Mobile personal health records for pregnancy ...

computer methods and programs in biomedicine 134 (2016) 121–135

j o u r n a l h o m e p a g e : w w w. i n t l . e l s e v i e r h e a l t h . c o m / j o u r n a l s / c m p b

Mobile personal health records for pregnancy monitoring functionalities: Analysis and potential Mariam Bachiri a,*, Ali Idri a, José Luis Fernández-Alemán b, Ambrosio Toval b a b

Software Project Management research Team, ENSIAS, Mohammed V University in Rabat, Rabat, Morocco Department of Informatics and Systems, Faculty of Computer Science, University of Murcia, Murcia, Spain

A R T I C L E

I N F O

A B S T R A C T

Article history:

Background and objective: Personal Health Records (PHRs) are a rapidly growing area of health

Received 9 October 2015

information technology. PHR users are able to manage their own health data and commu-

Received in revised form

nicate with doctors in order to improve healthcare quality and efficiency. Mobile PHR (mPHR)

20 May 2016

applications for mobile devices have obtained an interesting market quota since the ap-

Accepted 30 June 2016

pearance of more powerful mobile devices. These devices allow users to gain access to applications that used to be available only for personal computers. This paper analyzes the

Keywords:

functionalities of mobile PHRs that are specific to pregnancy monitoring.

Personal Health Record

Methods: A well-known Systematic Literature Review (SLR) protocol was used in the analy-

Pregnancy monitoring

sis process. A questionnaire was developed for this task, based on the rigorous study of

Mobile health

scientific literature concerning pregnancy and applications available on the market, with 9

Functionality

data items and 35 quality assessments. The data items contain calendars, pregnancy information, health habits, counters, diaries, mobile features, security, backup, configuration and architectural design. Results: A total of 33 mPHRs for pregnancy monitoring, available for iOS and Android, were selected from Apple App store and Google Play store, respectively. The results show that none of the mPHRs selected met 100% of the functionalities analyzed in this paper. The highest score achieved was 77%, while the lowest was 17%. Conclusions: In this paper, these features are discussed and possible paths for future development of similar applications are proposed, which may lead to a more efficient use of smartphone capabilities. © 2016 Elsevier Ireland Ltd. All rights reserved.

1.

Introduction

Electronic Health Record Systems (EHRs) allow authorized clinicians from different health care organizations to share information on a common patient. Personal Health Records (PHRs) rely on patients to control their own data, allowing them to both access and record events that are relevant to their

conditions [1,2]. From a technological point of view, PHRs are undergoing a rapid growth in the area of health information [3]. The risk of the limited adoption of PHRs by an individual may, however, be a problem [4]. PHRs are usually filled with medical terminologies, whereas patients need health knowledge that is useful and easier to understand [5]. Usability concerns and socio-cultural influences are also among barriers to the adoption and use of PHRs [6,7], in addition to privacy

* Corresponding author. Software Project Management research Team, ENSIAS, Mohammed V University in Rabat, Rabat, Morocco. Fax: +212537777230. E-mail address: [email protected] (M. Bachiri). http://dx.doi.org/10.1016/j.cmpb.2016.06.008 0169-2607/© 2016 Elsevier Ireland Ltd. All rights reserved.

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and security issues, since sensitive data and vital information are stored in PHRs [8,9]. In 2010 there were already more than 250 million smartphones, and more than 5 billion people are expected to own one by 2025 [10]. Mobile phones are a particularly attractive avenue in regard to delivering health interventions [11], owing to their widespread adoption with increasingly powerful technical capabilities and people’s attachment to their phones [12], since they take them almost everywhere [13]. We spend even more time with our phones than we do with our partners or even at our workplace [14]. Both physicians and patients are rapidly integrating application delivery channels such as Apple App store and Google Play store into clinical practice [15]. Mobile health applications are also targeting specific conditions that are common to many people and require extensive monitoring, such as diabetes [16]. PHRs for pregnancy are an interesting focus because of the heightened attention paid to health information by pregnant women. Pregnancy, as a health condition, lasts for a finite period of time of 40 to 41 weeks in the case of most normal pregnancies. Detecting problems in time is crucial if complications are to be prevented in this period of life [17]. Pregnancy monitoring is encouraged by obstetricians and gynecologists, which explains why there are already several PHRs for pregnancy monitoring for personal computers and as online services [18]. Previous studies have covered the evaluation and analysis of the functionalities of Web-based PHRs [19] and USB-based PHRs [20], in addition to the evaluation of the functionalities of mobile PHR (mPHRs) in general [21] or mPHRs for specific purposes such as blood donation [22]. The aim of this paper is to analyze the features and functionalities of mobile PHRs focused on pregnancy monitoring, in order to discover whether or not they comply with the needs, guidelines and scientific pregnancy literature in regard to tracking pregnancy. The results of this study can be used to identify possible lines for improvement in the near future. The study of the current status will be performed through the analysis of applications available for iPhone from the Apple App store and for Android devices from Google Play store.

2.

Method

In order to carry out the review of the mPHRs for pregnancy monitoring, a method based on the popular SLR process was applied [23] (Fig. 1). In this paper, a set of recommendations obtained from PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analysis) [24] was followed. This method has been used in previous e-health studies, such as studies concerning blood donation [22,25] or diabetes [26], in addition to those regarding PHRs [19], mPHRs [27] or m-Health apps in general [28]. The first step of the method involves determining the research questions (RQ), which will guide the next phases. The second step consists of selecting the sources from which the candidate apps will be collected, and setting the terms and keywords used to fulfill the search in these sources. The aim of the third step is to define the eligibility criteria and apply them to the candidate apps in order to retrieve those eventually

Fig. 1 – Description of the method used.

selected. Finally, in the fourth step, a group of data items that should be extracted from each application is defined, which will serve to develop a quality assessment questionnaire in order to evaluate the apps selected.

2.1.

