What Makes a Quality Health App-Developing a Global Research-Based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: Delphi Study.

BACKGROUND: The lack of an international standard for assessing and communicating health app quality and the lack of consensus about what makes a high-quality health app negatively affect the uptake of such apps. At the request of the European Commission, the international Standard Development Organizations (SDOs), European Committee for Standardization, International Organization for Standardization, and International Electrotechnical Commission have joined forces to develop a technical specification (TS) for assessing the quality and reliability of health and wellness apps. OBJECTIVE: This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality. METHODS: A 2-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42, 51%) or both (n=41, 49%) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the maximum 100 requirement questions for the uptake of apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries that participated in the SDO technical committees were invited to comment on 4 working drafts and subsequently vote on the TS. RESULTS: The final quality assessment framework includes 81 questions, 67 (83%) of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as "Healthy and safe," "Easy to use," "Secure data," and "Robust build." The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2-4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs, including 6 of the 10 most populous countries worldwide. CONCLUSIONS: A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers enhance and efficiently demonstrate the quality of health apps, consumers, and health care professionals to make informed decisions on health apps. It will also help insurers to make reimbursement decisions on health apps.

The NICE Evidence Standards Framework for digital health and care technologies - Developing and maintaining an innovative evidence framework with global impact.

OBJECTIVE: In 2018, the UK National Institute for Health and Care Excellence (NICE), in partnership with Public Health England, NHS England, NHS Improvement and others, developed an evidence standards framework (ESF) for digital health and care technologies (DHTs). The ESF was designed to provide a standardised approach to guide developers and commissioners on the levels of evidence needed for the clinical and economic evaluation of DHTs by health and care systems. METHODS: The framework was developed using an agile and iterative methodology that included a literature review of existing initiatives and comparison of these against the requirements set by NHS England; iterative consultation with stakeholders through an expert working group and workshops; and questionnaire-based stakeholder input on a publicly available draft document. RESULTS: The evidence standards framework has been well-received and to date the ESF has been viewed online over 55,000 times and downloaded over 19,000 times. CONCLUSIONS: In April 2021 we published an update to the ESF. Here, we summarise the process through which the ESF was developed, reflect on its global impact to date, and describe NICE's ongoing work to maintain and improve the framework in the context for a fast moving, innovative field.

A novel method of non-clinical dispatch is associated with a higher rate of critical Helicopter Emergency Medical Service intervention.

BACKGROUND: Helicopter Emergency Medical Services (HEMS) are a scarce resource that can provide advanced emergency medical care to unwell or injured patients. Accurate tasking of HEMS is required to incidents where advanced pre-hospital clinical care is needed. We sought to evaluate any association between non-clinically trained dispatchers, following a bespoke algorithm, compared with HEMS paramedic dispatchers with respect to incidents requiring a critical HEMS intervention. METHODS: Retrospective analysis of prospectively collected data from two 12-month periods was performed (Period one: 1st April 2014 - 1st April 2015; Period two: 1st April 2016 - 1st April 2017). Period 1 was a Paramedic-led dispatch process. Period 2 was a non-clinical HEMS dispatcher assisted by a bespoke algorithm. Kent, Surrey & Sussex HEMS (KSS HEMS) is tasked to approximately 2500 cases annually and operates 24/7 across south-east England. The primary outcome measure was incidence of a HEMS intervention. RESULTS: A total of 4703 incidents were included; 2510 in period one and 2184 in period two. Variation in tasking was reduced by introducing non-clinical dispatchers. There was no difference in median time from 999 call to HEMS activation between period one and two (period one; median 7 min (IQR 4-17) vs period two; median 7 min (IQR 4-18). Non-clinical dispatch improved accuracy of HEMS tasking to a mission where a critical care intervention was required (OR 1.25, 95% CI 1.04-1.51, p = 0.02). CONCLUSION: The introduction of non-clinical, HEMS-specific dispatch, aided by a bespoke algorithm improved accuracy of HEMS tasking. Further research is warranted to explore where this model could be effective in other HEMS services.

