001). CONCLUSION: Given the rising demand for children's emergency services, GP in ED care models may improve the management of non-urgent ED presentations. However, further research that incorporates causative study designs is required.

Using Large-Scale Additive Manufacturing as a Bridge Manufacturing Process in Response to Shortages in Personal Protective Equipment during the COVID-19 Outbreak.

The global coronavirus disease (COVID)-19 pandemic has led to an international shortage of personal protective equipment (PPE), with traditional supply chains unable to cope with the significant demand leading to critical shortfalls. A number of open and crowdsourcing initiatives have sought to address this shortfall by producing equipment such as protective face shields using additive manufacturing techniques such as fused filament fabrication (FFF). This paper reports the process of designing and manufacturing protective face shields using large-scale additive manufacturing (LSAM) to produce the major thermoplastic components of the face shield. LSAM offers significant advantages over other additive manufacturing technologies in bridge manufacturing scenarios as a true transition between prototypes and mass production techniques such as injection molding. In the context of production of COVID-19 face shields, the ability to produce the optimized components in under 5 min compared to what would typically take 1 - 2 h using another additive manufacturing technologies meant that significant production volume could be achieved rapidly with minimal staffing.

Accuracy of a Modified qSOFA Score for Predicting Critical Care Admission in Febrile Children.

BACKGROUND AND OBJECTIVES: The identification of life-threatening infection in febrile children presenting to the emergency department (ED) remains difficult. The quick Sequential Organ Failure Assessment (qSOFA) was only derived for adult populations, implying an urgent need for pediatric scores. We developed and validated a novel, adapted qSOFA score (Liverpool quick Sequential Organ Failure Assessment [LqSOFA]) and compared its performance with qSOFA, Pediatric Early Warning Score (PEWS), and National Institute for Health and Care Excellence (NICE) high-risk criteria in predicting critical care (CC) admission in febrile children presenting to the ED. METHODS: The LqSOFA (range, 0-4) incorporates age-adjusted heart rate, respiratory rate, capillary refill, and consciousness level on the Alert, Voice, Pain, Unresponsive scale. The primary outcome was CC admission within 48 hours of ED presentation, and the secondary outcome was sepsis-related mortality. LqSOFA, qSOFA, PEWS, and NICE high-risk criteria scores were calculated, and performance characteristics, including area under the receiver operating characteristic curve, were calculated for each score. RESULTS: In the initial (n = 1121) cohort, 47 CC admissions (4.2%) occurred, and in the validation (n = 12 241) cohort, 135 CC admissions (1.1%) occurred, and there were 5 sepsis-related deaths. In the validation cohort, LqSOFA predicted CC admission with an area under the receiver operating characteristic curve of 0.81 (95% confidence interval [CI], 0.76 to 0.86), versus qSOFA (0.66; 95% CI, 0.60 to 0.71), PEWS (0.93; 95% CI, 0.90 to 0.95), and NICE high-risk criteria (0.81; 95% CI, 0.78 to 0.85). For predicting CC admission, the LqSOFA outperformed the qSOFA, with a net reclassification index of 10.4% (95% CI, 1.0% to 19.9%). CONCLUSIONS: In this large study, we demonstrate improved performance of the LqSOFA over qSOFA in identifying febrile children at risk for CC admission and sepsis-related mortality. Further validation is required in other settings.

Barriers and Facilitators to the Adoption of Mobile Health Among Health Care Professionals From the United Kingdom: Discrete Choice Experiment.