Research questions and protocol

As the first step of the method used, five research questions have been established by the authors for the purpose of analyzing the features and functionalities of mPHRs for pregnancy monitoring for both iOS and Android. The research questions have been formulated on the basis of the existing mobile applications for pregnancy monitoring on the market, in addition to an analysis of scientific literature concerning pregnancy, in order to study the relevant features and functionalities that this study will cover [29–31]. These research questions are detailed in Table 1.

2.2.

Application sources and search terms

The search was based on two main sources: Apple App store and Google Play store. These repositories are currently the most relevant mobile application markets as regards the number of applications available for download (1.6 million apps in Google Play store and 1.5 million apps in Apple App store by July 2015 [32]). They also represent the official app sources for the leading iOS and Android platforms, respectively. Both stores classify applications in categories. The applications in the Health & Fitness and Medical categories were considered in this review. The search string was determined by following the PICO criteria [33]: population, intervention, comparison and outcome,


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Table 1 – Research questions.

RQ1 RQ2 RQ3

RQ4

RQ5

Research Question (RQ)

Motivation

Which features and functionalities are most commonly used in the mPHRs for pregnancy monitoring? Which areas of pregnancy are most frequently covered by mPHRs for pregnancy monitoring? What is the difference between the most complete iOS and Android mPHRs for pregnancy monitoring as regards their functionalities? Is there a relationship between the pregnancy monitoring mPHRs users’ ratings and the functionalities of these mPHRs? To what extent do the mPHRs for pregnancy monitoring adhere to the data items analyzed?

This question allows us to study the common features and functionalities as regards mPHR apps for pregnancy monitoring. The aim of this question is to identify the areas of pregnancy monitoring that are mostly frequently included in these apps. This question investigates the difference between the functionalities of the mPHRs for pregnancy monitoring for iOS and Android that are more complete in terms of functionalities. The objective of this question is to discover whether there is a relationship between users’ satisfaction and the functionalities presented in the mPHRs for pregnancy monitoring. This question illustrates the primary goal of this review, which is to analyze the degree of compliance of the mPHRs for pregnancy monitoring with the data items provided in this study.

which should provide the maximum coverage but be of a manageable size. The terms were fixed as follows: “Pregnancy” OR “Pregnant”. The terms selected were applied to the title and the description of the apps, by using the search tools in both Google Play store and Apple App store. The search process took place in March 2015. The procedure defined above was carried out independently by the first two authors. Any disagreements were discussed and resolved by all the authors. The selection of mPHRs for pregnancy monitoring was carried out by using an iterative process of individual assessments until the interrater reliability was acceptable (0.9). Interrater reliability in statistics is the degree of agreement among raters. The score provided by this degree reveals how much homogeneity there is in the ratings provided by judges. In order to measure this agreement, we used the Cohen kappa coefficient. The Cohen kappa [34] coefficient is a statistical measure of interrater reliability for qualitative (categorical) items. An interrater reliability of 0.9 indicates almost absolute agreement between the two assessments performed by the two authors.

2.3.

Eligibility criteria and application selection

During the application selection process, a set of inclusion criteria (IC) was applied in order to choose those mPHRs for pregnancy monitoring that would be included in the study. These criteria were linked using the Boolean operator AND, signifying that each app had to meet all criteria to be selected. IC1: Free or paid apps for iPhone and Android devices available in Apple App store and Google Play store, respectively. IC2: Apps that are in the Health & Fitness or Medical category in Apple App store or Google Play store. IC3: Apps that were updated after the 1st of January 2014. IC4: Apps that focus on pregnancy monitoring. The aim of IC1 was to select apps for both iOS and Android platforms. The Blackberry and Windows Phone mobile operating systems were excluded. The apps selected covered free apps, as they can be accessed by all mobile users, and paid apps owing to the extra functionalities that they may include. For

this review, the premium apps were considered if there was a difference between them and the free apps in terms of features or functionalities. IC2 selected the apps that belonged to the categories related to health and medicine in both repositories. IC3 was crucial as regards selecting the latest versions of the apps, as evidence of having been revised and fixed in the case of including bugs. Finally, IC4 focused on those apps that are related to pregnancy, and particularly those that record information about pregnancy. Upon applying the first inclusion criterion, 1077 applications were selected. After applying IC2, the number of apps selected was reduced to 690. A total of 310 outdated apps were eliminated by employing IC3. The remaining apps that were discarded by applying IC4 are focused on only one aspect of pregnancy monitoring. For instance, apps for specific purposes were found to contain calendars, such as My Pregnancy Calendar for iOS; serve to calculate the due date, such as Pregnancy Due date for iOS and Android; have the functionality of a contraction timer or kicks counter; and have an informational purpose, such as providing advice about nutrition or physical exercises during pregnancy. The number of apps selected was further reduced upon applying the exclusion criteria (EC) below, and also upon eliminating duplicate apps for two reasons: (1) if both iOS and Android versions for the same app had the same functionalities, they were counted as one app, otherwise the most complete version was taken into account, and (2) the free version of an app was discarded in the case of the existence of the premium version which had more functionalities. The complete selection process is shown in Fig. 2. An app was excluded if it was not in English (EC1), or if it was a hardware-based solution: depended entirely on an external device or sensor (EC2).

2.4.

Data items

A template was designed containing the data that should be extracted from each application, which would be the basis for the quality assessment questionnaire. The data items used for the evaluation were selected by focusing principally on pregnancy oriented aspects based on: (1) scientific literature regarding pregnancy, concerning in the first place the essential guidelines, practice and standards for prenatal care, and

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Fig. 2 – PRISMA flow diagram.

targeting both patients and obstetricians [29–31]; (2) facets with which to manage and organize pregnancy health record information by Oh, Sheble and Choemprayong [35], and some previous studies regarding health records for pregnant women [18,36,37]; and (3) mobile pregnancy PHRs available on the market for both iOS and Android. The data items extracted in this study were additionally validated by an obstetrician. The extraction of the data items was carried out by the first two authors. The consistency of the rating system in the features’ extraction step was obtained using triangulation [38] among the raters—that is, more than one author gathered and interpreted the features for the apps. We used a Cohen kappa coefficient of 0.95, which indicates an almost absolute agreement between the two extractions made by the two authors [34].

