Towards a High Performance Personal Health Record

Marcos Athanasoulis, M.P.H., Dr.P.H., Crohnology.MD Technical Director, Healthy Communities Institute

A common hope among non-developers in the e-health and mobile space is that the personal health record (PHR) is the nirvana for keeping all data in one place and enabling a whole host of PHR applications. Although the PHR can do a pretty good job of keeping data in one place, what is often misunderstood is that for developers to do anything useful with a PHR, they inevitably need to have a local copy of that data. And, as soon as an application has its own data, it is a slippery slope to having its own data definitions, data that isn’t shared, and data that gets out of sync with the primary PHR. Until some major barriers are addressed, mobile application developers are faced with real challenges to actually building applications that run directly off of PHR repositories.”

Let’s take a look at the top four barriers to using PHRs as a true backbone for applications:

1: Performance

If you are querying a significant amount of data at once, rather than getting one measurement for one period, it is often not practical to rely on a remote query to database – especially if you want results in anything less than the time it takes to get a cup of coffee down the hall.

2: Network Availability

Most mobile applications cannot count on having a connection to the Internet. If the developer relies on a remote PHR to get their data, and there is no Internet connection, then the developer will not able to provide the user with the data they need. If the developer keeps a local copy, then they can access it with or without a network connection. 

3: Tools Availability

Most application development environments are optimized for a standard database backend. Most developers know how to write SQL to fetch data from a database, and they have the tools to readily use that data in an application. Adding a layer of an API call for every piece of data adds a considerable layer of complexity to the development process.

4: Lack of Standards

Even if there were a high performance, distributed PHR that let you write SQL directly against it, which one would you pick? You might have chosen Google Health. But because Google is discontinuing the product, Google Health is no longer a good choice. You could choose Microsoft HealthVault, but you are tying your fortunes to Microsoft. There is not yet a true distributed, open PHR that developers can count on for the next five years – or even the next year.

None of these barriers is insignificant. The Project HealthDesign teams have struck a balance by maintaining local copies of data, but, when possible, pushing data to and pulling data from PHRs like Google Health and Microsoft HealthVault. But until an open architecture for high performance exchange of PHR data is invented and adopted, mobile health applications developers will continue to maintain data locally and use the tools that allow them to build mobile health applications that really help people.

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Thinking about Science, Evaluation and e-Health Design

Linda Neuhauser, Dr.P.H., Crohnology.MD Co-Principal Investigator, School of Public Health, University of California, Berkeley

One of the big challenges we have faced in the Crohnology.MD project is developing an evaluation plan. We are all familiar with the trade-offs between using qualitative and quantitative methods. If we choose a primarily quantitative approach, we may have statistical results, but may not really understand the phenomena being tested. If we select a qualitative approach, it’s hard to know whether the results would be similar if tested on a larger cohort. This is the typical tension in evaluation design. My view is that traditional evaluation methods are not well suited to novel e-health experiments, like the Project HealthDesign projects. I’ll start with a personal story:

Last March, I participated in a conference on Artificial Intelligence and Health Communication at Stanford University. There were many fascinating state-of-the-art projects. I was especially intrigued by a project using avatars as health coaches. The developers described how they gathered some preliminary (formative) information at the project outset, implemented the project, and then quantitatively evaluated the outcomes. The developers and the funder considered this an acceptable design, as would many evaluators. However, the results uncovered an important problem—the users did not find the avatars adequately believable and that interfered with their engagement with the virtual coaching. Similar surprises cropped up in other projects that were presented, even though the developers of the projects were highly talented, had given careful thought to the evaluation, and had used both qualitative and quantitative methods. As a result, a number of these projects will now need to be re-funded, redesigned and re-evaluated. I left the conference with the strong impression that some of these problems could have been avoided if the developers had used different evaluation methods. Certainly, e-health evaluation is an area that needs a lot more attention.

