The Breast 23 (2014) 683e689
Contents lists available at ScienceDirect
The Breast journal homepage: www.elsevier.com/brst
Original article
Smartphone breast applications e What's the evidence? Mohammad H. Mobasheri a, *, Maximilian Johnston a, Dominic King b, Daniel Leff b, Paul Thiruchelvam c, Ara Darzi b a
Department of Surgery & Cancer, Imperial College London, UK Institute of Global Health Innovation, Imperial College London, UK c Department of Breast Surgery, Imperial College London, UK b
a r t i c l e i n f o
a b s t r a c t
Article history: Received 23 May 2014 Accepted 30 July 2014 Available online 19 August 2014
Introduction: There are around 40,000 healthcare applications (apps) available for smartphones. Apps have been reviewed in many specialties. Breast cancer is the most common malignancy in females with almost 1.38 million new cases a year worldwide. Despite the high prevalence of breast disease, apps in this field have not been reviewed to date. We have evaluated apps relevant to breast disease with an emphasis on their evidence base (EB) and medical professional involvement (MPI). Methods: Searching the major app stores (apple iTunes, Google Play, BlackBerry World, Windows Phone) using the most common breast symptoms and diseases identified relevant apps. Extracted data for each app included target consumer, disease focus, app function, documentation of any EB, documentation of MPI in development, and potential safety concerns. Results: One-hundred-and-eighty-five apps were reviewed. The majority focused on breast cancer (n ¼ 139, 75.1%). Educational (n ¼ 94) and self-assessment tools (n ¼ 30) were the most common functions demonstrated. EB and MPI was identified in 14.2% and 12.8% of apps respectively. Potential safety concerns were identified in 29 (15.7%) apps. Conclusions: There is a lack of EB and MPI in the development of current breast apps. Safety concerns highlight the need for regulation, full authorship disclosure and clinical trials. A robust framework for identifying high quality applications is necessary. This will address the current barrier pertaining to a lack of consumer confidence in their use and further aid to promote their widespread implementation within healthcare. © 2014 Elsevier Ltd. All rights reserved.
Keywords: Breast disease Cancer Apps Smartphone mHealth Mobile health
Introduction Mobile phones have become a ubiquitous technology in both the developed and developing worlds [1]. Earlier handsets offering only phone call and text messaging capabilities have been replaced by increasingly sophisticated devices known as smartphones.
Abbreviations: App, application; EB, evidence base; FDA, Food and Drug Administration; GPS, global positioning system; IT, information technology; MHRA, Medicines and Healthcare Products Regulatory Agency; MPI, medical professional involvement; NHS, National Health Service; mHealth, mobile health; UK, United Kingdom; US, United States. * Corresponding author: Department of Surgery & Cancer, Division of Surgery, Imperial College London, 10th Floor QEQM Building, St Mary's Hospital, Praed Street, London, W2 1NY, UK. Tel.: þ44 (0) 20 3312 1310; fax: þ44 (0) 20 3312 6950. E-mail addresses: [email protected] (M.H. Mobasheri), m.johnston@ imperial.ac.uk (M. Johnston), [email protected] (D. King), d.leff@ imperial.ac.uk (D. Leff), [email protected] (P. Thiruchelvam), a.darzi@ imperial.ac.uk (A. Darzi). http://dx.doi.org/10.1016/j.breast.2014.07.006 0960-9776/© 2014 Elsevier Ltd. All rights reserved.
Smartphones are powered by computer operating systems and offer increased functionality such as touch screen technology, audio, video, internet access and house a host of in-built sensors such as wi-fi, Bluetooth, GPS (global positioning system), accelerometers, and cameras. These devices are capable of running standalone software applications known as apps. App markets have grown rapidly with the increasing usage and acceptance of smartphones [2]. The most popular examples of such markets include Apple iTunes, Android Google Play, BlackBerry World, and Windows Phone Stores. It is estimated that there were 102 billion app downloads in 2013 generating revenues of $26 billion [3]. Mobile health (mHealth) is defined as the delivery of healthcare or health related services through the use of portable devices [4]. Smartphone and app technologies have been responsible for expansion within this sector. There are currently around 40,000 healthcare related apps (mHealth apps) available through app stores and their use in clinical practice is becoming increasingly
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common [5]. Examples of medical apps in widespread use currently include the Medscape and Epocrates apps which are clinical reference tools, and the MedCalc app which provides physicians with access to complex medical formulae, scoring systems, scales, and classifications. The use of mHealth apps has been evaluated in various fields of medical practice including obesity surgery [2], colorectal surgery [6], vascular surgery [7], hernia surgery [8], pain management [9], urology [10] and more [11e15]. Concern regarding misleading content, a lack of evidence base, and an absence of medical professional involvement in app development has emerged through these studies, with repeated calls for regulation and robust clinical trials to prove efficacy [2,6,8,9,13,16e18]. Despite the high prevalence of both benign and malignant breast disease mHealth apps within this field have not been reviewed to date. Breast pathology is responsible for a large proportion of presentations to general practitioners and breast cancer is the commonest malignancy in females worldwide with the highest incidences occurring in Europe, Australia, new Zealand and North America [19,20]. A woman's lifetime risk of developing breast cancer in the United Kingdom (UK) is 1 in 8 [19]. There are almost 1.38 million new cases a year worldwide and breast cancer accounts for 23% of all cancers and 14% of deaths from cancer [21]. The aim of this study is to assess the status of contemporary apps targeted at breast disease with particular focus on their documented evidence base (EB) and the degree of medical professional involvement (MPI) in design. Methods Smartphone mHealth apps specifically relating to breast disease were identified by searching the four largest app stores (Apple iTunes, Google Play, BlackBerry World, Windows Phone). Each app store was searched using terms related to the most prevalent breast diseases and presentations. With respect to breast disease the terms breast cancer, fibroadenoma, fibrocystic breast disease,
fibroadenosis, breast cysts, gynaecomastia, mastitis, breast abscess, breast infection, and Paget's disease were used. With respect to breast presentation the terms breast lump, breast mass, breast pain, mastalgia, nipple discharge, galactorrhoea, and breast augmentation were used. Searches were performed in February 2014. For each app data was extracted from the app store overview provided by the developer and from the developer website, and consisted of: 1) app store category, 2) year of release and publisher information, 3) app price, 4) target consumer, 5) focus of the app within the field of breast medicine, 6) app function, 7) documentation of EB, 8) documentation of MPI, 9) potential safety concerns, 10) commercial interests, 11) number and length of written reviews, and 12) number and score of star rating reviews. Only apps in the English language and specifically targeting breast disease were included. Apps that incorporated breast disease as a small component of a larger remit were excluded (for example, apps that provided users with information on multiple cancers such as bowel, lung, prostate, and breast, were excluded as their primary focus was not breast disease). Apps targeted at breastfeeding were also excluded.