The final list of fields is as follows: Calendar, reminders and notifications. Keravnou emphasized the importance of measuring time as an essential element of medical systems. The human body can be compared with a dynamic physical system, diseases with temporal processes, and patient records with temporal databases [39]. Organization, better presentation and easier access to personal pregnancy health data can be achieved through the use of calendars [40]. During the pregnancy process, there are several events such as visits to gynecologist, visits to the midwife or managing medication. Sarasohn-Kahn argued that adherence to medication is a problem among patients with chronic conditions, and suggested that technology may play an important role [41]. Attaching information to these events,


such as pictures or documents or even statistics, can make it easier not to forget any detail during each event. Information about the mother, the baby and the pregnancy. There are several points of interest as regards the wellbeing of the mother during pregnancy, which involve the systematic record and analysis of weight, waist measurements, Body Mass Index (BMI) or levels of glucose and blood pressure. By using the mother’s health history data, an application could provide specific information on possible risks related to the condition and measurements to take into account during pregnancy. For example, increased maternal gestational weight gain is associated with increased risks of fetal macrosomia [42]. Applications could also provide additional support for serology (Human Immunodeficiency Virus (HIV), hepatitis, toxoplasmosis, rubella, chickenpox), Complete Blood Counts (CBC) (hematocrit level, hemoglobin), curve (O’Sullivan test), past obstetrical history (number of previous pregnancies, miscarriage), and current medications or family background history. Relevant monitoring variables related to the baby that it is of interest to monitor should also be included, such as the weight, length or heart rate. In addition to the information about the mother and the baby, the monitoring of the pregnancy itself is also considered as an item to study in these applications. Various features can be considered in this respect: calculating the estimated date of birth, in addition to a progress bar or countdown to that date, by displaying the remaining days until the estimated birth date. The application can therefore use the information provided as a basis, on which to estimate an approximate range of dates when giving birth would be optimal for both the baby’s and the mother’s wellbeing. Once this date has been calculated, the application can show the evolution of the pregnancy at all times. This feature may even include descriptions about each stage of the pregnancy and provide useful information, such as fetal development tracking. Health habits. Special health habits during pregnancy should be encouraged and can be suggested in this kind of PHR mobile applications as preventive measures [43]. An application with these characteristics could even prioritize the suggestion of some habits, by analyzing the information the user provides. For example, a PHR could recommend some sort of diet [44,45] if the weight is over the normal rates, or suggest some physical activities that may be beneficial and safe for the pregnant woman [29]. Diary and notes. Diaries have proven to have a positive effect during pregnancy [46]. Recording perceptions of events and the mother’s feelings during the pregnancy period, then translating these concerns to the doctor or midwife during visits, can help detect pregnancy problems. Uploading pictures or videos may also be helpful as regards tracking occurrences or different memories during and after pregnancy [36]. Records and counters. The registration of quantifiable information about the pregnancy is a very useful feature to have in a mobile PHR application for pregnancy monitoring. Contractions or baby kicks could occur at any time and may be difficult to record properly. Making it possible to perform this in a mobile application makes it much easier for the user. Applications could include a counter for contractions and a means to measure the time of each contraction

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[47]. Moreover, counting and keeping a record of the baby’s kicks during the third trimester is a simple and inexpensive way in which to decrease the chance of a stillbirth [48]. In a Danish experiment, 95% of subjects experienced heartburn, nausea or vomiting during pregnancy [49]. Both nausea and vomiting are a normal part of pregnancy, and keeping a record of them may help to detect dehydration [50,51]. This information can be tracked by the mother using counters on a mobile PHR, and relayed to the healthcare practitioner so that a strategy can be formulated to address the nausea and vomiting. Mobile features and social media. Including nearby hospitals and how to arrive at them as soon as possible may be critical to the prompt identification and treatment of health conditions during pregnancy. This feature could also include the location of pharmacies at which to obtain the prescription medication. Communication with health professionals is also crucial for patients in the case of an emergency or consultation [52]. Therefore, it is necessary to have access to a phone book or to be able to chat with health providers. The importance of community-based features in PHRs has been suggested in order to improve the user’s acceptance of them [53,54]. Applications can provide the possibility of sharing announcements and information concerning pregnancy by using e-mail, forums and even social networks. Online social networking has fundamentally changed the manner in which people obtain information, and this also applies to the health field [55]. Forums also allow users to interact with each other, share experiences, discover relevant information about pregnancy, and can even promote the exchange of specific second hand equipment for pregnancy. Security and backup. The information stored in these kinds of applications is very sensitive. Therefore, it should be protected by at least two out of the following three authentication methods [56]: (1) asking the patient for something that she knows, such as the classical username and password [57,58]; (2) asking the patient for something that she owns, such as a physical token that may need external devices to make it work; (3) checking for something exclusive to the user, such as a biometric measurement. Modern mobile devices include a front camera that could be used for face [59,60] or fingerprint recognition [61]. Configuration. Two main configuration elements are considered necessary: language selection and measurement unit configuration. If an application is going to be available in different countries in an international application store, such as the Apple App store or the Google Play store, then the application should be both multilingual and adapted to the different metric systems, in order to reach the largest possible amount of users. Architectural design. The “anywhere and anytime” availability of the mobile application should be considered as a significant point [62]. If the data are stored on a server, the application should be synchronized regularly, in order to ensure that the information is accessible to the users in the offline mode. Moreover, a PHR system may be untethered or tethered. Untethered PHRs contain only patient maintained health records, whereas tethered PHRs also contain records retrieved from medical institutions and other stakeholders [63].