I believe the roots of the evaluation conundrum lie in the foundations of scientific inquiry. Before the mid-20^th century, the dominant “positivist” view was that truth is knowable and generalizable and the focus was on discovering the laws that govern the physical world. This perspective advanced the idea that quantitative methods (like randomized controlled trials) should be the gold standard of research and that their findings could be broadly extrapolated. In the past 50 years, the scientific paradigm has shifted. In the “post-positivist” world, the “critical realists” have emerged and posit that it is impossible for humans to adequately perceive the real world, and that claims about reality must be subjected to the widest possible examination.

There is now a greater understanding that it can be very difficult to define what we want to study, much less quantify the results. This is particularly true when we move from the natural sciences to human sciences—people don’t follow the more predictable laws of the physical world. In the health arena, we now have a host of social sciences to help us understand the connections between people and health. Changes in evaluation design have paralleled changes in views about scientific inquiry. Qualitative methods are considered increasingly important to achieve a deeper understanding of the complicated nature of human health and behavior. Likewise, there is a growing recognition that formative work needs to take place before investigators even know enough to finalize a research design that focuses on outcomes.

Scientists have identified a newer research challenge: one posed by what is now called “design (or artificial) sciences.” This field is concerned “not with how things are, but with how they might be.” (Simon, 1996).  Those who study design sciences say that they pose special challenges for research methods because understanding a problem and solving that problem often happen at the same time. Similarly, there is no “end” to the design and problem-solving process. Obviously, design science efforts are not well suited to traditional research approaches that test a priori hypotheses. For this reason, design sciences emphasize real-time, iterative investigative approaches, such as usability testing, over the more simplistic “before” and “after” methods of traditional evaluations. In other words, just as we are experimenting with observations of daily living (ODLs) to get finer, time-sensitive information about participant data, we need to do the same in our evaluations.

In my view, the Project HealthDesign projects, which create new technologies and measure complex daily interactions between people, their environments, and their health, lie at the intersection of human and design sciences. Effective evaluation designs for these projects will need to include a strong focus on usability and other iterative testing over time, artfully linked with formative and outcome measures. There is no definitive guidance for such evaluation designs. Fortunately, the Project HealthDesign teams have taken a pioneering experimental approach to finding a better path forward.

Have you successfully employed both quantitative and qualitative evaluation techniques on a project? What advice can you share with us?

Reference:
Simon, H. 1996. The Sciences of the Artificial, 3^rd Ed. MIT Press.

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Kirienko Provides Patient Perspective on Improving Patient Access to Health Information at Consumer Health IT Summit

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

A Sept. 11 article in USA Today featured Nikolai “Kolya” Kirienko, patient advocate and project director of Project HealthDesign’s Crohnology.MD study. The story, “HHS Aims to Improve Patients' Access to Electronic Records,” previewed new initiatives that support patients as they seek access to their own health information.

The following initiatives were then formally introduced at the U.S. Department of Health and Human Services (HHS) Consumer Health IT Summit on Sept. 12:

• Federal rules (pdf) that would strengthen patients’ rights to access their own laboratory test results.
• A straightforward model privacy notice for personal health record (PHR) vendors.
• BlueButtonData.org, which encourages organizations to register their commitment to offering Blue Button data download functionality to their patients and users.

Kirienko, who has Chron’s disease, also appeared at the Consumer Health IT Summit, along with patient advocates Donna Cryer and Denis Stasulis. "We desperately need collaborative medical records,” said Kirienko, whose story illustrates how patient access to health information and patient-clinician cooperation can help improve care for patients with chronic diseases.

As project director of Crohnology.MD, Kirienko has casted a vision for and helped to develop a mobile personal health application that allows patients with Crohn’s disease to self-track observations of daily living (ODLs) and symptoms between clinical visits. Because the application allows users to customize data views and share them with their clinicians, he and his team hope to see the application spark and support richer conversations between patients and providers during clinical visits.

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The Cohort Selection Process for Crohnology.MD

Elena Rodriguez Fisher, R.N., FNP-C, Crohnology.MD Clinical Partner

Would you like an iPad?

Offering an iPad in exchange for participating in a study that aims to improve patient-provider communication instantly gets people’s attention. But even without the iPads, recruiting 30 study participants with moderate to severe Crohn’s Disease is far from difficult.

