Tag Archive for: mobile health

September 2021 Digital Health Roundup

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More and more technologies, from gaming technology to artificial intelligence, are being used in the quest to beat cancer. Electronic appointments are helping with taking medicine, and steps are being taken to protect patient data.

The Federal Trade Commission (FTC) is working to combat breaches of personal data by making health apps more accountable when it comes to telling patients their data has been exposed, reports mobihealthnews.com. In a recently released statement, the FTC announced that health apps will need to notify users, the FTC, and possibly the media when data is compromised, and if they fail to make the notifications, they could be fined more than $40,000 a day. Learn more here.

Electronic directly observed therapy (eDOT) is a technology that is becoming more popular for providing medical services to patients, especially when it comes to taking medicine correctly, says ardorcomm-media.com. The eDOT appointments can be scheduled live, or they can be recorded. Providers can ensure that medications are taken properly and on time, and they can observe any side effects that may occur. Providers can also provide coaching or training during the appointments. The eDOT appointments require less time and resources than in-person visits. Find out more here.

Researchers are using 3D printing to create models of glioblastoma tumors, reports reuters.com. The models are made by taking part of the tumor from the patient’s brain and using it to print a 3D model of the tumor and then to fill it with the patient’s blood, creating a viable tumor. Researchers are then able to test how well various treatments will treat the tumor before they try them on the patient. Glioblastoma is the most common brain cancer in adults and is an aggressive cancer with poor prognosis. Learn more here.

Researchers have been inspired by gaming technology to create a virtual tool to study cancer, reports webmd.com. The tool, a virtual cancer tracker named Theia, for the Greek goddess of sight and clairvoyance, allows researchers from around the world to interact and study the cancer using 3D models and virtual reality. Get more information here.

A new type of artificial intelligence (AI) is being developed to detect lung cancer, says genengnews.com. It is a blood testing technology that can potentially detect over 90 percent of lung cancers. The test is called DELFI, which stands for DNA evaluation of fragments for early interception, and it can detect the fragmentation of DNA from cancer cells that circulate in the bloodstream. Researchers are hopeful that if lung cancer screening is as simple as a blood test, more people may get screened, and the cancer could be detected at earlier, more treatable stages. Learn more here.

Mobile Doctor’s Appointments? Do They Work?

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Dr. On Demand Dashboard

Dr. On Demand Dashboard

Hate the doctor’s office and don’t want to go to Urgent Care or the E.R.? There’s an app for that. Doctor On Demand is a mobile application that allows you to have a video appointment with a doctor from your own home. On their website they claim, “At Doctor On Demand we provide fast, easy and cost-effective access to some of the best doctors, psychologists, and other healthcare providers in the country. Our patients can have Video Visits with these providers on their smartphone or computers at any time of day.” Recently a friend of mine used this app for the first time because of a strange lump in her armpit, so I decided to sit in to see what it was all about and if it can actually replace an in-person visit.

Before

First thing you do is download the app, create an account, and fill out your health and insurance information. Then, you are given the option to choose a specific doctor or specific time. If you chose the specific time route, you are assigned a doctor. My friend chose a specific time and told me that it was a very easy, user-friendly process. To prepare for the appointment, you fill out all your symptoms and take pictures of your problem (if applicable) to have on hand. I asked my friend why they chose Doctor On Demand over a traditional doctor, Urgent Care, or E.R., and she said this way she won’t have to waste time stuck in a doctor’s office, could be seen quicker, and the appointment times worked better with her work schedule. However, she was hesitant because the doctor would not be able to feel or see the issue in person, which may affect the diagnosis.

During

Once your call begins, the doctor begins by reviewing your chart before coming on camera. Next, the doctor comes on camera and asks to explain the problem and the symptoms she was having. The appointment is set up like a FaceTime call. The doctor assigned to my friend was very friendly and attentive. This when those photos you took beforehand are useful because then she asked my friend to upload the photos for her to look at.

After

After the issue was thoroughly explained, the doctor was unable to diagnose what was going on without further testing. She did explain the several possibilities of what could be occurring and what tests may be needed. However, in the end the doctor did recommend that my friend go see a doctor in-person to get an accurate diagnosis.

Overall

In conclusion, my friend was reassured that it didn’t require immediate attention and that she shouldn’t worry. She also felt better and more relax about the few days it would be before she could be seen by a doctor. She and I would both recommend using Dr. On Demand, especially for the simpler alignments, such as colds, because the doctors are able to write prescriptions to your local pharmacy saving you the time wasted in a waiting room. My friend had this to say about her overall experience:

“This was a quick solution to put my mind at ease that something more serious was not going on before I was able to schedule an in-person doctor’s appointment”

Stay On Top Of Your Health – With The Help Of a Smartphone App

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After visiting the doctor, you are usually on your own. You are responsible for taking your meds on a regular basis and for keeping track of your symptoms. This can be challenging in everyday life – especially when you need to take more than one pill per day. According to a study by the World Health Organization 50% of all prescribed meds are either taken incorrectly or aren’t taken at all. But non-compliance can be fatal: in the US about 125,000 people die annually because of not following the doctor’s prescription[1]. This is why it’s so important to take your meds as prescribed and to keep track of your vitals and symptoms. But it’s also just as important to take over the reins when it comes to your health. Because it’s your body and your health you need to stay on top of it. I would like to introduce you to a smartphone app that can simplify how you manage your health – a digital assistant that helps you to stick to your treatment plan: MyTherapy.

[1] http://www.medscape.com/viewarticle/818850

MyTherapy_Reminder

I know exactly what you think: “Wow, just another pill reminder.” But MyTherapy is much more than that. MyTherapy is a health app that reminds you to take your meds, check your vitals and to get active. In short: with MyTherapy you have your whole therapy in one app. Therefore, the app translates your therapy into a simple to do list and motivates you to check off your tasks and to empty the list. The integrated scanner makes it easy to find your meds by scanning the barcode on your medication package.MyTherapy_Scanner

The built-in health report allows you to stay on top of your vitals. You can print your report and share it with your doctor. This is a great way for you to take your health into your own hands.