BACKGROUND: Despite the increasing availability of mobile health services, clinical engagement remains minimal. OBJECTIVE: This study aims to identify and weight barriers to and drivers of health app use among health care professionals (HCPs) from the United Kingdom. METHODS: A discrete choice experiment was conducted with 222 HCPs using a web-based survey between March 2019 and June 2019. Participants were recruited to take part via social media and asked to choose their preferred option of 2 hypothetical health apps to prescribe to a hypothetical patient or to prescribe neither. Choices were characterized by differing levels of patient age, cost, published evidence bases, whether they had a National Health Service (NHS) stamp of approval, personal familiarity with the technology, and whether they were recommended by a fellow HCP. The results were analyzed using a mixed logit model, with subgroup analyses to account for heterogeneity. RESULTS: We received 230 responses, a total of 96.5% (n=222/230) of respondents understood the survey task and passed the test of rationality. The median age was between 36 and 45 years, and 62.6% (n=139/222) of the health care providers responding to the survey had previously recommended the use of health apps to patients. Health apps were most likely to be prescribed to patients if they had an NHS stamp of approval or if they were recommended by another HCP (both P<.001). Published studies detailing clinical effectiveness were important (P<.001), but it would take five published studies to have the same impact on prescribing behavior as an NHS stamp of approval and two studies to be as convincing as having used the technology personally. Increasing patient age and costs resulted in significant reductions in digital health prescribing (P<.001), none more so than among allied health professionals. Willingness-to-pay for health apps increased by £124.61 (US $151.14) if an NHS stamp of approval was present and by £29.20 (US $35.42) for each published study. Overall, 8.1% (n=18/222) of respondents were reluctant to use health apps, always choosing the I would prescribe neither option, particularly among older HCPs, nurses, and those who do not use health apps personally. Subgroup analyses revealed significant differences in preferences among HCPs of differing ages and clinical backgrounds. CONCLUSIONS: An NHS stamp of approval, published studies, and recommendations from fellow HCPs are significant facilitators of digital prescribing, whereas increasing costs and patient age are significant barriers to engagement. These findings suggest that demonstrating assurances of health apps and supporting both the dissemination and peer-to-peer recommendation of evidence-based technologies are critical if the NHS is to achieve its long-term digital transformation ambitions.

What matters when managing childhood fever in the emergency department? A discrete-choice experiment comparing the preferences of parents and healthcare professionals in the UK.

BACKGROUND: Fever among children is a leading cause of emergency department (ED) attendance and a diagnostic conundrum; yet robust quantitative evidence regarding the preferences of parents and healthcare providers (HCPs) for managing fever is scarce. OBJECTIVE: To determine parental and HCP preferences for the management of paediatric febrile illness in the ED. SETTING: Ten children's centres and a children's ED in England from June 2018 to January 2019. PARTICIPANTS: 98 parents of children aged 0-11 years, and 99 HCPs took part. METHODS: Nine focus-groups and coin-ranking exercises were conducted with parents, and a discrete-choice experiment (DCE) was conducted with both parents and HCPs, which asked respondents to choose their preferred option of several hypothetical management scenarios for paediatric febrile illness, with differing levels of visit time, out-of-pocket costs, antibiotic prescribing, HCP grade and pain/discomfort from investigations. RESULTS: The mean focus-group size was 4.4 participants (range 3-7), with a mean duration of 27.4 min (range 18-46 min). Response rates to the DCE among parents and HCPs were 94.2% and 98.2%, respectively. Avoiding pain from diagnostics, receiving a faster diagnosis and minimising wait times were major concerns for both parents and HCPs, with parents willing-to-pay £16.89 for every 1 hour reduction in waiting times. Both groups preferred treatment by consultants and nurse practitioners to treatment by doctors in postgraduate training. Parents were willing to trade-off considerable increases in waiting times (24.1 min) to be seen by consultants and to avoid additional pain from diagnostics (45.6 min). Reducing antibiotic prescribing was important to HCPs but not parents. CONCLUSIONS: Both parents and HCPs care strongly about reducing visit time, avoiding pain from invasive investigations and receiving diagnostic insights faster when managing paediatric febrile illness. As such, overdue advances in diagnostic capabilities should improve child and carer experience and HCP satisfaction considerably in managing paediatric febrile illness.

Design and fabrication of 3-D printed conductive polymer structures for THz polarization control.

In this paper, we numerically and experimentally demonstrate the inverse polarization effect in three-dimensional (3-D) printed polarizers for the frequency range of 0.5 - 2.7 THz. The polarizers simply consist of 3-D printed strip lines of conductive polylactic acid (CPLA, Proto-Pasta) and do not require a substrate or any further metallic deposition. The experimental and numerical results show that the proposed structure acts as a broadband polarizer between the range of 0.3 THz to 2.7 THz, in which the inverse polarization effect is clearly seen for frequencies above 0.5 THz. In the inverse polarization effect, the transmission of the transverse electric (TE) component exceeds that of the TM component, in contrast to the behavior of a typical wire-grid polarizer. We show how the performance of the polarizers depends on the spacing and thickness of the CPLA structure; extinction ratios higher than 20 dB are achieved. This is the first report using CPLA to fabricate THz polarizers, demonstrating the potential of using conductive polymers to design THz components efficiently and robustly.