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2.5.


Mobile features and social media (M):

Quality assessment questionnaire

In order to extract data from the apps selected and evaluate each one separately, a set of quality assessment questions, presented below, was developed based on each data item. The questionnaire was validated by a midwife and a gynecologist, who are both advanced users of new technologies. The data obtained by using the questionnaire were used to answer the research questions. The questions were scored as follows: Yes (Y), if the application can offer this functionality. Y = 1 point. No (N), if the application does not provide this functionality. N = 0 point. Calendar, reminders and notifications (C): C1

Does the application include reminders concerning visits to the doctor or midwife?

C2

Does the application include a calendar with events and notifications?

C3

Does the application include a To-Do list?

C4

Does the application include reminders to record wellness data?

Information about the mother, the baby and the pregnancy (I): I1

Does the application include an estimated birth date?

I2

Does the application include a progress bar or a birth date countdown?

I3

Does the application include information about the different stages of pregnancy?

I4

Does the application monitor the weight and length of the baby?

I5

Does the application monitor the weight, waist measurements, BMI and other information about the mother?

I6

Is the information recorded accessible in the form of graphs?

I7

Does the application allow the mother to enter her health history?

Health Habits (H): H1

Does the application include suggestions or tips about health habits?

H2

Does the application include a nutrition guide?

H3

Does the application recommend certain physical activities?

Diary and notes (D): D1

Does the application include a diary or notes?

D2

Does the application include assistance to manage questions for the doctor?

D3

Is it possible to attach pictures or videos to the diary/notes?

Records and counters (R): R1

Does the application include a counter for contractions?

R2

Does the application include a record of fluid intake?

R3

Does the application include a counter for baby kicks?

R4

Does the application include a record for nausea and vomiting?

R5

Is it possible to connect a sensor to record measurements?

M1

Does the application include geolocation features?

M2

Is the application integrated with Facebook, Twitter or other Social Networks?

M3

Does the application include forums or any other way in which to share information among users?

M4

Does the application include email support?

M5

Does the application include a FAQ section?

M6

Is it possible to contact the doctor directly from the application?

Security and backup (S): S1

Does the application include at least two data protection methods?

S2

Does the application include a password method of protection?

S3

Does the application include backup support?

Configuration (F): F1

Does the application include support for more than one language?

F2

Does the application include support as regards selecting the metric system in which quantities are displayed?

Architectural design (A): A1

Are data available when the application is working offline?

A2

Is the application connected to a medical institution or to other stakeholders?

3.

Results and discussion

This section provides a summary of the main results and findings of this study. These findings were obtained after applying the quality assessment questionnaire to the apps selected and extracting data. This section also presents the implications of these findings for the users and developers of pregnancy mPHRs. As shown in Table S2 in the Appendix, the apps selected are listed by mentioning the principal details retrieved from the app market: The full name of the app, the operating system (Android or iOS), the pricing information (if the app is free or paid), the app’s website (if it is available), and otherwise the app’s link in Google Play store or Apple App store. The country of origin was also recorded, as were a list of the extra features from these apps or their websites. A total of 33 applications were selected, of which 8 run on Android, 20 on iOS and 5 were selected for both OS (Android and iOS). Only 4 paid apps were selected. Moreover, we noted that 13 apps originated from the United States, while the remaining apps were from various countries such as India, the Philippines, Spain, Italy, Egypt, the United Kingdom, Ukraine and Latvia. This diversity of the countries of origin shows that the interest in pregnancy monitoring in the mobile field is shared on four continents. The results of the assessment questionnaire are presented in Tables S3 and S4 in the Appendix, which describe the results of the evaluation for each app selected, by giving the answers to each question, in addition to the total score


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Fig. 3 – Selected apps’ score classification.

percentage obtained for each app and each question. The maximum score for an app is 35 points (the number of questions in the questionnaire). The app to obtain the highest score (27 points) was therefore Pregnancy & Maternity Tracker, Baby Due Date Calculator for iOS, while Expecting Baby by Enfamil® Pregnancy Journal for iOS had the lowest score with 6 points. The maximum score that a question can attain is 33 points (the number of apps selected). Question I1 attained a score of 100%, while question M1 attained the lowest score with only 6%. RQ1: Which features and functionalities are most commonly used in the mPHRs for pregnancy monitoring? This question was answered by considering the results of the assessment questions. As presented in Table S3 in the Appendix, the only feature studied that is implemented in all of the applications analyzed is the presence of the estimated due date (I1). This is added manually or calculated from the last menstrual period (LMP) provided by the user. This information is crucial for the pregnant woman as it helps her to follow the evolution of her pregnancy and to be aware of the days remaining. The estimated due date can be presented on a progress bar or by means of a date countdown. Timelines are particularly effective visual structures with which to present information, because they are both graphically and conceptually familiar, and because they can be adapted to many diverse contexts and ideas [64]. Eighty-two percent of the apps include a progress bar or a birth date countdown. The second most frequently covered feature is weight tracking, waist measurements, the BMI calculator and the monitoring of other variables related to the woman’s health (I5). This feature is included in 97% of the apps studied (the only exception being Expecting Baby by Enfamil® Pregnancy Journal). Lastly, 94% of the

apps studied offer information related to each stage of the pregnancy by weeks or trimesters (I3). This informational part of the apps helps the pregnant woman to be aware of the different changes occurring in her body during pregnancy, the evolution of the size of the fetus and problems or risks related to each stage. These common features can be considered as basic for the future analysis and studies of similar applications. For an intuitive presentation, Figs. 3 and 4 provide graphic illustrations of the scores achieved by the apps selected. Fig. 3 presents the scores for each block of questions that matches a data item, while Fig. 4 presents the scores for the assessment questions. RQ2: Which areas of pregnancy are most frequently covered by mPHRs for pregnancy monitoring? In order to keep the period of pregnancy less stressful for pregnant women, mPHRs for pregnancy monitoring should cover most of the areas that can help the pregnant woman and her fetus stay healthy and protected from complications that may occur during the pregnancy. As extracted from the evaluation results, 94% of the apps studied, in addition to other functionalities, focus on providing the pregnant woman with information about the progress of her pregnancy, as regards the changes in her body and the baby’s development (weight and size). This information is sometimes presented in videos or 3D drawings, as visualizing this evolution is more perceptible than text [64], which is essential for her, since she should understand every stage of this period [65]. Tools for tracking the weight, waist size, blood pressure or a BMI calculator present data in the form of value tables or graphs, for a better display of the evolutions over time. These variables are necessary for the pregnant woman since, for instance, being overweight or

