Dr. Kevin Sheth, one of the lead investigators in this trial and a member of the C3O Telemedicine’s clinical team has been researching avenues to reduce complications following an acute stroke. One major contributor to poor outcomes after a stroke is brain swelling and was found to be reduced by intravenous glyburide treatment according to phase 2 clinical trial. The information collected from the study is further used for other phases of clinical trial.
Accumulation of excess fluid in the brain may cause brain swelling. This usually occurs during stroke which is mainly due to a blockage in the blood supply to the brain. Swelling in the brain may increase pressure and pushes the brain out of the skull resulting in 50% of the mortality rate. Surgery procedures like hemicraniectomy ( removing a portion of the skull to reduce swelling) may not be possible with all patients and treatment using drugs may also be less effective.
According to previous animal studies, glyburide utilized in the treatment of diabetes was found to reduce brain swelling in stroke patients. The phase 2 clinical trial for glyburide was sponsored by Remedy Pharmaceuticals following a pilot study conducted by Kimberly and co-author Kevin Sheth, MD, Department of Neurology, Yale University School of Medicine, which reported that glyburide was found to be safe for stroke patients.
Glyburide Advantage in Malignant Edema and Stroke (GAMES-RP) trial was conducted in 18 hospitals across the United States. About 77 stroke patients were randomly assigned to continuous glyburide treatment or placebo for 72 hours.
The results were obtained from patients after 90 days, using a standardized stroke scale ranging from 0 to 4 indicating no symptoms to moderate and severe brain swelling. About 40% of the patients met the criteria and were able to survive without surgery.
Sheth said that the decision for performing surgery seems to be complicated and was noted only in cases where physicians decide based on the wishes of the patient or their family. And this was found to be the main reason for not reaching the endpoint of the clinical trial.
However, the results of the clinical trials were able to show a reduced degree of the midline shift in the brain by 40% after treatment with glyburide and was also able to reduce MM-9 biomarker which was associated with brain swelling in previous studies. These results will further be used in 2017 for phase 3 clinical trials.
Rogove Testifies at Congressional Hearing: Technology And Treatment: Telemedicine In The VA Healthcare System
Technology and Treatment: Telemedicine in the VA Healthcare System
Dr. Kevin Galpin M.D.
Acting Executive Director for Telehealth, Veterans Health Administration, on behalf of U.S. Department of Veterans Affairs
Dr. Scotte Hartronft M.D., MBA, FACP, FACHE
Chief of Staff, VA Greater Los Angeles Healthcare System, Veterans Health Administration, VA Desert Pacific Healthcare Network (VISN 22), on behalf of U.S. Department of Veterans Affairs
Dr. Herb Rogove DO, FCCM, FACP
President and Chief Executive Officer, C30 Telemedicine
Zachary D. Walker
The issue of interstate medical licensing has been alive and in ill health for over 20 years. Recently in an op-ed in the WSJ (http://on.wsj.com/2b3ekFX) the suggestion, once again, for one medical license to practice in all fifty states fits under the aegis of the federal government accepting the credo that telemedicine occurs where the physician is and NOT the patient. Under this logic, telemedicine practice is considered under the commerce clause of the Constitution. Patient protection under the state medical board is upheld, no additional costs are added to the healthcare bill, and telemedicine programs can be implemented after the hospital credentialing process (for hospital-based programs). Too logical, yes. Too reasonable, yes. Too Twenty-First century, yes. Will it occur, NO! The FSMB’s compact is just a smoke screen, and anyone with knowledge or serious interest in telemedicine should be indignant that after twenty years, our state medical boards need to catch up to our own Veterans Administration or even the European Union.
A group of fifteen physicians compared interpretation of chest x-rays using established 23 major findings from cardiology, radiology, and pulmonary-critical care via Google Glass screen, viewing on Google Glass and interpreting on a mobile device, and viewing the original chest x-ray on a desktop computer screen. A top score was maximum 23 points.
Google Glass: 14.1
Google Glass photo on mobile device: 18.5
Desktop computer: 21.3
Of the 15 physicians, 11 (73%) felt confident in detecting findings using photographs taken by Google Glass as viewed by mobile devices.