The cost of diagnostic uncertainty: a prospective economic analysis of febrile children attending an NHS emergency department.

BACKGROUND: Paediatric fever is a common cause of emergency department (ED) attendance. A lack of prompt and definitive diagnostics makes it difficult to distinguish viral from potentially life-threatening bacterial causes, necessitating a cautious approach. This may result in extended periods of observation, additional radiography, and the precautionary use of antibiotics (ABs) prior to evidence of bacterial foci. This study examines resource use, service costs, and health outcomes. METHODS: We studied an all-year prospective, comprehensive, and representative cohort of 6518 febrile children (aged < 16 years), attending Alder Hey Children's Hospital, an NHS-affiliated paediatric care provider in the North West of England, over a 1-year period. Performing a time-driven and activity-based micro-costing, we estimated the economic impact of managing paediatric febrile illness, with focus on nurse/clinician time, investigations, radiography, and inpatient stay. Using bootstrapped generalised linear modelling (GLM, gamma, log), we identified the patient and healthcare provider characteristics associated with increased resource use, applying retrospective case-note identification to determine rates of potentially avoidable AB prescribing. RESULTS: Infants aged less than 3 months incurred significantly higher resource use than any other age group, at £1000.28 [95% CI £82.39-£2993.37] per child, (p < 0.001), while lesser experienced doctors exhibited 3.2-fold [95% CI 2.0-5.1-fold] higher resource use than consultants (p < 0.001). Approximately 32.4% of febrile children received antibiotics, and 7.1% were diagnosed with bacterial infections. Children with viral illnesses for whom antibiotic prescription was potentially avoidable incurred 9.9-fold [95% CI 6.5-13.2-fold] cost increases compared to those not receiving antibiotics, equal to an additional £1352.10 per child, predominantly resulting from a 53.9-h increase in observation and inpatient stay (57.1 vs. 3.2 h). Bootstrapped GLM suggested that infants aged below 3 months and those prompting a respiratory rate 'red flag', treatment by lesser experienced doctors, and Manchester Triage System (MTS) yellow or higher were statistically significant predictors of higher resource use in 100% of bootstrap simulations. CONCLUSION: The economic impact of diagnostic uncertainty when managing paediatric febrile illness is significant, and the precautionary use of antibiotics is strongly associated with increased costs. The use of ED resources is highest among infants (aged less than 3 months) and those infants managed by lesser experienced doctors, independent of clinical severity. Diagnostic advances which could increase confidence to withhold antibiotics may yield considerable efficiency gains in these groups, where the perceived risks of failing to identify potentially life-threatening bacterial infections are greatest.

The cost-effectiveness of seven behavioural interventions to prevent drug misuse in vulnerable populations.

BACKGROUND: The National Institute for Health and Care Excellence (NICE) developed a guideline on drug misuse prevention in vulnerable populations. Part of the guideline development process involved evaluating cost-effectiveness and determining which interventions represented good value for money. METHODS: Economic models were developed for seven interventions which aimed to prevent drug use in vulnerable populations. The models compared the costs (to the health and crime sectors) and health benefits (in quality-adjusted life years (QALYs)) of each intervention and its comparator. Sensitivity analysis explored the uncertainty associated with the cost of each intervention and duration of its effect. RESULTS: The reduction in drug use for each intervention partly offset the costs of the intervention, and improved health outcomes (QALYs). However, with high intervention costs and low QALY gains, none of the interventions were estimated to be cost-effective in the base case. Sensitivity analysis found that some of the interventions could be cost-effective if they could be delivered at a lower cost, or if the effect could be sustained for more than two years. CONCLUSIONS: For drug misuse prevention to be prioritised by funders, the consequences of drug misuse need to be understood, and interventions need to be shown to be effective and cost-effective. Quantifying the wider harms of drug misuse and wider benefits of prevention interventions poses challenges in evaluating the cost-effectiveness of drug misuse prevention interventions. A greater understanding of the consequences of drug misuse and causal factors could facilitate development of cost-effective interventions to prevent drug misuse.

