About our project
The problem we solve: Little is known about the complex relationship between influenza infections and diabetes mellitus. What we do know is that patients with diabetes are at risk when they have influenza infections. Patients with diabetes may ignore their symptoms for too long, get dehydrated or experience sudden changes in their blood sugars and insulin needs - at the same the flu symptoms make it hard to be proactive and to stay engaged.
About our solution:
The ViVI Score is the first prospectively validated outcome measure for influenza and flu-like illness in children and adults. It has been used in precision medicine and quality improvement programs at academic hospitals and community clinics in the US and Europe.
We plan to take this development further to create a specific version of the app tailored to the needs of patients with diabetes mellitus: The ViVI ScoreDM mobile app will help diabetic patients and their doctors to monitor flu severity and risk factors, virus diagnostics, vaccination status, antiviral/antibiotic use at the same time with key diabetes parameters including BMI, hydration status, blood sugars, insulin needs, and HbA1c –all in one place. Real-time data integration will enable a precision medicine approach to navigating the complex interaction between influenza infection and metabolic changes, along with improved patient-doctor communication and timely disease management, tailored to patients' individual needs.
Progress to
date:The ViVI Score mobile app has been scientifically validated and is now available in the Apple Store and Google Playstore for doctors and healthcare providers interested in participating in the PEDSIDEA program.
https://score.vi-vi.org/
PEDSIDEA stands for "Partnering for Enhanced Digital Surveillance of Influenza-like Disease and the Effect of Antivirals and Vaccines". The program started in Europe and is now extended to hospitals and community clinics in the USA.
The layperson version for patient-reported outcomes, ViVI ScoreMe, and a new version specifically for people living with diabetes, ViVi ScoreDM, will be developed through this Campaign.
About Our Team
Creator: Barbara Rath
Location: Louisiana
Education: Stanford Duke Tulane; Universities in Europe
Bio: Barbara A. Rath, MD PhD is a pediatrics and infectious disease specialist with 20+ years experience in clinical trials, quality improvement and global health innovation in the US, Latin America and Europe. Dr. Rath is honorary professor at the University of Nottingham School of Medicine - WHO Collaborating Centre for Pandemic Influenza and board member with the International Society for Influenza and Other Respiratory Viruses. Dr. Rath received her medical school education in Germany, the United States and Spain, and her doctoral degrees from the University of Basel, Switzerland and the University of Besançon, France. In addition to a post-doctoral fellowship at the Stanford Center for AIDS Research, she has received pediatric residency and infectious disease subspecialty training at Duke and Tulane Universities, USA. Recent research focused on defining a precision medicine approach to helping patients with acute respiratory infections. In collaboration with public health agencies she developed innovative real-time monitoring systems for influenza-like illness and the immuno-safety of vaccines and antivirals.
Dr. Rath is co-founder and chair of the Vienna Vaccine Safety Initiative, an international think tank and non-profit-organization focused on new avenues for the treatment, communication and prevention of infectious diseases.
Hospital Affiliation: University of Nottingham, UK
Title: Co-funder, Chair
Advanced Degree(s): MD, PHD
About Our Company
The Vienna Vaccine Safety Initiative
Location: 900 Camp Street
335
New Orleans, LA 70130
Founded: 2015
Website: http://vi-vi.org
Twitter: @Vi_VIorg
Other link: https://score.vi-vi.org/
Product
Stage: Prototype/MVP
YTD Sales: Working on it
Employees: 1-2
How We Help Patients
This current flu season is no exception: scary news headlines are abundant, describing how healthy young people may become very ill from the flu. Some have died. This may be rare, but who could have known ahead of time that they were at risk? Did they really "just think they had a simple cold" or "ignore their symptoms for too long"? Don't we usually do the same? Do we know our personal risks, and do we know when we need to see a doctor? What about our children? What can we do to keep them safe and to give our doctors the information they need to take the right decisions at the right time?
The ViVI ScoreMe mobile app for patient-reported outcomes will help patients and their families to monitor flu symptoms based on scientific criteria. That way we can give doctors the most important information they need to take the right decisions.
Experts tell us that there are groups of individuals that may carry an even greater risk: Diabetes is one of the most important risk factors for severe flu. For overweight people, the risk may increase even further.
What does this mean to me as a person living with diabetes?
The ViVI ScoreDM mobile app for people living with diabetes will help me record symptoms to communicate with my doctor more efficiently. That way, I can adjust insulin and medication needs in time, while gaining a better understanding of flu and diabetes and how these conditions may influence each other.
How We Help Physicians
Every year during flu season, emergency rooms are crowded with patients complaining of flu-like symptoms and acute respiratory infections. Even though most cases are viral in origin, antibiotics are prescribed frequently. As physicians, we are worried about missing a rare case, when a simple flu may progress to a serious or even life-threatening condition. Those of us taking care of children know that initial symptoms may be subtle and non-specific. Here, we find it even more challenging to know ahead of time, who may need special attention and who can be sent back home safely. When a patient is admitted to the hospital, how do we monitor progress consistently, and how do we communicate disease severity during rounds or during sign-over from one shift to another?
