NIH’s All of Us Research Issues Initial Research Protocol

August 8, 2017

by Heather Landi

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The National Institute of Health’s All of Us Research Program, previously called the Precision Medicine Initiative, released its initial research protocol, or research plan.
The All of Us Research Program’s 61-page protocol includes information on consent forms, the ethical issues associated with the project and explanations for how participants will be able to provide secure access to their electronic health records (EHRs).

The goal of the All of Us Research Program is to gather health-related information from one million or more diverse participants to detect association between genetic and environmental exposures and a wide variety of health outcomes.

The NIH states that longitudinal tracking of health outcomes through EHRs is an important component of the program. Through a consenting process, participants will be asked to authorize linkage of their EHR information. EHR data may be sent directly by the participant’s health care providers to the DRC or sent by the participant to the program through Sync for Science.

Access to EHR data will be repeated regularly throughout the life of the program. The initial data types to be included are demographics, visits, diagnoses, procedures, medications, laboratory tests, and vital signs, but may be expanded to all parts of the EHR, including health care provider notes. The feed may include mental health data, HIV status, substance abuse and alcohol data, and genomic information stored in the EHR

Participants may need to complete and sign a separate informed consent module to authorize access to their complete EHRs.

“We will create an informatics infrastructure to clean and standardize data from disparate EHR systems across the United States; this broadly applicable system will be a key contribution of the All of Us Research Program to health informatics research efforts nationwide. For participants enrolled by their health care provider organization, the site will extract data from the participant’s EHR, format it according to the DRC’s data model (based on the Observational Medical Outcomes Partnership [OMOP] Common Data Model version 5, and transfer it to the DRC using secure protocols,” NIH stated in a press release.
And, the NIH states that although obtaining EHR data from direct volunteers presents unique challenges, early pilot studies have demonstrated feasibility of such an approach. “For example, the Sync for Science (S4S) project launched by NIH and the Office of the National Coordinator for Health IT is creating a technology that aims to make it easy and safe for people to securely share their EHR data for research. S4S has been adopted by the All of Us Research Program and initially will be enabled in a small pilot for DV participants at S4S-enabled direct volunteer sites,” the NIH states.

All of Us Research Program direct volunteer participants who have enrolled at one of these pilot sites will be able to sign into their healthcare provider’s patient portal using the S4S workflow and authorize sharing their EHR data with the program. Their health care provider’s system will provide a secure application program interface (API), which is used by the research program, rather than the provider sending out data, and transmitted to the Us of All Research program.

And, NIH notes that this is just the first version of its protocol. In future versions, NIH intends to include plans to pilot test wearable devices for real-time data collection.

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Boost Your eHealth Knowledge. Advance Your Career. Early Bird Deadline for HI Bootcamp Booster Shot Course in 2 Weeks.