Remote chest x-ray interpretation using hands-free Google Glass is less accurate than description using a desktop computer or a mobile device. Further technical improvements Google Glass are needed before widespread application and acceptance.
What others say
Google Glass is revolutionizing the healthcare world. As in fields like higher education, third-party application developers and users are embracing Glass to deliver highly empowering, meaningful Glassware with amazing results. Mark Taglietti, head of ICT delivery services and vendor management at London University College Hospitals says, “Google Glass represents a step change in technical innovation, wearable technology, and the convergence of personal devices in the workplace. The healthcare applications of Glass are wide-ranging, insightful and impactful, from enabling hands-free real-time access to clinical and patient information, to the transmission of point of view audio and video for surgical research and educational purposes. Glass marks the beginning of a remarkable journey for technical innovation within healthcare, enabling providers to improve the delivery of care, as well as overall quality and patient experience.”
The nature of telemedicine is to connect doctors to patients on-demand. The range of telemedicine scenarios is vast. Glass can provide synchronous video conversations with physicians at remote locations. Remotely-conducted procedures can be recorded and embedded in patient records for future reference. With Glass, physicians at rural hospitals can consult with specialists located anywhere in the world in real-time to provide world-class service to their patients. Telemedicine also plays a significant role in streamlining care to hospice patients. Care providers can communicate with physicians remotely and proactively monitor patients whose EHRs can be transmitted in real-time. The seemingly high $1,500 price of Google Glass is significantly less than other types of hospital videoconferencing, which can run upwards of $40,000.
More work in developing the technology may result in radiology’s quick acceptance and adaptation.
Published by Dove Press 21 April 2016 Volume 2016:11(1) Pages 809—822
Thorbjørn L Gregersen,1 Allan Green,1 Ejvind Frausing,1 Thomas Ringbæk,1,2 Eva Brøndum,1 Charlotte Suppli Ulrik1,2
1Department of Pulmonary Medicine, Hvidovre Hospital, Hvidovre, 2Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
Objective: To summarize studies addressing the impact of telehealth on Quality of Life (QoL) in patients with COPD.
Design: Systematic review.
Methods: A series of systematic searches were carried out using multiple databases: from 2000 to 2015. A predefined search algorithm was utilized with the intention to capture all results related to COPD, QoL, and telehealth published since the year 2000.
Outcome measures: Primary outcome was QoL, assessed by validated measures.
Results: Out of the 18 studies fulfilling the criteria for inclusion in this review, three studies found statistically significant improvements in QoL for patients allocated to telemedical interventions. However, all of the other included studies found no statistically significant differences between control and telemedical intervention groups regarding QoL.
Conclusion: Telehealth does not make a strong case for itself when exclusively looking at QoL as an outcome since statistically significant improvements relative to control groups have been observed only in few of the available studies. Nonetheless, this does not only rule out the possibility that telehealth is superior to standard care concerning other outcomes but also seems to call for more research, not least in large-scale controlled trials.
Comments: While this important meta-analysis shows an insignificant improvement in the quality of life, once must keep in mind the number of advancements in technology since 2000. For example, some recent data from the application Propeller (formerly Asthmapolis) has shown more compliance with inhalers and potentially a decrease in hospital admissions. That in itself might be considered an improvement in the QoL. A rush to judgment after reviewing this study should be tempered by an update within the next few years. Don’t throw the bath water out so soon!
Why is Healthcare Broken?
Why is healthcare broken? There is a multitude of reasons, but the poor delivery of care is often the result of ignorance. Yes, for years quality experts and specialists from all medical specialties have worked on guidelines that are based on scientific evidence. The problem is will physicians adapt them? Will hospital and hospital systems ensure compliance with the guidelines?
Let me give an illustration that recently appeared in DHealthcare Daily where the CEO of Methodist Health System was interviewed. The CEO is quoted as saying “So last year we spent a lot of hours working on a condition called sepsis, which has a very high mortality. It’s lethal in many cases, and it’s lethal not only in the elderly but the young as well. So our learning in that, learning the early symptoms and the early interventions that need to take place, and how the key is early intervention, and the impact that has had on the way we practice across Methodist as it relates to sepsis is dramatically different today than it was 12 months ago. And the impact, well, it’s a life saver. There’s no question about it. We were average in that area, I would say, among hospitals in America. Today I would say we’re in the top decile.”