Results The app store search revealed 215 relevant apps (Fig. 1). Thirty of these were identified as duplicates, available for download in both the Google Play app store and one other. In all cases duplicates were removed from the less popular app market, resulting in the exclusion of 28 apps from the Apple App Store, and a single app from each of the Windows Phone and BlackBerry World app stores. The remaining 185 apps were included in the study for further analysis (118 apps in Google Play, 59 in Apple iTunes, 6 in Windows Phone, and 2 in BlackBerry World app stores). The first breast app was released in 2009. A total of 3 apps were released that year with a general year on year increase thereafter.
Fig. 1. Search methodology.
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Eighteen apps were released in 2010, 18 apps in 2011, 40 apps in 2012, and 103 apps in 2013. App stores organized the 185 applications into various categories; 49.2% were categorized as Health & Fitness, 31.4% as medical, 8.1% as lifestyle, 2.1% each in the education and business, 1.6% in each of the books & reference, and social categories. The final 3.8% of apps were placed in other categories as shown in Fig. 2. A large proportion of apps, 135 (73.0%), were targeted at the general public. Of those remaining, 30 apps (16.2%) were targeted at patients, 18 (9.7%) at clinicians, and 2 (1.1%) at medical students. Applications focused on various aspects of breast medicine as shown in Fig. 3. The vast majority of apps, 139 (75.1%), were targeted at breast cancer (30 of these focused primarily on breast cancer in the context of a breast lump), followed by 31 apps (16.8%) looking at breast augmentation and 9 apps (4.9%) focussing on gynaecomastia. Forty-four apps (23.8%) charged for download. The cost ranged from £0.61 to £19.42, with a median price of £1.25 (interquartile range of £0.69e£2.50). App functionality Applications included in this study had various functionalities, some more than one (refer to Table 1). A large number of apps (n ¼ 94) were educational tools, and the vast majority of these focused on breast cancer, providing users with information ranging from diagnosis through to treatment and prognosis. Thirty apps were self-assessment tools teaching users how to self-examine their breasts, and a further 30 apps were aimed at raising breast cancer awareness through fund-raising, the advertisement of upcoming events of various breast cancer foundations and charities (e.g. walks or runs), or through other means. Thirteen applications were clinical guideline tools. A further 8 apps were appointment management tools allowing users to input details of future clinic and screening mammogram appointments. Reminders or “push notifications” are sent through these apps to ensure appointments are not forgotten or missed. Another 8 applications were clinician advertisement tools that promoted the practice of either an individual surgeon, a group of surgeons, or a centre for surgery. All of these were within the field of breast augmentation, aimed at patient recruitment, and one was focused on reconstruction following cancer surgery. There were 8 apps that functioned as social
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networking tools allowing users to share their stories and experiences of breast cancer with peers. Six applications were visualization tools focused on breast augmentation. These tools allowed users to visualize themselves with breasts of various proportions. Less common app functionalities included conference guide tools (5 apps), glossaries (4 apps), risk calculator tools that calculate a users breast cancer risk (3 apps), a patient diary tool that allows users to record breast pain symptoms (1 app), a breast services listing tool that listed “accredited” breast cancer services (1 app), and a product advertisement tool promoting a topical breast cream and dietary supplements that claim to increase breast size. Two apps claimed to enhance breast size through the use of audio. The first played music to users mimicking the noises made by a breast-feeding baby. By fooling the mind into believing the user was lactating the app claimed to cause natural breast enlargement. The second played recorded scripts of a hypnotherapist to psychologically convince users that they possessed larger breasts. Finally, there were 2 apps that functioned as remote healing tools. These apps linked users to a healer who claimed to heal breast cancer remotely. Evidence base and medical professional involvement in development Apps designed solely for the purposes of increasing breast cancer awareness through fund-raising and advertisement of upcoming events of breast cancer foundations and charities, social networking, clinician advertisement, breast services listing, and conference guide apps were deemed not to require an EB or MPI in design and were thus excluded from this section of the analysis. Thirty-seven (20.0%) apps were excluded on this basis. Of the 148 remaining apps, only 21 (14.2%) had a documented EB. Nineteen apps (12.8%) had documented MPI in their development and 15 (78.9%) of these specifically named the medical professional(s) involved. It is noteworthy that of the 30 apps that functioned as selfassessment tools, only 2 (6.7%) had a documented EB and 4 (13.3%) had MPI in development. The 2 remote healing apps and the single app that advertised a topical breast cream and dietary supplements for increasing breast size had no documented EB or MPI.
