Dataset Information

Standards for Mobile Health-Related Apps: Systematic Review and Development of a Guide.

ABSTRACT: BACKGROUND:In recent years, the considerable increase in the number of mobile health (mHealth) apps has made health care more accessible and affordable for all. However, the exponential growth in mHealth solutions has occurred with almost no control or regulation of any kind. Despite some recent initiatives, there is still no specific regulation procedure, accreditation system, or standards to help the development of the apps, mitigate risks, or guarantee quality. OBJECTIVE:The main aim of this study was to propose a set of criteria for mHealth-related apps on the basis of what is available from published studies, guidelines, and standards in the various areas that are related to health app development. METHODS:We used three sources of information to identify the most important criteria. First, we conducted a systematic review of all the studies published on pain-related apps. Second, we searched for health app recommendations on the websites of professional organizations. Third, we looked for standards governing the development of software for medical devices on the specialized websites of regulatory organizations. Then, we grouped and subsumed the criteria we had identified on the basis of their shared characteristics. Finally, the comprehensibility and perceived importance of the resulting criteria were evaluated for face validity with a group of 18 stakeholders. RESULTS:We identified a total of 503 criteria from all sources, which, after close analysis, were grouped into eight different categories, including 36 important criteria for health apps. The resulting categories were usability, privacy, security, appropriateness and suitability, transparency and content, safety, technical support and updates, and technology. The results of the preliminary analysis showed that the criteria were mostly understood by the group of stakeholders. In addition, they perceived all of them as important. CONCLUSIONS:This set of criteria can help health care providers, developers, patients, and other stakeholders to guide the development of mHealth-related apps and, potentially, to measure the quality of an mHealth app.

SUBMITTER: Llorens-Vernet P

PROVIDER: S-EPMC7078629 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Standards for Mobile Health-Related Apps: Systematic Review and Development of a Guide.

Llorens-Vernet Pere P Miró Jordi J

JMIR mHealth and uHealth 20200303 3

<h4>Background</h4>In recent years, the considerable increase in the number of mobile health (mHealth) apps has made health care more accessible and affordable for all. However, the exponential growth in mHealth solutions has occurred with almost no control or regulation of any kind. Despite some recent initiatives, there is still no specific regulation procedure, accreditation system, or standards to help the development of the apps, mitigate risks, or guarantee quality.<h4>Objective</h4>The ma ...[more]

PMID: 32130169

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Project description:BackgroundThere are an increasing number of mobile apps available for adolescents with mental health problems and an increasing interest in assimilating mobile health (mHealth) into mental health services. Despite the growing number of apps available, the evidence base for their efficacy is unclear.ObjectiveThis review aimed to systematically appraise the available research evidence on the efficacy and acceptability of mobile apps for mental health in children and adolescents younger than 18 years.MethodsThe following were systematically searched for relevant publications between January 2008 and July 2016: APA PsychNet, ACM Digital Library, Cochrane Library, Community Care Inform-Children, EMBASE, Google Scholar, PubMed, Scopus, Social Policy and Practice, Web of Science, Journal of Medical Internet Research, Cyberpsychology, Behavior and Social Networking, and OpenGrey. Abstracts were included if they described mental health apps (targeting depression, bipolar disorder, anxiety disorders, self-harm, suicide prevention, conduct disorder, eating disorders and body image issues, schizophrenia, psychosis, and insomnia) for mobile devices and for use by adolescents younger than 18 years.ResultsA total of 24 publications met the inclusion criteria. These described 15 apps, two of which were available to download. Two small randomized trials and one case study failed to demonstrate a significant effect of three apps on intended mental health outcomes. Articles that analyzed the content of six apps for children and adolescents that were available to download established that none had undergone any research evaluation. Feasibility outcomes suggest acceptability of apps was good and app usage was moderate.ConclusionsOverall, there is currently insufficient research evidence to support the effectiveness of apps for children, preadolescents, and adolescents with mental health problems. Given the number and pace at which mHealth apps are being released on app stores, methodologically robust research studies evaluating their safety, efficacy, and effectiveness is promptly needed.

