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.publishedVersionPeer reviewe

REducing delay through edUcation on eXacerbations for people with chronic lung disease: Study protocol of a single-arm pre-post study

Abstract Aim: This study protocol aims to examine the effectiveness and preconditions of a self-management program—named REducing Delay through edUcation on eXacerbations (REDUX)—in China. Background: The high disease burden in people with chronic lung disease is mainly due to exacerbations. There is a need for effective exacerbation-management interventions. A nurse-led program, REDUX, helped patients self-manage exacerbations. Design: A single-arm pre-post study. Methods: Fifty-four patients and 24 healthcare professionals (HCPs) in Chinese primary care will be included. The core element of the program is a personalized action plan. HCPs will receive training in using the action plan to help patients manage exacerbations. The intervention will start when a patient is referred to the nurse for a post-exacerbation consultation and ends when the patient presents for the second post-exacerbation consultation. During the first post-exacerbation consultation, the patient and nurse will create the action plan. The primary outcomes in patients will include the delays between the onset of exacerbation and recognition, between exacerbation recognition and action, between exacerbation recognition and consultation with a doctor, and when the patients feel better after receiving medical help from HCPs. The secondary outcomes will include preconditions of the program. The ethics approval was obtained in September 2021. Discussion: This study will discuss a culturally adapted nurse-led self-management intervention for people with chronic lung disease in China. The intervention could help Chinese HCPs provide efficient care and reduce their workload. Furthermore, it will inform future research on tailoring nurse-led self-management interventions in different contexts. Impact: The study will contribute to the evidence on the effectiveness and preconditions of REDUX in China. If effective, the result will assist the nursing of people with chronic lung disease. Trial registration: Registered in the Chinese clinical trial registry (ID: 2100051782)

Associations between obesity and multidimensional frailty in older Chinese people with hypertension

Purpose: To investigate the prevalence of multidimensional frailty in older people with hypertension and to examine a possible relationship of general obesity and abdominal obesity to frailty in older people with hypertension.Patients and Methods: A sample of 995 community-dwelling older people with hypertension, aged 65 years and older and living in Zhengzhou (China), completed the Tilburg Frailty Indicator (TFI), a validated self-report questionnaire for assessing multidimensional frailty. In addition, socio-demographic and lifestyle characteristics were assessed by self-report, and obesity was determined by measuring waist circumference and calculating the body mass index.Results: The prevalence of multidimensional frailty in this older population with hypertension was 46.5%. Using multiple linear regression analysis, body mass index was significantly associated with physical frailty (p = 0.001), and waist circumference was significantly positively associated with multidimensional frailty and all three frailty domains. Older age was positively associated with multidimensional frailty, physical frailty, and psychological frailty, while gender (woman) was positively associated with multidimensional, psychological, and social frailty. Furthermore, comorbid diseases and being without a partner were positively associated with multidimensional, physical, psychological, and social frailty. Of the lifestyle characteristics, drinking alcohol was positively associated with frailty domains.Conclusion: Multidimensional frailty was highly prevalent among Chinese community-dwelling older people with hypertension. Abdominal obesity could be a concern in physical frailty, psychological frailty, and social frailty, while general obesity was concerning in relation to physical frailty.Prevention, Population and Disease management (PrePoD)Public Health and primary car

Blended self-management interventions to reduce disease burden in patients with chronic obstructive pulmonary disease and asthma : systematic review and meta-analysis

