Constructing an assessment framework for the quality of asthma smartphone applications

Background Enhancing the self-management capability of asthma patients can improve their level of asthma control. Although the use of mobile health technology among asthmatics to facilitate self-management has become a growing area of research, studies of mobile health applications (apps), especially for evaluating indicators of asthma apps, are deficient in scope. This study aimed to develop a reliable framework to assess asthma apps (i.e., content and behavior change strategies) using the Delphi survey technique. Methods An initial list of quality rating criteria for asthma apps was derived from reviewing the literature and experts in the fields of respiratory disease and nursing informatics rated the items on the list in three rounds. The weights of items were determined employing an analytic hierarchy process (AHP). Results Sixty-two items were retained within 10 domains. Consensus was reached on 32 items concerning asthma self-management education, 25 items concerning behavioral change strategies, and five items concerning principles for app design. There was moderate agreement among participants across all items in round three. The weights of the dimensions, sub-dimensions, and items ranged from 0.049 to 0.203, 0.138 to 1.000, and 0.064 to 1.000, respectively. All random consistency ratio values were less than 0.1. Conclusions Asthma self-management education and strategies are essential parts to support self-management for patients. This analysis provides evidence of evaluating criteria for apps targeting chronic and common diseases.


Background
Asthma is the most common chronic respiratory disease affecting up to 18% of the people in the world [1]. An estimated 334 million people suffer from asthma [2], and the disease is uncontrolled for many patients in developing and undeveloped countries. For example, in Asia, asthma was controlled in only 2.5% of the affected population in 2006 [3], burdening patients, families, governments, and healthcare systems [4]. To prevent the processes of asthma, a myriad of effective measures have been identified and international guidelines concerning asthma self-management education have been promulgated, that have had a positive effect on outcomes [5].
Asthma causes long-term inflammation in the lungs that requires patients to modify their lifestyles-such as smoking cessation and the avoidance of passive smoke. Therefore, healthcare providers at the point of care should be skilled and experienced in asthma selfmanagement education and behavior change strategies to improve the quality-of-life of asthma sufferers [6]. Germane to asthma self-management education, numerous randomized controlled trials have demonstrated positive changes in patient-centered outcomes related to education and behavioral interventions [7]. Nevertheless, many healthcare providers lack training in selfmanagement education and many have little time or motivation to help patients develop those skills [8].
As the use of mobile devices and smartphones becomes more ubiquitous, patients could make full use of applications (apps) on these devices for asthma selfmanagement [8]. Currently, apps on mobile devices can enable patients to monitor and manage the disease, obtain education, and improve health behavior. Communication among users or with practitioners can become more frequent with mHealth apps and mobile technology [9]. Therefore, healthcare providers should assist asthmatics in identifying mHealth smartphone apps that help manage the disease and enable them to provide detailed and personalized feedback to patients at any time [10]. For example, the China Internet Network Information Center (CNNIC) released its annual report on the development of the Internet in China in June 2017, indicating China had 751 million Internet users and 724 million mobile Internet users, an increase of 28.3 million from 2016 [11]. Two hundred fifty-nine thousand mHealth apps were available on major app stores worldwide [12]. These apps have the potential to help a variety of patients improve self-management of their long-term, chronic conditions [13].
Although mHealth apps hold promise and provide advantages for improving health, their quality and suitability for use in clinical practice must be evaluated. Currently, user-based rating systems are provided by the Apple App Store and Google Play (previously Android Market). These rating systems allow users to rank apps from one to five stars in terms of criteria such as usability; however, the validity and reliability of these rating systems and ratings have yet to be reported [14]. As long as the mHealth apps available on these platforms do not make misleading advertising claims and protects the data and identities of the users, they can provide benefit to potential users with chronic diseases [15]. Nevertheless, mHealth apps have rarely adhered to evidence-based principles and peer-reviewed guidelines [16]. For example, Rosser and Eccleston reviewed apps for pain management and report that 86% of the apps indicated no involvement of medical professionals [17]. Moreover, the health information delivered on mHealth apps frequently lacks scientific basis and validity [18]. Furthermore, malfunctions, breaches of patient confidentiality, and conflicts of interests involving apps all conspire against the provision of safe patient care [19]. The staggering number and variety of these mHealth apps makes it difficult for clinicians and the public to identify which of the apps are the safest and most effective [20,21]. In addition, a lack of standardized rating tools further limits the potential use of apps as part of legitimate healthy lifestyle interventions. Although several assessment frameworks have been published to help rate app quality (e.g., Huckvale et al. developed criteria to assess the content quality of asthma apps [22], and Tinschert et al. applied review frameworks [i.e., behavior change techniques and information] to investigate the potential of asthma apps for self-management [23]), no single instrument addresses the unique combination of information and behavior strategies necessary for asthma patients to effectively self-manage their care.
Clearly, an objective and reliable instrument is necessary to rate the quality of mHealth apps-especially those related to asthma. This instrument initially could be used by researchers and later be made available to app developers and health professionals. This study aimed to develop a reliable and multidimensional index system for rating the mHealth apps for asthma patients that would satisfy the following criteria: (1) provides evidence for patients with asthma and healthcare providers for choosing apps to treat asthma; (2) presents a reference for developers to design asthma apps systematically and scientifically; (3) contributes to improving quality evaluation standards for apps targeting chronic and common diseases.