It is eHealth Design & Architecture Week! "Too many men slip out of the habit of studious reading, and yet that is essential" — William Osler Stay in the habit. Continue your learning With NIHI HI Bootcamp Booster Shot Early Bird Deadline Only 2 Weeks Away   HI Bootcamp Booster Shot September 19 & 26; October 3, 10, & 17, 2017 | 12:00-3:00 PM ET 15 - 20  CPE Hours Canada’s iconic HI Bootcamp is back! Be the first to take the new HI Bootcamp Booster Shot. Learn from the best…Professor Dominic Covvey, one of Canada’s top HI experts, and Dr. Tom Rosenal, one of Canada’s foremost authorities in clinical Informatics. Learn the new essential competencies and capabilities for today’s informatics professionals: - Analytics and Big Data.  - The Internet of Things (IoT). - Artificial intelligence. - The Cloud.  - Precision/Personalized Medicine.  - Consumer Informatics. - Devices, Sensors, Sensor Networks and data produced. - Personal Attitudes and implications in our workforce.  - Biomedical Engineering and Health Informatics. - Complexity in health care and quantization of Health Informatics - And many others.  Registration & More Information Featured eHealth Design & Architecture Education Sessions Best Practices in HIT Implementation Although health technology implementations have come a long way in the last decade, the risk of partial success and having a 'zombie' project is still high. Given the extensive investments made in health technologies and the high hopes for their effectiveness for health provider productivity and patient safety, best practices in health technology implementation are still topical. Learn about best practices in HIT implementation from a systematic review of the literature with high quality statistical analysis of the findings. The published paper has received over 4000 reads on ResearchGate, a social media site for researchers. Come learn what everyone is so excited about. Canada's Chronic Disease Surveillance Network: Architecture & Next Steps Canada's chronic disease surveillance network (www.cpcssn.ca) recently reached 1000 physicians and 1 million de-identified patients in its database. CPCSSN is revolutionizing primary care by making research easier and faster and by making it easier to apply quality improvement to patient populations. How did we get here? What makes CPCSSN sustainable? What are the impacts of primary care research? Where do we need to go next? Creating the Next Generation mHealth App: A reference Architecture mHealth apps in smartphone app stores are languishing; downloaded and abandoned because they don't solve people's problems. What is the ideal design for an mhealth app? What's working? What's not working? Why? This presentation addresses these questions and proposes a new paradigm for patient mhealth apps that could potentially solve the log-jam. Learning from Amazon: Building the Next Generation EMR Form What if electronic medical record (EMR) systems were designed like the World Wide Web? What if we could improve user experience rapidly because we could see how users were using the software? What if we could make actionable information available at the point of care instantly using Big Data techniques? What if we could quickly test whether new ideas will work and make them available into all EMRs immediately? Lowering Costs in Health Care: Architecting Health Care for Diabetes Prevention What if we could predict who would get diabetes, long before they actually got it? What if we could provide high risk patients with training, support and counselling to prevent diabetes? What if we provided diabetes prevention services to elderly patients who already have other diseases? What Diabetes Prevention Apps Should Have and Why mHealth apps are not being used. Over 45,000 mhealth apps are languishing in mobile app stores. We evaluated over 200 diabetes mobile apps found in the Apple and Google app stores against a Reference Architecture for high quality mobile apps. Surprisingly, we identified a niche where apps do work well and are popular with patients in this space. However, the vast majority of patients with diabetes are not served by these niche apps. Email Philip Grove at pgrove@nihi.ca for assistance

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Reflections on a Health Hackathon

After the first Health Hackathon experience, would I do another one?

The main take away message for me was that the ideas for a pitch/solution should be driven by real needs.  The idea should come from a real world community of healthcare practitioners/patients. I just tossed out some ideas and made a pitch out of one them. It would have been easier and maybe better if I had just attended and joined an interesting team.  That way, I could get experience observing just how these events are organized. I am grateful though that I was able to work on a pitch idea and have a few people interested in sharing the work.

I learned a lot on the weekend about IBM Bluemix, the FHIR standard for medical terminology transport, the skillfulness of the programmers at the event, and the care and consideration that teams brought to their projects to help people better their health. This latter was very inspirational for me. If I ever attend another event like this, I would give more attention to this.

I was also very impressed with how the event was organized, the low registration cost, the venue (Mohawk College library) the mentoring, coaching, and judging abilities. The cool jazz musicians at the beginning of the event was, well, cool!  That all helped remove the actual stress of making a pitch to others in the competition. Every team was a winner in my books.

The Health Hackathons would make a good ethnographic research project. Probably been done before, but while Health Hackathons are still active and up and running, there is still a possibility there I think.

The criteria for judging a winning pitch are the core disciplines of eHealth - business model, patient care impact, and technological feasibility.

Hacking Health in Hamilton Ontario - Let's hear that pitch!

What compelled me to register for a weekend Health Hackathon? Anyway, I could soon be up to my ears in it.

A pubmed search on Health Hackathons...https://www.ncbi.nlm.nih.gov/pubmed/28250965 came up with a research article that shows that Hacking Health does have very useful benefits. I am intrigue and would even like to do my own research on this.

I attended a pitch workshop and learned that intellectual property on ideas is not what it appears to be. From that perspective, and in the interests of ehealth promotion:

1. Medical School ePortfolio - So you want be a Doctor eh? [app, educational]
Problem:
Getting into medical school is like a lottery. Or is it? How can students best prepare so they don't become disappointed or feel like they are gambling getting in, or getting in and realizing it is not their ideal career choice?