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Fig. 4 – Questions scores classification.

having high blood pressure may cause severe problems for the fetus and the woman [66,67]. It is also crucial to record the baby’s kicks and the frequency and duration of contractions [68], which is included in 17 out of 33 apps. With regard to tracking the pregnant woman’s health, tracking symptoms like nausea, vomiting, headaches and back pain is also beneficial if complications are to be avoided [69]. This functionality is included in only 39% of the apps studied. Furthermore, social support during pregnancy is not included to a high degree in the apps studied, as the inclusion of forums and tools by which to share information with other pregnant women occurs in only 33% of the apps. This should be considered as a fundamental point, because with the increasing prevalence of social networks, pregnant women may need to have a private space in which to exchange their experiences, ask questions and feel less stressed. This may positively affect their mental and physical health during this period [70]. Finally, for a better monitoring of the pregnancy, nutrition and physical exercises should be controlled moderately [71,72], and these were included in almost half of the apps analyzed. RQ3: What is the difference between the most complete iOS and Android mPHRs for pregnancy monitoring as regards their functionalities? The interpretation of the results obtained in Tables S2, S3 and S4 (see Appendix), regarding the evaluation of the mPHRs for pregnancy monitoring, and the comparison of apps that have the same developer can help to answer this question. While selecting apps, in order to eliminate duplicate apps, if an app was available on both Android and iOS, and they had the same functionalities, they were counted as one app, which was the case of My pregnancy today, Pregnancy++, BabyBump Pregnancy Pro, Pregnancy View™ and Gestavida Pregnancy. Despite having the same functionalities and names, the structure may not be the same in both versions. For instance, in the case of the app My pregnancy today, the menu bar in the Android app is fixed at the top, while in the iOS app it is fixed at the bottom of the screen. Similarly, the position of the progress bar is reversed in the two versions. Some apps were discarded if the Android or iOS version had more advanced functionalities than the

other. This condition was applied to target the maximum number of functionalities in the apps selected. For example, the iOS app Ovia Pregnancy Tracker and Baby Calendar includes a section called “Trends” that allows users to access the tracking of weight, sleep, blood pressure, nutrition and others, while the Android app does not include this. The iOS app also makes it possible to connect an external device to the app, and includes a section called “Goals” to motivate the pregnant woman to achieve certain goals concerning nutrition and physical activities. It also has a feature that reports birth by giving different information related to the baby after giving birth. Of the apps selected, only 24% are Android apps, 16% are both Android and iOS, while the remaining 60% are iOS apps. Three out of the top 5 apps that attained the highest scores are apps selected for both Android and iOS. However, of the apps that attained scores higher than the total average score of all apps, 4 apps belong to Android, 7 apps belong to iOS and 4 apps are in both operating systems. RQ4: Is there a relationship between the pregnancy monitoring mPHRs users’ ratings and the functionalities of these mPHRs? Reviewing or rating apps in their stores is a form of expressing the users’ satisfaction with the reliability of the apps, their performance or the content. Table S5 in the Appendix introduces the ratings attained by each of the apps selected and the number of total raters, which were extracted from the store in which the app is published. In Google Play store, the total number of ratings is presented as the average number of stars given by the users for all the app updates, in addition to the number of raters. As noted in Table S5 (see Appendix), the number of raters is much higher for Android than for iOS apps. The results of the Mann Whitney U test showed that the ranks of the number of raters for mPHRs for pregnancy monitoring differ significantly (U = 13, Z = −2.576, p = 0.010) between iOS and Android. A Student’s t-test also showed significant differences (t (18) = 2.2980, p = 0.034) between ratings for mPHRs in iOS and Android. Ratings for mPHRs in iOS (mean 4.64) were higher than in Android (mean 4.26). For Apple App store, there is a distinction between the ratings for the current version and


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Fig. 5 – Scatter plot for the ratings and questionnaire scores.

the older versions of the app, but they are presented in the same way as in Google Play store. Ratings for the current version for iOS apps were taken into account in the study, and the extraction of the apps’ ratings took place in May 2015. A difference was detected in the number of raters of the apps that were selected for both Android and iOS. We observed that the number of raters for the Android version was notably higher than the number of raters for the iOS version. This may be owing to the fact that Android is the most frequently used OS in smartphones [73], and explains the absence of ratings for the current versions of some iOS apps. This question was answered by comparing the results shown in Table S5 (see Appendix). The correlation between the ratings and the scores of those apps selected for which ratings were available, was calculated using the Pearson correlation coefficient. We obtained a correlation coefficient of r = 0,42, which is interpreted as a technically positive but weak degree of correlation between both variables [74]. Fig. 5 illustrates a scatter plot of both variables, which includes the regression line. Correspondence between identifiers used in this scatter plot and apps is presented in Table S5 in the Appendix. Eighteen apps for which ratings are not available are discarded in this scatter plot. Observe that 17.1 percent of the variability of the quality score can be predicted by the user’s rating. Moreover, with the exception of those apps for which ratings are not available, it will be observed that the top 10 apps in the evaluation questionnaire have ratings of between 4 and 5 stars. These ratings can be translated to a compliance between the apps’ functionalities and the users’ satisfaction. There are, however, some exceptions, such as some apps that have more than 4 stars in ratings, like I’m Pregnant/ Pregnancy App and Pregnancy Mode Free for Android, but which attained a score of only 40% and 34%, respectively, in the questionnaire. A low number of raters may generate exceptions. However, the number of additional features provided by these