MyTherapy_Graph

MyTherapy is made in Germany and strictly protects your privacy: you can use the app without subscribing and your personal data won’t be shared with third parties. MyTherapy is free of charge and can be downloaded on the Google Play Store and App Store. The app is available in English, German, Spanish, French and Italian. Further, MyTherapy is developed in cooperation with patients and established doctors. They all work together to constantly improve the app. Several studies – among others with Germany’s largest university hospital Charité Berlin – confirm MyTherapy’s positive impact on medication adherence and its outstanding usability for patients of all age groups.

Can the Apple Watch Be the Next New Thing in Cancer Treatment?

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Apple watches are cool devices for checking email on the go and staying in touch. But researchers at MD Anderson Cancer Center wondered if they could also be a useful tool for helping breast cancer patients with their treatments.   This past December, a study was launched in collaboration with Polaris Health Directions who provided Polestar™, a health management app.

Participants in this trial will use the Apple Watch to answer questions about their symptoms, treatment side effects, and mood. The watch will also monitor physical activity, quality of sleep, and heart rate. The end result of all this monitoring? First, researchers hope to more accurately monitor each patient’s health during treatment, intervening earlier if needed. Secondly, cancer patients are undergoing huge lifestyle changes. The Apple Watch and Polestar app can help patients remembering drug ingestion schedules, and connect them with other patients who are experiencing similar challenges.

Cori McMahon, PsyD, director of Behavioral Medicine at MD Anderson at Cooper, “I think a huge piece of addressing the uncertainty felt by cancer patients is advancing their health literacy. When patients are able to monitor their own behaviors, they are able to better understand the correlations between those behaviors and how they are feeling, and even change those behaviors to improve their quality of life.” The hope is that cancer patients will feel more in charge of their medical journey. That has shown to increase positive thoughts and feelings – a definitely non-technological but time-proven aid to battling illness.

Across the pond, researchers at King’s College Hospital in London are also utilizing Apple watches and related apps in their own study. Cancer patients familiar with “chemo mind” will recognize the difficulty in keeping track of medication schedules. Thanks to a nifty feature on the Apple watch called the Taptic Engine, the cancer patient is gently reminded to take his or her medication by a soft pat on the wrist. This feature also monitors body temperature which helps doctors head off possible side effect complications quickly.

Both of these studies are concerned with patients feeling more in control of their disease management. As more cancers move from acute to chronic, lifestyle changes become very important in managing the disease. Thanks to products like the Apple watch and associated apps, patients can become more active drivers of their health – and surf the net as well!

References:

http://mobihealthnews.com/content/md-anderson-cancer-center-kicks-apple-watch-pilot

http://www.phillyvoice.com/cooper-breast-cancer-patients-use-apple-watches-aid-treatment/

http://mobihealthnews.com/43537/london-hospital-pilots-apple-watch-for-chemo-patients

Designing With The Patient in Mind

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Incorporating patient values, preferences and needs into digital health interventions.

“We are stuck with technology when what we really want is just stuff that works.” Douglas Adams, The Hitchhikers Guide To The Galaxy.

A new report by Accenture [1]reveals that just two percent of patients at hospitals are using health apps provided for them. The research, which assessed mobile app use among the 100 largest U.S. hospitals, found that 66 percent of the hospitals have mobile apps for consumers and 38 percent of that subset have developed proprietary apps for their patients. However, a mere two percent of patients at those hospitals are using apps provided to them. This staggeringly low figure represents an alarming waste of resources in the healthcare industry.

Accenture found that “hospital apps are failing to engage patients by not aligning their functionality and user experience with what consumers expect and need.” For example, only 11 percent of the apps surveyed offer at least one of three functions most desired by patients: access to medical records; the ability to book, change and cancel appointments; and the ability to request prescription refills. Brian Kalis, managing director of the health practice at Accenture, recommends that hospitals “must adopt a more patient-centric approach when developing new mobile health apps, or when revamping existing mobile apps.”

Respondents to a 2013 pilot study of 250 patient and consumer groups worldwide specified five main requirements of mobile health applications:

  1. Give people more control over their condition, or keep them healthy
  2. Be easy to use
  3. Be capable of being used regularly
  4. Allow networking with other people like them
  5. Be trustworthy

Whilst all patients rated these five specificities as important, the degree of importance varied. For instance, those with a long-term chronic condition, such as diabetes, specified that their top priority for a health app is to help them manage their condition; while people with a condition that affects personal mobility, such as a rheumatological condition, placed ease of use as a top priority for their apps.

As I wrote in a previous article, app developers appear to be motivated more by the cleverness of a technology than actual improvements in health outcomes. The lack of user involvement is one of the major reasons why health apps have failed to deliver thus far. We cannot design health care solutions or services without taking into account patient values and preferences and the context in which they live their lives.  If an application does not solve a real problem for the patient it will not be adopted.

The most successful health applications are those that understand the real-life problems that come with living with a condition and create solutions that meet real needs and make real impact. As Amy Tenderich, founder of Diabetes Mine has said, “we will use tools that answer our questions and solve our problems. We will avoid tools that help us do what you think we should do and we won’t use tools that add to the work of caring for ourselves.” Alex Butler, in an article entitled How To Build Successful Mobile Health Applications, wrote, “The question is not, ‘Does it solve a problem for the developer, or even the patient’s clinician?’ The real question is, ‘Does it help the patient directly?‘ If an application is in any way a hindrance, or adds any further time to the investment people must make into their healthcare, it will not be used.”