Fig. 2. App store categorisation of applications.
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Fig. 3. Focus of apps within breast medicine.
Commercial interests
Discussion
Some 82 (44.3%) of the 185 apps had one or more commercial interests. In terms of breakdown, 44 were paid apps, 14 apps aimed to recruit patients through clinician advertisement or other means (the two remote healing apps are included here), 22 were fundraising apps, 4 apps provided links to websites selling some form of product, 3 apps allowed “in-app” purchasing of products, and 2 apps installed icons on smartphones that would link to other apps or games.
As a technology the portability, ubiquity, accessibility at point of care delivery, and processing power of smartphones offers huge potential in the healthcare context. Implementation of new technology within healthcare infrastructures has traditionally been a challenging process requiring institutional change, a process fraught with both technical and socio-cultural barriers [22]. However, the ubiquity of smartphone technology use on a personal level has meant that its translation into the clinical arena has faced fewer barriers than has been the case with other technologies. As a consequence, adoption and utilisation of smartphone technology in the clinical context is expanding [23], bringing with it huge opportunities to improve efficiency within medical practice. This is the first study to review apps specifically targeted at the field of breast disease and is a valuable reference for clinicians, app designers, and policy makers with an interest in the area. It demonstrates a larger number of applications than seen in earlier reviews of other specialties [2,6e15], with a year on year increase in app release. This is in keeping with the rapid expansion of mHealth application markets and the high prevalence and emotive nature of breast disease [24]. It is not surprising that the majority of apps (n 139: 75.1%) focused on breast cancer given its high incidence and prevalence [19]. A total of 16 different functionalities were identified through this review highlighting the diverse potential of apps targeted at breast disease. These ranged from simple educational reference tools, and glossaries to more complex functions such as selfassessment through video tutorials, appointment management and reminders, and social networking tools allowing users to share their experiences of breast pathology with their peers. However, as with reviews of apps in other specialties [2,6e15], there was a concerning lack of documented EB and MPI in app development within this field (14.2% and 12.8% respectively). Of particular note, thirty apps identified through this review taught breast self-examination techniques but only a minority had a documented EB or MPI in their development. When diagnosed at an early stage breast cancer has an excellent prognosis with 5 year survival rates in excess of 90% [25]. Studies have shown that a large proportion of women diagnosed with cancer under the age of 40 present after detecting their own breast abnormalities [26] and that
Safety concerns and confidential data storage Twenty-nine of the included apps (15.7%) had the potential to cause indirect harm thereby compromising consumer safety. Twenty-six of these were self-assessment tools without documented MPI, and a further 2 were remote healing tools without an EB or MPI. The final app was a product advertisement tool for a breast cream and dietary supplements aimed at increasing breast size that also lacked an evidence base and medical input in development. We expand on this area further within the discussion. A total of 10 apps (5.4%) stored some form of confidential data ranging from a users self-assessment findings and breast size to the details of test results. None of these stated security measures taken to protect such data (e.g. the use of passwords or data encryption). App store review data App stores used two methods for rating apps. The first was a star scoring system where an app was given 1 (worst score) e 5 (best score) stars depending on user satisfaction and the second was through written reviews. Sixty-eight apps (36.8%) had one or more star rating reviews. The average (mean) star rating was 4.3 out of 5 and the average (median) number of star reviews per app was 3.5 (range of 1e205, with an interquartile range of 2e8). Forty apps (21.6%) had one or more written reviews. The average (mean) length of review was 13.2 words (range 1e52 words) and the average (median) number of written reviews per app was 2 (range 1e50, with an interquartile range of 1e4 reviews).