apps cannot explain the variation between the high ratings and the low scores. For instance, I’m Pregnant/Pregnancy App and Pregnancy Mode Free provide only 3 and 2 extra features, respectively. Usability may also affect the users’ experience, as it is identified as one of the main issues as regards mPHR adoption and use [27]. The features in Tables S3 and S4 (see Appendix) were coded as dummy variables (1 for present, 0 for absent), in order to carry out a multiple regression with which to predict the users’ rating from each of the nine data item categories. The features in “Calendar, reminders and notifications”, F(4, 15) = 3.393, p = 0.036, R2 = 0.475, were variables which predicted the users’ rating in a statistically significant manner. In particular, C3 added statistic significance to the prediction, p = 0.004, which concerns having a TO-DO list. Using a TO-DO list during pregnancy can be useful in various situations, such as creating a birth plan [75], which involves the partner, the family and also the medical team, in order for labor and delivery to occur in the best conditions. It also helps in scheduling daily or weekly health habits and even managing checkups [35]. Although the features in “Security and backup”, F(3, 16) = 1.877, p = 0.174, R2 = 0.260, were not statistically significant together, data item S3 made a statistically significant contribution to the prediction, p = 0.034, which concerns backing up data. It is also one of the requirements that should be present in mPHRs, because it helps recover sensitive data stored in the app [76]. RQ5: To what extent do the mPHRs for Pregnancy monitoring adhere to the data items analyzed? The answer to this question is the primary aim of this study. In an attempt to measure the degree of compliance between the mPHRs for pregnancy monitoring studied and the data items analyzed, the results of the assessment questionnaire presented in Tables S3 and S4 (see Appendix) were considered.

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Suggestions for features and functionalities are also presented in this section. Calendar, reminders and notifications. 14 out of 33 applications studied include the use of a calendar and the possibility of adding reminders and notifications for determined events. WomanLog Pregnancy Pro implements the calendar as its main feature. Fifty-one percent of the applications support notifications and use them to record relevant pregnancy events. Only 15 apps include a TO-DO List to help the pregnant woman organize her tasks by weeks or trimesters. Information about the mother, the baby and the pregnancy. Every application includes an estimated birth date. Information about the evolution of the pregnancy or a countdown until the estimated birth date is also available in most of the applications studied, with the exception of 6 apps. It is presented by means of either a countdown, a progress bar, or both. Only My baby day and ExpectingBaby by Enfamil® Pregnancy Journal do not provide information about each stage of the pregnancy. Most of the other applications show information about the current stage of the pregnancy, which is calculated from the estimated due date. Moreover, some applications only implement listed information about the different stages of the pregnancy, organized in weeks or trimesters, that users can access by selecting the week in which they are interested. They also include pictures and drawings of the fetus and the mother in each week of pregnancy, and information on how the fetus is developing by giving its length and weight. All of the applications record information about the mother’s weight and waist measurements, with the exception of ExpectingBaby by Enfamil® Pregnancy Journal. In 11 of these apps, the information recorded is not accessible through graphs. Some apps, such as Pregnancy++ and Pregnancy Birth Defects Prevention, focus on tracking information about both the mother and the baby. They even provide baby name catalogs and ideas about shopping needs. Only 3 apps: Gestavida Pregnancy, Pregnancy buddy app and Pregnancy & Maternity Tracker, Baby Due Date Calculator, provide the user with additional support, by using her background health history data, which will be easily available to medical staff in case of an emergency. Medication management is rarely present in the apps studied. This can cover a medication safety part, which relies on a full database, to help the pregnant woman check the description of each medicine, as occurs with the Ovia Pregnancy Tracker and Baby Calendar app, or to be aware of what to avoid during pregnancy, as is the case of the WebMD Pregnancy app. A pregnant woman who is undergoing medical treatment needs a detailed list of the drugs in question to be included in the app. With regard to the content, none of the applications studied are based on an open standard or an existing open platform. Several PHR open platforms and standards are currently either available or being developed. One of these is the Indivo Platform [77,78], which includes a framework that eases the development process of applications for iOS. In this system, the information is centralized and can therefore be accessed and managed by the user from different applications available for mobile devices or personal computers. Each application includes its own source of

