Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com
Role of Informatics in Precision Medicine: Notes from Boston Healthcare Webinar: Can It Drive the Next Cost Efficiencies in Oncology Care? Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)
Role of Informatics in Precision Medicine: Notes from Boston Healthcare Webinar: Can It Drive the Next Cost Efficiencies in Oncology Care?
Reporter: Stephen J. Williams, Ph.D.
Boston Healthcare sponsored a Webinar recently entitled ” Role of Informatics in Precision Medicine: Implications for Innovators”. The webinar focused on the different informatic needs along the Oncology Care value chain from drug discovery through clinicians, C-suite executives and payers. The presentation, by Joseph Ferrara and Mark Girardi, discussed the specific informatics needs and deficiencies experienced by all players in oncology care and how innovators in this space could create value. The final part of the webinar discussed artificial intelligence and the role in cancer informatics.
Below is the mp4 video and audio for this webinar. Notes on each of the slides with a few representative slides are also given below:
Please click below for the mp4 of the webinar:
worldwide oncology related care to increase by 40% in 2020
big movement to participatory care: moving decision making to the patient. Need for information
cost components focused on clinical action
use informatics before clinical stage might add value to cost chain
Key unmet needs from perspectives of different players in oncology care where informatics may help in decision making
Needs of Clinicians
– informatic needs for clinical enrollment
– informatic needs for obtaining drug access/newer therapies
2. Needs of C-suite/health system executives
– informatic needs to help focus of quality of care
– informatic needs to determine health outcomes/metrics
3. Needs of Payers
– informatic needs to determine quality metrics and managing costs
– informatics needs to form guidelines
– informatics needs to determine if biomarkers are used consistently and properly
– population level data analytics
What are the kind of value innovations that tech entrepreneurs need to create in this space? Two areas/problems need to be solved.
innovations in data depth and breadth
need to aggregate information to inform intervention
Different players in value chains have different data needs
Data Depth: Cumulative Understanding of disease
Data Depth: Cumulative number of oncology transactions
technology innovators rely on LEGACY businesses (those that already have technology) and these LEGACY businesses either have data breath or data depth BUT NOT BOTH; (IS THIS WHERE THE GREATEST VALUE CAN BE INNOVATED?)
NEED to provide ACTIONABLE as well as PHENOTYPIC/GENOTYPIC DATA
data depth more important in clinical setting as it drives solutions and cost effective interventions. For example Foundation Medicine, who supplies genotypic/phenotypic data for patient samples supplies high data depth
technologies are moving to data support
evidence will need to be tied to umbrella value propositions
Informatic solutions will have to prove outcome benefit
How will Machine Learning be involved in the healthcare value chain?
increased emphasis on real time datasets – CONSTANT UPDATES NEED TO OCCUR. THIS IS NOT HAPPENING BUT VALUED BY MANY PLAYERS IN THIS SPACE
Interoperability of DATABASES Important! Many Players in this space don’t understand the complexities integrating these datasets
Other Articles on this topic of healthcare informatics, value based oncology, and healthcare IT on this OPEN ACCESS JOURNAL include:
Oracle Health Sciences: Life Sciences & HealthCare — the Solutions for Big Data
Healthcare and life sciences organizations are facing unprecedented challenges to improve drug development and efficacy while driving toward more targeted and personalized drugs, devices, therapies, and care. Organizations are facing an urgent need to meet the unique demands of patients, regulators, and payers, necessitating a move toward a more patient-centric, value-driven, and personalized healthcare ecosystem.
Meeting these challenges requires redesigning clinical R&D processes, drug therapies, and care delivery through innovative software solutions, IT systems, data analysis, and bench-to-bedside knowledge. The core mission is to improve the health, well-being, and lives of people globally by:
Optimizing clinical research and development, speeding time to market, reducing costs, and mitigating risk
Accelerating efficiency by using business analytics, costing, and performance management technologies
Establishing a global infrastructure for collaborative clinical discovery and care delivery models
Scaling innovations with world-class, transformative technology solutions
Harnessing the power of big data to improve patient experience and outcomes
Oracle Life Sciences Data Hub. Better Insights, More Informed Decision-Making. Provides an integrated environment for clinical data, improving regulatory …
This Knowledge Zone was specifically developed for partners interested in reselling or specializing in Oracle Life Sciences solutions. To become a specialized …
Oracle Health Sciences Suite of. Life Sciences Solutions. Integrated Solutions for Global Clinical Trials. Oracle Health Sciences provides the world’s broadest set …
10:15AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston
Reporter: Aviva Lev-Ari, PhD, RN
REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com
10:15 a.m. Panel Discussion — IT/Big Data
IT/Big Data
The human genome is composed of 6 billion nucleotides (using the genetic alphabet of T, C, G and A). As the cost of sequencing the human genome is decreasing at a rapid rate, it might not be too far into the future that every human being will be sequenced at least once in their lifetime. The sequence data together with the clinical data are going to be used more and more frequently to make clinical decisions. If that is true, we need to have secure methods of storing, retrieving and analyzing all of these data. Some people argue that this is a tsunami of data that we are not ready to handle. The panel will discuss the types and volumes of data that are being generated and how to deal with it.