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Table 1 Breakdown of applications based on functionality. App function (n)
Focus within breast medicine n apps
Educational tools
n apps
EB*
n n Median cost apps apps (Range)
70
Patients
18
28
n n n Apps Av* SR apps apps with (Mean) 1 1e5 review
Written review (WR) Av n of SR per app (Median)
n apps Av length with of WR 1 (Mean) review
Av n of WR per app (Median)
£1.25 9 (£0.61 - £19.42)
11
31
4.4
4
14
11.8 words
2
30
Increasing breast cancer awareness Clinical guideline tools
30
13
Breast cancer
30
8
Breast cancer
8
8
8
Public Patients
7 1
0
e
NA
NA
3
4
2
1
5 words
8
Breast augmentation (One aimed at reconstruction following cancer surgery) Breast cancer
8
Patients
8
1
£1.48
NA
NA
5
4.8
7
2
6
Breast augmentation
6
Public
6
4
0
3
2
1.5
85
2
5
Breast cancer
5
Physicians
5
0
£0.68 (£0.66e£0.69) e
37.5 6 words 8.5 words 8.5
NA
NA
1
1
1
0
NA
4
Breast cancer
4
0
0
2
4.8
3.5
2
Breast cancer
3
1 3 3
3
3
Public Patients Public
1
2
0
3
5
4
2
2
Breast augmentation
2
Public
2
2
£1.70 (£0.89e£2.50)
1
0
1
4.4
8
1
32.5 1.5 words 12.5 2.5 words 12 words 2
2
Breast cancer
2
Patients
2
0
e
0
0
2
3.4
3.5
1
1 1
Breast pain Breast cancer
1 1
Public Public
1 1
0 0
e e
0 NA
0 NA
1 0
5 NA
1 NA
1
Breast augmentation
1
Public
1
0
e
NA
NA
0
NA
NA
Risk calculator tools Breast enhancement through use of audio Remote healing tools Patient diary tools Breast services listing tools Product advertisement tools
Public
MPI* Star rating (SR)
Self-assessment tools
Social networking tools Visualisation tools Conference guide tools Glossaries
59 21 9 2 1 1 1
Paid apps
Breast cancer Breast augmentation Gynaecomastia Breast imaging Breast rash Breast pain Breast medicine as a whole Breast cancer (In the context of breast lump) Breast cancer
Appointment management tools Clinician advertisement tools
94
Target consumer
Physicians
4
Medical Students Public
2 30
3
£0.69 (£0.69e£1.25)
2
4
15
3.7
4
12
10.5 words
2
30
Public Patients
28 2
4
£1.69 (£069e£1.85)
NA
NA
11
4.1
3
9
15.4 words
2
Public Patients Physicians Public Patients
4 1 8 7 1
5
£1.99 (£1.24e£6.99)
7
3
1
4.1
21
1
21 words
7
0
e
1
1
5
4.14
21
4
13.2 words
20
1
30
£0.93 (£0.62e£1.22) £0.62
NA
0 0
11 words NA NA
1 NA NA
0
NA
NA
*EB ¼ evidence base, MPI ¼ medical professional involvement, SR ¼ star rating, WR ¼ written review, Av ¼ average, n ¼ number.
when taught properly self-examination can result in earlier diagnosis [27]. In this regard, app based interventions have been shown to be useful in improving self-examination behaviours [28]. A lack of EB or MPI in the development of such apps may result in the teaching of inappropriate self-examination techniques. It is not farfetched to see how this can potentially delay detection of abnormalities and the diagnosis of breast cancer resulting in a poorer prognosis [29]. Of even greater concern were two apps that claimed to offer users remote healing of their cancers without any documented EB or MPI. Such apps can potentially delay the delivery of wellestablished evidence based treatments such as surgery, chemotherapy and radiotherapy. Aside from the pathophysiological consequences associated with such delay there is also the psychological damage caused by offering hope unsubstantiated by an EB.
The current paper is not the first to highlight safety concerns surrounding mHealth apps [30]. In order to safeguard consumers, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has recently followed the example set by the United States Food and Drug Administration (FDA) and widened its public health responsibility for ensuring the safety of medical devices to include specific categories of mHealth apps [31,32]. It is the responsibility of individual app developers to ensure legal compliance and app stores are exempt from any liability in this regard. With around 40,000 mHealth apps currently available through app stores it is imperative that consumers have an effective means by which to identify those of high quality not only in terms of safety but also content, usability, functionality, EB, and efficacy. This study, similar to others [2,6,8], has demonstrated that the peer star rating and written review systems employed by all major app stores are flawed in this respect. Firstly only the minority of apps are reviewed
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(21.6% and 36.8% had written and star rating reviews respectively). Secondly with respect to written reviews, when provided these are short (mean length of 13.2 words in this review), subjective, and unstructured. Clinical trials [6,16], structured in-depth critical appraisal [33,34], and vetting processes [35e37] have been proposed as potential solutions to the problem. The latter aim to certify apps to a set standard, stamping those that are compliant with a seal of approval thus allowing consumers to be confident of their use. Although a step in the right direction, certification is voluntary and to date only a handful of mHealth apps have been certified thereby limiting the value of such platforms. The main limitation of this study was its reliance on app store overviews and developer websites for data extraction. It was beyond the scope of this unfunded project to download applications, many of which require payment for installation. Although it is possible that in some instances developers may only disclose EB and MPI once apps are fully downloaded, this seems unlikely given that such features are positive selling points and would therefore likely be mentioned in app store overviews if present. Furthermore, it can be argued that app store overviews and developer websites are the only information available to most consumers when deciding whether to download a given application. Conclusion This study demonstrates a large number and wide diversity of function amongst mHealth apps available in the field of breast disease. Such applications empower users with the ability to portably and rapidly access educational material (and in the case of physicians to access this material at the point of care delivery), manage mammogram and clinic appointments, learn how to examine their breasts for abnormalities, calculate their risks of developing breast cancer, locate and make appointments with breast cancer services, and more. However, despite their huge potential there is a concerning lack of EB and MPI in app development, both in this field and others, resulting in concerns around their safety. In this regard there is a need for full authorship disclosure and high quality clinical trials of smartphone based mHealth interventions. A robust framework for evaluating mHealth apps is required to allow consumers to readily identify high quality apps from the many thousands available. Such a framework would also serve to promote the widespread adoption of smartphone technology and apps in the clinical arena. Ethical approval Ethical approval was not required for this study. Role of funding source Johnston, King and Darzi are affiliated with the Centre for Patient Safety and Service Quality (www.cpssq.org) of the Department of Surgery & Cancer at Imperial College London which receives funding from the National Institute for Health Research (UK). The funding source had no role to play in the design, collection, analysis and interpretation of data, writing of the manuscript or the decision to submit the manuscript for publication. Conflict of interest statement All authors declare no conflicts of interest.