What is disturbing is that sepsis had been around for years. The fact that the Society of Critical Care Medicine along with other professional societies published scientific guidelines on the recognition and treatment of sepsis back in 2002. Why 14 years later are healthcare professionals suddenly realizing this is a major problem that affects almost 800,000 patients a year? Why is the dissemination and utilization of sound medical evidence not being implemented immediately?
The above example is one of many that may be attributed of hospitals not having the expertise of quality programs or specialists in certain areas of medicine. It may also be the result of physicians either not accepting guidelines or not paying attention. Telemedicine may have a very significant impact on improving quality. Telemedicine may very well be the conduit to provide intensivist and infectious disease expertise to hospitals that lack these specialties. The same services may enhance both accessibility and speed to obtain highly efficient treatment modalities. There is growing evidence to suggest that remote care by distant intensivists and infectious disease physicians provide a significant quality benefit to patients often unable, because of geography, not have access to these providers.
Certain diseases that affect larger portions of our population often have associated evidence-based guidelines for physicians. It is up to hospital leadership to ensure compliance. When expertise is needed for patients that are complex, then telemedicine is certainly an alternative that must be utilized.
The evolving role of ICU Telemedicine is the cover story for Critical Connections (Volume 15, Number 1). At this time, more than 11% of nonfederal adult ICU beds in the United States are covered by ICU telemedicine. These programs are a means to fill the gap for the growing need for intensivists. Demand now exceeds supply. Many rural hospitals do not have on-site intensivists, but with telemedicine, they have an unparalleled link to critical care.
Early results from small studies show a reduction in ED delays, ICU length of stay, and a decrease in mortality. Some newer studies now show a decline in response times for abnormal laboratory values and alerts for abnormal physiological vital signs.
ICU telemedicine provides population management solutions that have been shown to increase adherence to best patient practices and reduce preventable complications which ultimately increase costs. Observers have also noted almost real time review of performance reports by an efficient ICU governance team.
Recent ICU telemedicine financial data has shown that these programs are extremely cost-effective in most cases and cost savings in some.
The Society of Critical Care Medicine’s Tele-ICU committee recently did a survey which demonstrated an increasing use of telemedicine as a useful tool. Additionally, the committee also identified that many ICU’s are incorporating personal electronics that are HIPAA compliant. Telecommunications are providing a means for families to be in contact with the ICU if they are traveling or at work. Use of electronic billboards identifies family questions and concerns. Families may even participate in patient rounds remotely.
“New telemedicine-related technologies are focused on more efficient critical care workflows that enable 0ff-site patient management using reliable standardized protocols and oversight.” Multipath medical device integration will now allow titratable therapy based upon laboratory results and physiological parameter monitoring.
Malpractice claims may also diminish.
The ultimate goal of ICU telemedicine is the improvement of the quality and safety of the care of critically ill and injured patients. As usual, further well-designed studies are required.
An analysis of direct-to-consumer (DTC) telemedicine in California suggests that the use of a commercial telemedicine provider disputes the value of access for rural patients.The data, published in the April issue of Telemedicine and e-Health, reveal telemedicine use is not higher in rural areas, a lower rate of diagnostic tests for low back pain, a significantly lower use of Streptococcal testing occurred, and higher use of antibiotics for bronchitis with the telemedicine provider .
The study compared the commercial provider Teladoc with office visits to primary care physicians who saw HMO patients insured by Blue Shield of California.
Most of the telemedicine encounters were by telephone and not videoconferencing suggesting a comparison with providers that utilize videoconferencing is imperative.
Teladoc patients were ordered a strep test only 5% of the time compared to 50% of the physician offices. The Infectious Disease Society recommends testing for all adults.
For bronchitis, for which antibiotics are not recommended, the Teledoc physicians performed worse (16.7%) than the physician offices (27.9%).
