Phone it in – Roma Maguire discusses the eSMART study

18 February 2016



Many clinical trials rely on the experience and reaction of participants rather than invasive observation, and thus lend themselves to the use of remote patient monitoring technology. Clinical Trials Insight speaks to Roma Maguire, professor of cancer care and head of e-health research at the University of Surrey, about the eSMART study, and what it could mean for mobile health applications and remote data collection in clinical trials.


In Europe, more than three million people each year are diagnosed with cancer, and it is widely expected that this number will increase dramatically in the next 20 years. This has led clinicians and technology innovators to look at new ways to manage a growing patient population more efficiently to ensure that the healthcare infrastructure can cope and, more importantly, patient outcomes improve.

At a time when people are increasingly reliant on mobile devices in many areas of their lives, it seems natural to extend the capability of those devices into healthcare, particularly for severe medical conditions where patient involvement and personalised care can have an enormous impact. Cancer is a prime example of a disease that requires continual support for patients and would benefit greatly from improvements in systems that support self-care for outpatients.

Remote patient monitoring - capturing information electronically off site - can improve the accuracy of clinical data and increase the frequency of data collection, as well as getting patients more involved in their care. Roma Maguire, professor of cancer care and head of e-health at the school of health sciences at the University of Surrey, is engaged in a pan-European study called eSMART (Electronic Symptom Management System Remote Technology) that could have huge implications for the future of mobile health (mHealth) applications.

"When you look at standard delivery of chemotherapy, it is largely done on an outpatient basis - the patient gets treatment and then goes home. That means that any reaction to the treatment will happen in the home environment, so it is up to the patients to decide whether they need to contact the hospital about any symptoms they might be experiencing. As a result, they may wait until the symptoms become severe and need more interaction from clinicians, or even a period of hospitalisation," she explains.

Get eSMART

Maguire has a long track record of research in e-health, cancer care, LTC management, patient experience and many other fields. The latest research she has embraced is the eSMART study, which is evaluating the impact of a mobile-phone-based remote patient monitoring system on chemotherapy-related toxicity.

The pioneering study has received funding from the European Union's Seventh Framework for research, technological development and demonstration. It could transform cancer care and significantly reduce healthcare costs by enabling cancer care clinicians to monitor patients undergoing chemotherapy treatment for breast, bowel and blood cancers via their mobile phones. Maguire is the project's deputy coordinator of the randomised controlled trial, which has received €6 million from the EU and will run for five years.

The project's backers hope that using the Advanced Symptom Management System (ASyMS) will help patients by reducing their symptom burden, improving their quality of life, and enabling informed changes in clinical practice and the delivery of care. For clinicians, too, there are many potential advantages, including better data quality and cost-efficiency.

"ASyMS uses real-time remote patient monitoring. Patients report data daily through their mobile phones, and we have risk algorithms that look at the ASyMS data and create a system of alerts for clinicians. If the alert is amber, then the clinician will know to make contact with the patient within four hours. If it is red, then contact will be immediate," explains Maguire.

"Clinicians can also look at this data in the context of other datasets on secure systems. They can look for historical patterns, for example, and they can automate some of the decision-making processes in terms of providing contact and care.

There is no need for the time-consuming process of looking through notes manually. This means that interventions are quicker. Care becomes anticipatory and preventative, not responsive. Patients get evidence-based advice on their symptoms through a virtual supportive care system for the homecare setting."

Remotely interested

Run from its headquarters at the University of Surrey, the eSMART trial involves providing a mobile phone to cancer patients that contains a program similar to any standard app people would normally download to such a device. It allows patients to identify and record their chemotherapy symptoms twice a day. The data is then sent securely to a central computer where an assessment of the symptoms can be made.

Based on analysis of the data, an alert is triggered that prompts doctors or nurses to assist the patient if necessary. As the data is delivered in real time, clinicians can provide information and advice on how to manage symptoms at home, which should reduce the need for patients to travel to hospital.

The researchers behind eSMART believe that such a system will result in a reduction in the side effects of chemotherapy and, when there are side effects, they will be identified and treated much quicker.

To ensure the project captures these potential benefits, a wide range of partners have been engaged. The project involves ten European and one US partner, and 17 sites across Europe - representing a total of 1,108 cancer patients (see 'Constructing the eSMART Study', above).

"eSMART is a randomised controlled study that is being undertaken throughout Europe. The feedback from patients has been very quick and, so far, it has been very positive.

"One of the most important factors is that the technology is very usable. It was developed based on user experience in order to ensure that it meets patients' needs and collects relevant information. Patients were involved in the development and testing phase. People in their 80s are using it and have no problems with the easy, touch-based interface. You need the technology to be simple to ensure that it collects relevant and useful information," Maguire remarks.