Role of Informatics, SW and HW in PM. Big data and Healthcare
How Lab and Clinics can be connected. Oncologist, Hematologist use labs in clinical setting, Role of IT and Technology in the environment of the Clinicians
at BWH since 1987 at 75% – push forward the Genomics Agenda, VA system 25% – VA is horizontally data integrated embed research and knowledge — baseline questionnaire 200,000 phenotypes – questionnaire and Genomics data to be integrated, Data hierarchical way to be curated, Simple phenotypes, validate phenotypes, Probability to have susceptibility for actual disease, Genomics Medicine will benefit Clinicians
Data must be of visible quality, collect data via Telephone VA – on Med compliance study, on Ability to tolerate medication
–>>Curation of data is very different than statistical analysis of Clinical Trial Data
–>>Integration of data at VA and at BWH are tow different models of SUCCESSFUL data integration models, accessing the data is also using a different model
–>>Data extraction from the Big data — an issue
–>>Where the answers are in the data, build algorithms that will pick up causes of disease: Alzheimer’s – very difficult to do
–>>system around all stakeholders: investment in connectivity, moving data, individual silo, HR, FIN, Clinical Research
Computer Scientist and Medical Student. Were the technology is going?
Messy situation, interaction IT and HC, Boston and Silicon Valley are focusing on Consumers, Google Engineers interested in developing Medical and HC applications — HUGE interest. Application or Wearable – new companies in this space, from Computer Science world to Medicine – Enterprise level – EMR or Consumer level – Wearable — both areas are very active in Silicon Valley
IT stuff in the hospital HARDER that IT in any other environment, great progress in last 5 years, security of data, privacy. Sequencing data cost of big data management with highest security
Constrained data vs non-constrained data
Opportunities for Government cooperation as a Lead needed for standardization of data objects
Questions from the Podium:
Where is the Truth: do we have all the tools or we don’t for Genomic data usage
Question on Interoperability
Big Valuable data — vs Big data
quality, uniform, large cohort, comprehensive Cancer Centers
Volume of data can compensate quality of data
Data from Imaging – Quality and interpretation – THREE radiologist will read cancer screening
8:00AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston
REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com
8:00 A.M. Welcome from Gary Gottlieb, M.D.
Opening Remarks:
Partners HealthCare is the largest healthcare organization in Massachusetts and whose founding members are Brigham and Women’s Hospital and Massachusetts General Hospital. Dr. Gottlieb has long been a supporter of personalized medicine and he will provide his vision on the role of genetics and genomics in healthcare across the many hospitals that are part of Partners HealthCare.
IT – GeneInsight – IT goal Clinicians empowered by a workflow geneticist assign cases, data entered into knowledge base, case history, GENEINSIGHT Lab — geneticists enter info in a codified way will trigger a report for the Geneticist – adding specific knowledge standardized report enters Medical Record. Available in many Clinics of Partners members.
Example: Management of Patient genetic profiles – Relationships built between the lab and the Clinician
Variety of Tools are in development
GenInsight Team –>> Pathology –>> Sunquest Relationship
Mass General (MGH) & Brigham Women’s (BWH) — Chart in EM will have the Genetic Profile of a Patients checking in
The Future
Genetic testing –>> other info (Pathology, Exams, Life Style Survey, Meds, Imaging) — Integrated Medical Record
Clinic of the Future-– >> Diagnostics – Genomics data and Variants integrated at the Clinician desk
Why is personalized medicine important to Partners?
From Healthcare system to the Specific Human Conditions
Lab translate results to therapy
Biobank +50,000 specimens links to Medical Records of patients – relevant to Clinician, Genomics to Clinical Applications
Questions from the Podium
test results are not yet available online for patients
clinicians and liability – delays from Lab to decide a variant needs to be reclassified – alert is triggered. Lab needs time to accumulated knowledge before reporting a change in state.
Training Clinicians in above type of IT infrastructure: Labs around the Nations deal with VARIANT RECLASSIFICATION- physician education is a must, Clinicians have access to REFERENCE links.