Effective? Engaging? Secure? Applying the ORCHA-24 framework to evaluate apps for chronic insomnia disorder.

BACKGROUND: Mobile health offers many opportunities; however, the 'side-effects' of health apps are often unclear. With no guarantee health apps first do no harm, their role as a viable, safe and effective therapeutic option is limited. OBJECTIVE: To assess the quality of apps for chronic insomnia disorder, available on the Android Google Play Store, and determine whether a novel approach to app assessment could identify high-quality and low-risk health apps in the absence of indicators such as National Health Service (NHS) approval. METHODS: The Organisation for the Review of Care and Health Applications- 24 Question Assessment (ORCHA-24), 24 app assessment criteria concerning data privacy, clinical efficacy and user experience, answered on a 'yes' or 'no' and evidence-driven basis, was applied to assess 18 insomnia apps identified via the Android Google Play Store, in addition to the NHS-approved iOS app Sleepio. FINDINGS: 63.2% of apps (12/19) provided a privacy policy, with seven (36.8%) stating no user data would be shared without explicit consent. 10.5% (2/19) stated they had been shown to be of benefit to those with insomnia, with cognitive behavioural therapy apps outperforming hypnosis and meditation apps (p=0.046). Both the number of app downloads (p=0.29) and user-review scores (p=0.23) were unrelated to ORCHA-24 scores. The NHS-approved app Sleepio, consistently outperformed non-accredited apps across all domains of the ORCHA-24. CONCLUSIONS: Apps for chronic insomnia disorder exhibit substantial variation in adherence to published data privacy, user experience and clinical efficacy standards, which are not clearly correlated with app downloads or user-review scores. CLINICAL IMPLICATIONS: In absence of formal app accreditation, the ORCHA-24 could feasibly be used to highlight the risk-benefit profiles of health apps prior to downloading.

Foley catheterisation versus oral misoprostol for induction of labour in hypertensive women in India (INFORM): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Between 62 000 and 77 000 women die annually from pre-eclampsia and eclampsia. Prompt delivery, preferably by the vaginal route, is vital for good maternal and neonatal outcomes. Two low-cost interventions-low-dose oral misoprostol tablets and transcervical Foley catheterisation-are already used in low-resource settings. We aimed to compare the relative risks and benefits of these interventions. METHODS: We undertook this multicentre, open-label, randomised controlled trial in two public hospitals in Nagpur, India. Women (aged ≥18 years) who were at 20 weeks' gestation or later with a live fetus and required delivery as a result of pre-eclampsia or hypertension were randomly assigned (1:1), via computer-generated block randomisation (block sizes of four, six, and eight) with concealment by use of opaque, sequentially numbered, sealed envelopes, to receive labour induction with either oral misoprostol 25 µg every 2 h (maximum of 12 doses) or a transcervical Foley catheter (silicone, size 18 F with 30 mL balloon). Randomisation was stratified by study centre. The catheter remained in place until active labour started, the catheter fell out, or 12 h had elapsed. If the catheter did not fall out within 12 h, induction continued with artificial membrane rupture and oxytocin, administered through a micro-drip gravity infusion set. Fetal monitoring was by intermittent auscultation. The primary outcome was vaginal birth within 24 h. Due to the nature of the interventions, masking of participants, study investigators, and care providers to group allocation was not possible. We analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01801410. FINDINGS: Between Dec 20, 2013, and June 29, 2015, we randomly assigned 602 women to induction with misoprostol (n=302) or the Foley catheter (n=300; intention-to-treat population). Vaginal birth within 24 h was more common in women in the misoprostol group than in the Foley catheter group (172 [57·0%] vs 141 [47·0%] women; absolute risk difference 10·0%, 95% CI 2·0-17·9; p=0·0136). Rates of uterine hyperstimulation were low in both the misoprostol and Foley catheter groups (two [0·7%] vs one [0·3%] cases; absolute risk difference 0·3%, 95% CI -0·8 to 1·5; p=0·566) and neonatal deaths did not differ significantly between groups (six [2·0%] vs three [1·0%] neonatal deaths; 1·0, -1·04 to 2·97; p=0·322). 17 serious adverse events (3%) were reported during the study: one case of intrapartum convulsion and one case of disseminated intravascular coagulation (both in the Foley group); ten perinatal deaths, including two stillbirths (both in the Foley catheter group) and eight neonatal deaths (n=5 in the misoprostol group and n=3 in the Foley catheter group); and five of neonatal morbidity, comprising birth asphyxia (n=3), septicaemia (n=1), and neonatal convulsion (n=1). INTERPRETATION: Oral misoprostol was more effective than transcervical Foley catheterisation for induction of labour in women with pre-eclampsia or hypertension. Future studies are required to assess whether oxytocin augmentation following misoprostol can be replaced by regular doses of oral misoprostol tablets. FUNDING: Medical Research Council, Department for International Development, and Wellcome Trust Joint Global Health Trials Scheme.