Project description:BACKGROUND:Pain is a common condition with a significant physical, psychosocial, and economic impact. Due to enormous progress in mobile device technology as well as the increase in smartphone ownership in the general population, mobile apps can be used to monitor patients with pain and support them in pain management. OBJECTIVE:The aim of this review was to assess the efficacy of smartphone or computer tablet apps in the management of patients with pain. METHODS:In December 2017, a literature search was performed in the following databases: MEDLINE, EMBASE, CINAHL, Cochrane, and PsycINFO. In addition, a bibliography search was conducted. We included studies with at least 20 participants per arm that evaluated the effects of apps on smartphones or computer tablets on improvement in pain. RESULTS:A total of 15 studies with 1962 patients met the inclusion criteria. Of these, 4 studies examined the effect of mobile apps on pain management in an in-clinic setting and 11 in an out-clinic setting. The majority of the original studies reported beneficial effects of the use of a pain app. Severity of pain decreased in most studies where patients were using an app compared with patients not using an app. Other outcomes, such as worst pain or quality of life showed improvements in patients using an app. Due to heterogeneity between the original studies-patient characteristics, app content, and study setting-a synthesis of the results by statistical methods was not performed. CONCLUSIONS:Apps for pain management may be beneficial for patients, particularly in an out-clinic setting. Studies have shown that pain apps are workable and well liked by patients and health care professionals. There is no doubt that in the near future, mobile technologies will develop further. Medicine could profit from this development as indicated by our results, but there is a need for more scientific inputs. It is desirable to know which elements of apps or additional devices and tools may improve usability and help patients in pain management.

Project description:INTRODUCTION:There is currently a lack of clear and accepted standards for the development (planning, requirement analysis and research, design and application testing) of apps for medical and healthcare use which poses different risks to developers, providers, patients and the public. The aim of this work is to provide an overview of the current standards, frameworks, best practices and guidelines for the development of digital health apps. This review is a critical 'stepping stone' for further work on producing appropriate standards that can help mitigate risks (eg, clinical, privacy and economic risks). METHODS AND ANALYSIS:A systematic review identifying criteria from applicable standards, guidelines, frameworks and best practices for the development of health apps. We will draw from standards for software for medical devices, clinical information systems and medicine because of their relatedness and hope to apply lessons learnt to apps. We will exclude other types of publications, and those published in languages other than English. We will search websites of relevant regulatory and professional organisations. For health apps, we will also search electronic research databases (eg, MEDLINE, Embase, SCOPUS, ProQuest Technology Collection and Engineering Index) because relevant publications may not be found on other websites. We will hand-search reference lists of included publications. The review will focus on international, USA, European and UK standards because these are the markets of primary interest to the majority of app developers currently. We will provide a narrative overview of findings and tabular summaries of extracted data. Also, we will examine the relationship between different standards and compare USA and European Union standards. ETHICS AND DISSEMINATION:No ethics approval is required. The review will be disseminated through peer-reviewed publications, conference presentations and inform efforts that aim to improve the quality of health apps through existing links with relevant organisations.