Study design
To develop a reliable and multidimensional assessment framework for rating the mHealth apps for asthma patients, a three round Delphi survey was conducted using paper-based forms. Experts were asked to indicate the importance of each item based on a 5-point Likert scale from 1 (i.e., not important) to 5 (i.e., extremely important) [24]. Experts provided feedback between each round of the survey and results were summarized. In a Delphi survey, the multi-round iterative process generally continues until the experts arrive at a common understanding of the qualitative data [25].
No standard methods are available to determine consensus levels [26]. In this study, consensus between participants was measured using the mean importance rating, the coefficient of variation (CV is the ratio of the standard deviation of the responses of the experts on a specific item to its corresponding mean average), and the percentage important (defined as the percentage of respondents who rated a particular item as extremely important) [27]. Items were either retained, removed, modified, or added in each Delphi round, based on this standard to reach consensus. The criterion of the mean importance rating and the percentage important is the mean of all items minus their standard deviation, and an item whose score greater than or equal to the criterion is preserved. The criterion of the coefficient of variation is all items' mean plus standard deviation, keeping the items whose score below or equal to the criterion. When item failed to meet either of the above criteria, were deleted. When the item meets one or two criteria, the decision was made after the discussion of a research group consisting of one associate professor, one university lecturer and three master degree students. Data analysis was performed by two of the authors.
After two rounds of the Delphi survey, the relative importance of each item (e.g., Asthma is a chronic respiratory disease, together with airway hyperresponsiveness and airway inflammation, and Asthma cannot be cured, but can be effectively controlled through effective management) was calculated. The analytic hierarchy process (AHP) fundamental scale developed by Saaty for pairwise comparisons was then used to construct the judgment matrix to calculate the weight of each item [28].
In the study, each participant compared all criteria pairwise with each other using a scale ranging from 1 to 9 to 1. For each pair, participants had to select which was more important, see Fig. 1. After collecting the questionnaires, the AHP module matrix written with Excel was utilized for data analysis.
In addition, a consistency test was conducted of the judgment matrix. When the random consistency ratio (CR) was less than 0.1, then the judgment matrices were considered acceptable.
The CR coefficient is calculated as follows [29]. CI represents the consistency index, and RCI represents random consistency index, which was used to modify the CI value (if n > 2). n means the order of the matrix.
λ max means an approximation of the maximum eigenvalue of the judgement matrix.
The CR coefficient is obtained by dividing the CI value by RCI. The value of RCI of the reciprocal matrix of 1-9 orders is given in Table 1.

Participant recruitment
Participants were active in the field of respiratory disease having expertise in asthma management. Experts were identified from Beijing and Tianjin working in general hospital or medical university. Experts were identified according to the following criteria: (1) they had to be engaged in the field of respiratory for more than 5 years; (2) they had to hold intermediate professional titles and a college degree or graduate degree in a respiratory field; (3) they had to be willing take part in all rounds of the Delphi survey.