Solution:
This app will be for students who want to be physicians. Maybe it could even be aimed at three levels; elementary, high school, and university. It would allow students to track their interest in a career in medicine from early days. Students are also getting into medical school after high school these days at Queens University. It could have tests and quizzes, links to schools, CV prep, volunteer opportunity suggestions, how to apply, what's involved in the actual application process at very schools. The book "So you want to be Doctor eh?" by Anne Berdl is an excellent resource to model this on. Also, many universities have learning portfolios and that is also a model. Possible mentor relationships or chats or talks with professionals in the field. By tests and quizzes, it could also have an educational role to survey student empathy, compassion training, aptitude, in addition to preparation for MCAT and other formal tests.

2.Smart Forms Builder for Healthcare [ app, software]
Problem:
Hospitals were faced with a crisis in screening patients and visitors for SARS at Ontario hospitals in 2003. The paper system they had was bogging down entry to the hospital. A LAMP (Linux, Apache, MySQL, PHP) online screening system was eventually created to streamline the process. Healthcare administrators and even IT need to develop online forms quickly without programming skills as well as have access to useful data.

Solution:
There are smartform software systems like Google docs and commercial ones like Jotform, but they are not private and secure for personal health information. As well, smart forms need to be smart enough so people without programming experience can quickly develop an application. These kind of systems are evolving, but they just need something more akin to artificial intelligence to make them really smart and inexpensive to setup. API, mobile and REST applications would also be good integration components.

3. eHealth enabled browser [ browser, app, big data]
Problem:
Personal Health Records come in many different types, tethered, stand alone, and integrated. The  people who benefit most are those who need to monitor and access a lot of medical records and visits. However, tracking health, IOT, and fitness device data can be integrated into Personal Health Records to create an overall digital health snapshot. Not everyone likes to login to a portal and track their health data.

Solution:
The idea here is to integrate Watson IBM analytics, or google alpha Go search engine analytics built into a dedicated open source browser built on chrome (or chromium). While this might sound just like an app running on a smartphone, the idea is to build a Firefox, Chrome or Safari browser that is actually a dedicated health analytics and digital health single sign on personal health record browser. What you search and read in every day life is all fodder for personal health anlaytics. This is digital "google flu" writ larger for an individual. In a way, think of it is a browser add on or extension that is a personal health record data collector, storage, and dashboard, but it is actually the browser itself.

4. Universal Healthcare Observatory [Big Data app]
Problem:

The problem is that not everyone has access to free healthcare. Statistically, millions of people are rising out of poverty every year, according to the late Global Health researcher Hans Rosling. Access to free or affordable healthcare should be a basic human right.

Solution:
The purpose of the project is based on the scientific based belief of evidence based medicine that "for profit healthcare is hazardous to your health". The United Nations and even the WHO have many observatories, and this one would be similar to the European Observatory of Health Systems and Policies. It will be a big data app that pulls data and statistics from disparate sources to monitor the global healthcare systems in the world and promote any trends towards universal healthcare. It might be able to use the Trendalyzer software. The bold target would be to achieve universal access to free or affordable healthcare for everyone on the planet by 2050.

5. eHealth Garage [ infrastructure, service]
Problem:
In my neighbourhood there are two former automobile/gas stations that are now a Vietnamese restaurant and a Holistic Health Clinic. Gas stations used be found on almost every block in every neighbourhood in every city and town. Cars no longer break down because the technology is better and gas monopolies are pushing gas stations out of neighbourhoods. Needless to say, electric cars are moving in soon. Also in my neighbourhood is a legal Medical Marijuana Clinic. Why not an eHealth Garage?

Solution:
With an aging population living longer and a coming generations that might may well live easily way over 100 years of age because of advances in exponential medicine, preventive medicine and holistic health services need to be accessible with digital health services in the community. This is also a way to deconstruct medicine.The eHealth Garage could be a component of a Family Health Team but they might call it an eHealth clinic. I see the Garage being full of healthcare technology: x-ray machines, ultrasound, MRI, fitbits, resistance training gym machines, Transcranial Magnetic Stimluation (TMS) - almost any health technology that can be coupled with a digital health technology or record. DIY healthcare, though with options for professional healthcare oversight.