Project description:BackgroundMindful eating is an emerging area of research for managing unhealthy eating and weight-related behaviors such as binge eating and emotional eating. Although there are numerous commercial mindful eating apps available, their quality, effectiveness, and whether they are accurately based on mindfulness-based eating awareness are unknown.ObjectiveThis review aimed to appraise the quality of the mindful eating apps and to appraise the quality of content on mindful eating apps.MethodsA review of mindful eating apps available on Apple iTunes was undertaken from March to April 2018. Relevant apps meeting the inclusion criteria were subjectively appraised for general app quality using the Mobile App Rating Scale (MARS) guidelines and for the quality of content on mindful eating. A total of 22 apps met the inclusion criteria and were appraised.ResultsMany of the reviewed apps were assessed as functional and had moderate scores in aesthetics based on the criteria in the MARS assessment. However, some received lower scores in the domains of information and engagement. The majority of the apps did not teach users how to eat mindfully using all five senses. Hence, they were scored as incomplete in accurately providing mindfulness-based eating awareness. Instead, most apps were either eating timers, hunger rating apps, or diaries. Areas of potential improvement were in comprehensiveness and diversity of media, in the quantity and quality of information, and in the inclusion of privacy and security policies. To truly teach mindful eating, the apps need to provide guided examples involving the five senses beyond simply timing eating or writing in a diary. They also need to include eating meditations to assist people with their disordered eating such as binge eating, fullness, satiety, and craving meditations that may help them with coping when experiencing difficulties. They should also have engaging and entertaining features delivered through diverse media to ensure sustained use and interest by consumers.ConclusionsFuture mindful eating apps could be improved by accurate adherence to mindful eating. Further improvement could be achieved by ameliorating the domains of information, engagement, and aesthetics and having adequate privacy policies.

Project description:BackgroundPrivacy has always been a concern, especially in the health domain. The proliferation of mobile health (mHealth) apps has led to a large amount of sensitive data being generated. Some authors have performed privacy assessments of mHealth apps. They have evaluated diverse privacy components; however, different authors have used different criteria for their assessments.ObjectiveThis scoping review aims to understand how privacy is assessed for mHealth apps, focusing on the components, scales, criteria, and scoring methods used. A simple taxonomy to categorize the privacy assessments of mHealth apps based on component evaluation is also proposed.MethodsWe followed the methodology defined by Arksey and O'Malley to conduct a scoping review. Included studies were categorized based on the privacy component, which was assessed using the proposed taxonomy.ResultsThe database searches retrieved a total of 710 citations-24 of them met the defined selection criteria, and data were extracted from them. Even though the inclusion criteria considered articles published since 2009, all the studies that were ultimately included were published from 2014 onward. Although 12 papers out of 24 (50%) analyzed only privacy, 8 (33%) analyzed both privacy and security. Moreover, 4 papers (17%) analyzed full apps, with privacy being just part of the assessment. The evaluation criteria used by authors were heterogeneous and were based on their experience, the literature, and/or existing legal frameworks. Regarding the set of items used for the assessments, each article defined a different one. Items included app permissions, analysis of the destination, analysis of the content of communications, study of the privacy policy, use of remote storage, and existence of a password to access the app, among many others. Most of the included studies provided a scoring method that enables the comparison of privacy among apps.ConclusionsThe privacy assessment of mHealth apps is a complex task, as the criteria used by different authors for their evaluations are very heterogeneous. Although some studies about privacy assessment have been conducted, a very large set of items to evaluate privacy has been used up until now. In-app information and privacy policies are primarily utilized by the scientific community to extract privacy information from mHealth apps. The creation of a scale based on more objective criteria is a desirable step forward for privacy assessment in the future.

