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.

Simulation of lung function evolution after heart-lung transplantation using a numerical model.

A morphometry-based computational model for expiratory flow in humans was used to study the unusual configuration of the maximum expiratory flow-volume (MEFV) curve associated with alterations in lung function after heart-lung transplantation (HLT). The postoperative MEFV curve showed a peak, followed by a gently sloping plateau over the midvolume range, ending in a knee where the flow suddenly fell, instead of the usual observed uniform decrease in expiratory flow. We have tested several hypotheses about the relationship between the pattern of changes in the configuration of the MEFV curve and pathological changes in the airway mechanics through computer simulations. Principally, effects of lung denervation and airway obstruction, associated with the development of bronchiolitis obliterans in the lung periphery, have been investigated. The calculated curves are similar in appearance to the measured postoperative flow-volume curves and confirm reliability of the earlier hypotheses. We conclude that the plateau-knee configuration of the MEFV curve can result from flow limitation in one of the first airway generations, that this flow limitation coupled with an increase in peripheral airway resistance results in plateau shortening, and that flows exceeding predicted values during the second part of expiration may be produced by lung denervation. Additionally our results demonstrate that airways larger than the transitional and respiratory bronchioles can be involved in pulmonary function deterioration observed in patients affected with obliterative bronchiolitis. Our findings indicate that the computational model, based on a symmetrical dichotomous branching structure of the bronchial tree, along with pathological data, can be employed to evaluate the effects of heterogeneous changes in the lung periphery. Index Terms-Airway mechanics, forced expiration, lung transplantation, mathematical modeling, maximal expiratory flow-volume curve.

Internet-based home monitoring of pulmonary function after lung transplantation.

Home monitoring of spirometry has been advocated in lung transplant recipients for the early detection of acute infection and rejection of the allograft. We have developed a user-friendly, Internet-based telemonitoring system providing direct transmission of home spirometry to the hospital. In this prospective study, we assessed patient adherence with the monitoring, agreement between home and hospital spirometry, intrasubject coefficient of variation (CV) for FEV(1) and FEF(25-75), and sensitivity of these variables for the detection of acute complications. Twenty-two bilateral-lung and heart-lung transplant recipients were followed for a median of 473 d (range, 60-822), during which 13,833 measurements were obtained. Patient compliance was 55% for two measurements a day and 84% for one measurement a day. Agreement between home and hospital spirometry was within 4% for FEV(1) and 6% for FEF(25-75). Mean CV was 3.2% for FEV(1) and 7.5% for FEF(25-75). Using transbronchial lung biopsy and/or bronchoalveolar lavage as gold standards, the sensitivity of home spirometry was 63%, and 23% of true positives were detected by changes in FEF(25-75) alone. We conclude that home monitoring of pulmonary function in lung transplant recipients via the Internet is feasible and provides very reproducible data; yet it has only a mild sensitivity for the detection of acute allograft dysfunction.