All clinicians accessing this IT infrastructure — are trained. Most are not yet trained
Coordination within Countries and Across Nations — Platforms are Group specific – PARTNERS vs the US IT Infrastructure — Genomics access to EMR — from 20% to 70% Nationwide during the Years of the Obama Adm.
Shakeout in SW linking Genetic Labs to reach Gold Standard
Can Mobile Health Apps Improve Oral-Chemotherapy Adherence? The Benefit of Gamification.
Reporter: Stephen J. Williams, PhD
Article ID #144: Can Mobile Health Apps Improve Oral-Chemotherapy Adherence? The Benefit of Gamification. Published on 6/17/2014
WordCloud Image Produced by Adam Tubman
A report on how gamification mobile applications, like CyberDoctor’s PatientPartner, may improve patient adherence to oral chemotherapy.
(includes interviews with CyberDoctor’s CEO Akhila Satish and various oncologists)
Writer/Curator: Stephen J. Williams, Ph.D.
UPDATE 5/15/2019
Please see below for an UPDATE on this post including results from the poll conducted here on the value of a gamification strategy for oral chemotherapy patient adherence as well as a paper describing a well designed development of an application specifically to address this clinical problem.
Studies have pointed to a growing need to monitor and improve medical adherence, especially with outpatient prescription drugs across many diseases, including cancer.
The trend to develop oral chemotherapies, so patients can take their medications in the convenience of their home, has introduced produced a unique problem concerning cancer patient-medication adherence. Traditionally, chemotherapies were administered by a parental (for example intravenous) route by clinic staff, however, as noted by Jennifer M Gangloff in her article Troubling Trend: Medication Adherence:
with the trend of cancer patients taking their oral medication at home, the burden of adherence has shifted from clinicians to the patients and their families.
A few highlights from Jennifer Gangloff’s article highlight the degree and scope of the problem:
There is a wide range of adherence for oral chemo– as low as 16% up to 100% adherence rates have been seen in multiple studies
High cost in lives and money: estimates in US of 125,000 deaths and $300 billion in healthcare costs due to nonadherence to oral anticancer medications
Factors not related to the patient can contribute to nonadherence including lack of information provided by the healthcare system and socioeconomic factors
Numerous methods to improve adherence issues (hospital informative seminars, talking pill bottles, reminder phone calls etc.) have met with mixed results.
More strikingly, patient adherence rates can drastically decline over treatment, with one study showing an adherence rate drop from 87% to 50% over 4 years of adjuvant tamoxifen therapy.
Tackling The Oral Chemotherapy-Patient Adherence Problem
Documented factors leading to non-adherence to oral oncology medications include
Patient feels better so stop taking the drug
Patient feels worse so stops taking the drug
Confusing and complicated dosing regimen
Inability to afford medications
Poor provider-patient relationships
Adverse effects of medication
Cognitive impairment (“chemo fog”; mental impairment due to chemotherapy
Inadequate education/instruction of discharge
There are many examples of each reason why a patient stopped taking medication. One patient was prescribed capecitabine for her metastatic breast cancer and, upon feeling nausea, started to use antacids, which precipitated toxicities as a result of increased plasma levels of capecitabine.
This review also documented the difficulties in accurately measuring patient adherence including:
Inaccuracy of self-reporting
Lack of applicability of external measurements such as pill counts
Hawthorne effect: i.e. patient pill documentation reminds them to take next dose
The group suggests that using MTM programs, especially telephony systems involving oncology nurses and pharmacists and utilizing:
Therapy support (dosing reminders)
Education
Side effect management
may be a cost-efficient methodology to improve medical adherence.
Although nurses are important intermediary educating patients about their oral chemotherapies, it does not appear that solely relying on nurses to monitor patient adherence will be sufficient, as indicated in a survey-based Japanese study.
Survey results indicated that 90% of nurses reported asking patients on oral chemotherapy about emergency contacts, side effects, and family/friend support. Nurses also provided patients with education materials on their assigned medication.
However, less than one-third of nurses asked if their patients felt confident about managing their oral chemotherapy.
“Nurses were less likely to ask adherence-related questions of patients with refilled prescriptions than of new patients,” the researchers wrote. “Regarding unused doses of anticancer agents, 35.5% of nurses reported that they did not confirm the number of unused doses when patients had refilled prescriptions.”
From the Roswell Park Cancer Institute blog post Making Mobile Health Work
US physicians are recognizing the need for the adoption of mobile in their practice but choice of apps and mobile strategies must be carefully examined before implementation. In addition, most physicians are using mobile communications as a free-complementary service and these physicians are not being reimbursed for their time.