Patients with Crohn’s may require immunosuppressive medications to help control their disease and many have had complications that have necessitated surgery. As a result, Crohn’s patients tend to be highly motivated and are often up for trying anything that may limit the symptoms of the disease or improve their quality of life. The harmful effects of assorted medications, therapies, surgeries, and impositions on personal and professional pursuits tend to foster this openness toward new approaches if there is a chance their health may be improved.

The selection criteria for our study require that participants must:

1. Currently be under the care of a health care provider at the University of California, San Francisco Center for Colitis and Crohn’s Disease;
   
   
2. Possess the means and be willing to communicate with their provider electronically;
   
   
3. Be willing to attend clinical follow-up visit(s) with their provider during the study period;
   
   
4. Be open to participating in focus groups, completing surveys and using technology to collect and integrate observations of daily living (ODLs);
   
   
5. Be able to read, write and speak English; and
   
   
6. Be eighteen years old or older at the time the study begins.  

Potential participants received informational handouts at scheduled office visits or after contacting their providers via email. These handouts instructed them to contact the nurse practitioner at the Center for Colitis and Crohn’s Disease via email if they were interested in enrolling in the study. Most candidates quickly responded to express interest. When discussing the study, many potential participants even disclosed that they already tracked their symptoms using paper or electronic diaries, spread sheets, or timelines.

Most candidates were selected because they have a history of emailing their health care provider two or more times a year or because they expressed an interest in doing so. Most of the candidates who declined to participate in the study cited the time commitment or their current life demands as the primary reasons for refusing to participate. The selection process occurred over a 2 1/2 month  period, and the study enrollment goal was reached prior to study initiation.

Study participants are genuinely excited to be involved; though, as one might expect, they do frequently ask, “When do we get our iPads?”

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Selecting Observations of Daily Living (ODLs) – Patient and Provider Priorities

Kathleen Morrison, M.P.H., Crohnology.MD Project Co-Director, Health Communities Foundation

Crohn’s disease is a painful and often burdensome disease. Although debate is ongoing as to the exact cause of the disease, we do know that there is a genetic component, as well as an environmental component to the disease. We know that the disease is nearly nonexistent in Southeast Asia, but that when Southeast Asians move to the U.S., we start to see Crohn’s disease in that population. Jonathan Terdiman, M.D., our clinical principal investigator, describes the disease as “… a war going on between different types bacteria in the intestines of an individual.” The standard of treatment varies, depending on the severity and extent of the disease in the patient. For this reason, Crohn’s disease provides a perfect opportunity for patients and providers to explore the usefulness of observations of daily living (ODLs) in promoting increased collaboration and communication in the understanding and treatment of the disease.

We knew that in order to capture the ODLs that would be most useful for our project, we had to get input from both patients and providers. Prior to our focus groups with both of these groups, we reviewed the literature, taking into account the most often used of quality of life indices for Crohn’s disease – the Crohn’s Disease Activity Index and the Harvey-Bradshaw index. In addition, we reviewed the quality of life markers identified in the Inflammatory Bowel Disease Questionnaire (IBDQ). We selected a baseline set of ODLs based on the markers that had been identified as most useful and presented them (separately) to our patient and provider focus groups. We then asked them to rank the ODLs.

Although ODLs are patient-directed observations, we wanted to make sure that the providers felt that the ODL information being collected would help inform their treatment decisions. Our goal is to create an ODL collection system that is both personally relevant to patients and clinically useful for providers. Our budget allows us to identify and collect data on 6-10 standardized ODLs—including a few biometric measures such as weight and test results—and we were very curious about how much overlap there would be between the patient and provider focus groups.

Provider Priorities

Not surprisingly, there were both similarities and clear differences between the priorities of the representative focus groups. Both groups agreed upon the importance of pain, activity level, bowel movements (BM), medications, weight and test results. Yet the providers acknowledged that the level of ODL importance really does vary by patient. For example, although BM is an important indicator of Crohn’s severity, many different aspects of the disease can impact BM, including where the disease is impacting the colon, how far the disease has progressed and food intake. Because of the entirely subjective nature of this marker, the providers broadly felt that it would not be one of the most useful indicators to follow in this study. Similarly, they felt that energy level and mood were subjective measures that would vary by patient and that these ODLs would not necessarily assist the providers in their treatment decisions.