Procedure
Developing the initial index system The asthma self-management education and behavior change techniques (BCT) and corresponding items to be evaluated through the Delphi survey were identified through (1) a content analysis of 110 asthma apps from the Apple App Store and Google Play that covered selfmanagement education and functions [30] and (2)  , and WanFang) were searched using the keywords asthma and self-management or behavior change techniques or mobile app* and evaluate* or mobile app* and assess* between the date January 2013 and October 2017. There were 10,545 articles retrieved, 6363 were removed as duplicates, and after initial screening of title and abstract, only 734 articles that reported asthma self-management education, behavior change techniques and evaluation instrument of apps were included. After reading their full text, 14 major relevant articles were identified.
App assessment items were extracted by analyzing the major relevant literature [2,6,9,23,[31][32][33][34][35][36][37][38][39][40] by two authors, who then drafted a set of provisional dimensions for the items and sorted them by dimension. A total of 105 items were identified. That fell into 10 major dimensions: (1) goals and planning, (2) feedback and monitoring, (3) shaping knowledge, (4) social support, (5) reward and threat, (6) natural consequences, (7) improving the compliance, (8) asthma information, (9) patient skills training, and (10) non-pharmacological interventions. After removing redundant items, 87 items      remained, which the authors then grouped into 23 subdimensions, defining the 10 major dimensions. They were (1) goal setting (outcome/behavior), (2) asthma action plans, (3) self-monitoring of behavior, (4) selfmonitoring of outcomes of behavior, (5) feedback, (6) demonstration of the behavior, (7) behavior substitution, (8) practical social support, (9) emotional support, (10) social reward, (11) threat, (12) information about health consequences, (13) salience of consequences, (14) prompts. (15)  The research group ensure that the survey questionnaire did not include items that were difficult to understand or repetitive. The preliminary list of proposed items underwent a process of revision and adaptation to reach a definitive version that was approved by all authors. The questionnaire was sent to each expert who agreed to participate in the study and the Delphi process was explained to these participants. The original list appears in Table 2.

Round 1 of Delphi survey
In All expert participants in round one were female whose ages ranging from 31 to 55 years (mean = 42.28; SD = 6.58). Participants were drawn from three main occupational groups: nurse educators in higher education, clinical head nurses, and respiratory physicians. The first-round questionnaire contained 10 dimensions, 23 sub-dimensions, and 87 items. In addition, the questionnaire contained of 50 items related to behavioral change strategies and 37 items related to asthma selfmanagement education.
The first section of the first-round questionnaire (1) describes the background and objectives of the study and (2) specifies the deadline for returning the completed questionnaire. The second section elicits the opinions of experts concerning not only the revision, addition, and/or deletion of any items, but also the importance of each item based on a 5-point Likert scale. In addition, participants were given an option to suggest additional items. The third section elicited demographic information from the participants, which included professional background (i.e., years engaged in work, educational background, professional title, and affiliation). In this section, the expert degree of authority also was measured. The authority coefficient (C r ), in relation to the participants' technical ability to evaluate the items, was determined by two factors: the participants' familiarity with the items (C s ) and the judgment criteria for the items (C a ) [41]. Familiarity with items was measured on a 5-point Likert Scale in the following order and score: unfamiliar (0), somewhat unfamiliar (0.2), somewhat familiar (0.5), very familiar (0.8), extremely familiar (1). The judgment criteria for the items encompassed parameters such as experience in asthma self-management, theoretical analysis of items, knowledge of the literature, and instinct. A scoring system was used to rate the experts' criterion for their judgments (see Table 3) [42], and the rating was done by the participants. Informed consent was obtained from each participant once they accepted the invitation to participate.

Round 2 of Delphi survey-determining the weight of each item through AHP
The second round of the Delphi survey ended in January, 2018 with 24 experts participating. Of these, 20 participated in the first-round and four new experts were added. The five participants who dropped out after the first round did so because of vacations. The secondround questionnaires were based on the results of the first-round, according to both the agreement on each item and the suggestions of experts. Participants were required to (1) re-rate the importance of the items on the questionnaire regarding the apps and (2) provide additional edits, revisions, suggestions, comments, and/ or questions. The three sections of the round two  questionnaire followed the same format as the round one questionnaire. However, in the second-round questionnaire, expert participants were provided judgment criteria to evaluate the relative importance of 10 dimensions, using a series of pairwise comparisons, and the median of the score of each item was used to construct judgement matrices of the 10 dimensions by first author (see Fig. 2) [43]. Meanwhile, the number of subdimension and items are large, affects the judgement of experts. So, in this study, the average score of importance of each item minus the average score of other items from the second Delphi round was used to extract the intensity of importance (formula 3), then construct judgment matrices, Table 4 exhibits standard of pairwise comparison values for sub-dimensions and items [44]. According to formula 3 and standard of intensity of importance, we got the judgement matrices B subdimension of asthma knowledge (see Fig. 3).
The eigenvector of judgement matrix was calculated, and then the weight of each item was obtained.