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Contents lists available at ScienceDirect
The Breast journal homepage: www.elsevier.com/brst
Original article
Smartphone breast applications e What's the evidence? Mohammad H. Mobasheri a, *, Maximilian Johnston a, Dominic King b, Daniel Leff b, Paul Thiruchelvam c, Ara Darzi b a
Department of Surgery & Cancer, Imperial College London, UK Institute of Global Health Innovation, Imperial College London, UK c Department of Breast Surgery, Imperial College London, UK b
a r t i c l e i n f o
a b s t r a c t
Article history: Received 23 May 2014 Accepted 30 July 2014 Available online 19 August 2014
Introduction: There are around 40,000 healthcare applications (apps) available for smartphones. Apps have been reviewed in many specialties. Breast cancer is the most common malignancy in females with almost 1.38 million new cases a year worldwide. Despite the high prevalence of breast disease, apps in this field have not been reviewed to date. We have evaluated apps relevant to breast disease with an emphasis on their evidence base (EB) and medical professional involvement (MPI). Methods: Searching the major app stores (apple iTunes, Google Play, BlackBerry World, Windows Phone) using the most common breast symptoms and diseases identified relevant apps. Extracted data for each app included target consumer, disease focus, app function, documentation of any EB, documentation of MPI in development, and potential safety concerns. Results: One-hundred-and-eighty-five apps were reviewed. The majority focused on breast cancer (n ¼ 139, 75.1%). Educational (n ¼ 94) and self-assessment tools (n ¼ 30) were the most common functions demonstrated. EB and MPI was identified in 14.2% and 12.8% of apps respectively. Potential safety concerns were identified in 29 (15.7%) apps. Conclusions: There is a lack of EB and MPI in the development of current breast apps. Safety concerns highlight the need for regulation, full authorship disclosure and clinical trials. A robust framework for identifying high quality applications is necessary. This will address the current barrier pertaining to a lack of consumer confidence in their use and further aid to promote their widespread implementation within healthcare. © 2014 Elsevier Ltd. All rights reserved.
Keywords: Breast disease Cancer Apps Smartphone mHealth Mobile health
Introduction Mobile phones have become a ubiquitous technology in both the developed and developing worlds [1]. Earlier handsets offering only phone call and text messaging capabilities have been replaced by increasingly sophisticated devices known as smartphones.
Abbreviations: App, application; EB, evidence base; FDA, Food and Drug Administration; GPS, global positioning system; IT, information technology; MHRA, Medicines and Healthcare Products Regulatory Agency; MPI, medical professional involvement; NHS, National Health Service; mHealth, mobile health; UK, United Kingdom; US, United States. * Corresponding author: Department of Surgery & Cancer, Division of Surgery, Imperial College London, 10th Floor QEQM Building, St Mary's Hospital, Praed Street, London, W2 1NY, UK. Tel.: þ44 (0) 20 3312 1310; fax: þ44 (0) 20 3312 6950. E-mail addresses: [email protected] (M.H. Mobasheri), m.johnston@ imperial.ac.uk (M. Johnston), [email protected] (D. King), d.leff@ imperial.ac.uk (D. Leff), [email protected] (P. Thiruchelvam), a.darzi@ imperial.ac.uk (A. Darzi). http://dx.doi.org/10.1016/j.breast.2014.07.006 0960-9776/© 2014 Elsevier Ltd. All rights reserved.
Smartphones are powered by computer operating systems and offer increased functionality such as touch screen technology, audio, video, internet access and house a host of in-built sensors such as wi-fi, Bluetooth, GPS (global positioning system), accelerometers, and cameras. These devices are capable of running standalone software applications known as apps. App markets have grown rapidly with the increasing usage and acceptance of smartphones [2]. The most popular examples of such markets include Apple iTunes, Android Google Play, BlackBerry World, and Windows Phone Stores. It is estimated that there were 102 billion app downloads in 2013 generating revenues of $26 billion [3]. Mobile health (mHealth) is defined as the delivery of healthcare or health related services through the use of portable devices [4]. Smartphone and app technologies have been responsible for expansion within this sector. There are currently around 40,000 healthcare related apps (mHealth apps) available through app stores and their use in clinical practice is becoming increasingly
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common [5]. Examples of medical apps in widespread use currently include the Medscape and Epocrates apps which are clinical reference tools, and the MedCalc app which provides physicians with access to complex medical formulae, scoring systems, scales, and classifications. The use of mHealth apps has been evaluated in various fields of medical practice including obesity surgery [2], colorectal surgery [6], vascular surgery [7], hernia surgery [8], pain management [9], urology [10] and more [11e15]. Concern regarding misleading content, a lack of evidence base, and an absence of medical professional involvement in app development has emerged through these studies, with repeated calls for regulation and robust clinical trials to prove efficacy [2,6,8,9,13,16e18]. Despite the high prevalence of both benign and malignant breast disease mHealth apps within this field have not been reviewed to date. Breast pathology is responsible for a large proportion of presentations to general practitioners and breast cancer is the commonest malignancy in females worldwide with the highest incidences occurring in Europe, Australia, new Zealand and North America [19,20]. A woman's lifetime risk of developing breast cancer in the United Kingdom (UK) is 1 in 8 [19]. There are almost 1.38 million new cases a year worldwide and breast cancer accounts for 23% of all cancers and 14% of deaths from cancer [21]. The aim of this study is to assess the status of contemporary apps targeted at breast disease with particular focus on their documented evidence base (EB) and the degree of medical professional involvement (MPI) in design. Methods Smartphone mHealth apps specifically relating to breast disease were identified by searching the four largest app stores (Apple iTunes, Google Play, BlackBerry World, Windows Phone). Each app store was searched using terms related to the most prevalent breast diseases and presentations. With respect to breast disease the terms breast cancer, fibroadenoma, fibrocystic breast disease,
fibroadenosis, breast cysts, gynaecomastia, mastitis, breast abscess, breast infection, and Paget's disease were used. With respect to breast presentation the terms breast lump, breast mass, breast pain, mastalgia, nipple discharge, galactorrhoea, and breast augmentation were used. Searches were performed in February 2014. For each app data was extracted from the app store overview provided by the developer and from the developer website, and consisted of: 1) app store category, 2) year of release and publisher information, 3) app price, 4) target consumer, 5) focus of the app within the field of breast medicine, 6) app function, 7) documentation of EB, 8) documentation of MPI, 9) potential safety concerns, 10) commercial interests, 11) number and length of written reviews, and 12) number and score of star rating reviews. Only apps in the English language and specifically targeting breast disease were included. Apps that incorporated breast disease as a small component of a larger remit were excluded (for example, apps that provided users with information on multiple cancers such as bowel, lung, prostate, and breast, were excluded as their primary focus was not breast disease). Apps targeted at breastfeeding were also excluded.
