THE QUESTION: WHAT EXACTLY IS “TELEMEDICINE?”
By: Edward Triebell
A web search using LEXICO defines telemedicine as “The remote diagnosis and treatment of patients by means of telecommunications technology.” The World Health Organization (WHO) refers to telemedicine as “healing from a distance; it is the use of telecommunications technology and information technologies to provide remote clinical services to patients.”
This technology makes it easier for patients who have difficulty traveling to receive health care. It can offer those living in remote or rural areas access to a specialist not otherwise available. It also has the benefit of potentially saving patients time when compared to an in-person appointment.
As a person who has been in the telecommunications industry for the past 30 years, what this definition reveals is “telemedicine” has been around for a very long time. In my lifetime, the original applications of telemedicine began with simple phone calls to your local family doctor’s office about feeling sick or your child having a fever and being given a diagnosis and plan to address that illness. As the healthcare industry has moved to adopt technology solutions, the range of telemedicine services has expanded significantly.
Last year, when I felt like I had the onset of the flu, I went on-line to the web portal of my “private, nonprofit, integrated health system” provider here in San Diego, filled out a questionnaire about my symptoms and within a day, got an e-mail with a diagnosis of a viral infection with recommendations for care including them sending prescriptions to my local pharmacy to pick up.
Recently, the healthcare industry has provided “virtual visits” with your doctor or a nurse from your computer or mobile phone as a way to have immediate access to a medical attention. Many of us may have seen the TV commercials from United Healthcare when sleep-deprived new parents discover something unusual in their baby’s diaper, they know they need to talk to a doctor right away. The wife video chats with her doctor through UHC’s Virtual Visits service while her husband ices the shoulder he hurt while looking for her phone and falling into shelves. The doctor confirms the baby’s diaper contents are normal, . . . . . . . . . and so is the parents’ sleep deprivation.
So, in general, all of the above services, whether a phone call or an on-line, web-portal questionnaire followed be a diagnosis/treatment or a video chat with a healthcare worker are all “telemedicine” services.
You may have heard the term “telehealth” and wondered what is the difference between “telemedicine” and “telehealth?” From healthIT.gov, we have the following definitions:
“The Health Resources Services Administration defines telehealth as the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration. Technologies include videoconferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications.
Telehealth is different from telemedicine because it refers to a broader scope of remote healthcare services than telemedicine. While telemedicine refers specifically to remote clinical services, telehealth can refer to remote non-clinical services, such as provider training, administrative meetings, and continuing medical education, in addition to clinical services.”
THE NEXT QUESTION: WHAT ABOUT THE USE OF “TELEMEDICINE” IN CLINICAL TRIALS?
Recently, I have participated in several webinars with Subject Matter Experts (SMEs) from the clinical trials industry focused on decentralized clinical trials and specifically the impact of COVID-19 on traditional clinical trials. In these webinars, there are, of course, active discussions on the planned and hopeful use of “telemedicine” for the immediate needs of current clinical trials during this COVID pandemic to provide support of participating patient needs from their homes versus coming into a medical facility. This may be described as the forced “decentralizing” of traditional clinical trials.
The hopeful impact to the clinical trials industry is that this pandemic and the forced decentralizing of traditional clinical trials is the “tipping point” for a dramatic change in how clinical trials will be conducted in the future – from site-based clinical trials to decentralized clinical trials where patients remain engaged remotely as much as possible.
The Clinical Trials Transformation Initiative (CTTI) defines decentralized trials as those clinical trials executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model. They were originally called “virtual clinical trials” and that term has morphed into the more appropriate terms Decentralized Clinical Trials (DCT) and Decentralized and Remote Clinical Trials (DRCT); there was a belief that use of the term “virtual” created the perception that they were “non-real” in the strict interpretation of the definition of “virtual.”
Traditional clinical trials have required patients are required to travel to a hospital or participating clinician’s office be enrolled, for dosing, for wellness checks that may include complex diagnostic testing (e.g., X-rays, MRI scans, blood draws, etc.), completion of validated assessments (like the 6-minute walk test), and other treatments and processes.