It is still early days for the project. Although the ball started rolling in 2014, it was only in July 2015 that the hard work of writing the grant application, receiving funding, receiving input on how to conduct the trial from all partners, translating all of the questionnaires, getting the systems in place to use the smartphone technology across Europe and training the clinicians across the many clinical sites was completed.

"It all started in February 2014, and it is a five-year study. In the first year, the focus was on adapting the technology for different European settings and languages. Now, we are in the pilot phase: people are testing the technology and using it in clinical sites across Europe, from Norway to Greece, and in the UK and Ireland. Because the technology is very easy to use, and complies with data governance and security requirements, we find that the integrity of the data is very good. A clinical trials centre is also involved to ensure that we have high-quality data," says Maguire.

At the end of the project, it is hoped that eSMART will have demonstrated the effectiveness of delivering patient-focused, anticipatory care using mobile technology to improve outcomes for people with cancer, while also showing how such a data-gathering infrastructure can address the issue of increasing demands on acute services across Europe.

Next step on the mHealth road

Concrete improvements in clinical processes, enhanced patient outcomes, improved patient quality of life, and a reduction of social and economic barriers in cancer care all seem likely to emerge from the eSMART project but, in a broader sense, it will also add momentum to the move towards mHealth.

"The use of mHealth is growing - and it needs to. We have an aging population with increasingly complex healthcare needs and, often, complex morbidity where patients are not only dealing with cancer but also other conditions. This is a problem for the whole world, and eSMART, because its scale is Europe-wide, will provide valuable insight," says Maguire.

"The self-care agenda has been there for more than ten years, and we expect patients to be active partners in their care. With technology like ASyMS, patients will get useful, simple and immediate information for self-care. It can make a real difference in patient outcomes. It moves healthcare away from the paternalistic approach it has had in the past towards more community-based care.

"We also need to have the right technology in the workforce to optimise patient outcomes. Some people in the workforce have not been brought up in the technological age, so they need training to engage with mHealth or there could be a risk to future innovation."

Changes in the communication infrastructure will also have a bearing on mHealth, which depends on data connectivity, among other things, for effective remote patient monitoring. The emergence of 5G - the next major phase of mobile telecommunications standards - will dramatically increase the rate of data transmission for many users of mobile devices and could help to ensure reliable links between mHealth components. This would be a big step towards personalised medicine.

"Back-end systems and interoperability are crucial," says Maguire. "Systems need to talk to each other to enable the use of real-time daily data in the delivery of personalised care; mHealth is a very powerful tool in that," says Maguire.

The potential benefits of eSMART - and mHealth in general - have certainly focused the efforts of those involved and, for Maguire, it is that human element that is every bit as important as the technological factors.

"We are fortunate to have a very motivated group around mHealth in cancer care. All of the partners in eSMART are very engaged in innovation. The cost-benefit analysis is very important, and the analysis of that element is led by King's College London, but it ties in with better results for patients.

"Measuring symptoms in real time picks up risks early in their trajectory, so there will be more low-level interventions and more community-based care, while there will be fewer hospital admissions. That is the hypothesis."

Constructing the eSMART study

The project group works with expert partners in health and academia. These are: the University of Surrey; the University of Athens; King's College London; University College Dublin; the University of California, San Francisco; the European Cancer Patient Coalition; the Medical University of Vienna, Austria; Sykehuset Innlandet Hospital, Norway; NHS24; Docobo; and the University of Dundee.

The eSMART project consists of seven work packages (WPs):

WP1: integration of the Advanced Symptom Management System (ASyMS) within different healthcare systems across Europe
WP2: demonstration of the effects of ASyMS on patient outcomes during chemotherapy treatment
WP3: demonstration of the sustained effects of ASyMS in the year following completion of chemotherapy
WP4: changes in clinical practice following the introduction of ASyMS
WP5: predictive risk model to deliver personalised care
WP6: dissemination and exploitation
WP7: management.

There are 14 clinical sites involved in deploying ASyMS technology to patient groups across Europe:

UK: Clatterbridge Cancer Centre, Wirral; Mount Vernon Cancer Centre, Middlesex; Guy's and St Thomas' Hospital, London; Royal Surrey Hospital, Guildford; and St George's, University of London.
Ireland: St James's Hospital, Dublin; St Vincent's University Hospital, Dublin; St Vincent's Private Hospital, Dublin; and University Hospital Waterford.
Norway: Lillehammer Hospital.
Austria: Medical University of Vienna.
Greece: Metropolitan Private Hospital; Air Force General Hospital; and Agii Anargiri General Oncological Hospital of Kifissia.

Patients could report real-time data daily through mobile phones.


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