Run-time Reconfigurable Acceleration for Genetic Programming Fitness Evaluation in Trading Strategies.

Genetic programming can be used to identify complex patterns in financial markets which may lead to more advanced trading strategies. However, the computationally intensive nature of genetic programming makes it difficult to apply to real world problems, particularly in real-time constrained scenarios. In this work we propose the use of Field Programmable Gate Array technology to accelerate the fitness evaluation step, one of the most computationally demanding operations in genetic programming. We propose to develop a fully-pipelined, mixed precision design using run-time reconfiguration to accelerate fitness evaluation. We show that run-time reconfiguration can reduce resource consumption by a factor of 2 compared to previous solutions on certain configurations. The proposed design is up to 22 times faster than an optimised, multithreaded software implementation while achieving comparable financial returns.

The Impact of Helicopter Emergency Medical Service Night Operations in South East England.

OBJECTIVE: This study sought to assess the impact of a helicopter emergency medical service (HEMS) capable of night operations. METHODS: This is a retrospective case review of all night HEMS missions attended by a charity air ambulance service in South East England over a 2-year period (October 1, 2013, to October 1, 2015). RESULTS: During the 2-year trial period, the HEMS service undertook a total of 5,004 missions and attended to 3,728 patients. Of these, 1,373 missions, or 27.4% of the total HEMS activity, were night missions. Night missions increased from year 1 (n = 617) to year 2 (n = 756). A mean of 1.9 missions per night were conducted, resulting in the treatment of 1.3 patients per night. A higher proportion of patients were transported to a major trauma center at night (64% vs. 51%, χ2 = 41.8, P < .0001). Weather conditions prevented HEMS from responding at night via air for 15% of the night operational hours. CONCLUSION: A 2-year trial period of a night HEMS service in South East England showed the predicted activation rate, with a mean of 1.3 patients attended to per night. Patients transported to a major trauma center had a mean Injury Severity Score of 23. Further research is warranted to determine if the night HEMS service conveys a patient outcome benefit.

Forearm skin tissue dielectric constant measured at 300 MHz: effect of changes in skin vascular volume and blood flow.

Skin tissue dielectric constant (TDC) values measured via the open-ended coaxial probe method are useful non-invasive indices of local skin tissue water. However, the effect of skin blood flow (SBF) or skin blood volume (SBV) on TDC values is unknown. To determine the magnitude of such effects, we decreased forearm SBV via vertical arm raising for 5 min (test 1) and increased SBV by bicep cuff compression to 50 mmHg for 5 min (test 2) in 20 healthy supine subjects (10 men). TDC values were measured to a depth of 1·5 mm on anterior forearm, and SBF was measured with laser-Doppler system simultaneously on forearm and finger. Results indicate that decreasing vascular volume (test 1) was associated with a small but statistically significant reduction in TDC (3·0 ± 4·3%, P = 0·003) and increasing vascular volume (test 2) was associated with a slight but statistically significant increase in TDC (3·5 ± 3·0%, P<0·001). SBF changes depended on test and measurement site. For forearm, test 1 significantly increased SBF (102·6 ± 156·2%, P<0·001) and test 2 significantly decreased it (39·5 ± 13·1%, P<0·001). In finger, SBF was significantly reduced by both tests: in test 1 by 55·3 ± 32·1%, P<0·001 and in test 2 by 53·3 ± 27·6%, P<0·001. We conclude that the small percentage changes in TDC values (3·0-3·5%) over the wide range of induced SBV and SBF changes suggest a minor effect on clinically determined TDC values because of SBV or SBF changes or differences when comparing TDC longitudinally over time or among individuals of different groups in a research setting.

Increased male-male courtship in ecdysone receptor deficient adult flies.

Male-male courtship is infrequent among mature adult Drosophila melanogaster. After pairs of mature adult males expressing a temperature-sensitive allele of the ecdysone receptor (EcR) gene were treated at a restrictive temperature, however, they engaged in elevated levels of male-male courtship. EcR-deficient males courted wildtype males and females, but were not courted by wildtype males. These results suggest that the ecdysone steroid hormone system may have a role in courtship initiation by adult male fruit flies.