Craig Scherer, cofounder and senior partner of Insight Product Development, a design innovation consultancy that specializes in medical devices, consumer healthcare, and drug-delivery systems recommends an a design-approach which:

  • Understands the ergonomics and the physical experiences of how the device will be used
  • Curates the information that is most relevant to the user
  • Puts the device in the context of an user’s environment and lifestyle

Ergonomics concerns physical comfort and ease of use; curation means making the most importation information visible first; and finally, it’s important to understand how the device will work in the patient’s own environment. Developers must consider all aspects of the user’s interaction, not just the product itself. Adrian James, co-founder of Omada Health, a digital health company that designed a 16-week diabetes prevention program, recognized early on that one of the first steps in creating the company was getting user feedback – even before there was a product. “We’d walk with people through their homes,” James explained, “we’d hear their story, and then we’d put this concept in their hands and just let them tell us about what it was.”

Build It And They Will Come

An oft-repeated pattern reflects the pervasive notion that if we simply build a solution the “right way,” patients will embrace it. Not so. Dameyon Bonson, a national advisor on suicide prevention in Australia, is currently leading up a Movember funded research project using digital interventions to help men take action on mental health. He firmly believes “that there has been a rush to be ‘first’ to develop mobile health, taking the minimal viable product (MVP) approach a little too literally. MVP doesn’t mean serving up anything quickly; a lot of these mobile applications seem to have then been made ‘in a rush’. Evidence, and I mean good evidence, needs to support the development and I don’t think that (evidence) actually exists just yet. Simply automating what currently exists into mobile application, in my opinion is fraught with failure, and costly. Very costly. We are talking about the merging of two completely different worlds, mental health and technology.”

An app must seamlessly integrate into a user’s lifestyle to be accepted and well used; it needs to fulfill some kind of utility that is integral to our daily lives. It must also engage the end user. Dr Mitesh Patel and colleagues have recently argued that “the successful use and potential health benefits related to these devices depend more on the design of the engagement strategies than on the features of their technology.” Stanford behavioral health expert Stephanie Habif believes that emotional resonance is an important factor in designing successful health applications. “It’s not just enough to infect the brain and implant the knowledge”, she said, “You have to stir up the desire engine. You have to tap into emotion.”

Health Does Not Happen In A Silo

The most successful health applications understand the real problems that come with living with a disease or condition, and offer something that genuinely helps. A failure to recognize the complexity of health systems and the reality of patients’ lives will continue to lead to short-sighted digital health initiatives. It is patient input into a solution’s design, ongoing practice and evaluation that ultimately holds the key to the development and adoption of innovative therapies and clinical solutions that truly meet patients’ needs. After all, to quote Darla Brown – a cancer patient who co-created digital health company Intake.Me – in a Stanford MedicineX session on patients as entrepreneurs, “who knows better than the patient what will have the most impact on their ability to get and stay well?” Co-panelist, Michael Seres, a digital health entrepreneur and founder of 11Health, a connected medical device company, describes himself as a “digital entrepreneur by accident and necessity.” “I was in hospital post [bowel] transplant with a stoma [a surgically created opening from an area inside the body to the outside] that leaked and healthcare professionals asking me to measure output. I just assumed there was a solution, so I did what I assumed everyone would do. I asked other patients. Let’s face it the greatest under-utilized resource in healthcare is patients. We usually have a solution for a practical problem. One thing is certain; we understand the end user needs. 20,000 patients online told me that there was no real solution to my problems so I built one. I had one big advantage, I understood what I needed. It always amazes me that in healthcare we spend millions building solutions that the end users don’t want. Why? Well often we are never asked. Would Amazon build a platform without consulting the end user? Would GM produce a new car without understanding their consumer? So why do we do it in healthcare? At every step I consulted patients and healthcare professionals as to whether it made sense. It just seemed obvious to me to do it this way.”

We have now entered an age in which the digital world will revolutionize health care, much as it has done in other industries. Yet while digital technology is poised to transform healthcare, its full potential will never be realized unless stakeholders work alongside patients in co-designing solutions that will truly engage, enable, and empower the end-user. To quote the late Jessie Gruman, founder of the Center for Advancing Health, in an open letter to mobile health developers, “While I can’t promise you that consultation with us is the magic key to successful, well-used apps, I can tell you that without it, your app doesn’t stand a chance.”

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Resource Links

[1] Accenture 

Are We Ready for Mobile Health?

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Mobile health, also called mHealth, is a term used for the practice of medicine and public health supported by mobile devices. It is a growing industry fuelled by the rise in ownership of personal mobile devices. A new national survey shows that more than eighty percent of US residents between the ages of 18 and 49 currently own an app-enabled mobile phone. Fifteen percent of the population have purchased wearable devices that connect to their phones adding functionality such as tracking capabilities. These devices worn on the body or incorporated into garments and accessories such as wristbands and watches, have given rise to a development known as the “quantified self” movement. By routinely tracking everyday behaviors, such as sleeping patterns and activity levels, wearables aim to move individuals closer to better health habits. According to the International Data Corporation Worldwide Quarterly Wearable Device Tracker, wearable device shipments reached 76.1 million units in 2015, up 163.6% from the 28.9 million units shipped in 2014.  But beyond the hype of the industry’s claims about the scale of wearable technology, how ready are we to use them in a clinical setting?

In spite of all the buzz and excitement, the reality is that the industry is still at the early stages of development and adoption. Many doctors question the clinical value of activity trackers and struggle to know what to do with the deluge of data wearables produce. Recording individual numbers is of little value when there is no system to extract meaning from it and show how it all works together. In an online survey conducted in September 2015  just 5% of respondents indicated that their organizations were “very prepared” to develop patient insight from emerging data sources like wearables. Nearly a quarter indicated their organizations were “very unprepared” and nearly half called their organizations “unprepared.”