Some companies are providing their own oncology-related mobile app services:
San Francisco, August 13, 2013 – CollabRx, Inc. (NASDAQ: CLRX), a healthcare information technology company focused on informing clinical decision making in molecular medicine, today announced a multi-year agreement with Everyday Health’s MedPage Today. The forthcoming app, which will target oncologists and pathologists, will focus on the molecular aspects of laboratory testing and therapy development. Over time, the expectation is that this app will serve as a comprehensive point of care resource for physicians and patients to obtain highly credible, expert-vetted and dynamically updated information to guide cancer treatment planning.
The McKesson Foundation’s Mobilizing for Health initiative
has awarded a grant to Partners HealthCare’s Center for Connected Health to develop a mobile health program that uses a smartphone application to help patients with cancer adhere to oral chemotherapy treatments and monitor their symptoms, FierceMobileHealthcare reports.
CancerNet announces mobile application (from cancer.net)
The report suggests that there are too many apps either offering information, suggesting behavior/lifestyle changes, or measuring compliance data but little evidence to suggest any of these are working the way they intended. The article suggests the plethora of apps may just be adding to the confusion.
MyCyberDoctor™, a True Gamification App, Shows Great Results in Improving Diabetics Medical Adherence and Health Outcome
Most of the mobile health apps discussed above, would be classified as tracking apps, because the applications simply record a patient’s actions, whether filling a prescription, interacting with a doctor, nurse, pharmacist, or going to a website to gain information. However, as discussed before, there is no hard evidence this is really impacting health outcomes.
Another type of application, termed gamification apps, rely on role-playing by the patient to affect patient learning and ultimately behavior.
An interested twist on this method was designed by Akhila Satish, CEO and developer of CyberDoctor and a complementary application PatientPartner.
As reported here, the PatientPartner application was used in the first IRB-approved mhealth clinical-trial to see if the gamification app could improve medical adherence and outcomes in diabetic patients. PatientPartner is a story-driven game in changing health behavior and biomarkers (blood glucose levels in this trial). In the clinical trial, 100 non-adherent patients with diabetes played the PatientPartner game for 15 minutes. Results were amazing, as the trial demonstrated an increase in patient adherence, with only 15 minutes of game playing.
Results from the study
Patients with diabetes who used PatientPartner showed significant improvement in three key areas – medication, diet, and exercise:
Medication adherence increased by 37%, from 58% to 95% – equivalent to three additional days of medication adherence per week.
Diet adherence increased by 24% – equivalent to two days of additional adherence a week.
Exercise adherence increased by 14% – equivalent to one additional day of adherence per week.
HbA1c (a blood sugar measure) decreased from 10.7% to 9.7%.
As mentioned in the article:
The unique, universal, non-disease specific approach allows PatientPartner to be effective in improving adherence in all patient populations.
PatientPartner is available in the iTunes store and works on the iPhone and iPod Touch. For information on PatientPartner, visit www.mypatientpartner.com.
Ms. Satish, who was named one of the top female CEO’s at the Health Conference, gratuitously offered to answer a few questions for Leaders in Pharmaceutical Business Intelligence (LPBI) on the feasibility of using such a game (role-playing) application to improve medical adherence in the oncology field.
LPBI: The results you had obtained with patient-compliance in the area of diabetes are compelling and the clinical trial well-designed. In the oncology field, due to the increase in use of oral chemotherapeutics, patient-compliance has become a huge issue. Other than diabetes, are there plans for MyCyberDoctor and PatientPartner to be used in other therapeutic areas to assist with patient-compliance and patient-physician relations?
Ms. Satish: Absolutely! We tested the application in diabetes because we wanted to measure adherence from an objective blood marker (hbA1c). However, the method behind PatientPartner- teaching patients how to make healthy choices- is universal and applicable across therapeutic areas.
LPBI: Recently, there have been a plethora of apps developed which claim to impact patient-compliance and provide information. Some of these apps have been niche (for example only providing prescription information but tied to pharmacy records and company databases). Your app seems to be the only one with robust clinical data behind it and approaches from a different angle, namely adjusting behavior using a gamefying experience and teaching the patient the importance of compliance. How do you feel this approach geared more toward patient education sets PatientPartner apart from other compliance-based apps?
Ms. Satish: PatientPartner really focuses on the how of patient decision making, rather than the specifics of each decision that is made. It’s a unique approach, and part of the reason PatientPartner works so effectively with such a short initial intervention! We are able to achieve more with less “app” time as a result of this method.
LPBI: There have been multiple studies attempting to correlate patient adherence, decision-making, and health outcome to socioeconomic status. In some circumstances there is a socioeconomic correlation while other cases such as patient-decision to undergo genetic testing or compliance to breast cancer treatment in rural areas, level of patient education may play a bigger role. Do you have data from your diabetes trial which would suggest any differences in patient adherence, outcome to any socioeconomic status? Do you feel use of PatientPartner would break any socioeconomic barriers to full patient adherence?