Patient Priorities

The patients preferred that the ODLs be very individualized. The women in the group wanted to track their menstrual cycles in order to see the correlation with pain and other indicators. This topic never came up in our discussion with providers. Several patients mentioned that missed workdays could be used as a proxy for pain, missed sleep or BM complications. The patients felt that energy level and mood were directly correlated with how sick they were and how motivated they were to exercise and work; they felt strongly that these indicators were related to their pain and disease symptoms. This group of patients was interested in investigating the interactions between two or more ODLs and the biometric measures, including medications taken. The patients had strong ideas about which ODLs they would track and why. In fact, some of them had already been tracking their symptoms for some time. Interestingly, the patients all commented that they would be more likely to collect ODL information when they were not feeling well. “When I feel good, I want to forget that I have Crohn’s disease, and I want to stay as far away as possible from it,” said one patient.

A Collaboration Between Patients and Providers

It took several weeks for our team to identify our final list of ODLs to be tracked.  We took into consideration factors identified in the literature; by the providers; and by the patients. Given the wide range of patient preferences about which ODLs to track, as well as Dr. Terdiman’s recommendation that the patients and providers should work together to identify the most relevant ODLs to track, it seems that a collaborative process is already in the works. In order to accommodate the ODLs that patients wish to track, but that are not on our official ODL list, our developers have introduced journaling functionality, whereby patients will be able to add and tag other ODL data that they deem important and relevant to follow. We hope that both patients and providers find the process of ODL identification and collection to be illuminating and rewarding.

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Creating an ODL Prescription [Video]

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

 

Deryk Van Brunt, Chronology.MD principal investigator, describes the social contract between a patient and a clinician that would comprise an ODL Prescription. This prescription, or joint agreement, would allow patients and clinicians to choose which observations of daily living (ODLs) the patient will track between clinical visits, as well as the frequency, duration and method of ODL capture.

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ODL Prescriptions and Patient Data Capture - Is Provider Liability an Issue?

Deryk Van Brunt, Dr.P.H., Chronology.MD Principal Investigator, University of California, Berkeley, Healthy Communities Foundation
Kathleen Morrison, M.P.H., Chronology.MD Project Manager, Healthy Communities Foundation

We live in a country where the American Trial Lawyer’s Association is one of the biggest contributors to political campaigns — to whichever party is in office. Although several attempts at federal legislative overhaul of our medical malpractice system have been introduced in the last 25 years, none has succeeded. The threat of medical malpractice lawsuits can influence the way providers practice medicine. One consequence is the practice of “defensive medicine,” which often results in more expensive care — including unnecessary tests and procedures, as well as recommended protocols. Although attempts have been made to reduce the fear and threat of malpractice liability in the medical profession (e.g., clinical guidelines, best practices, etc.), the reality is that this threat remains quite salient for many providers.

It should come as no surprise, therefore, that liability was a significant concern in the early phases of the design of our technology. On Pioneering Ideas, Steve Downs recently mentioned the Crohnology.MD ODL Prescription (read his post). The concept of the ODL Prescription, put forward here by Dan Bernstein, Nikolai Kirienko, Deryk Van Brunt and Kathleen Morrison, was developed out of a collaboration between iMedic8 and the Healthy Communities Foundation and has been embraced by the Crohnology.MD team.

The ODL Prescription is an agreement between patients and providers that details which biometrics and observations of daily living (ODLs) will be captured between visits. An ODL Prescription is the outcome of a patient/provider negotiation and represents a balance between collecting what’s important to both parties while also considering what’s most relevant in managing the patient's health. The ODL Prescription identifies which ODLs the patient will track and designates how often and when they will be collected. This patient ODL data will be captured and viewable by the patient, and it will then be shared with the provider during the next clinical appointment.