Providers have concerns about reliability, interoperability and reimbursement. Research conducted at UCSF Center for Digital Health Innovation compared the data reported by consumer wearable devices to relevant clinical gold standards in multiple studies over the past two years. It found that very few devices currently on the market perform with the reliability of a medical-grade device. It’s a key point to note. Most health-related wearables aren’t regulated in the same way as medical-grade devices. Physicians are not only worried about the accuracy of the data being collected, but also have questions about unauthorized device use and data leaks. Consumers also need to trust that the data collected in their health apps will not be used for other purposes of which they are unaware. We can add to these concerns the fact that most health apps are limited in functionality, operate in isolation from each other and are interoperable within existing healthcare systems.

Even for those consumers who see value, faced with a multitude of fitness trackers, the unregulated and fragmented world of mHealth makes it difficult to select applications that provide true health benefits. User retention is also an issue. According to an MIT Technology Review report, about two-thirds of consumers who have downloaded an mHealth app have stopped using it. There are further consumer concerns such as privacy issues, the ability to transfer data across platforms and software, high data entry burden and cost factors which also limit mHealth efficacy.

Given the questionable clinical relevance and poor usability scores, is mobile health technology of any real value in health care? While activity trackers can help you get fit, consumer wearables and apps have yet to be clinically proven. However, there is another type of health technology which shows more promise in a clinical setting. These target a specific clinical issue, for example a wristband which can detect seizures for people with epilepsy, a mobile app which helps manage cancer pain, a smart pill dispenser, and apps for monitoring post-operative quality of recovery of patients at home. A global survey conducted by market research company research2guidance, showed that people with chronic conditions are the most common target audience for app developers, and hospitals have replaced physicians as the second biggest target audience. A recent article in the Wall Street Journal reports that hospitals are developing mobile apps to help patients manage serious medical conditions and feed information back to their doctors between visits, often in real time.

Research conducted by Mayo Clinic showed that patients who attended cardiac rehabilitation and used a smartphone-based app to record daily measurements such as weight and blood pressure had greater improvements in cardiovascular risk factors. They also were less likely to be readmitted to hospital within 90 days of discharge, compared with patients who only attended cardiac rehabilitation. MD Anderson has also stepped up patient care with its new Apple Watch feasibility study. Its cancer center is distributing 30 Apple Watches to patients in various stages of treatment for breast cancer. An app called emPower will run on the Apple Watches and the users’ phones. Patients will use the device to answer quick multiple-choice questions about their mood, symptoms, possible treatment side effects (like headaches or nausea), and more. The provider will also use the device to capture activity and heart rate data to help them anticipate potential issues before they worsen and intervene sooner.

Apple’s release of its ResearchKit earlier this year opens up a promising avenue to extend mHealth applications to medical research. ResearchKit is an open-source set of tools that researchers can use to create a clinical research study. It can facilitate unprecedented, real-time access to potentially tens of millions of people, who will participate in research by submitting data through their iPhones. Within a day of launching, 11,000 participants signed up for a Stanford University cardiovascular trial. Stanford said at the time that it would normally take a national year-long effort to get that kind of scale.

What makes a health app successful?

Developers appear to be motivated more by the cleverness of a technology than actual improvements in health outcomes. A new study from the New York University School of Medicine Department of Population Health reports that only 29% of smartphone owners using health apps say the apps have made a big impact on their health. That’s compared with 60.3% who see little to moderate improvement and 10.5% who say their health did not improve or even declined. A recent global study which analyzed the views of patient and carer groups to determine what they want, but are not getting from current apps, reported that respondents wanted an app which provides trustworthy, accurate information alongside a guarantee that their personal data are secure. Respondents also wanted more meaningful and timely communication with their healthcare provider, including the ability to easily schedule a doctor’s appointment, or refill a prescription. Other factors included the ability to self-manage and make informed choices, taking into account different levels of health literacy and differing patient experiences with a medical condition or user experiences when health.

What can developers do to improve the current design and broaden the appeal adoption of mHealth applications?

The involvement of end users during the process of inventing and designing new technologies is a critical success factor. We cannot design health care solutions or services without taking into account patient values and preferences and the context in which they live their lives.   The lack of user involvement is one of the major reasons why health apps have failed to deliver thus far. Developers should involve patients, carers, and healthcare professionals at each stage of the app’s development, making sure it is in line with their needs. If an application does not solve a real problem for the patient it will not be adopted. The most successful health applications are those that understand the real-life problems that come with living with a condition and create solutions that meet real needs and make real impact. This can only be done by co-creating applications with patients and their carers.  It is patient input into a solution’s design, ongoing practice and evaluation that ultimately holds the key to success. After all, who knows better than the patient what will have the most impact on their ability to get and stay well?

mHealth Potential and Pitfalls

The rise in mobile and wireless technologies has the potential to transform the way healthcare services are delivered, particularly in the management of chronic diseases. Numerous studies have shown that patients who are “activated” in their care experience better health outcomes at lower costs compared to less activated patients. By creating an ecosystem of connected, wearable devices, we can deliver more timely care and monitor patient activity in real-time, thereby reducing hospital readmission rates, improving outcomes, and delivering cost savings. Global consulting firm Accenture recently conducted a study revealing that the United States would save approximately ten billion dollars annually with the introduction of a wider range of digital health services.

Mobile health technologies also have the potential to make healthcare more patient-centric, shifting the balance of power in the patient’s favor. Instead of being solely dependent on health providers, patients can manage their health more proactively. A new study presented this month at the American Medical Informatics Association conference in San Francisco reports that mHealth makes patients feel empowered in caring for their diabetes, leading to tangible health improvements in just a few weeks, as well as a heightened sense of control.

But for health consumers to fully tap the benefits of mHealth, the technology needs to be able to provide meaningful and actionable insights, alongside a UX that is easy and engaging. The value of an app or wearable will remain limited if it does not provide access to actionable data. Tracking metrics in isolation is not enough; you also need to know how to extract meaning from the numbers to turn data into smarter health decisions.