Results The app store search revealed 215 relevant apps (Fig. 1). Thirty of these were identified as duplicates, available for download in both the Google Play app store and one other. In all cases duplicates were removed from the less popular app market, resulting in the exclusion of 28 apps from the Apple App Store, and a single app from each of the Windows Phone and BlackBerry World app stores. The remaining 185 apps were included in the study for further analysis (118 apps in Google Play, 59 in Apple iTunes, 6 in Windows Phone, and 2 in BlackBerry World app stores). The first breast app was released in 2009. A total of 3 apps were released that year with a general year on year increase thereafter.
Fig. 1. Search methodology.
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Eighteen apps were released in 2010, 18 apps in 2011, 40 apps in 2012, and 103 apps in 2013. App stores organized the 185 applications into various categories; 49.2% were categorized as Health & Fitness, 31.4% as medical, 8.1% as lifestyle, 2.1% each in the education and business, 1.6% in each of the books & reference, and social categories. The final 3.8% of apps were placed in other categories as shown in Fig. 2. A large proportion of apps, 135 (73.0%), were targeted at the general public. Of those remaining, 30 apps (16.2%) were targeted at patients, 18 (9.7%) at clinicians, and 2 (1.1%) at medical students. Applications focused on various aspects of breast medicine as shown in Fig. 3. The vast majority of apps, 139 (75.1%), were targeted at breast cancer (30 of these focused primarily on breast cancer in the context of a breast lump), followed by 31 apps (16.8%) looking at breast augmentation and 9 apps (4.9%) focussing on gynaecomastia. Forty-four apps (23.8%) charged for download. The cost ranged from £0.61 to £19.42, with a median price of £1.25 (interquartile range of £0.69e£2.50). App functionality Applications included in this study had various functionalities, some more than one (refer to Table 1). A large number of apps (n ¼ 94) were educational tools, and the vast majority of these focused on breast cancer, providing users with information ranging from diagnosis through to treatment and prognosis. Thirty apps were self-assessment tools teaching users how to self-examine their breasts, and a further 30 apps were aimed at raising breast cancer awareness through fund-raising, the advertisement of upcoming events of various breast cancer foundations and charities (e.g. walks or runs), or through other means. Thirteen applications were clinical guideline tools. A further 8 apps were appointment management tools allowing users to input details of future clinic and screening mammogram appointments. Reminders or “push notifications” are sent through these apps to ensure appointments are not forgotten or missed. Another 8 applications were clinician advertisement tools that promoted the practice of either an individual surgeon, a group of surgeons, or a centre for surgery. All of these were within the field of breast augmentation, aimed at patient recruitment, and one was focused on reconstruction following cancer surgery. There were 8 apps that functioned as social
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networking tools allowing users to share their stories and experiences of breast cancer with peers. Six applications were visualization tools focused on breast augmentation. These tools allowed users to visualize themselves with breasts of various proportions. Less common app functionalities included conference guide tools (5 apps), glossaries (4 apps), risk calculator tools that calculate a users breast cancer risk (3 apps), a patient diary tool that allows users to record breast pain symptoms (1 app), a breast services listing tool that listed “accredited” breast cancer services (1 app), and a product advertisement tool promoting a topical breast cream and dietary supplements that claim to increase breast size. Two apps claimed to enhance breast size through the use of audio. The first played music to users mimicking the noises made by a breast-feeding baby. By fooling the mind into believing the user was lactating the app claimed to cause natural breast enlargement. The second played recorded scripts of a hypnotherapist to psychologically convince users that they possessed larger breasts. Finally, there were 2 apps that functioned as remote healing tools. These apps linked users to a healer who claimed to heal breast cancer remotely. Evidence base and medical professional involvement in development Apps designed solely for the purposes of increasing breast cancer awareness through fund-raising and advertisement of upcoming events of breast cancer foundations and charities, social networking, clinician advertisement, breast services listing, and conference guide apps were deemed not to require an EB or MPI in design and were thus excluded from this section of the analysis. Thirty-seven (20.0%) apps were excluded on this basis. Of the 148 remaining apps, only 21 (14.2%) had a documented EB. Nineteen apps (12.8%) had documented MPI in their development and 15 (78.9%) of these specifically named the medical professional(s) involved. It is noteworthy that of the 30 apps that functioned as selfassessment tools, only 2 (6.7%) had a documented EB and 4 (13.3%) had MPI in development. The 2 remote healing apps and the single app that advertised a topical breast cream and dietary supplements for increasing breast size had no documented EB or MPI.