information, which is sometimes created by the user herself. In other cases, information is based on reports or official documents. For example, Gestavida Pregnancy provides pregnancy information, which is based on a report about pregnancy care edited by the Spanish Health Ministry [79]. These external sources could provide the user with application-built support for medication control and management, and information through several articles. MedLine Plus is one of these free services and is managed by the National Library of Medicine, the National Institutes of Health and other government agencies in the U.S. [80]. Health habits. The interaction time during a clinical encounter is usually short, with an average of no more than 20 minutes [81]. It is not possible to obtain sufficient information about healthy habits from healthcare professionals in this limited amount of time [82]. Seventy-six percent of the applications reviewed include tips about health habits, mostly on the home screen (daily or weekly recommendations). Sixteen Apps recommend some physical activities for the pregnant women, such as a list of yoga positions to be adopted during pregnancy, which can be beneficial for both the mother and the baby. Fourteen apps include a nutrition guide especially designed for pregnant women. Diary and notes. Seventeen applications provide the user with this functionality, but only 7 have the additional possibility of attaching pictures or videos to these notes. However, 19 apps include assistance to manage questions for the doctor, as this can help the pregnant woman during checkups. Records and counters. Counters for contractions are included in 64% of the applications by recording their frequency and duration, while the baby’s kicks are recorded in 70%. Only 5 apps are able to record the mother’s number of liquid intakes, while 13 apps include counters for nausea and vomiting in addition to other symptoms. Mood is also tracked in some apps, such as My Baby Day or WomanLog Pregnancy Pro. Moreover, only 4 apps offer the possibility of connecting a sensor to the app to record some type of measurement. For instance, Ovia Pregnancy Tracker and Baby Calendar presents a list of possible sensors to connect to the app in order to track sleep, weight or steps. The pregnant woman needs feedback to reassure her about her health. iPHRs (Intelligent Personal Health Records System) therefore provide users with personalized healthcare information, obtained by intelligent algorithms that analyze health knowledge and information regarding the patient’s current state [82]. The record of information about the mother, the baby and the pregnancy (quality assessments I1 to I7), along with the records and counters (quality assessments R1 to R5) available in the applications studied, can be considered a highly rated information system about the pregnancy process. This kind of information can be processed by intelligent algorithms in order to suggest specific health habits to the user (quality assessments H1 to H3), adapted to her actual status. For example, if the system identifies a significant increase in weight, it could suggest exercising through different selfcare activities, or could even suggest a healthy diet. Mobile features and social media. Functionalities related to geolocation are only supported by Gestavida Pregnancy and Pregnancy for Android, which include an interactive map that finds nearby hospitals and clinics. The integration of social


networks, such as Twitter, Facebook or others, in order to share information is supported in only 7 apps, and 64% include electronic mail support. The use of forums is implemented in 33% of the apps, mostly represented as communities related to each app. As the pregnant woman needs more support during this period, some apps such as Pregnancy & Maternity Tracker, Baby Due Date Calculator and Ovia Pregnancy Tracker and Baby Calendar include the possibility of adding the partner’s information and invite him to use the application. Therefore, this enables each partner to follow the progress of the pregnancy and be kept informed about it. This feature should also be extended to family members. A total of 7 apps permit the doctor to be contacted. This is done by creating medical contacts and saving their numbers in a number book. In Pregnancy++, it is possible to make calls directly from the app. A FAQ section is included in 11 apps, which can be displayed as a set of instructions upon opening of the app. Finally, there is a feature that is included in only some iOS apps such as Pregnancy++, Ovia Pregnancy Tracker and Baby Calendar and Pregnancy & Maternity Tracker, Baby Due Date Calculator. This is the synchronization of health data with the Apple app denominated as HealthKit, which was recently added to the iOS 8 [83]. The pregnancy-oriented mPHRs studied in this article are not yet fully adapted to the possibilities that mobile devices offer. Modern mobile devices usually have a large variety of sensors, including an acceleration sensor (accelerometer), a location sensor (GPS), a direction sensor (compass), an audio sensor (microphone), an image sensor (camera), a proximity sensor, a light sensor and a temperature sensor. These sensors provide us with an unprecedented view of people’s lives, and an excellent opportunity for data mining [84]. Although these features are available for use by developers in their applications, only the camera is commonly used to add pictures to reminders and to visits to the doctor or notes (quality assessments C1, C2 and D3). The camera could be used for much more advanced techniques of disease recognition. For example, according to Bourouis et al. [85], one of the medical areas which needs mobile health technology is skin analysis to identify diseases. Skin images can be scanned through the use of a smartphone camera. Therefore, intelligent learning algorithms can be employed to detect skin diseases inherent to pregnancy, such as gestational pemphigoid or cholestasis of pregnancy [85]. Activity of Daily Living (ADL) is a means to describe the functional status of a person [86]. Recognition of ADL is a significant problem in human caring systems, particularly in the care of the elderly and other conditions such as pregnancy. Light physical activity for over 7 hours per day has been shown to protect against a low birth weight [87], and can also reduce the possibility of liquid retentions that may lead to cutaneous edema. Recent research [88] makes use of accelerometers to infer and study ADL. This can also be achieved through a combination of the GPS system (quality assessment M1), the accelerometer and the compass, thus monitoring the exact movement pattern of the patient rather than the amount of movement, and providing an even better estimation of the ADL and the amount of calories burned.

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Security and backup. Password protection is offered in only 4 out of 33 applications. For iOS apps, every application analyzed stores the information locally in the iOS file system. This information is backed up when users synchronize their device with iTunes and it is therefore possible to back up the information in every application. Otherwise, of the mPHRs studied, only 8 apps provide the possibility of making an online backup on their servers. In order to secure the authentication to the app, Gestavida Pregnancy, Pregnancy & Maternity Tracker, Baby Due Date Calculator and WebMD Pregnancy, in addition to the conventional authentication with email and password, provide a second authentication using a PIN/password or a security question. The main issue of mPHRs is the transmission of health records over the Internet, especially in the case of apps that are connected to medical institutions or stakeholders, which need to meet all security and privacy issues fully [5]. Security is one of the main adaptation barriers PHRs have to confront. One of the main concerns of the PHR users surveyed by Patel et al. in 2012 [89] was the security of their personal information. Up to 98% of those surveyed considered safeguards against unauthorized viewing to be essential or very important. This could be achieved through a strong authentication mechanism (quality assessment S1). Moreover, in order to evaluate the liability of the mPHRs selected, in the case of each app, we have verified whether they have a disclaimer regarding the medical content they are providing, and the presence of a privacy policy, as shown in Table S6. This information was extracted up to March 2016. We found that 21 out of 33 apps have a disclaimer that states that the content is for educational purpose only, and that it is not intended to replace a healthcare provider. Moreover, 16 out of 33 apps have a privacy policy. As is shown in Table S6, we have extracted some sections about the access control and data protection in the privacy policy of these mPHRs. Only the WebMD Pregnancy and I’m Expecting— pregnancy app mPHRs comply with the HONcode standard for trustworthy health information [9]. Configuration. Sixty-one percent of the apps only support the English language, while 39% offer support for at least another language, either through the app or by changing the phone’s language settings. Fifty-four percent of the applications support different metric systems, allowing the user to choose the unit for the weight, length, waist and other variables. While applications that support different metric systems have restricted measurement units, Gestavida Pregnancy allows the user to add any kind of unit, through the use of a text field that the user fills in with the name of the unit. Architectural design. Twenty-five out of 33 apps can work in offline mode and retrieve data from the server, while the remaining apps need a network connection to work. Only 5 apps are connected to other stakeholders. For instance, I’m expecting—pregnancy app is connected to the MedHelp health platform, where the user can access records, notes, diary and all data. In addition to the features covered by the quality assessment in this study, the extra features covered by the apps selected were also extracted, as shown in Table S2. Only 5 out of 33 apps do not have extra features. However, the most