Key factors for adoption by providers and payers include technical support for integration, creating practical reimbursement models and ensuring interoperability within and across healthcare systems. The National Health Service (NHS) in England has begun to address issues of app curation and evaluation by creating its own apps library of health issues. By giving them official backing the NHS hope to give clinicians, patients and carers more confidence in using health apps. In the US two new academic partnerships are set to tackle app curation The MIT/Harvard partnership, Hacking Medicine Institute, believes the most effective apps will be chosen by consumers, not their doctors. Meanwhile a partnership between Columbia University’s HITLAB and Las Vegas-based Social Wealth is focused on putting apps through a rigorous set of standards.

As the mHealth market matures and standards improve, clear winners will emerge. The industry needs to shift its focus on delivering clinically effective tools that make a real impact in the lives of individuals. Only then can we truly declare mHealth a game-changer in health-care.

Can Digital Wearables Help in Clinical Trials?

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Today’s healthcare consumer can log and produce a range of data through wearable devices, smart fabrics, and intelligent sensors that are worn on the body or incorporated into garments and accessories, such as wristbands and watches. To date, wearables have been limited to tracking information related to health and fitness, but as the technology behind wearables for healthcare evolves, there is a growing interest in its potential in medical settings. New wearables show promise for addressing a range of medical conditions from diabetes to dementia. When applied to clinical trials, wearable technology is a potentially powerful research tool to gather clinical data in real-time and provide remote patient monitoring.

digital wearables

photo from http://www.alivecor.com/home

The clinical trials process could be optimized by leveraging existing smart technology, such as electrocardiogram (ECG) monitors like AliveCor, which enables anytime recording of ECGs; and smart pill technology (also known as “ingestibles”) which allows for both wireless patient monitoring and diagnostic imaging. Digital health company Proteus Digital has developed FDA approved wearable and ingestible sensors that work together to detect ingestions and physiologic data. The sensor is taken alongside medications, and is powered by the body’s biochemistry. The patch, body-worn and disposable, receives the data from the ingestible sensor, tracking medication-taking, steps, activity, rest, and heart rate and forwards that information to a Bluetooth enabled mobile device. If life science companies can get enough insight early in development, they can potentially create a more efficient drug development process and prioritize resources for the most promising therapies, with the goal of getting effective drugs to market faster.

Clinical use adoption will depend on ease of use, relevance and accuracy. Google’s life sciences division at Google X is in the process of developing a wearable health sensor specifically for use in clinical trials. The developers, who have already created a glucose-sensing contact lens, want to see how a continuous stream of medical-grade measurements of biological signals could be used to help earlier diagnosis or intervention in disease. The prototype wrist-worn sensor measures pulse, activity level, and skin temperature, alongside environmental information like light exposure and noise levels. Right now, it isn’t clear how Google’s prototype device will collect, analyse, and interpret data and incorporate information into a clinical trial data feed.  Issues of data standards and security will also need to be worked through. Google is in the early stages of the project, which will work with academic researchers and drug makers to test the wristband’s accuracy and seek regulatory clearance in the U.S. and Europe. The project will also draw on Google’s ongoing Baseline study, a medical and genomics project involving Stanford University and Duke University, which aims to map a healthy human body. Google Baseline will use a combination of genetic testing and digital health sensors to collect “baseline” data on healthy people. The project aims to establish genetic biomarkers relating to how we metabolize food, nutrients and drugs, how fast our hearts beat under stress, and how chemical reactions change the behavior of our genes.

Google’s wearable prototype, and other similar existing wearable devices, could give researchers insights that are currently only available intermittently (e.g. via a diagnostic test, or when a patient is being observed in a clinical setting).   Using sensors and wearables, drug efficacy and clinical trials outcomes might be better assessed through a variety of data points. It also allows for more objective measurement of data. For instance, obtaining objective metrics of hours of sleep in a clinical trial can be difficult to measure in a traditional trial setting when patients record this information at home. Being able to measure hours of sleep objectively through a wearable device could provide more complete data, although researchers still need to consider the context within which all data is captured. Having structured analysis of supplementary data may provide the additional evidence needed to show the benefits of a certain drug. However, more data does not necessarily translate into better data. The use of a wearable device alone does not add value to the clinical trial process. The real value lies in the ability to extract raw data and leverage real-time analytics to monitor trial progress in the moment, thereby facilitating early intervention which may reduce trial risks. In addition, continuous tracking of vital signs outside of a laboratory provides patients with better support through remote patient monitoring. Wearable technology’s transformative potential therefore lies not with the wearable itself, but with the real-time response to the data it collects.

As the healthcare ecosystem continues to shift to patient-centered care, a key consideration in designing the clinical trial of the future is the ability to make the process highly responsive and seamlessly connected to the patient’s every-day life. Currently the clinical trials process is inconvenient for participants; both in terms of time spent travelling to and from the trial location, and the time required to log physiological and drug reactions. Wearable devices can reduce the number of times patients need to go to a clinic and can provide a better, fuller picture of physiological data needed to measure a drug’s impact. Medidata and Garmin are collaborating to use Garmin’s activity tracker —the vivofit — in clinical studies. The vivofit measures steps taken, calories burned, and hours slept to capture patient data during clinical trials 24/7, without the need for clinic visits. The clinical trial data it collects is integrated with the Medidata Clinical Cloud repository that includes information such as vitals, medical histories, laboratories, and adverse events. Used in this way, wearables not only lead to increased data, but through remote monitoring, can reduce interruptions in a volunteer’s day.

Clinical trials are often criticized for not being sufficiently patient-centric. Innovating through the use of wearable devices can address this challenge by streamlining the process and creating greater patient engagement. The Clinical Innovation team at Eli Lilly recently offered a glimpse into the future through an interactive and immersive clinical trial simulation for Stanford Medicine X conference attendees. The team highlighted design considerations for remote clinical trials, as well as working prototypes for a mobile patient trial app, provider trial app, and a medical-grade biosensor. In order to contextualize and make data actionable, the design team at Eli Lilly is working on a closed-loop system that triggers an alert when certain metric points are activated, thereby allowing for real-time adjustments to be made.