Fig. 2. App store categorisation of applications.
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Fig. 3. Focus of apps within breast medicine.
Commercial interests
Discussion
Some 82 (44.3%) of the 185 apps had one or more commercial interests. In terms of breakdown, 44 were paid apps, 14 apps aimed to recruit patients through clinician advertisement or other means (the two remote healing apps are included here), 22 were fundraising apps, 4 apps provided links to websites selling some form of product, 3 apps allowed “in-app” purchasing of products, and 2 apps installed icons on smartphones that would link to other apps or games.
As a technology the portability, ubiquity, accessibility at point of care delivery, and processing power of smartphones offers huge potential in the healthcare context. Implementation of new technology within healthcare infrastructures has traditionally been a challenging process requiring institutional change, a process fraught with both technical and socio-cultural barriers [22]. However, the ubiquity of smartphone technology use on a personal level has meant that its translation into the clinical arena has faced fewer barriers than has been the case with other technologies. As a consequence, adoption and utilisation of smartphone technology in the clinical context is expanding [23], bringing with it huge opportunities to improve efficiency within medical practice. This is the first study to review apps specifically targeted at the field of breast disease and is a valuable reference for clinicians, app designers, and policy makers with an interest in the area. It demonstrates a larger number of applications than seen in earlier reviews of other specialties [2,6e15], with a year on year increase in app release. This is in keeping with the rapid expansion of mHealth application markets and the high prevalence and emotive nature of breast disease [24]. It is not surprising that the majority of apps (n 139: 75.1%) focused on breast cancer given its high incidence and prevalence [19]. A total of 16 different functionalities were identified through this review highlighting the diverse potential of apps targeted at breast disease. These ranged from simple educational reference tools, and glossaries to more complex functions such as selfassessment through video tutorials, appointment management and reminders, and social networking tools allowing users to share their experiences of breast pathology with their peers. However, as with reviews of apps in other specialties [2,6e15], there was a concerning lack of documented EB and MPI in app development within this field (14.2% and 12.8% respectively). Of particular note, thirty apps identified through this review taught breast self-examination techniques but only a minority had a documented EB or MPI in their development. When diagnosed at an early stage breast cancer has an excellent prognosis with 5 year survival rates in excess of 90% [25]. Studies have shown that a large proportion of women diagnosed with cancer under the age of 40 present after detecting their own breast abnormalities [26] and that
Safety concerns and confidential data storage Twenty-nine of the included apps (15.7%) had the potential to cause indirect harm thereby compromising consumer safety. Twenty-six of these were self-assessment tools without documented MPI, and a further 2 were remote healing tools without an EB or MPI. The final app was a product advertisement tool for a breast cream and dietary supplements aimed at increasing breast size that also lacked an evidence base and medical input in development. We expand on this area further within the discussion. A total of 10 apps (5.4%) stored some form of confidential data ranging from a users self-assessment findings and breast size to the details of test results. None of these stated security measures taken to protect such data (e.g. the use of passwords or data encryption). App store review data App stores used two methods for rating apps. The first was a star scoring system where an app was given 1 (worst score) e 5 (best score) stars depending on user satisfaction and the second was through written reviews. Sixty-eight apps (36.8%) had one or more star rating reviews. The average (mean) star rating was 4.3 out of 5 and the average (median) number of star reviews per app was 3.5 (range of 1e205, with an interquartile range of 2e8). Forty apps (21.6%) had one or more written reviews. The average (mean) length of review was 13.2 words (range 1e52 words) and the average (median) number of written reviews per app was 2 (range 1e50, with an interquartile range of 1e4 reviews).