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frequently covered extra feature is Baby names, which is present in 10 apps. The second most frequently covered extra feature is Hospital bag, which is present in 8 apps. The presence of a birth plan and medication reminders is covered in only 6 apps.

4.

Limitations of the study

There may be some threats to the validity of this study, despite the fact that the process was planned with the aim of attaining the utmost achievable accuracy and objectivity. The search was performed in Google Play store and Apple App store, the official repositories for Android and iOS applications, respectively, using the PICO criteria in the search string. The main drawbacks were: (1) the results do not appear in the same way and in the same order each time; (2) the search motors of both Apple App Store and Google Play store have a limited functionality in terms of filtering the results. This may have excluded apps that would have been included in the review after applying the IC and EC criteria. In order to alleviate this threat to the construct validity, the selection depended on the two authors who conducted the search process, and if a disagreement occurred between them, a discussion among all the authors took place until an agreement was attained. The development of both the quality assessment questionnaire and the data items, in addition to the evaluation of the mPHRs for pregnancy monitoring selected, was performed by two independent authors. This strategy reduced the risk of a threat to the conclusion and internal validity. Finally, the unavailability of ratings for some iOS apps may have threatened the external validity. In order to reduce this threat, the study covered the ratings of only 7 apps for iOS and 13 for Android. Finally, since IC1 criterion excluded apps running on OS other than iOS and Android, and in order to mitigate the threat to the external validity of this paper, another extended study including other OS, such as Windows phone or Blackberry, should be carried out in future work.

5.

Main findings

The main findings of this study are summarized as follows: • Registering the estimated birth date or calculating it by entering the last menstrual period is the only functionality used in all the mPHRs for pregnancy monitoring analyzed. • Some applications focus on offering information to the user and others focus on monitoring the information provided by the user. • The most frequently ignored feature in the mPHRs for pregnancy monitoring studied is the geolocation of nearby medical services. • The social aspect is not commonly included in mPHRs for pregnancy monitoring; forums or communities could be included to allow users to share information. Communication with health providers is also crucial for pregnant women in cases of emergency. • Security and privacy should be considered by developers. Only 9% of the applications studied include at least two data

protection methods, and 12% use a password method of protection. • Only 5 of the apps analyzed are connected to other stakeholders. MPHRs for pregnancy monitoring should interact with medical institutions in order to provide users with valuable content. • The top 10 apps that attained the highest scores in the quality assessment questionnaire also attained high users’ ratings (between 4 and 5 stars), which may demonstrate the compliance between the apps’ functionalities and users’ positive feedback. • The possibility of connecting sensors to mPHRs for pregnancy monitoring should be taken into consideration. Only 12% of the apps studied include this feature, which is crucial to acquire accurate and correct record values.

6.

Conclusion and future work

The advancement of smartphone features and the improvements to their capacities increase the chances of a more efficient use of the mPHRs for pregnancy monitoring. This paper has analyzed and assessed the functionalities of 33 iOS and Android based mPHRs for pregnancy. A questionnaire containing 35 questions was defined to assist stakeholders to select the application that best fits their needs. Designers and developers have been given the opportunity to benchmark and compare their application with other similar ones. Our findings show that not all applications for pregnancy monitoring offer the same functionalities. Of the applications studied, Pregnancy & Maternity Tracker, Baby Due Date Calculator and The Best I’m Expecting Guide attained the best score (27 points), Gestavida Pregnancy obtained the second highest score (25 points), while ExpectingBaby by Enfamil® Pregnancy Journal attained the lowest score (6 points). The findings of this study allow us to conclude that mPHRs for pregnancy monitoring should cover the maximum areas of pregnancy for an accurate and complete pregnancy tracking. Mobile features should also be adapted to the pregnant woman’s needs, in order to provide a wide use of the mPHRs, which will motivate developers to build higher quality apps. Moreover, this study enhances the functionality quality characteristic of the ISO/IEC 25010 quality standard [90]. Functionality is considered as fundamental in the e-Health field [91]. Studying functionality for mPHRs for pregnancy monitoring will allow quality auditors to successfully apply this quality standard to mobile software for audit purposes, by carrying out a quality evaluation of the mPHRs for pregnancy monitoring. Lastly, the security of mPHRs still needs to be checked and improved. As future work, we plan to study the use of these apps in the third world for maternal health. Moreover, we plan to analyze the frequency of using the features evaluated in this study and their usefulness for pregnant women. Furthermore, we intend to add other data items, in addition to covering more quality characteristics such as Usability, Performance, Efficiency and Reliability [92,93]. We also expect to involve pregnant women in the evaluation of mPHRs for pregnancy monitoring. Finally, a software requirements specification for


an mPHR for pregnancy monitoring could be established for developers.

Acknowledgment This research is part of the mPHR project in Morocco financed by the Ministry of Higher Education and Scientific Research in Morocco 2015–2018 (PPR1-15-17), and part of the project GINSENG (TIN2015-70259-C2-2-R) supported by the Spanish Ministry of Economy and Competitiveness and European FEDER funds.

Appendix. Supplementary data Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.cmpb.2016.06.008.

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