Making the clinical trial process more convenient and connected through wearable devices could potentially explode the sample size of clinical studies, not just numerically, but also in terms of diversity – gender, ethnic, geographic, economic. We might then begin to get a more stratified picture of individual variation; hard to do with current methods of traditional clinical studies. The large uptake of Apple’s ResearchKit (an open source software framework for app development) on its release earlier this year, signals a greater willingness to take part in research when tools are designed to make participation easier. Within a day of ResearchKit’s launch, 11,000 volunteers signed up for a Stanford University cardiovascular trial; an unprecedented uptake. At the time, Stanford said it would normally take a national year-long effort to get that kind of scale.  However impressive these numbers are, a large test sample only matters if there are enough quality results. Furthermore, diversity is compromised if lower socioeconomic populations are excluded through restricting sampling to people that are iPhone users. If the very people who tend to be most affected by chronic diseases are excluded, research will be skewed toward a demographic that is markedly different than the one typically affected by the target disease. Still the future looks hopeful. With any study, there are challenges around how representative the study cohort is. The expectation is that smartphone apps, wearable devices, and biosensors can make the clinical trials process more responsive to volunteers, expand recruitment, and make the data source richer.

Challenges and Opportunities

The clinical trial of the future will increasingly take place outside the walls of the clinic. Tailored to the patient’s lifestyle, wearables can lead to increased patient engagement and ultimately bigger and smarter data. Trial volunteers will wear a device that continuously measures their activity and provides a complete picture of movement without having to disrupt their day. Physicians and researchers will have access to a much richer, more objective data set, thereby providing a real-world, real-time measure of patient physiology and how a drug affects quality of life. This will allow us to have a more holistic view of the patient than we have ever had before.

Wearables are emerging as a tool for creating a more responsive and efficient clinical trial process. At the same time, wearable devices can increase the volume and speed of data collection through a more seamless collection of large quantities of longitudinal physiological measurement data. This approach to clinical trial management promises to significantly change how trials are conducted and increase the value of trial data. However, the challenge lies in how to unlock the data’s value to make it more actionable, contextualized and meaningful. How will researchers turn the sheer volume of data they collect into quantifiable safety and efficacy measures and endpoints? At this point wearables don’t yet offer the type of medical or diagnostic-quality data that’s necessary for most clinical trials. Researchers must ensure not just accuracy of data, but also be able to evaluate and identify the data pertinent to the clinical trial outcome. For instance, a sleep monitor on its own cannot contextualize the reason why people wake up – they may be having an asthmatic attack, or a bad dream, or simply need the bathroom, but the monitor registers each of these instances as the same event. Or take the scenario of a trial participant who transfers his/her activity tracker to someone else – what would happen to the validity of the data in this case? How can researchers handle patient device use and adherence variability?

Stakeholders must work together to determine how to best deploy wearable devices to patients, define standard use, mitigate variability of use, link the data from these devices to traditional clinical data, account for data collection in a non-controlled environment, and maintain privacy and data security. With much work still to be done to scientifically evaluate the real impact of wearables on clinical trial data, regulatory compliance in collecting clinical data outside of a controlled research environment is an on-going challenge. Wearables offer an opportunity to disrupt the clinical trial process, leading to a radical redesign of patient-centered clinical trials.  For now, we must learn to balance the hype which surrounds wearable technology with the operational and design challenges posed by standardizing and controlling the data collected for use in clinical trials. Focusing on these challenges will help to ground wearable technology in the reality of what is achievable, while the industry takes its first steps on the path toward designing next-generation clinical trials through wearables, and ultimately new ground-breaking drugs and treatments.

Clinical Trials 2.0: Reinventing Research For The Social Age

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Clinical research is changing. No longer the sole preserve of clinicians and researchers, the Internet and new digital technologies are reinventing the way in which patients take part in the clinical trials process.

In the past decade there has been a revolution in how patients access health information. The Internet is increasingly the first port of call on our health-seeking journey. According to Pew Research Center’s Internet and American Life data, one in three U.S. adults have gone online to figure out a medical condition; 34% of Internet users have read someone else’s commentary or experience about health or medical issues on an online news group, website, or blog; and 18% of Internet users have gone online to find others who might have health concerns similar to theirs.

“Clinical research” is among the most-searched terms on the Internet; yet every year hundreds of trials are delayed or abandoned because they can’t recruit enough patients. Poor rates of trial recruitment are a major obstacle to the successful and efficient completion of clinical trials. Insufficient recruitment of study participants may result in losing the statistical power of a predictive conclusion, as well as prolonging the time it takes to get the trial drug to market. Oncology trials in particular are failing to meet enrollment goals, with most delays in conducting trials stemming from recruitment. 85 percent of cancer patients don’t know trials are an option. 55 percent of clinical oncology sites fail to get a single patient because they simply can’t find them and one third of trials fail to recruit a single patient1.

Given that enrollment into a clinical trial is frequently the best treatment option for patients with cancer, how might we make more patients aware of the benefits of clinical trials? Combining the power of new technologies with social networking and patient activation is our best chance at galvanizing the process of patient recruitment, and perhaps even an opportunity for us to completely reinvent the process of clinical research itself.

The world-wide web has opened a window to the world of clinical research. With the click of a mouse, we can now access information on the latest trials, download medical information to our portable devices, connect with researchers in real-time, and find other patients with the same condition. Dedicated websites such as the U.S government’s ClinicalTrials.gov site, and the World Health Organization’s International Clinical Trials Registry Platform (ICTRP), help patients easily find information on clinical trials. The launch of these sites represented a paradigm shift in clinical research; information that had once been closely guarded is now available to all. Some other note-worthy websites include The Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to educating and informing the public about clinical research; and clinical trial recruitment sites, such as ClinicalConnection, TrialReach, EmergingMed and CureLauncher which exist to match eligible patients to appropriate trials. A new digital platform Cure Forward uses a patient’s uploaded genetic sequencing to connect cancer patients to clinical trials. The site, which is currently in beta, also offers cancer patients more information on the mutations and treatments available in “gene stories” specific to their genome.