Some members of our team were concerned about the liability risk to our participating providers. For example, is it possible that once a patient logs ODL data, then the provider could be liable if a negative outcome were to result? And what if clues in the patient’s ODL data had pointed toward the negative result?

Our clinical partner, Dr. Jonathan Terdiman, quickly put the liability fears to rest. From his perspective, the ODL information that would be shared at the time of the clinical visit does not represent new information beyond what was previously being discussed; the information is just being captured and shared more thoroughly and reliably. Because the ODL data will only be shared with the clinician at the time of the clinical visit, this data is, in effect, no different from any other information a patient discusses with his or her provider at the time of the clinical appointment. The key element is that initially the system will not even allow the physician to retrieve and see the data between visits. This data workflow will be reinforced once we make our clinicians and patients aware of this protocol. Because there is an understanding that the data will not be shared between appointments, nor reviewed by the clinicians outside of the appointments, we see the ODL data as a visually enhanced — and perhaps more comprehensive — patient narrative.

This approach does, however, raise questions for future versions of our system — and other systems — as we consider sharing the ODL data in real time. Certainly, if a patient’s ODLs indicate that a situation is urgent and requires immediate clinical attention, then that data could be used to inform the clinician of the situation and to instruct the patient to seek treatment immediately. In such a case, would the clinical team be held responsible and liable if they do not act upon this data? The answer will likely relate to the expectations established and agreements made between the patient and his or her care team.

In the meantime, the ODL Prescription will allow our Chronology.MD patients to collect data that may be both clinically and personally significant, allowing us to evaluate whether the information positively impacts the efficiency and value of the patient narrative.

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Project HealthDesign Workshop and Emerging ODL Themes

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

We routinely hold workshops that allow the five Project HealthDesign teams, the national program office and other project advisers to meet in person. At a recent workshop at the Vanderbilt Center for Better Health, we focused on the evaluation phase of the project.

 

During the workshop, we identified several themes that resonate across the five teams:

Patients and clinicians have different perspectives on which ODLs are important.
The observations of daily living (ODLs) that are crucial to a particular patient’s daily life and health may not seem as important to his or her clinician. Or, a patient may grow tired of collecting data about an ODL that the clinician finds important. In “Whose ODLs Are They Anyway?” on Pioneering Ideas, Steve Downs, chief technology and information officer at Robert Wood Johnson Foundation, further examines this difference in perspective, and also details the Crohnology.MD team’s innovative approach to negotiating common ground between the two perspectives.

Patients may want flexibility in how they use ODLs.
Because the projects are breaking new ground as they look to see whether and how ODLs enter the clinical decision-making process, several teams left a measure of flexibility for patient preference. They recognized that even though patient and clinician focus groups helped to choose and prioritize the ODLs tracked in each study, each individual patient might value another ODL that is not part of the study’s standard ODL set. The iN Touch team, for example, allows participants to choose an extra function in The Carrot platform that they’re interested in tracking. Additionally, each participant in the BreathEasy study will be able to use a journal feature to write narratives pertaining to the ODLs that matter to him or her.

Clinical workflow varies by team, but several use “intermediaries” to review ODL data.
The five project teams were chosen, in part, for the various types of clinical partners with which they work. Thus, it is no surprise that each project team has taken a different approach to incorporating ODLs into the clinical workflow. We were intrigued, however, to see that several teams are using an “intermediary,” such as a health coach or nurse, to routinely analyze the ODL data and act upon the findings.

 

Our teams are beginning to recruit (and even enroll) patients for the evaluation phase of their projects. We’re excited to think that data is already being collected from sensors in several elders’ apartments as they use the phone, and dozens of overweight teens are meeting regularly with their health coaches and collecting ODLs. Rest assured that the teams will soon be sharing new developments as their studies progress!

Participatory Medicine @ UCSF: Off the Whiteboard and onto the Smartphone

By Nikolai Kirienko, UC Berkeley

As a patient at UCSF, I’ve witnessed bedside technology evolve at a rapid pace over the years. From nurses capturing vitals on tablet computers, to patients escaping through 50-inch HDTVs, high tech surfaces are helping us connect and accomplish our age-old goals in very modern ways.

