Oral misoprostol alone, compared with oral misoprostol followed by oxytocin, in women induced for hypertension of pregnancy: A multicentre randomised trial.

OBJECTIVE: To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low-dose oral misoprostol is superior to intravenous oxytocin. DESIGN: Open-label, superiority randomised trial. SETTING: Government hospitals in India. POPULATION: Women who were induced for hypertensive disease in pregnancy and had undergone cervical ripening with oral misoprostol, but required continuing stimulation after artificial membrane rupture. METHODS: Participants received misoprostol (25 micrograms, orally, 2-hourly) or titrated oxytocin through an infusion pump. All women had one-to-one care; fetal monitoring was conducted using a mixture of intermittent and continuous electronic fetal monitoring. MAIN OUTCOME MEASURES: Caesarean birth. RESULTS: A total of 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced with the use of misoprostol (misoprostol, 84/260, 32.3%, vs oxytocin, 71/260, 27.3%; aOR 1.23; 95% CI 0.81-1.85; P = 0.33). The interval from randomisation to birth was somewhat longer with misoprostol (225 min, 207-244 min, vs 194 min, 179-210 min; aOR 1.137; 95% CI 1.023-1.264; P = 0.017). There were no cases of hyperstimulation in either arm. The rates of fetal heart rate abnormalities and maternal side effects were similar. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group; aOR 0.463; 95% CI 0.203-1.058; P = 0.068) and there were no neonatal deaths in the misoprostol group, compared with three neonatal deaths in the oxytocin arm. Women's acceptability ratings were high in both study groups. CONCLUSIONS: Following cervical preparation with oral misoprostol and membrane rupture, the use of continuing oral misoprostol for augmentation did not significantly reduce caesarean rates, compared with the use of oxytocin. There were no hyperstimulation or significant adverse events in either arm of the trial.

Patient and Public Willingness to Share Personal Health Data for Third-Party or Secondary Uses: Systematic Review.

BACKGROUND: International advances in information communication, eHealth, and other digital health technologies have led to significant expansions in the collection and analysis of personal health data. However, following a series of high-profile data sharing scandals and the emergence of COVID-19, critical exploration of public willingness to share personal health data remains limited, particularly for third-party or secondary uses. OBJECTIVE: This systematic review aims to explore factors that affect public willingness to share personal health data for third-party or secondary uses. METHODS: A systematic search of 6 databases (MEDLINE, Embase, PsycINFO, CINAHL, Scopus, and SocINDEX) was conducted with review findings analyzed using inductive-thematic analysis and synthesized using a narrative approach. RESULTS: Of the 13,949 papers identified, 135 were included. Factors most commonly identified as a barrier to data sharing from a public perspective included data privacy, security, and management concerns. Other factors found to influence willingness to share personal health data included the type of data being collected (ie, perceived sensitivity); the type of user requesting their data to be shared, including their perceived motivation, profit prioritization, and ability to directly impact patient care; trust in the data user, as well as in associated processes, often established through individual choice and control over what data are shared with whom, when, and for how long, supported by appropriate models of dynamic consent; the presence of a feedback loop; and clearly articulated benefits or issue relevance including valued incentivization and compensation at both an individual and collective or societal level. CONCLUSIONS: There is general, yet conditional public support for sharing personal health data for third-party or secondary use. Clarity, transparency, and individual control over who has access to what data, when, and for how long are widely regarded as essential prerequisites for public data sharing support. Individual levels of control and choice need to operate within the auspices of assured data privacy and security processes, underpinned by dynamic and responsive models of consent that prioritize individual or collective benefits over and above commercial gain. Failure to understand, design, and refine data sharing approaches in response to changeable patient preferences will only jeopardize the tangible benefits of data sharing practices being fully realized.

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.

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.

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.

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.

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."

Walk a mile in my shoes: perspectives towards sharing of health and experience data among individuals living with sickle cell disorder.