Ms. Satish: Within our trial, we had several different clinical sites. This helped us test the product out in a broad, socioeconomically diverse population. It is our hope that with a tool as easy to scale and use as PatientPartner we have the opportunity to see the product used widely, even in populations that are traditionally harder to reach.
LPBI: There has been a big push for the development of individual, personalized physician networks which use the internet as the primary point of contact between a primary physician and the patient. Individuals may sign up to these networks bypassing the traditional insurance-based networks. How would your application assist in these types of personalized networks?
Ms. Satish: PatientPartner can easily be plugged into any existing framework of communication between patient and provider. We facilitate patient awareness, engagement and accountability- all of which are important regardless of the network structure.
LBPI: Thank you Akhila!
A debate has begun about regulating mobile health applications, and although will be another post, I would just like to summarize a nice article in May, 2014 Oncology Times by Sarah Digiulo “Mobile Health Apps: Should They be Regulated?
In general, in the US there are HIPAA regulations about the dissemination of health related information between a patient and physician. Most of the concerns are related to personal health information made public in an open-access platform such as Twitter or Facebook.
In addition, according to Dr. Don Dizon M.D., Director of the Oncology Sexual Health Clinic at Massachusetts General Hospital, it may be more difficult to design applications directed against a vast, complex disease like cancer with its multiple subtypes than for diabetes.
Mobile Health Applications on Rise in Developing World: Worldwide Opportunity
According to International Telecommunication Union (ITU) statistics, world-wide mobile phone use has expanded tremendously in the past 5 years, reaching almost 6 billion subscriptions. By the end of this year it is estimated that over 95% of the world’s population will have access to mobile phones/devices, including smartphones.
This presents a tremendous and cost-effective opportunity in developing countries, and especially rural areas, for physicians to reach patients using mHealth platforms.
Drs. Clara Aranda-Jan Neo Mohutsiwa and Svetla Loukanova had conducted a systematic review of the literature on mHealth projects conducted in Africa[1] to assess the reliability of mobile phone and applications to assist in patient-physician relationships and health outcomes. The authors reviewed forty four studies on mHealth projects in Africa, determining their:
strengths
weaknesses
opportunities
threats
to patient outcomes using these mHealth projects. In general, the authors found that mHealth projects were beneficial for health-related outcomes and their success related to
accessibility
acceptance and low-cost
adaptation to local culture
government involvement
while threats to such projects could include
lack of funding
unreliable infrastructure
unclear healthcare system responsibilities
Dr.Sreedhar Tirunagari, an oncologist in India, agrees that mHealth, especially gamification applications could greatly foster better patient education and adherencealthough he notes that mHealth applications are not really used in India and may not be of much use for those oncology patients living in rural areas, as cell phone use is not as prevalent as in the bigger inner cities such as Delhi and Calcutta.
1) do you see a use for such apps which either track drug compliance or use gamification systems to teach patients the importance of continuing their full schedule of drug therapy
2) do you feel patient- drug compliance issues in the oncology practice is due to lack of information available to the patient or issues related to drug side effects?
“I think that Apps could help in this setting, we are in
Informatics era but..
The main question is that chronic patients are special ones.
Cancer patients have to deal with prognosis, even in therapies
with curative intent such as aromatase inhibitors are potent
Drugs that can cure; only in the future the patients know.
But meanwhile he or she has to deal with side-effects every day. A PC can help but suffer this symptoms…it. Is a real problem believe me!”
“The main app is his/her doctor”
I would like to invite all oncologists to answer the poll question ABOVE about the use of such gamification apps, like PatientPartner, for improving medical adherence to oral chemotherapy.
UPDATE 5/15/2019
The results of the above poll, although limited, revealed some interesting insights. Although only five oncologists answered the poll whether they felt gamification applications could help with oral chemotherapy patient adherence, all agreed it would be worthwhile to develop apps based on gamification to assist in the outpatient setting. In addition, one oncologist felt that the success of mobile patient adherence application would depend on the type of cancer. None of the oncologist who answered the survey thought that gamification apps would have no positive effect on patient adherence to their chemotherapy. With this in light, a recent paper by Joel Fishbein of University of Colorado and Joseph Greer from Massachusetts General Hospital, describes the development of a mobile application, in clinical trial, to promote patient adherence to their oral chemotherapy.
Mobile Applications to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development
Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer. While oral chemotherapy includes benefits such as ease of administration, convenience, and minimization of invasive infusions, patients receive less oversight, support, and symptom monitoring from clinicians. Additionally, adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens. With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology, we created a mobile health intervention for medication and symptom management.