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Table 1 Breakdown of applications based on functionality. App function (n)
Focus within breast medicine n apps
Educational tools
n apps
EB*
n n Median cost apps apps (Range)
70
Patients
18
28
n n n Apps Av* SR apps apps with (Mean) 1 1e5 review
Written review (WR) Av n of SR per app (Median)
n apps Av length with of WR 1 (Mean) review
Av n of WR per app (Median)
£1.25 9 (£0.61 - £19.42)
11
31
4.4
4
14
11.8 words
2
30
Increasing breast cancer awareness Clinical guideline tools
30
13
Breast cancer
30
8
Breast cancer
8
8
8
Public Patients
7 1
0
e
NA
NA
3
4
2
1
5 words
8
Breast augmentation (One aimed at reconstruction following cancer surgery) Breast cancer
8
Patients
8
1
£1.48
NA
NA
5
4.8
7
2
6
Breast augmentation
6
Public
6
4
0
3
2
1.5
85
2
5
Breast cancer
5
Physicians
5
0
£0.68 (£0.66e£0.69) e
37.5 6 words 8.5 words 8.5
NA
NA
1
1
1
0
NA
4
Breast cancer
4
0
0
2
4.8
3.5
2
Breast cancer
3
1 3 3
3
3
Public Patients Public
1
2
0
3
5
4
2
2
Breast augmentation
2
Public
2
2
£1.70 (£0.89e£2.50)
1
0
1
4.4
8
1
32.5 1.5 words 12.5 2.5 words 12 words 2
2
Breast cancer
2
Patients
2
0
e
0
0
2
3.4
3.5
1
1 1
Breast pain Breast cancer
1 1
Public Public
1 1
0 0
e e
0 NA
0 NA
1 0
5 NA
1 NA
1
Breast augmentation
1
Public
1
0
e
NA
NA
0
NA
NA
Risk calculator tools Breast enhancement through use of audio Remote healing tools Patient diary tools Breast services listing tools Product advertisement tools
Public
MPI* Star rating (SR)
Self-assessment tools
Social networking tools Visualisation tools Conference guide tools Glossaries
59 21 9 2 1 1 1
Paid apps
Breast cancer Breast augmentation Gynaecomastia Breast imaging Breast rash Breast pain Breast medicine as a whole Breast cancer (In the context of breast lump) Breast cancer
Appointment management tools Clinician advertisement tools
94
Target consumer
Physicians
4
Medical Students Public
2 30
3
£0.69 (£0.69e£1.25)
2
4
15
3.7
4
12
10.5 words
2
30
Public Patients
28 2
4
£1.69 (£069e£1.85)
NA
NA
11
4.1
3
9
15.4 words
2
Public Patients Physicians Public Patients
4 1 8 7 1
5
£1.99 (£1.24e£6.99)
7
3
1
4.1
21
1
21 words
7
0
e
1
1
5
4.14
21
4
13.2 words
20
1
30
£0.93 (£0.62e£1.22) £0.62
NA
0 0
11 words NA NA
1 NA NA
0
NA
NA
*EB ¼ evidence base, MPI ¼ medical professional involvement, SR ¼ star rating, WR ¼ written review, Av ¼ average, n ¼ number.
when taught properly self-examination can result in earlier diagnosis [27]. In this regard, app based interventions have been shown to be useful in improving self-examination behaviours [28]. A lack of EB or MPI in the development of such apps may result in the teaching of inappropriate self-examination techniques. It is not farfetched to see how this can potentially delay detection of abnormalities and the diagnosis of breast cancer resulting in a poorer prognosis [29]. Of even greater concern were two apps that claimed to offer users remote healing of their cancers without any documented EB or MPI. Such apps can potentially delay the delivery of wellestablished evidence based treatments such as surgery, chemotherapy and radiotherapy. Aside from the pathophysiological consequences associated with such delay there is also the psychological damage caused by offering hope unsubstantiated by an EB.
The current paper is not the first to highlight safety concerns surrounding mHealth apps [30]. In order to safeguard consumers, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has recently followed the example set by the United States Food and Drug Administration (FDA) and widened its public health responsibility for ensuring the safety of medical devices to include specific categories of mHealth apps [31,32]. It is the responsibility of individual app developers to ensure legal compliance and app stores are exempt from any liability in this regard. With around 40,000 mHealth apps currently available through app stores it is imperative that consumers have an effective means by which to identify those of high quality not only in terms of safety but also content, usability, functionality, EB, and efficacy. This study, similar to others [2,6,8], has demonstrated that the peer star rating and written review systems employed by all major app stores are flawed in this respect. Firstly only the minority of apps are reviewed
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(21.6% and 36.8% had written and star rating reviews respectively). Secondly with respect to written reviews, when provided these are short (mean length of 13.2 words in this review), subjective, and unstructured. Clinical trials [6,16], structured in-depth critical appraisal [33,34], and vetting processes [35e37] have been proposed as potential solutions to the problem. The latter aim to certify apps to a set standard, stamping those that are compliant with a seal of approval thus allowing consumers to be confident of their use. Although a step in the right direction, certification is voluntary and to date only a handful of mHealth apps have been certified thereby limiting the value of such platforms. The main limitation of this study was its reliance on app store overviews and developer websites for data extraction. It was beyond the scope of this unfunded project to download applications, many of which require payment for installation. Although it is possible that in some instances developers may only disclose EB and MPI once apps are fully downloaded, this seems unlikely given that such features are positive selling points and would therefore likely be mentioned in app store overviews if present. Furthermore, it can be argued that app store overviews and developer websites are the only information available to most consumers when deciding whether to download a given application. Conclusion This study demonstrates a large number and wide diversity of function amongst mHealth apps available in the field of breast disease. Such applications empower users with the ability to portably and rapidly access educational material (and in the case of physicians to access this material at the point of care delivery), manage mammogram and clinic appointments, learn how to examine their breasts for abnormalities, calculate their risks of developing breast cancer, locate and make appointments with breast cancer services, and more. However, despite their huge potential there is a concerning lack of EB and MPI in app development, both in this field and others, resulting in concerns around their safety. In this regard there is a need for full authorship disclosure and high quality clinical trials of smartphone based mHealth interventions. A robust framework for evaluating mHealth apps is required to allow consumers to readily identify high quality apps from the many thousands available. Such a framework would also serve to promote the widespread adoption of smartphone technology and apps in the clinical arena. Ethical approval Ethical approval was not required for this study. Role of funding source Johnston, King and Darzi are affiliated with the Centre for Patient Safety and Service Quality (www.cpssq.org) of the Department of Surgery & Cancer at Imperial College London which receives funding from the National Institute for Health Research (UK). The funding source had no role to play in the design, collection, analysis and interpretation of data, writing of the manuscript or the decision to submit the manuscript for publication. Conflict of interest statement All authors declare no conflicts of interest.
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