Mobile applications can be downloaded from the Apple and Google Play Stores to give patients real-time access to current information about cancer clinical trials. This is opening up opportunities for better medical treatment and care, and allows those in regional and remote areas equal access to clinical trial information.  Some sites, such as the Novartis Clinical Trials website provide users with an interactive tool for finding relevant trials taking place near their location. A GPS search function allows users to see all the trials taking place in their country by location. For those looking further afield, the Novartis site features a global search function that displays clinical trials taking place in any country.

Popular social networking sites such as Twitter, Facebook, and YouTube are being used, alongside dedicated social media patient communities, to raise awareness and encourage wider participation in clinical research. The TrialX site encourages patients to send a tweet to @trialX, preceeded by “CT” describing the type of clinical trials they are seeking. Dr. Susan Love Research Foundation’s Army of Women Program (AOW) taps into the power of its social networks to mobilize research into the causes of breast cancer.

 

“The word Army, which means a large group of people united for a specific purpose, quickly and clearly describes who we are. The image of us all joining in a virtual Army to get this done is a powerful one” – Dr. Susan Love Research Foundation.

 

 

The traditional methods of advertising clinical trials through print media, brochures or poster displays, meant geographic limitations narrowed the pool of potential recruits. Using popular social networking sites, researchers can now accelerate the recruitment process by extending their social reach to take in a global pool of potential recruits. According to US hospital group, Mayo Clinic, social media is especially effective at recruiting patients for its studies into rare diseases. Social media and online networks could help researchers assemble large and demographically diverse patient groups more quickly and inexpensively than traditional outreach methods. “Patients with rare diseases tend to find one another and connect because they are searching for information and support,” says Mayo Clinic’s Marysia Tweet, M.D. “Studies of rare diseases often are underfunded, and people with these conditions are quite motivated.”

One such motivated patient is Katherine Leon, an SCAD (spontaneous coronary artery dissection) survivor, who was determined to find the cause of her disease, and prevent it from happening to others. At the time of her diagnosis, SCAD, a traumatic cardiac event that affects fewer than 200,000 Americans, was a poorly understood and under-researched condition. Physicians had no clinical studies on which to base treatment plans. Leon connected with fellow SCAD survivors through social media and used their collective voice to launch research at the Mayo Clinic. The study recruited 18 participants in less than a week, six more than could participate in the initial study of 12 patients. This rapid enrollment of participants through social networking served as proof of concept for future research studies to harness the power of highly-motivated patient communities. Leon credits social media as a key research accelerant. “Social media absolutely gets the credit for making scientific study of SCAD possible” she says. “In 2003, my cardiologist told me I would never meet another SCAD patient. It was just too rare. Today, I “know” more than 1,000 fellow survivors thanks to Inspire, Facebook ‎and Google. These patients are connected to the clinical trials immediately — at hello!”

Harnessing this dynamic combination of new digital and mobile platforms, social media, and activated patients offers an unprecedented opportunity for patients and researchers to find each other with greater speed and precision, which in turn can speed up the process of recruitment to clinical trials.

Peer-To-Peer Education

The ability to engage interactively through social media further enhances the benefits to patients. Reading information in a brochure doesn’t compare to the ability to interact and ask questions in a social networking site. What is it really like to take part in a clinical trial? Would you need to travel? Will it incur any personal expenses? What kind of side-effects might you have? Trial sponsors can respond in real-time to these questions, thus speeding up the recruitment process. In addition, patients already enrolled on the trial, can provide personal insight into what is involved. One patient, who has participated in two Phase 1 clinical trials, said that he was motivated to sign up for them, by reading others’ stories online. Hearing about the experiences of others who had participated and “come out the other side” encouraged him to take part.

Sometimes there can be an open sense of distrust about the nature of clinical trials – a fear on the part of some that they will be treated as a “guinea pig”. For patients who may be wary of research agendas (particularly when pharma-led) peer-to-peer education is a vital ingredient in building trust and confidence in clinical trials. Patient advocate, Stacey Tinianov believes “there is great value in patients and caregivers leveraging the connected platforms to educate themselves on the benefits and realities of clinical trials. Learning patient to patient is often more accessible for a variety of reasons, not the least of which is a certain trust”.

Moreover, social networking has the potential to empower patients and care-givers with a greater sense of control. All too often, patients who face serious illness can feel isolated and powerless; joining an online community can help enormously. By exchanging coping tips, offering encouragement and support, and sharing information on the latest clinical research, patients feel a greater sense of agency. Breast cancer survivor Diane Glassmeyer, took part in a Sierra-Stanford study of the effectiveness of support groups conducted via online video. The randomized clinical trial was designed to help researchers determine whether this type of video-mediated support group improves the well-being and quality of life of breast cancer patients who live in rural areas. Glassmeyer described the Skype Support Group as “an amazing experience to be able to see and talk to everyone in the group each week from all over the state”.

The role of the care-giver must not be overlooked in peer-to-peer support. Half of health information searches within the U.S. are on behalf of someone else. In the case of late stage oncology, or a paediatric trial, the caregiver’s involvement is imperative. We need to focus more on establishing communication and maintaining an on-going relationship, not just with the study participant, but with all involved in care-giving for the patient. Patient advocate, Andrea Borondy Kitts, a care-giver for her husband with lung cancer, says: “For the patient (my husband did not go on-line but I did) it was great to have technical help and sharing of latest research. I found out about Lucanix on the Inspire website and pursued it. When I needed to help my oncologist with the process of getting FDA approval for individual patient compassionate use, one of the Inspire members had the whole process documented and shared it with me”.