Background: Advancements in digital health technologies (DHTs) mean people are increasingly recording and managing personal health data. As observed during the COVID-19 pandemic, sharing of such data may provide unrivalled opportunities in advancing our understanding of conditions otherwise poorly understood, including rare conditions. Methods: A semi-structured focus group (n=25) explored perspectives and experiences of sharing health data among those with a group of rare haematological conditions, sickle cell disorder (SCD). The focus group explored (I) what 'feeling well' looks like; (II) how this could be monitored using DHTs; (III) which data healthcare professionals (HCPs) should pay greater attention to and; (IV) types of data willing to be shared, with whom, and under which conditions. Key themes were further assessed via an online survey (n=50). Results: Patient-relevant measures of condition-management focused on "everything else that comes with" SCD, suggesting HCPs did not pay sufficient attention to day-to-day symptom variability. This was juxtaposed against the "fixed and one-off" electronic health record (EHR), collecting pre-specified data at pre-determined snapshots of time, not considered reflective of outcomes associated with "feeling well" day-to-day. Forty-four-point-seven percent of respondents had previously shared health data. Most were willing to share data concerning symptoms and health service utilisation, but were less willing to share genomic and EHR data. Sixty-one-point-seven percent believed HCPs did not pay enough attention to daily fluctuations in mental and physical health. Financial benefits (74.5%), trust in organisations seeking data (72.3%), and knowing how data will be used (61.7%) were key facilitators of data sharing. Seventy-one percent, 70% and 65.2% had not previously shared health data with the pharmaceutical industry, charitable organisations and digital health interventions respectively, but were open to doing so in the future. Conclusions: Those living with the rare condition SCD were supportive of collecting and sharing data to foster research and improve understanding and outcomes. However, specific requirements were identified to respect privacy and informational needs regarding future use of data. DHTs can be a valuable tool in improving understanding of the day-to-day impact of health conditions, but understanding patient needs is critical in ensuring involvement in the process, as not all data types are considered of equal value, benefit, or risk.

Don't judge a book or health app by its cover: User ratings and downloads are not linked to quality.

OBJECTIVE: To analyse the relationship between health app quality with user ratings and the number of downloads of corresponding health apps. MATERIALS AND METHODS: Utilising a dataset of 881 Android-based health apps, assessed via the 300-point objective Organisation for the Review of Care and Health Applications (ORCHA) assessment tool, we explored whether subjective user-level indicators of quality (user ratings and downloads) correlate with objective quality scores in the domains of user experience, data privacy and professional/clinical assurance. For this purpose, we applied spearman correlation and multiple linear regression models. RESULTS: For user experience, professional/clinical assurance and data privacy scores, all models had very low adjusted R squared values (< .02). Suggesting that there is no meaningful link between subjective user ratings or the number of health app downloads and objective quality measures. Spearman correlations suggested that prior downloads only had a very weak positive correlation with user experience scores (Spearman = .084, p = .012) and data privacy scores (Spearman = .088, p = .009). There was a very weak negative correlation between downloads and professional/clinical assurance score (Spearman = -.081, p = .016). Additionally, user ratings demonstrated a very weak correlation with no statistically significant correlations observed between user ratings and the scores (all p > 0.05). For ORCHA scores multiple linear regression had adjusted R-squared = -.002. CONCLUSION: This study highlights that widely available proxies which users may perceive to signify the quality of health apps, namely user ratings and downloads, are inaccurate predictors for estimating quality. This indicates the need for wider use of quality assurance methodologies which can accurately determine the quality, safety, and compliance of health apps. Findings suggest more should be done to enable users to recognise high-quality health apps, including digital health literacy training and the provision of nationally endorsed "libraries".

Fabrication of 3-dimensional cellular constructs via microstereolithography using a simple, three-component, poly(ethylene glycol) acrylate-based system.

A novel method for the production of inhibitor- and solvent-free resins suitable for three-dimensional (3D) microstereolithography is reported. Using an exemplar poly(ethylene glycol)-based resin, the control of features in the X, Y, and Z planes is demonstrated such that complex structures can be manufactured. Human mesenchymal stem cells cultured on the manufactured scaffolds remained viable during the 7 day assessment period, with proliferation rates comparable to those observed on tissue culture polystyrene. These data suggest that this novel, yet simple, method is suitable for the production of 3D scaffolds for tissue engineering and regenerative medicine applications.

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.

Attitudes Toward Personal Health Data Sharing Among People Living With Sickle Cell Disorder, Exemplar for Study of Rare Disease Populations.