Alternative approaches and solutions in the adoption of decentralize clinical trials include:
- Dispensing of investigational products (the drugs) by authorized carriers (USPS, FedEx or UPS or other global carriers),
- Home nursing visits for quality of health assessments provided by service organizations like Marken, Firma Clinical, MRN, and others.
- Use of mobile devices (phones and tablets) and computers to accomplish ePRO, eDiary assessments either through a mobile app or web portal.
- Video conferencing as a telemedicine service.
- FUTURE: Continuous collection of patient health data by smart wearable devices
So, in the purist definition of “telemedicine,” the clinical trials industry certainly has already started using telemedicine services in their relationships between patients and their clinicians using phone calls and e-mails. And the industry has adopted use of mobile phones for ePRO-based services to accomplish assessments and eDiary reports and adverse events. So, the real change in the use of “telemedicine” is the adoption and use of video conferencing now.
NOTE: Moving forward, when I say, “telemedicine,” the intended definition applies to video conferencing services between the patient and other medical professionals in the clinical trial.
THE CHALLENGE: WHAT IS NEEDED FOR SUCCESSFUL TELEMEDICINE DEPLOYMENTS
The deployment of video conferencing as part of a comprehensive telemedicine service offering is dramatically different than all the other traditional ePRO/eCOA and eConsent services which are more short-term usage-based interactions; the technical term is “bursty”.
Video conferencing telemedicine really needs to be viewed as the deployment of a “high bandwidth/high speed” private telecommunications network with a focus on the “NETWORK” for successful operation and acceptable Quality of Service (QoS).
What I have seen from my engagements with Sponsors and CROs, from the vantage point of a vendor selling a SaaS/PaaS software platform that includes telemedicine, is a lack of discussion and a full disclosure and understanding and appreciation and definition of the operational requirements of the NETWORK associated with the telemedicine service and the importance of the NETWORK between the patient and their pharma/CRO contact using the video conferencing service.
There are certainly short demonstrations of a vendor’s telemedicine platform in a tightly controlled operating environment and discussions on the possible use of telemedicine, in addition to discussions about the protocol, the ideas for patient engagement and continuity services and the use of video conferencing, but at some level, there appears to be a belief that NETWORK will always be available and network connectivity issues will not be a problem. THAT BELIEF IS A BIG RED FLAG!
When I was selling complex, multi-site, digital satellite communication networks that often included video conferencing services, an integral part of the design, the proposal, the deployment and the acceptance testing was focus on Quality of Services (QoS), Network Availability, and bandwidth (data speeds), and other technical operational and performance criteria. And of course, the discussion also centered on my company’s experience and successful deployments as a testament and validation to a history of success, both in terms of the technology solution and the skills/capabilities of the company. I have not seen this focus, yet, in the discussions with vendors of telemedicine offerings.
With clinical trials, this is challenging because the NETWORK is not owned by either the pharma/CRO or the vendor but uses public Internet Service Providers (ISPs) and mobile/cellular carriers with data services. However, that operational reality doesn’t really change the need to discuss and set expectations on operational processes and operational requirements that can be established to ensure success in the deployment of telemedicine/video conferencing services in clinical trials.
THE REALITY: THE NETWORK DRIVES THE QUALITY OF SERVICE FOR TELEMEDICINE
My career in global sales has allowed me to travel the world, to 69 countries to date, and what I have found is THE NETWORK IS ALWAYS THE ISSUE – whether it is the Internet service in my home, or the cellular network or the cellular data network, or the Internet service at the airport, or the Internet service in the airplane, or the Internet service in my hotel room, or my client’s offices.
Last year, I was on a pilgrimage in Italy and what I found during the two-week tour across Italy was available Internet services and Internet data speeds varied widely and paled in comparison to what was available in my hometown of San Diego, CA. I faced numerous technical and operational challenges in trying to get e-mails, to send files, to accomplish Zoom-based client meetings where I wanted to share overview presentations and live demonstrations of a SaaS/PaaS-based mClinical health platform. And often, the worst quality service for Internet access was in my hotel room and I would need to go to the hotel lobby or even out towards the roads for improved quality of service (higher data speeds).
Providers of Internet services always highlight their speeds, but what details they market is really limited to the download speed; rarely will you find detailed information advertised about their upload speeds and with telemedicine, it is the performance of the upload speed that matters!
Category: Healthcare, Uncategorized