Round 3 of Delphi survey
The third round of the Delphi survey ended in April, 2018. Eleven participants from the first round were invited and agreed to take part. Their ages ranging from 32 to 53 (mean = 41.00; SD = 6.55) in round three. Table 5 exhibits the demographic data and characteristics of the expert participants who took part in the three rounds of the Delphi survey. The round-three questionnaires featured the format as the round-one and round-two questionnaires. The expert participants were asked to re-rate the importance of the items on the questionnaire, using the same 5-point Likert scale.
Participants remained anonymous to each other during the entire survey process, and they were required to complete the questionnaires within 3 weeks. Data collection was performed by the same member of the research team. All of the questionnaires and the data collection procedures were checked by the all members of the research team to assure credibility. The data was doubleentered and checked for accuracy.

Data analysis
Quantitative data were entered into Microsoft Excel 2010 and IBM SPSS 20.0 Statistics for Windows for analysis, and descriptive statistics were used. The rating for each item was analyzed and expressed as a mean value with standard deviation (SD). Following this, nonparametric statistics (e.g., chi-squared test of association) were used to determine the possibility of any response group bias. Coefficient of variation (CV) and Kendall's coefficient of concordance (Kendall's W) were used to test the dispersion of the participants' opinions. A p value of less than 0.05 was considered statistically significant.

Survey results
In round one of the Delphi survey, the authoritative coefficient for the expert participants ranged from 0.80 to 0.96, with an average authority coefficient of 0.89. The mean importance ratings for dimensions ranged from 3.28 to 4.88, and the coefficient of variation ranged from 0.07 to 0.37. The mean importance ratings for subdimensions ranged from 3.20 to 4.86, and the coefficient of variation ranged from 0.04 to 0.39. The mean importance ratings for items ranged from 3.44 to 4.92, and the coefficient of variation ranged from 0.06 to 0.32. In round two, the participants' degree of authority ranged from 0.65 to 1.00, with an average authority coefficient of 0.91. The mean importance ratings for dimensions ranged from 4.00 to 4.92, and the coefficient of variation ranged from 0.06 to 0.23. The mean importance ratings for sub-dimensions ranged from 4.00 to 4.88, and the coefficient of variation ranged from 0.07 to 0.26. The mean importance ratings for items ranged from 3.54 to 4.83, and the coefficient of variation ranged from 0.08 to 0.34. In round three, the participants' degree of authority ranged from 0.67 to 0.98, with an average authority coefficient of 0.90. The mean importance ratings for the dimensions ranged from 4.36 to 4.91, and the coefficient of variation ranged from 0.06 to 0.20. The mean importance ratings for the sub-dimensions ranged from 4.27 to 4.91, and the coefficient of variation ranged from 0.06 to 0.18. The mean importance ratings for the items ranged from 4.45 to 4.91, and the coefficient of variation ranged from 0.06 to 0.19. After modification of the items in the questionnaire, the coordination results in the third round were acceptable-the Kendall's W ranged from 0.654 to 0.693 (see Table 6). Table 7 illustrates the requirements for consensus for all items in rounds 1, 2 and 3. Criteria reaching consensus were retained while those not reaching consensus were removed.