OBJECTIVE:
The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app to support adherence to oral chemotherapy and symptom management in patients with cancer.
METHODS:
We used a 5-step development model to create a comprehensive mobile app with theoretically informed content. The research and technical development team worked together to develop and iteratively test the app. In addition to the research team, key stakeholders including patients and family members, oncology clinicians, health care representatives, and practice administrators contributed to the content refinement of the intervention. Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the randomized controlled trial.
RESULTS:
We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing. App components included medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback. We are conducting a randomized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy, quality of life, and burden of symptoms and side effects. At every stage in this trial, we are engaging stakeholders to solicit feedback on our progress and next steps.
CONCLUSIONS:
To our knowledge, we are the first to describe the development of an app designed for people taking oral chemotherapy. The app addresses many concerns with oral chemotherapy, such as medication adherence and symptom management. Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians. In our development process, we instantiated 7 of the 8 best practices proposed in a recent review of mobile health app development. Our process demonstrated the importance of effective communication between research groups and technical teams, as well as meticulous planning of technical specifications before development begins. Future efforts should consider incorporating other proven strategies in software, such as gamification, to bolster the impact of mobile health apps. Forthcoming results from our randomized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management.
In this paper, Fishbein et al. describe the methodology of the developoment of a mobile application to promote oral chemotherapy adherence. This mobile app intervention was named CORA or ChemOtheRapy Assistant.
Of the approximately 325,000 health related apps on the market (as of 2017), the US Food and Drug Administration (FDA) have only reviewed approximately 20 per year and as of 2016 cleared only about 36 health related apps.
According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. However, there is not much scientific literature providing a framework for design and creation of quality health related mobile applications.
Methods
The investigators separated the app development into two phases: Phase 1 consisted of the mobile application development process and initial results of alpha and beta testing to determine acceptability among the major stakeholders including patients, caregivers, oncologists, nurses, pharmacists, pharmacologists, health payers, and patient advocates. Phase 1 methodology and results were the main focus of this paper. Phase 2 consists of an ongoing clinical trial to determine efficacy and reliability of the application in a larger number of patients at different treatment sites and among differing tumor types.
The 5 step development process in phase 1 consisted of identifying features, content, and functionality of a mobile app in an iterative process, including expert collaboration and theoretical framework to guide initial development.
There were two distinct teams: a research team and a technical team. The multidisciplinary research team consisted of the principal investigator, co-investigators (experts in oncology, psychology and psychiatry), a project director, and 3 research assistants.
The technical team consisted of programmers and project managers at Partners HealthCare Connected Health. Stakeholders served as expert consultants including oncologists, health care representatives, practice administrators, patients, and family members (care givers). All were given questionaires (HIPAA compliant) and all involved in alpha and beta testing of the product.
There were 5 steps in the development process
Implementing a theoretical framework: Patients and their family caregivers now bear the primary responsibility for their medical adherence especially to oral chemotherapy which is now more frequently administered in the home setting not in the clinical setting. Four factors were identified as the most important barriers to oral chemotherapy adherence: complexity of medication regimes, symptom burden, poor self-management of side effects, and low clinical support. These four factors were integral in the design of the mobile app and made up a conceptual framework in its design.
Conducting Initial Focus Group Interviews with key stakeholders: Stakeholders were taken from within and outside the local community. In all 32 stakeholders served as study collaborators including 8 patient/families, 8 oncologists/clinicians, 8 cancer practice administrators, and 8 representatives of the health system, community, and overall society. The goal of these focus groups were to obtain feedback on the proposed study and design included perceived importance of monitoring of adherence to oral chemotherapy, barriers to communication between patients and oncology teams regarding side effects and medication adherence, potential role of mobile apps to address barriers of quality of cancer care, potential feasibility, acceptability, and usage and feedback on the overall study design.
Creation of Wireframes (like storyboards or page designs) and Collecting Initial Feedback: The research and design team, in conjunction with stakeholder input, created content wireframes, or screen blueprints) to provide a visual guide as to what the app would look like. These wireframes also served as basis for what the patient interviews would look like on the application. A total of 10 MGH (Massachusetts General Hospital) patients (6 female, 4 male) and most with higher education (BS or higher) participated in the interviews and design of wireframes. Eight MGH clinicians participated in this phase of wireframe design.
Developing, Programming, and Refining the App: CORA was designed to be supported by PHP/MySQL databases and run on LAMP hosts (Linux, Apache, MySQL, Perl/PHP/Python) and fully HIPAA compliant. Alpha testing was conducted with various stakeholders and the app refined by the development team (technical team) after feedback.
Final beta testing and App prototype for clinical trial: The research team considered the first 5 participants enrolled in the subsequent clinical trial for finalization of the app prototype.