The myUHN Patient Portal - Infoway Award Winner

The myUHN patient portal has won a second place award from a Canada Health Infoway contest. Here is the presentation they gave:
 http://imaginenationchallenge.ca/wp-content/uploads/2017/02/myUHN-Patient-Portal.pdf

Their infographic on the uptake of the portal is very impressive by the numbers - numbers which have been suggested as viable in research on patient portals (They didn't mention concern for the security of personal health information):
 http://www.uhn.ca/corporate/News/Documents/myUHN_infographic.pdf

The pilot study is over and a full launch began January 30, 2017. It is expected that 250,000 patients will register for it in 2017! Very, very interesting that the portal is integrated into all stages of the clinical experience and by all personnel.

Based on my research on patient portals this looks to be the very promising. Sunnybrook Hospital myChart was also a great pioneer in this area and they have taken a page from their book. It also appears to be an ideal integration solution that I think would work best for a healthcare system.

But what about primary care? Is there an API for that? And why are family docs still so worried about liability or whatever for using a PHR?

Looking closer at myUHN it is very much just a portal or window on the hospital EHR, with a limited but very useful and important set of interaction tools. It is not a personal health record where one can self-report and journal one's health, as is the one developed by McMaster Family Medicine, now called KindredPHR.

If I get sick, I am going to Toronto and the UHN:
 http://www.uhn.ca/PatientsFamilies/myUHN

mbant2 clinical trial - a super duper fitbit?

I noticed on the Journal of Medical Internet Research that the mbant2 clinical trial is starting.
 http://www.researchprotocols.org/2016/3/e174/

This is an ehealth cornerstone - evaluating the effectiveness of ehealth applications. mbant2 is a University of Toronto study, where Frederick Banting appropriately enough was one of the discovers of insulin.  I almost think the fitibt could help self-manage type 2 diabetes if there was also a way to measure glucose A1c levels. Apparently Medtronic is looking into exactly that.
 https://www.medtronicdiabetes.com/blog/partnering-with-fitbit-for-type-2-diabetes/

No google contact lens yet for tears to detect blood sugar insulin. Guess they are still working on it. The email alerts I have been getting about always make it sound it is off in the future somewhere. It would be great to have pin-prickless procedures and devices. The research is very hard to make that work well.

Pushing Drugs - American Style: Watching the news makes people sick.

This is a post from the blog of Professor emeritus Dr. Richard Hayes, who taught Buddhism and Sanskrit at McGill University, and is now back home in the 4 corners area of the United States. Dayamati Hayes is also a Quaker, peace activist, vegan, and a conscientious objector from the Viet Nam war. As a friend who I have known on internet lists and now on social media for more than several decades, Dr. Hayes is well known and respected for his wit, wisdom, and insight into our human condition. In fact, there are too many excellent posts one could share from Richard, but this one is only a sample, and one that has some relevance to digital health:

http://dayamati.blogspot.ca/2017/02/pushing-drugs-american-style.html

Watching the news makes people sick

At the outset I must confess to being addicted to watching the news on television. Although my favorite televised news sources are on PBS, on most nights I supplement the PBS News Hour with the news on one of the traditional network stations or a cable news channel. Something that has repeatedly struck me in watching the evening news on traditional network stations is that advertisers have obviously learned that the vast majority of people who watch the evening news are suffering from indigestion, irritable bowel syndrome, erectile dysfunction, atrial fibrillation not caused by a heart-valve problem, moderate to severe psoriasis, rheumatoid arthritis, osteoporosis, depression, insomnia, restless leg syndrome or dry eye disease. If not afflicted by one of those conditions, they are being assaulted by meatballs or chicken wings.

Not all the commercials are pushing drugs, of course. Interspersed with all the pharmaceutical products are commercials featuring lawyers who are prepared to sue pharmaceutical companies for offering products that have life-changing side effects, and health insurance plans that complement Medicare to provide coverage to pay for all those pharmaceuticals that TV viewers are urged to ask their doctors about. Given the evidence of television commercials, remarkably few of the people who watch the televised news are under the age of sixty-five and have sound minds in sound bodies.

An often-heard claim of those who are convinced that the Affordable Care and Patient Protection Act has all but destroyed the health-care system in the United States is that the ACA (which they persist in calling Obamacare) has driven insurance premiums through the ceiling, thus bringing financial ruin to small businesses and confronting hard-working Americans with having to choose between health insurance and sending their children to overpriced universities. What is missed in this analysis, of course, is that health insurance is expensive because medical care and pharmaceuticals are expensive. Also left out of consideration is that almost every pharmaceutical product sold in the United States is available in Canada for a fraction of the cost.