The Vienna Vaccine Safety Initiative (ViVI), an international scientific think tank and non-profit organization, developed the first prospectively validated disease severity score for influenza and other respiratory viral infections, which can be used consistently in infants and children as well as in adults. It was developed based on extensive literature review aligned with WHO criteria for uncomplicated and complicated disease.
The ViVI Disease Severity Score has since undergone extensive scientific validation in large cohorts and multi-center studies in collaboration with public health agencies in Europe and the US.
We are interested in working with you, to learn how you would integrate the ViVI Score mobile app into your clinic routines and how it will help you improve quality of care and risk communication.
In collaboration with patient organizations, we are developing a layperson version for patient-reported outcomes (ViVI ScoreMe) allowing patients and parents to track flu symptoms using the same scientific criteria. We expect that this will help them communicate with you, their healthcare provider, more efficiently.
For patients with diabetes (ViVI ScoreDM) we are developing a specific version of the app allowing the integration of key parameters for diabetics care, such as insulin and medication needs. This will enable us to gain a better understanding of the interaction of a complex metabolic condition with influenza and other respiratory viral infections.
How We Help Hospitals
Modern healthcare requires attention to detail as well as to the big picture. As an institution, you are expected to improve quality of care continuously, and to track patient outcomes consistently. Acute respiratory infections as unpredictable as the flu, may impact entire healthcare systems. Recent reports of the 2017/18 flu seasons in the Southern as well as the Northern Hemisphere, have illustrated this challenge once again.
The ViVI Score was specifically developed to meet this need when taking care of patients with influenza and other respiratory viral infections. It was developed out of the need to streamline triage procedures, patient flow, surveillance data, antibiotic stewardship and cost effectiveness. And most importantly, we intend to improve safety and patient satisfaction.
The ViVI Score mobile app allows healthcare professionals to quickly assess known risk factors and score disease severity within a few minutes. It can be used without any additional training – its user-friendly, intuitive design emerged from rapid prototyping and multiple iterations in direct collaboration between software developers and clinicians. The app was scientifically validated and studied extensively in the context of closely monitored, IRB approved quality improvement programs.
We are now interested in taking this tool to the next level. The development of a compatible patient-reporting tool (ViVI ScoreMe) is underway, as well as a specific version of the Score, ViVI ScoreDM for patients with diabetes mellitus. Adopting this state-of-the digital tool to the special needs of patients with diabetes, will help us tackle a challenge that often "falls through the cracks" between medical subspecialties.
The Vienna Vaccine Safety Initiative has a strong track record of combining the user-friendly innovation technique of Design Thinking with the scrutiny of scientific research, leading to the development of novel, reliable and well-designed tools for quality improvement and patient safety.
We are always interested in partnering with healthcare providers to ensure that our inventions and developments will improve patient safety and the interaction between patients and providers. Contact us at info@vi-vi.org for more information.
Challenge Mission
Market Size
The cost of seasonal influenza is immense.
As a non-profit organization we see it as our task to help healthcare providers use their resources more efficiently while improving quality of care to the patient’s benefit.
Studies have demonstrated the potential impact of the ViVI Score on antibiotic stewardship and cost effectiveness.
F Tief, C Hoppe, L Seeber, P Obermeier, X Chen, K Karsch, S Mühlhans, E Adamou, T Conrad, B Schweiger, T Adam, B Rath:
An inception cohort study assessing the role of pneumococcal and other bacterial pathogens in children with influenza and ILI and a clinical decision model for stringent antibiotic use
Antiviral Therapy 2016, 21(5):413-24. doi: 10.3851/IMP3034. Epub 2016 Feb 11. PMID: 26867096
Additional studies in different healthcare settings are underway.
Projected 3 Year Growth
N/A
How We Will Make Money
N/A
About our Competition
The ViVI Score is the first disease severity score for children and adults with influenza and other respiratory viral infections that has undergone large-scale prospective validation and scientific peer review. We plan to continue leading the field by being the first to market.
Progress with Customers to date
As a non-profit organization, our focus has been on research and development rather than sales revenue.
Our apps will be made available to different user groups, providing different user profiles and modes of access.
New Orleans and Our Company
We are "radically interdisciplinary scientific physician-innovators with a passion for the arts". We thrive in buzzing, creative environments and academic medicine.
After 10 years of incubation in Europe, we decided to establish a US non-profit organization in New Orleans.
This is a natural fit. We are working with local app developers. Our collaboration with local community clinics keeps us grounded.
Innovation Details
Intellectual Property Summary
A provisonal patent has been filed for the ViVI Disease Severity Score and other ViVI mobile applications.
Clinical Information
The ViVI Disease Severity Score was developed by an international non-profit organization, the Vienna Vaccine Safety Initiative (ViVI).