Project description:BackgroundThere are several mobile health (mHealth) apps in mobile app stores. These apps enter the business-to-customer market with limited controls. Both, apps that users use autonomously and those designed to be recommended by practitioners require an end-user validation to minimize the risk of using apps that are ineffective or harmful. Prior studies have reviewed the most relevant aspects in a tool designed for assessing mHealth app quality, and different options have been developed for this purpose. However, the psychometric properties of the mHealth quality measurement tools, that is, the validity and reliability of the tools for their purpose, also need to be studied. The Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) initiative has developed tools for selecting the most suitable measurement instrument for health outcomes, and one of the main fields of study was their psychometric properties.ObjectiveThis study aims to address and psychometrically analyze, following the COSMIN guideline, the quality of the tools that are used to measure the quality of mHealth apps.MethodsFrom February 1, 2019, to December 31, 2019, 2 reviewers searched PubMed and Embase databases, identifying mHealth app quality measurement tools and all the validation studies associated with each of them. For inclusion, the studies had to be meant to validate a tool designed to assess mHealth apps. Studies that used these tools for the assessment of mHealth apps but did not include any psychometric validation were excluded. The measurement tools were analyzed according to the 10 psychometric properties described in the COSMIN guideline. The dimensions and items analyzed in each tool were also analyzed.ResultsThe initial search showed 3372 articles. Only 10 finally met the inclusion criteria and were chosen for analysis in this review, analyzing 8 measurement tools. Of these tools, 4 validated ≥5 psychometric properties defined in the COSMIN guideline. Although some of the tools only measure the usability dimension, other tools provide information such as engagement, esthetics, or functionality. Furthermore, 2 measurement tools, Mobile App Rating Scale and mHealth Apps Usability Questionnaire, have a user version, as well as a professional version.ConclusionsThe Health Information Technology Usability Evaluation Scale and the Measurement Scales for Perceived Usefulness and Perceived Ease of Use were the most validated tools, but they were very focused on usability. The Mobile App Rating Scale showed a moderate number of validated psychometric properties, measures a significant number of quality dimensions, and has been validated in a large number of mHealth apps, and its use is widespread. It is suggested that the continuation of the validation of this tool in other psychometric properties could provide an appropriate option for evaluating the quality of mHealth apps.

Project description:BackgroundThere is increased research interest in the use of mobile phone apps to support diabetes management. However, there are divergent views on what constitute the minimum standards for inclusion in the development of mobile phone apps. Mobile phone apps require an evidence-based approach to development which will consequently impact on their effectiveness. Therefore, comprehensive information on developmental considerations could help designers and researchers to develop innovative and effective patient-centered self-management mobile phone apps for diabetes patients.ObjectiveThis systematic review examined the developmental considerations adopted in trials that engaged mobile phone applications for diabetes self-management.MethodsA comprehensive search strategy was implemented across 5 electronic databases; Medline, Scopus, Social Science Citation Index, the Cochrane Central Register of Controlled Trials and Cumulative Index of Nursing and Allied Health Literature (CINALHL) and supplemented by reference list from identified studies. Study quality was evaluated using the Joanna Briggs Critical appraisal checklist for trials. Information on developmental factors (health behavioral theory, functionality, pilot testing, user and clinical expert involvements, data privacy and app security) were assessed across experimental studies using a template developed for the review.ResultsA total of 11 studies (10 randomized controlled trials and 1 quasi-experimental trial) that fitted the inclusion criteria were identified. All the included studies had the functionality of self-monitoring of blood glucose. However, only some of them included functions for data analytics (7/11, 63.6%), education (6/11, 54.5%) and reminder (6/11, 54.5%). There were 5/11(45.5%) studies with significantly improved glycosylated hemoglobin in the intervention groups where educational functionality was present in the apps used in the 5 trials. Only 1 (1/11, 9.1%) study considered health behavioral theory and user involvement, while 2 (2/11, 18.1%) other studies reported the involvement of clinical experts in the development of their apps. There were 4 (4/11, 36.4%) studies which referred to data security and privacy considerations during their app development while 7 (7/12, 63.6%) studies provided information on pilot testing of apps before use in the full trial. Overall, none of the studies provided information on all developmental factors assessed in the review.ConclusionsThere is a lack of elaborate and detailed information in the literature regarding the factors considered in the development of apps used as interventions for diabetes self-management. Documentation and inclusion of such vital information will foster a transparent and shared decision-making process that will ultimately lead to the development of practical and user-friendly self-management apps that can enhance the quality of life for diabetes patients.

Dataset Information

Standards for Mobile Health-Related Apps: Systematic Review and Development of a Guide.

Publications

Standards for Mobile Health-Related Apps: Systematic Review and Development of a Guide.

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