Why don’t Canadians pay their share of the cost of drugs?

A claim I have heard many American make, clearly a claim that they have learned from the pharmaceutical companies themselves, is that the prices of pharmaceutical products are so high in the United States because it costs pharmaceutical companies a great deal of money to do the research necessary to develop new products. Some American friends have even showed indignation that Americans are subsidizing Canadians, who derive all the benefits of expensive medical research but pay none of the cost. Once, when I was still living in Canada, I received an email from a (former) friend in the United States who accused me, in language unsuitable for anyone not in either the navy or a motorcycle gang, of being a freeloader who was enjoying good health at the expense of poor Americans. That claim was false for two reasons. First, I have almost never been prescribed a pharmaceutical product and tend to avoid over-the-counter medical products. Second, there are better explanations for why pharmaceutical prices are outrageously high in the United States. So the answer to the question “Why don’t Canadians pay their share of the cost of drugs?” is that they in fact do pay their fair share. Americans pay more, not because they are subsidizing freeloading Canadians, but because Americans pay far more for products than it costs to develop and manufacture those products.

Why do Americans pay for overpriced pharmaceuticals?

The pharmaceutical companies typically claim that they must charge high prices for their products because of the high cost of developing them. It cannot be denied that running controlled tests on new products and making sure the products meet safety standards is costly. It should also be pointed out, however, that advertising the products once they are developed is also costly. To that can be added that pharmaceutical companies also tend to pay shareholders rather high dividends. When health care products are manufactured by for-profit corporations that have investors to reward with high dividends, then costs naturally rise. While the claim of many advocates of free-market capitalism is that competition keeps costs down, the opposite is often the case. If two companies are competing for a share of the market, the cost of the competition—the advertising of products to potential consumers of the products and to potential prescribers of those products—can be quite high.

Neither of those kinds of advertising is necessary. There is no justification whatsoever for running expensive advertisements on television that end with the line “As you doctor whether…is right for you.” There is no need to make the patient into a sales representative for a product that the patient may end up buying. If someone has, say, osteoporosis, then it should be sufficient for the physician to suggest a range of possible treatments, and to tell the patient the desired effects and the likely side effects of each of the possible treatments. And that information should be given directly to the physician in the form of the results of clinical trials, not in the form of slick presentations delivered in the context of work-vacations at expensive resorts. The cost of disseminating objective information is relatively low, whereas the cost of trying to persuade a physician to prescribe product A rather than the almost-identical product B is much higher.

One way to bring medical costs down is to make advertising of medical products illegal, as it is in some countries that have lower costs for pharmaceuticals and hands-on medical care. Another way is to have government-imposed limits on the amount of profit a company can make on a product, as is also the case in some countries that have reasonable consumer-costs for health-related products. A third way is to have a government-run insurance plan that negotiates prices with pharmaceutical companies and imposes a cap on how much a pharmaceutical company can receive for its products. There is no need for a government-run plan to be managed by the central government. In Canada each province has its own plan, and no two provinces have exactly the same setup.

Health care is far too important to be left to the vagaries of markets in a for-profit corporate scheme. The good health of the entire citizenry is far more important than the bank accounts of capitalist shareholders. There are plenty of other markets in which investors can make or lose their money. Pharmaceutical companies, manufacturers of medical devices, clinics, hospitals and retirement homes for the elderly should not be in the private investment sector of the economy. (Neither should correctional facilities, but that is a matter for another day.)

Americans desiring affordable health insurance should first advocate for more affordable treatments, and that is best achieved by a not-for-profit health-care system. They should be asking for, in fact demanding, more government involvement and less private-sector investment in products designed for health. Such a change in outlook would, however, require that Americans first seek a cure for their addiction to free-market capitalism and the delusion that the best way to keep costs down is to let the market determine prices. That strategy has been tried again and again, and it has failed again and again. It is time for Americans to considered an alternative system (not to be confused with “alternative facts”).

Next time you see a television commercial for an expensive treatment that you have seen a hundred times before, instead of simply reaching for the mute button on the remote control, ask your doctor whether socialized medicine is right for you. If you doctor says No, then consider seeking a second opinion.