Yet, during a recent admission, the interactive surface that most captured my attention was an upgrade to a decidedly low power device: the patient whiteboard. 

As strange as it may sound, this was the most engaging piece of technology in my hospital room: it was a collaborative medium for asking questions, coordinating specialist teams, mapping out treatment options and otherwise sequencing the series of events leading up to the most important day of my hospitalization: my planned date of discharge.

Dr. Niraj Sehgal, a product champion for the newly revamped whiteboards recently wrote in the Journal of Hospital Medicine, “Patient whiteboards can serve as a communication tool between hospital providers and as a mechanism to engage patients in their care, but little is known about their current use or best practices.” 

In my experience, I witnessed the whiteboards performing the function of ‘random access memory’ within our group collaboration process; a kind of short-term, shared memory vital to executing a task. It made sure that everyone was looking at the same information at the same time, much as we hope to accomplish with the design of Crohnology.MD.

So, perhaps the wisdom the whiteboards can offer us as designers of personal health care applications is an illustration of participatory medicine as best defined by patient engagement, which does not always require the latest in technology to be effective. For example, in preliminary user tests we've found that SMS can engage as well as or even better than a native app for capturing certain ODLs.

Ultimately, the whiteboards at UCSF, and the culture of patient participation they represent, are steadily paving the way for all the advanced bedside collaboration technologies destined to take their place. And even if people and their processes evolve slowly, when it comes to putting the patient in the driver’s seat, sometimes the right technology is just a surface to write on. In the meantime, I'll be snapping pictures on my smartphone- until we finish a smarter dashboard. 

Communication and ODLs – Unedited, a Physician's Perspective

By John Liesveld, Web and Social Media Support, Project HealthDesign

Seated on the crinkly paper of the examination table, under the pasty sterile glow of fluorescence, wearing only a lightweight gown and skivvies, a lot of editing can occur in the mind of a patient before he speaks to his doctor.

But when it comes to a chronic illness, such as Crohn's disease, an honest, accurate and timely account of ODLs makes a profound difference - sometimes between life and death. It's an idea that epitomizes one of Project HealthDesign's major themes -- more efficient, accurate and streamlined communication.

Dr. Jonathan Terdiman, a professor of Clinical Medicine and Surgery at the University of California at San Francisco who specializes in inflammatory bowel disease (IBD) and serves as a co-principal investigator for the Crohnology.MD project, says discrepancies in communication create one of the biggest barriers for doctors to overcome in treating and improving patient health and can result in adverse health outcomes.

An illness like Crohn’s disease produces a series of debilitating symptoms that fluctuate daily, sometimes hourly, and require critical attention from both a doctor and a patient in order to maintain health. Unfortunately, without good methods for recording and evaluating symptoms and their potential causes, patients are more likely to provide inaccurate summaries of their ODLs and may affect their doctor’s ability to effectively treat the disease.

The complex symptomatic variations of an illness can lead to a common barrier that physicians like Terdiman face with each patient: communication. And he emphasizes, it is “very hard to capture the full depth [of a patient’s health] in a single visit." Whether it’s simply forgetting to mention something or only saying what the patient thinks the doctor wants to hear, finding a way around communication barriers like these is key to accurately tracking ODLs.

“One of the challenges is to try to come up with some sort of a compromise to assimilate, tabulate and streamline data,” Terdiman said. He explains that by providing a patient with the right tools (e.g. a smartphone containing specific software apps) they can record and track symptoms in real time, correlate those symptoms with diet and medications and then upload the data to an EMR that allows physicians to depict trends in a graphical display.

With the right tool and software we will “enhance our ability to really understand what’s happening with the patient," Terdiman explains.

Developing that tool is a major objective of Crohnology.MD and other research projects developed by Project HealthDesign. In practice, Terdiman has long recognized a need, identified by patients, for a tool that records, assimilates and summarizes data in way that identifies trends and possible underlying causes of symptoms and is excited to work with the grantees to make the tool a reality.