Purpose: Rare conditions are often poorly understood, creating barriers in determining the value treatments can provide. This study explored barriers and facilitators to personal health data sharing among those with one particular group of rare hematologic disorders, ie, sickle cell disorder (SCD) and its variants. Methods: A single online focus group among those >18 years of age and living with SCD was conducted. Participants (N=25) were recruited through a United Kingdom-based SCD charity. Discussions were transcribed verbatim, with data therein analyzed using inductive thematic analysis. Results: Five primary motivators for sharing health data were identified: improving awareness; knowing this would help others; evidencing impact; financial incentives; and being recognized as "experts with lived experience" rather than "specimens to be studied." Barriers included lack of clarity regarding "why" data was sought and "who" benefited. Participants stated that electronic health record (EHR) and genetic data were often "too detailed" and therefore "off limits" for sharing. However, experiences, mindset, and well-being data, often hidden from the EHR, were acceptable to share and considered a better barometer of how rare conditions treat patients day-to-day. Conclusions: Utilizing patient experience data obtained under real-world conditions is key to painting the most accurate picture of needs and understanding how SCD impacts patients' day-to-day lives. Study findings suggest that patients with SCD are not merely passive providers of health data, but rather experts by experience. To appreciate the value that patient perspectives bring, we must revisit this status quo, amending our approach to patient centricity and reframing patients as high-value managers of their condition and personal health data who crucially decide what, how, and when they share it.

Association Between the Characteristics of mHealth Apps and User Input During Development and Testing: Secondary Analysis of App Assessment Data.

BACKGROUND: User involvement is increasingly acknowledged as a central part of health care innovation. However, meaningful user involvement during the development and testing of mobile health apps is often not fully realized. OBJECTIVE: This study aims to examine in which areas user input is most prevalent and whether there is an association between user inclusion and compliance with best practices for mobile health apps. METHODS: A secondary analysis was conducted on an assessment data set of 1595 health apps. The data set contained information on whether the apps had been developed or tested with user input and whether they followed best practices across several domains. Background information was also available regarding the apps' country of origin, targeted condition areas, subjective user ratings, download numbers, and risk (as per the National Institute for Health and Care Excellence Evidence Standards Framework [ESF]). Descriptive statistics, Mann-Whitney U tests, and Pearson chi-square analyses were applied to the data. RESULTS: User involvement was reported by 8.71% (139/1595) of apps for only the development phase, by 33.67% (537/1595) of apps for only the testing phase, by 21.88% (349/1595) of apps for both phases, and by 35.74% (570/1595) of apps for neither phase. The highest percentage of health apps with reported user input during development was observed in Denmark (19/24, 79%); in the condition areas of diabetes (38/79, 48%), cardiology (15/32, 47%), pain management (20/43, 47%), and oncology (25/54, 46%); and for high app risk (ESF tier 3a; 105/263, 39.9%). The highest percentage of health apps with reported user input during testing was observed in Belgium (10/11, 91%), Sweden (29/34, 85%), and France (13/16, 81%); in the condition areas of neurodiversity (42/52, 81%), respiratory health (58/76, 76%), cardiology (23/32, 72%), and diabetes (56/79, 71%); and for high app risk (ESF tier 3a; 176/263, 66.9%). Notably, apps that reported seeking user input during testing demonstrated significantly more downloads than those that did not (P=.008), and user inclusion was associated with better compliance with best practices in clinical assurance, data privacy, risk management, and user experience. CONCLUSIONS: The countries and condition areas in which the highest percentage of health apps with user involvement were observed tended to be those with higher digital maturity in health care and more funding availability, respectively. This suggests that there may be a trade-off between developers' willingness or ability to involve users and the need to meet challenges arising from infrastructure limitations and financial constraints. Moreover, the finding of a positive association between user inclusion and compliance with best practices indicates that, where no other guidance is available, users may benefit from prioritizing health apps developed with user input as the latter may be a proxy for broader app quality.

Quality of Digital Health Interventions Across Different Health Care Domains: Secondary Data Analysis Study.