A Tale of Two Thresholds: A Framework for Prioritization within the Cancer Drugs Fund.

BACKGOUND: The Cancer Drugs Fund (CDF) has been the subject of controversy since its inception, with critics arguing that it creates a "backdoor" to the National Health Service (NHS), circumventing the National Institute for Health and Care Excellence and its health technology assessment program. Nonetheless, with its creation comes a new decision problem, how to best allocate resources among cancer drugs. OBJECTIVES: Our objective was to estimate CDF's willingness and ability to pay for cancer drugs, providing guidance regarding where CDF funds are best spent, and determining the number of NHS quality-adjusted life-years (QALYs) displaced through the existence of the fund. METHODS: Using CDF utilization figures, cost-per-QALY, and treatment episode costs from National Institute for Health and Care Excellence health technology assessment reports, the league-table approach was applied to determine appropriate cost-effectiveness thresholds to inform the CDF's decision making. RESULTS: The CDF exhibits a willingness-to-pay value of £223,627 per QALY, with 74% and 33% of expenditure for drugs with incremental cost-effectiveness ratios of more than £50,000 and more than £90,000, respectively. During 2013-2014, CDF expenditure generated 4,677 QALYs, compared with a potential 13,485 if the same funds were used as part of routine NHS commissioning, displacing 8,808 QALYs. By ring fencing 10%, 25%, and 50% of the CDF budget for the provision of unevaluated drugs, cost-effectiveness thresholds of £149,000, £111,400, and £68,600 were calculated, respectively. CONCLUSIONS: Adopting the proposed framework for CDF prioritization would result in disinvestment from a number of highly cost-ineffective drugs applicable for CDF reimbursement. The present lack of a formal economic evaluation not only results in net health losses but also compromises a founding principle of the NHS, that of "equal access for equal need."

Comparing applets and oranges: barriers to evidence-based practice for app-based psychological interventions.

Poor-quality pharmaceuticals and medical devices rarely make it to market; however, the same cannot be said for app-based interventions. With a high availability but low evidence base for mHealth, apps are an increasingly uncertain prospect to users and healthcare professionals alike. Although in a first-best situation, the burden of proof concerning app safety, clinical and cost-effectiveness 'should' ultimately lie with app developers; a number of barriers to evidence generation, including the fact that 'acceptable evidence' itself is largely open to interpretation, mean that it may be folly to expect this paucity of real-world effectiveness research to improve. While the health technology assessment of established therapeutic modalities including pharmaceuticals and talking therapies benefits from the existence of approved evaluative guidelines, unfortunately the same cannot be said for app-based interventions, specifically with regard to outcomes measurement. As such, it would seem that in order to prevent the comparative assessment of apps simply becoming an exercise comparing apples and oranges, there is a clear need for consensus and guidance for app developers, as to which patient-reported outcome measures, among the hundreds available, are of clinical use to those making decisions, and should therefore be used when developing app-based interventions. By negating the fear that any evidence collected may be of poor quality, we can reincentivise developers to engage in evidence generation, and in doing so, maximise the likelihood of evidence-based decision-making taking a firm hold. However, only by dispelling the ambiguity around what acceptable evidence can and should look like, can we begin to do so.