Background: Chronic obstructive pulmonary disease (COPD) and asthma have a high prevalence and disease burden. Blended self-management interventions, which combine eHealth with face-to-face interventions, can help reduce the disease burden.Objective: This systematic review and meta-analysis aims to examine the effectiveness of blended self-management interventions on health-related effectiveness and process outcomes for people with COPD or asthma. Methods: PubMed, Web of Science, COCHRANE Library, Emcare, and Embase were searched in December 2018 and updated in November 2020. Study quality was assessed using the Cochrane risk of bias (ROB) 2 tool and the Grading of Recommendations, Assessment, Development, and Evaluation.Results: A total of 15 COPD and 7 asthma randomized controlled trials were included in this study. The meta-analysis of COPD studies found that the blended intervention showed a small improvement in exercise capacity (standardized mean difference [SMD] 0.48; 95% CI 0.10-0.85) and a significant improvement in the quality of life (QoL; SMD 0.81; 95% CI 0.11-1.51). Blended intervention also reduced the admission rate (relative ratio [RR] 0.61; 95% CI 0.38-0.97). In the COPD systematic review, regarding the exacerbation frequency, both studies found that the intervention reduced exacerbation frequency (RR 0.38; 95% CI 0.26-0.56). A large effect was found on BMI (d=0.81; 95% CI 0.25-1.34); however, the effect was inconclusive because only 1 study was included. Regarding medication adherence, 2 of 3 studies found a moderate effect (d=0.73; 95% CI 0.50-0.96), and 1 study reported a mixed effect. Regarding self-management ability, 1 study reported a large effect (d=1.15; 95% CI 0.66-1.62), and no effect was reported in that study. No effect was found on other process outcomes. The meta-analysis of asthma studies found that blended intervention had a small improvement in lung function (SMD 0.40; 95% CI 0.18-0.62) and QoL (SMD 0.36; 95% CI 0.21-0.50) and a moderate improvement in asthma control (SMD 0.67; 95% CI 0.40-0.93). A large effect was found on BMI (d=1.42; 95% CI 0.28-2.42) and exercise capacity (d=1.50; 95% CI 0.35-2.50); however, 1 study was included per outcome. There was no effect on other outcomes. Furthermore, the majority of the 22 studies showed some concerns about the ROB, and the quality of evidence varied.Conclusions: In patients with COPD, the blended self-management interventions had mixed effects on health-related outcomes, with the strongest evidence found for exercise capacity, QoL, and admission rate. Furthermore, the review suggested that the interventions resulted in small effects on lung function and QoL and a moderate effect on asthma control in patients with asthma. There is some evidence for the effectiveness of blended self-management interventions for patients with COPD and asthma; however, more research is needed.Prevention, Population and Disease management (PrePoD)Public Health and primary car

Associations Between Obesity and Multidimensional Frailty in Older Chinese People with Hypertension

Purpose: To investigate the prevalence of multidimensional frailty in older people with hypertension and to examine a possible relationship of general obesity and abdominal obesity to frailty in older people with hypertension. Patients and Methods: A sample of 995 community-dwelling older people with hypertension, aged 65 years and older and living in Zhengzhou (China), completed the Tilburg Frailty Indicator (TFI), a validated self-report questionnaire for assessing multidimensional frailty. In addition, socio-demographic and lifestyle characteristics were assessed by self-report, and obesity was determined by measuring waist circumference and calculating the body mass index. Results: The prevalence of multidimensional frailty in this older population with hypertension was 46.5%. Using multiple linear regression analysis, body mass index was significantly associated with physical frailty (p = 0.001), and waist circumference was significantly positively associated with multidimensional frailty and all three frailty domains. Older age was positively associated with multidimensional frailty, physical frailty, and psychological frailty, while gender (woman) was positively associated with multidimensional, psychological, and social frailty. Furthermore, comorbid diseases and being without a partner were positively associated with multidimensional, physical, psychological, and social frailty. Of the lifestyle characteristics, drinking alcohol was positively associated with frailty domains. Conclusion: Multidimensional frailty was highly prevalent among Chinese community-dwelling older people with hypertension. Abdominal obesity could be a concern in physical frailty, psychological frailty, and social frailty, while general obesity was concerning in relation to physical frailty

Blended Self-Management Interventions to Reduce Disease Burden in Patients With Chronic Obstructive Pulmonary Disease and Asthma: Systematic Review and Meta-analysis