There were 7 updated versions of the app during the initial clinical trial phase and 4 updates addressed technical issues related to smartphone operating system upgrades.
Finally, the investigators list a few limitations in their design and study of this application. First the patient population was homogenous as all were from an academic hospital setting. Second most of the patients were of Caucasian ethnic background and most were highly educated, all of which may introduce study bias. In addition, CORA was available on smartphone and tablet only, so a larger patient population who either have no access to these devices or are not technically savvy may experience issues related to this limitation.
In addition other articles on this site related to Mobile Health applications and Health Outcomes include
Aranda-Jan CB, Mohutsiwa-Dibe N, Loukanova S: Systematic review on what works, what does not work and why of implementation of mobile health (mHealth) projects in Africa. BMC public health 2014, 14:188.
Healthcare Startups Accelerator is Reaching Out: Deadline November 11, 2013
Reporter: Aviva Lev-Ari, PhD, RN
Applications for companies are due November 11, 2013.
We are also seeking exceptional individuals looking to join a team, particularly those with software development or data science skills. Individuals interested in working with one of the startups can also apply to the program and applications for individuals are due December 16, 2013. Individuals will be matched with companies throughout January.
DreamIt Health Baltimore is designed to speed the growth and success of early-stage health IT companies through its program in Central Maryland. Powered by the Johns Hopkins University, BioHealth Innovation, and DreamIt Ventures – the program gives participants access and advantages typically out-of-reach to healthcare startups.
DreamIt works with extraordinary teams to create exceptional companies, accomplishing in 3-6 months what would otherwise take years. DreamIt accelerators are characterized by seed capital, intense 1-on-1 mentorship from dedicated, previously successful tech entrepreneurs, access to key people, expertise, and information typically beyond the reach of a startup, informal education from leading industry practitioners, a robust network of DreamIt alumni, and a wide range of free services. Following a lean startup methodology, the selected teams focus on rapid, iterative interactions with their target markets to reduce risk and find product-market fit as quickly as possible.
DreamIt Health Baltimore 2014 will select up to ten companies from around the world to participate in a four-month accelerator program. In addition to receiving up to a $50,000 stipend and professional services, the startups will be paired with and work closely with exited entrepreneurs-turned-mentors with domain expertise specific to their needs; benefit from an intense startup and healthcare curriculum taught by accomplished practitioners; meet with subject matter experts and investors; and enjoy access to executives, information systems, and data from leading industry players including providers, payers, biopharma, device makers, and federal agencies. Participating teams will also benefit from DreamIt’s extensive network and expertise in guiding the growth of young technology companies.
DreamIt Health Baltimore is expected to take advantage of many of the strengths of the region, giving participating startups the opportunity to work closely with Johns Hopkins Medicine for potential pilots and also access to key individuals throughout the region’s wealth of federal health care institutions including the Center for Medicare and Medicaid Services, the Food and Drug Administration, the National Institutes of Health and the Agency for Healthcare Research and Quality.
The program will be led by Elliot Menschik, MD PhD, a Johns Hopkins alum and successfully-exited health IT entrepreneur.
DreamIt Health startup accelerator is reaching out in the hopes that you might be open to getting the word out among Health 2.0 Israel members about the upcoming DreamIt Health startup accelerator in partnership with Johns Hopkins.
DreamIt Health startup accelerator are recruiting for (and applications are open for) up to ten healthtech startups from around the world to come to Baltimore for a four-month program to achieve significant business milestones in delivering products that solve real problems for key healthcare stakeholders. DreamIt Health startup accelerator do this by removing as many obstacles as possible from the team’s path and providing guidance and access to people and resources otherwise out of their reach. The capstone of the program, Demo Day, gives these teams the opportunity to unveil their products and progress before a few hundred early stage investors and key industry figures.
In addition to receiving up to a $50,000 stipend, free workspace and top-shelf legal services, the startups will be paired 1-on-1 with previously successful entrepreneurs customized to the needs of each team. These mentors will contribute considerable time and effort to guide and assist the founders. Participants will also benefit from an intense startup and healthcare curriculum taught by accomplished practitioners, meet regularly with subject matter experts and investors, and enjoy access to executives, systems, and data from leading industry players including providers, payers, biopharma, device makers, and federal agencies. Participating teams will also benefit from DreamIt’s extensive network and expertise in guiding the growth of young technology companies.