Item modifications
In round one of the Delphi survey, based on consensus criteria and team discussion, two dimensions were deleted, reward and threat was deleted because of its negative impact on patients, and natural consequences were deleted because of perceived duplication. Five of subdimensions (i.e., social reward, threat, information about health consequences, salience of consequences, and regulation) and 24 of items were deleted. An example for retaining items based on consensus criteria was shown in Table 8. In addition, the three dimensions were changed, improving the compliance was reworded as prompts, Asthma information was changed to asthma knowledge, and patient skills training was reworded as skills training for effective self-management because of its inaccurate language. Seven of sub-dimensions (i.e., prompts, the nature of asthma, management of comorbidities, peak flow meter usage, inhaler technique, identifying and avoiding Intermediate value between the two adjacent judgements 2,4,6,8 In round two, no new items were generated. Based on the criteria and team discussion, three of subdimensions (i.e., behavior substitution, unconstraint, and security) and 10 items were deleted. Three items were changed (Information released by apps can help patients to make decision was changed to The app can be easily accessed and obtained information.; The app can help patients to improve the efficiency of self-management was changed to Information released by apps is to patients' needs and value; The app can help patients to know the recent knowledge was changed to The app is updated regularly and timely) based on the suggestions of the expert participants. As a result, 10 dimensions, 23 subdimensions, and 63 items were generated for the second round of the Delphi survey. In addition, we added descriptions and/or examples for items in the questionnaire.
In round three, only one item (i.e., the app allows users to re-set the goals based on patients' health data) was deleted because difficult to be measured. As a result, the final version of asthma apps assessment framework Table 5 Demographic data and characteristics of the expert panel

Discussion
Much of the literature concerning the evaluation of mHealth apps has merely addressed the technical aspects of apps [45][46][47][48][49]. The purpose of this study was to develop a framework to assess and improve the quality of asthma smartphone apps for use on smartphones. The three-round Delphi survey process produced consensus on the items comprising a framework for assessing the quality of asthma apps, from the perspective of both asthma self-management education and behavior change strategies. The framework features 10 dimensions and corresponding items, which reflect the material content of asthma apps currently available for download on smartphones. This framework is an important first step in using asthma apps as part of the set of strategies available to healthcare providers to improve quality of life (QOL) among asthmatics. Through the three-round Delphi survey process, the number of items to be included in the assessment framework was reduced from 87 to 62, by merging overlapping items and deleting items that would be difficult to operationalize and measure, based on feedback. Asthma self-management should address asthma knowledge, skills training for effective self-management, nonpharmacological interventions, goals and planning, feedback and monitoring, shaping knowledge, social support, and prompts (i.e., brief messages that encourage the user to engage in particular behaviors).
Among the dimensions, skills training for effective selfmanagement had the highest weight (0.203), followed by asthma knowledge (0.105), shaping knowledge (0.105), ease of use (0.105) and usability (0.105). Therefore, skills training for effective self-management is the most important factor in asthma self-management, from the perspective of participating experts and consistent with the literature [50,51]. Moreover, reports of web-based interventions have shown that interventions involving more behavior change techniques are indeed effective [52].
The framework can be used to create an evaluation instrument which could then be tried out and evaluated itself for validity and reliability.

Limitations
This study identified a framework and a needed next step would be to derive and validate an actual instrument. The framework only reflects the judgement of the participants' choosen and that another group, perhaps in another country or composed of more multidisciplinary experts, might produce a different framework. The fact that participants were all asthma experts explains why the framework's content is so heavily focused on the disease and its treatment and why an essential item for all health related apps like privacy and security is missing. Cost, software reliability, and whether patients understand the information apps present might be concerns of those in the telemedicine field. While ease of use may touch upon this, another telemedicine concern flowing from understandability is how much knowledge apps assume patients have.
In addition, the whole research was conducted in China (a middle-income Asian nation). The sample size was small, leading to many semi-qualitative results. Also, the path for future research in applying the framework in culturally diverging regions of lower (e.g. sub-Saharan Africa) and/or higher (e.g. Europe) exists. The framework designed surveyed providers (and not patients) about what they think is good for patients. Future research might include an analogous methodology used with severely affected ("expert") asthma patients, etc. Still, the current framework provides guidance for assessing asthma content and behavioral strategies in existing apps on developing new one.

Conclusion
This study involved 29 experts who were active in respiratory disease field for more than 5 years. The     assessment framework created can be used to develop evaluation instruments for asthma apps that can be used by health researchers and healthcare professionals wishing to incorporate them in their treatment plans and to guide the development of quality asthma apps supporting patient self-management. Among them, portion of behavior change strategies of the framework can be used in evaluation of HIT apps for other chronic and common disorders.