Abstract: Background: Chronic obstructive pulmonary disease (COPD) and asthma have a high prevalence and disease burden. Blended self-management interventions, which combine eHealth with face-to-face interventions, can help reduce the disease burden. Objective: This systematic review and meta-analysis aims to examine the effectiveness of blended self-management interventions on health-related effectiveness and process outcomes for people with COPD or asthma. Methods: PubMed, Web of Science, COCHRANE Library, Emcare, and Embase were searched in December 2018 and updated in November 2020. Study quality was assessed using the Cochrane risk of bias (ROB) 2 tool and the Grading of Recommendations, Assessment, Development, and Evaluation. Results: A total of 15 COPD and 7 asthma randomized controlled trials were included in this study. The meta-analysis of COPD studies found that the blended intervention showed a small improvement in exercise capacity (standardized mean difference [SMD] 0.48; 95% CI 0.10-0.85) and a significant improvement in the quality of life (QoL; SMD 0.81; 95% CI 0.11-1.51). Blended intervention also reduced the admission rate (relative ratio [RR] 0.61; 95% CI 0.38-0.97). In the COPD systematic review, regarding the exacerbation frequency, both studies found that the intervention reduced exacerbation frequency (RR 0.38; 95% CI 0.26-0.56). A large effect was found on BMI (d=0.81; 95% CI 0.25-1.34); however, the effect was inconclusive because only 1 study was included. Regarding medication adherence, 2 of 3 studies found a moderate effect (d=0.73; 95% CI 0.50-0.96), and 1 study reported a mixed effect. Regarding self-management ability, 1 study reported a large effect (d=1.15; 95% CI 0.66-1.62), and no effect was reported in that study. No effect was found on other process outcomes. The meta-analysis of asthma studies found that blended intervention had a small improvement in lung function (SMD 0.40; 95% CI 0.18-0.62) and QoL (SMD 0.36; 95% CI 0.21-0.50) and a moderate improvement in asthma control (SMD 0.67; 95% CI 0.40-0.93). A large effect was found on BMI (d=1.42; 95% CI 0.28-2.42) and exercise capacity (d=1.50; 95% CI 0.35-2.50); however, 1 study was included per outcome. There was no effect on other outcomes. Furthermore, the majority of the 22 studies showed some concerns about the ROB, and the quality of evidence varied. Conclusions: In patients with COPD, the blended self-management interventions had mixed effects on health-related outcomes, with the strongest evidence found for exercise capacity, QoL, and admission rate. Furthermore, the review suggested that the interventions resulted in small effects on lung function and QoL and a moderate effect on asthma control in patients with asthma. There is some evidence for the effectiveness of blended self-management interventions for patients with COPD and asthma; however, more research is needed. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019119894; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=11989

SERIES: eHealth in primary care. Part 6: Global perspectives: Learning from eHealth for low-resource primary care settings and across high-, middle- and low-income countries

AbstractBackground eHealth offers opportunities to improve health and healthcare systems and overcome primary care challenges in low-resource settings (LRS). LRS has been typically associated with low- and middle-income countries (LMIC), but they can be found in high-income countries (HIC) when human, physical or financial resources are constrained. Adopting a concept of LRS that applies to LMIC and HIC can facilitate knowledge interchange between eHealth initiatives while improving healthcare provision for socioeconomically disadvantaged groups across the globe.Objectives To outline the contributions and challenges of eHealth in low-resource primary care settings.Strategy We adopt a socio-ecological understanding of LRS, making LRS relevant to LMIC and HIC. To assess the potential of eHealth in primary care settings, we discuss four case studies according to the WHO ‘building blocks for strengthening healthcare systems’.Results and discussion The case studies illustrate eHealth’s potential to improve the provision of healthcare by i) improving the delivery of healthcare (using AI-generated chats); ii) supporting the workforce (using telemedicine platforms); iii) strengthening the healthcare information system (through patient-centred healthcare information systems), and iv) improving system-related elements of healthcare (through a mobile health financing platform). Nevertheless, we found that development and implementation are hindered by user-related, technical, financial, regulatory and evaluation challenges. We formulated six recommendations to help anticipate or overcome these challenges: 1) evaluate eHealth’s appropriateness, 2) know the end users, 3) establish evaluation methods, 4) prioritise the human component, 5) profit from collaborations, ensure sustainable financing and local ownership, 6) and contextualise and evaluate the implementation strategies