DreamIt Health startup accelerator were founded in 2008 and are run by a group of successful tech entrepreneurs. To date, DreamIt has worked closely with 127 companies from around the world through accelerators in Philadelphia, New York, Austin, and Tel Aviv. These programs are characterized by seed capital, intense 1-on-1 mentorship from dedicated, previously successful tech entrepreneurs, access to key people, expertise, and information typically beyond the reach of a startup, informal education from leading industry practitioners, a robust network of DreamIt alumni, and a wide range of free services. Following a lean startup methodology, the selected teams focus on rapid, iterative interactions with their target markets to reduce risk and find product-market fit as quickly as possible. Forbes has named DreamIt among the top three accelerators in the world and DreamIt companies have gone on to raise nearly $100M in follow-on capital with an aggregate value north of $400M.
DreamIt Health startup accelerator are looking for extraordinary people and teams developing IT-based products with the potential to solve significant problems faced by key stakeholders in the industry including providers, payers, public health, biopharma, device makers, employers and patients themselves. Interested teams can apply at http://www.dreamithealth.com. Applications for companies are due November 11, 2013. We are also seeking exceptional individuals looking to join a team, particularly those with software development or data science skills. Individuals interested in working with one of the startups can also apply to the program and applications for individuals are due December 16, 2013. Individuals will be matched with companies throughout January.
Gil David and Larry Bernstein have developed a first generation software agent under the supervision of Prof. Ronal Coifman, in the Yale UniversityApplied Mathematics Program that is the equivalent of an intelligent EHR Dashboard that learns. What is a Dashboard? A Dashboard is a visual display of essential metrics. The primary purpose is to gather information and generate the metrics relatively quickly, and analyze it, meeting the highest standard of accuracy. This invention is a leap across traditional boundaries of Health Information Technology in that it integrates and digests extractable information sources from the medical record using the laboratory, the extractable vital signs, EKG, for instance, and documented clinical descriptors to form one or more provisional diagnoses describing the patient status by inference from a nonparametric network algorithm. This is the first generation of a “convergence” of medicine and information science. The diagnoses are complete only after review of thousands of records to which diagnoses are first provided, and then training the algorithm, and validating the software by applying to a second set of data, and reviewing the accuracy of the diagnoses.
The only limitation of the algorithm is sparsity of data in some subsets, which doesn’t permit a probability calculation until sufficient data is obtained. The limitation is not so serious because it does not disable the system from recognizing at least 95 percent of the information used in medical decision-making, and adequately covers the top 15 medical diagnoses. An example of this exception would be the diagnosis of alpha or beta thalassemia, with a microcytic picture (MCV low) and RBC high with a low Hgb). The accuracy is very high because the anomaly detection used for classifying the data creates aggregates that have common features. The aggregates themselves are consistent within separatory rules that pertain to any class. As the model grows, however, there is unknown potential for there to be prognostic, as well as diagnostic information within classes (subclasses), and a further potential to uncover therapeutic differences within classes – which will be made coherent with new classes of drugs (personalized medicine) that are emerging from the “convergence” of genomics, metabolomics, and translational biology.
The fact that such algorithms have already been used for limited data sets and unencumbered diagnoses in many cases using the approach of studies with inclusions and exclusions common for clinical trials, the approach has proved ever more costly when used outside the study environment. The elephant in the room is age-related co-morbidities and co-existence of obesity, lipid derangements, renal function impairment, genetic and environmental factors that are hidden from view. The approach envisioned is manageable, overcoming these obstacles, and handles both inputs and outputs with considerable ease.
We anticipate that the effect of implementing this artificial intelligence diagnostic amplifier would result in higher physician productivity at a time of great human resource limitation(s), safer prescribing practices, rapid identification of unusual patients, better assignment of patients to observation, inpatient beds, intemsive care, or referral to clinic, shortened length of patients ICU and bed days. If the observation of systemic issues in “To err is human” is now 10 years old with marginal improvement at great cost, this should be a quantum leap forward for the patient, the physician, the caregiving team, and the society that adopts it.
APPLY TODAY
2012pharmaceutical
Amandeep Kaur
Aashir Awan, Phd
Abhisar Anand
Adina Hazan
Alan F. Kaul, PharmD., MS, MBA, FCCP
alexcrystal6
anamikasarkar
apreconasia
aptubman
Arav Gandhi
aviralvatsa
David Orchard-Webb, PhD
danutdaagmailcom
Demet Sag, Ph.D., CRA, GCP
Dror Nir
dsmolyar
Ethan Coomber
evelinacohn
Gail S Thornton
Irina Robu
jayzmit48
jdpmd
jshertok
kellyperlman
Ed Kislauskis
larryhbern
Madison Davis
marzankhan
megbaker58
ofermar2020
Dr. Pati
pkandala
ritusaxena
Rick Mandahl
sjwilliamspa
Srinivas Sriram
stuartlpbi
Dr. Sudipta Saha
tildabarliya
zraviv06
zs22