BACKGROUND: There are more than 350,000 digital health interventions (DHIs) in the app stores. To ensure that they are effective and safe to use, they should be assessed for compliance with best practice standards. OBJECTIVE: The objective of this paper was to examine and compare the compliance of DHIs with best practice standards and adherence to user experience (UX), professional and clinical assurance (PCA), and data privacy (DP). METHODS: We collected assessment data from 1574 DHIs using the Organisation for the Review of Care and Health Apps Baseline Review (OBR) assessment tool. As part of the assessment, each DHI received a score out of 100 for each of the abovementioned areas (ie, UX, PCA, and DP). These 3 OBR scores are combined to make up the overall ORCHA score (a proxy for quality). Inferential statistics, probability distributions, Kruskal-Wallis, Wilcoxon rank sum test, Cliff delta, and Dunn tests were used to conduct the data analysis. RESULTS: We found that 57.3% (902/1574) of the DHIs had an Organisation for the Review of Care and Health Apps (ORCHA) score below the threshold of 65. The overall median OBR score (ORCHA score) for all DHIs was 61.5 (IQR 51.0-73.0) out of 100. A total of 46.2% (12/26) of DHI's health care domains had a median equal to or above the ORCHA threshold score of 65. For the 3 assessment areas (UX, DP, and PCA), DHIs scored the highest for the UX assessment 75.2 (IQR 70.0-79.6), followed by DP 65.1 (IQR 55.0-73.4) and PCA 49.6 (IQR 31.9-76.1). UX scores had the least variance (SD 13.9), while PCA scores had the most (SD 24.8). Respiratory and urology DHIs were consistently highly ranked in the National Institute for Health and Care Excellence Evidence Standards Framework tiers B and C based on their ORCHA score. CONCLUSIONS: There is a high level of variability in the ORCHA scores of DHIs across different health care domains. This suggests that there is an urgent need to improve compliance with best practices in some health care areas. Possible explanations for the observed differences might include varied market maturity and commercial interests within the different health care domains. More investment to support the development of higher-quality DHIs in areas such as ophthalmology, allergy, women's health, sexual health, and dental care may be needed.

Physicians' Use of Digital Health Interventions in the Management of Nonalcoholic Fatty Liver Disease.

Globally, the use of digital health interventions (DHIs) is expanding, along with growing scientific evidence of their effectiveness. Given the high and increasing prevalence of noncommunicable liver disease, we surveyed 295 physicians across Spain about their knowledge, beliefs, attitudes, practices, and access with regard to DHIs for patient care and in particular for liver diseases, including nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Physicians reported high familiarity with DHIs, although most had not recommended them in patient care. Addressing concerns, including limited available time, evidence of effectiveness, education, training, and access may contribute to an increased uptake of these technologies.

The effectiveness of digital health technologies for patients with diabetes mellitus: A systematic review.

Introduction: Diabetes mellitus (DM) is a leading cause of morbidity and mortality worldwide. At the same time, digital health technologies (DHTs), which include mobile health apps (mHealth) have been rapidly gaining popularity in the self-management of chronic diseases, particularly following the COVID-19 pandemic. However, while a great variety of DM-specific mHealth apps exist on the market, the evidence supporting their clinical effectiveness is still limited. Methods: A systematic review was performed. A systematic search was conducted in a major electronic database to identify randomized controlled trials (RCTs) of mHealth interventions in DM published between June 2010 and June 2020. The studies were categorized by the type of DM and impact of DM-specific mHealth apps on the management of glycated haemoglobin (HbA1c) was analysed. Results: In total, 25 studies comprising 3,360 patients were included. The methodological quality of included trials was mixed. Overall, participants diagnosed with T1DM, T2DM and Prediabetes all demonstrated greater improvements in HbA1c as a result of using a DHT compared with those who experienced usual care. The analysis revealed an overall improvement in HbA1c compared with usual care, with a mean difference of -0.56% for T1DM, -0.90% for T2DM and -0.26% for Prediabetes. Conclusion: DM-specific mHealth apps may reduce HbA1c levels in patients with T1DM, T2DM and Prediabetes. The review highlights a need for further research on the wider clinical effectiveness of diabetes-specific mHealth specifically within T1DM and Prediabetes. These should include measures which go beyond HbA1c, capturing outcomes including short-term glycemic variability or hypoglycemic events.

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.

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.

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.