Quality data suggest that patients with low back pain often do not require an imaging study as symptoms often resolve within 30 days. Teladoc physicians seemed to do this more frequently than office physicians.
A total of 4, 657 Teladoc visits were used for analysis.
Slightly more patients using Teladoc were located in rural areas. There were no differences in drive time to a primary care office (3 minutes) or emergency room (10 minutes) compared to the advertised response time of 16-20 minutes for the virtual physician.
Teleadoc has embarked upon adding the ordering of diagnostic tests for patients with pharyngitis.
It is key remember that the study does not conclude that telemedicine is superior or inferior to office visits. It does educate the commercial providers of telemedicine that individual quality indicators be observed whether a patient is treated in person or virtually. A next good study should include comparison with providers of video encounters as well.
Another major outcome that needs further study is what happened clinically to the patients who did not receive a strep test? Were they later diagnosed? Detailed follow-up for outcomes is essential.
Urgent telehealth care quality varies by commercial provider. Quality may vary in six frequent conditions but the mode of delivery videoconferencing, telephone, and web chat was not a cause for variation in quality.
The 6 conditions included: ankle pain, streptococcal pharyngitis, viral pharyngitis, rhinosinusitis, low back pain, and recurrent female UTI.
The eight providers of telehealth selected by the University of California at San Francisco included Ameridoc, Amwell, Consult a Doctor, Doctor on Demand, MDAligne, MDLIVE, MeMD, and NowClinic. The selection was based upon data obtained from the most frequently used sites.
Primary outcomes were based upon a complete history and physical, correct or incorrect diagnosis, and compliance with national guidelines. Sixty-seven standardized patients were used for a total of 599 virtual visits. The standardized patients were either an actor with experience in the simulation center at UCSF or medical students. Completeness of the exam occurred in almost 76% of the patients. Of the eight companies, completeness varied from 51.7 to 82.4%. Correct diagnosis varied from 65.4% to 93.8%. Compliance with guidelines ranged from 34.4% to 66.1%.
For making the correct diagnosis, videoconferencing (85.8%) and telephone consults (77.7%) were better than webchat (66.1%).
The authors noted that variability of care is also seen in the traditional setting. A prominent example is the prescription of antibiotics. Interestingly, the ordering of tests was lower in the virtual care compared to the traditional setting.
At odds with the Texas medical board, which has outlawed telephone consults, this study found no statistical difference in adherence to national guidelines based upon a mode of consultation.
The variability of the different providers supports the need for improvement and perhaps the need for accreditation as is available through the American Telemedicine Association.
Finally, the limits of the study are that we do not know if a telemedicine visit is inferior or superior to an in-person visit. Since this is the first study of this nature, additional research is needed.
Secure messaging can have a positive impact on diabetes clinical outcomes according to an ahead of publication posting on Telemedicine and e-Health. According to this new review, “President Barack Obama signed into law the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009. HITECH stated that from 2011 to 2015, healthcare providers would be offered financial bonuses for meaningfully using electronic health records (EHRs) and penalized for not doing so. ‘‘Meaningful use’’ (MU) is meant to improve care quality and engage patients while maintaining privacy of information, to obtain better clinical outcomes, population health outcomes, and increased efficiency. There are three stages. One of the stage 2 core objectives introduced in 2014 was for eligible providers to use secure electronic messaging to communicate with patients.”
However, earlier EHR studies reveal only limited evidence for the value of these tools in managing chronic diseases. One systematic review of articles assessing the value and clinical outcomes of using EHRs in chronic disease management published between January 2000 and September 2010 found only three prospective randomized trials, all centered around diabetes care. The authors from the University of Miami, reviewed the more recent studies to determine outcomes for diabetes management.
In this pre-publication review slated for September release, “evidence from 7 of the 11 included studies suggests significant improvement in patients’ hemoglobin A1c (HbA1c) with the use of secure messaging. However, improvements in patients’ secondary outcomes, such as blood pressure and cholesterol, were inconsistent. Further work must be done to determine how to best maximize the potential of available tools such as secure messaging and EHRs to improve patient outcomes.”