Quality Assessment of Digital Health Apps: Umbrella Review.

BACKGROUND: With an increasing number of digital health apps available in app stores, it is important to assess these technologies reliably regarding their quality. This is done to mitigate the risks associated with their use. There are many different guidelines, methods, and metrics available to assess digital health apps with regard to their quality. OBJECTIVE: This study aimed to give a holistic summary of the current methods and "condition agnostic" frameworks that are broadly applicable for the quality assessment of all digital health apps. METHODS: A systematic search of literature was conducted on 4 databases: Scopus, PubMed, ACM Digital Library, and IEEE Xplore. We followed the PICOS (Population, Patient, or Problem; Intervention; Comparison; Outcomes; and Study Design) and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodologies when conducting this umbrella review. The search was conducted on January 26, 2024, for review articles published between 2018 and 2023. We identified 4781 candidate papers for inclusion; after title and abstract screening, 39 remained. After full-text analysis, we included 15 review articles in the full review. RESULTS: Of the 15 review articles, scoping reviews were the most common (n=6, 40%), followed by systematic reviews (n=4, 27%), narrative reviews (n=4, 27%), and a rapid review (n=1, 7%). A total of 4 (27%) review articles proposed assessment criteria for digital health apps. "Data privacy and/or security" was the most mentioned criterion (n=13, 87%) and "Cost" was the least mentioned criterion (n=1, 7%) for the assessment of digital health apps. The Mobile App Rating Scale was the most frequently used framework for quality assessment of digital health apps. CONCLUSIONS: There is a lack of unity or consolidation across identified frameworks, as most do not meet all the identified criteria from the reviewed articles. Safety concerns associated with the use of digital health apps may be mitigated with the use of quality frameworks.

Correction: Quality Assessment of Digital Health Apps: Umbrella Review.

[This corrects the article DOI: 10.2196/58616.].

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.

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".

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.