When Borondy Kitts’ husband was considering a clinical trial, she was able to get information from people with lung cancer about their experience, including side effects, with an experimental drug.  “When my husband had horrible side effects to his supposedly gentle chemo in Phase 3 clinical trial,  (Alimta /Pemetrexed), I found out from social media that many others had similar experiences and I also got tips on how to manage the side effects. My oncologist did not have enough patients in the trial to have observed these effects”.

 ePatient Reported Outcomes

Capturing Patient Reported Outcomes electronically (ePRO) through the web or mobile devices, offers a way to interact with trial participants, while also capturing critical data. Although patients for the most part face little or no restrictions on reporting their outcomes via social networking sites, there are some concerns about how this might affect the trial’s validity. Patients self-reporting on their trial treatment online and comparing notes with others may potentially jeopardize the trial. The exchange of personal experiences whilst enrollled in clinical trials can lead to patients (or any researchers on the same social network) to inadvertently “unblind”* themselves, leading to knowledge of treatment allocation. Concealment is crucial for unbiased reporting of results, and disclosures by one patient might unintentionally distort another patient’s awareness of their own symptoms, potentially skewing data reporting and potentially invalidating study results. The intersection of free speech, social media, and clinical research is still unchartered waters. Borondy Kitts, believes that while guidelines can be implemented to safeguard data integrity in a blinded trial, “for unblinded trials there should be very few limits on what can be shared.”

Patients Are Doing It For Themselves

The communication process which traditionally flowed from pharmaceutical companies to physicians to patients has been transformed by social media. Patients, who have traditionally relied on their doctors for information about the latest clinical research, are now realizing that information may be more readily found in their online patient communities. After she progressed following chemotherapy and radiation, Janet Freeman-Daily, a lung cancer survivor, took it upon herself to do her own research.

*A blinded study is a study done in such a way that the patients or subjects do not know (is blinded as to) what treatment they are receiving to ensure that the results are not affected by a placebo effect (the power of suggestion).

She found a molecular testing trial listed on ClinicalTrials.gov, and contacted trial sites until she found one accepting patients. The University of Colorado Cancer Center (UCCC) agreed to test her existing biopsy samples. Unfortunately, all her tests were negative.  However, she learned about more options online.  “Another patient told me I fit the profile of patients who had the ROS1 translocation,” said Freeman-Daily. “I was relatively young, had adenocarcinoma, was never a smoker, and tested negative for the three most common mutations.  He told me about the ROS1 trial, which he was in, and sent me the journal article with initial results as soon as it was published. However, my home hospital had not heard of ROS1, and did not know how to test for it.”  After she progressed following more chemo and radiation, Freeman-Daily contacted UCCC again and learned they had recently developed a test for ROS1.  This time her tissue tested positive, and she entered the ROS1 clinical trial in Denver.

Kathi Kolb describes the process of searching for a clinical trial after her diagnosis of cancer: “I searched the database of the National Cancer Institute and found a Phase 2 clinical trial to test a new medication to treat cancer-related fatigue in people with breast or prostate cancer. I had been doing a lot of research on the subject because I was suffering from horrible fatigue myself. Once I found a trial that fit and was close enough for me to get to, I followed the links provided and researched the cancer treatment center where it was taking place, as well as the clinicians in charge of the study. I was able to make initial contact with them by email. It was a really good experience overall.”

Janet Freeman-Daily, Kathi Kolb, Andrea Borondy Kitts, and Katherine Leon are part of a growing number of ePatients, empowered by the Internet and emerging new technologies, who are leveraging their online communities to drive and support the research agenda. From providing input into study design protocol, to raising awareness of the value of clinical trials and recruiting trial volunteers, patient influencers play a key role in accelerating the new research paradigm. AnneMarie Ciccarella, a patient advocate who serves on the Love Foundation Army of Women (AOW) Scientific Advisory Committee, believes patients have a valuable role to play in trial design. “The thing that interests me the most is trial design and having patients part of that process” she said. “Some grants require a patient advocate on the proposal. In some cases they are actively involved in the study design; in others, the researchers scramble to find an advocate before the submission deadline. I’ve participated as an advocate on a funded grant, possibly at the top of the list of things that mean the most to me. It’s about bringing patients and PIs [Principle Investigators] to the table when the questions are being formulated – a step ahead of actual trial design”.

The Future Is Social

 Ciccarella also serves on the advisory board of CureClick, an online platform which uses the power of crowdsourcing to share clinical trial information. As part of a group of key patient leaders, she helps recruit trial participant across all diseases. This new model of leveraging trusted patient leaders to educate their online communities about the benefits of clinical trials can do much to improve trial recruitment goals. CureClick ambassador Debbie Woodbury, explaining why she joined its advisory board, said: “I started working with CureClick early this year and serve on its advisory board because I feel that too often cancer patients find themselves in the curious situation of having too much, and too little, information. Many patients I’ve spoken to are overwhelmed with treatment decisions, and yet receive little to no information concerning clinical trials. The beauty of CureClick is the ease with which plain language information is shared peer to peer on social media, resulting in greater participation. It’s a win-win for everyone and I’m proud to be a part of it”.

The need for a faster and more globally scalable approach to trial recruitment, planning and design, is clear. To address challenges such as public awareness and understanding of clinical trials, increased competition for patients and decreased effectiveness of traditional advertising, requires new solutions. Social media are a key part of the solution. Social media offers patients greater accessibility and convenience of communication and information. For researchers, social media offers a unique opportunity for innovative trial recruitment modalities, increased efficiency and accelerated research outcomes. People are social creatures by nature; harnessing our innate desire for connection, to new information, social and technology platforms is the best chance we have to drive the next generation of research forward.

Refs

Malorye A. Can web 2.0 reboot clinical trials? Nature Biotechnology 27, 895 – 902 (2009).