Vienna Vaccine Safety Initiative
Human Vaccines and Immunotherapeutics 2017, Epub December 5;
doi.org/10.1080/21645515.2017.1412666. PMID: 29206079
The ViVI Disease Severity Score is based on extensive literature review and WHO criteria for uncomplicated and complicated flu. The Score was provided on a mobile app and validated in a large prospective cohort of 6000+ children 0-18 years of age in Europe.
B Rath, T Conrad, P Myles, M Alchikh, X Ma, C Hoppe, F Tief, X Chen, P Obermeier, B Kisler, B Schweiger: Influenza and other respiratory viruses: standardizing disease severity for surveillance and clinical trials
Expert Review of Anti-Infective Therapy 2017, Epub Feb 13. doi: 10.1080/14787210.2017.1295847
It was subsequently user-tested in adults and further validated in an international multi-center project (the PEDSIDEA Network). This feasibility study showed that using the ViVI Score mobile app at the point of care facilitates international collaboration, cross-cohort comparisons, and the evaluation of medical interventions.
M Alchikh, C Hoppe, MA Papagrigoriou-Theorodridou, V Papaevangelou, HC Maltezou, B Schweiger, B Rath: Harmonizing Disease Severity Assessments in Infants and Children: The PEDSIDEA Consortium
Options for The Control of Influenza IX Conference, Chicago IL, USA, August 24-28, 2016
Use of the ViVI Score in quality improvement programs has been shown to improve patient flow and antibiotic stewardship while lowering costs.
F Tief, C Hoppe, L Seeber, P Obermeier, X Chen, K Karsch, S Mühlhans, E Adamou,
T Conrad, B Schweiger, T Adam, B Rath: An inception cohort study assessing the role of pneumococcal and other bacterial pathogens in children with influenza and ILI and a clinical decision model for stringent antibiotic use
Antiviral Therapy 2016, 21(5):413-24. doi: 10.3851/IMP3034. Epub 2016 Feb 11. PMID: 26867096
The ViVI Score was used to measure severity in patients with any type of acute respiratory infection or flu-like illness, ranging from mild cases to severe cases requiring intensive care.
K Karsch§, X Chen§, O Miera, B Peters, P Obermeier, RC Francis, V Amann, S Duwe, P Fraaij, A Heider, M de Zwart, F Berger, A Osterhaus, B Schweiger, B Rath: Pharmacokinetics of PO and IV oseltamivir treatment of severe influenza B infection requiring organ replacement therapy
European Journal of Drug Metabolism and Pharmacokinetics 2016, Epub Mar 19; doi: 10.1007/s13318-016-0330-9. PMID: 26994602
The ViVI Score is now being introduced to community clinics and hospitals in the United States.
B Rath, T Conrad, P Myles, M Alchikh, X Ma, C Hoppe, F Tief, X Chen, P Obermeier, B Kisler, B Schweiger: The ViVI Disease Severity Score: Enabling Real-time Surveillance of Influenza Disease Severity for Multi-dimensional Mapping. Biodefense World Summit, Alexandria, VA, USA June 26-29, 2017
Use of the ViVI Score in quality improvement programs is not classified as human subject research and requirements for individual informed consent procedures have been waived by IRBs in Europe and the US.
Regulatory Status
The ViVI Score helps to standardize the way healthcare professionals grade disease severity in patients with flu and flu-like illness. It helps them apply state-of-the art scientific evidence to the point of care, while complying with international data stadards and guidance documents. The ViVI Score mobile app computes the score and ensures data integrity. It does not issue treatment recommendations and is not considered a medical device.
The ViVI Score as a standardized clinical endpoint and decision support software has been pesented to the Critical Path Innovation group at the US FDA and to the EMA innovation task force (ITF) in Europe.
How we will use the funds raised
The funding will be used to create a new version of the ViVI Severity Score (ViVI ScoreDM) tailored to the special needs of patients with diabetes mellitus type I and type II. This work will be done in collaboration with pediatric and adult endocrinologists and infectious disease specialists, as well as with the critical input of patient representative organizations.
ViVI ScoreDM, the new prototype for diabetes patients will be developed according to the user-centered principles of Design Thinking (rapid prototyping, user testing, multiple iterations). It will be compatible with the original ViVI Score for healthcare professionals, and ViVI ScoreMe for patient reporting, The final ViVI ScoreDM app will be created for iOS and Android devices in collaboration with a local IT development team in New Orleans, to then undergo peer-reviewed scientific research and validation in clinical practice.
Thank You
For a physician, witnessing a previously healthy person die of a common illness such as the flu, is a deeply humbling experience.
We can only imagine what this would mean to the family and loved ones.
We know so little, and we still have very little to offer. If we work together, we can do better.
How can we improve quality of care and help flu patients and their doctors take the right decisions at the right time?
How can we raise awareness among people affected by diabetes and help them get through flu season safely?
Don't wait. Let's innovate!
