Five Differences between Consumer and Patient Sensor Technologies

The technology industry has been buzzing of late because of the big players entering the wearable sensor market. We are very familiar with Misfit and Fitbit for some time. Others investing into the sector include Intel, Microsoft,  Apple and Samsung. There is no doubt that the inertia for fitness trackers is undergoing modulation. This is a result of both a dampening of the initial ‘wow’ factor by consumers and a maturation of the market. Recalls of Fitbits makes this officially a mainstream product.  As consumer fitness sensors navigate their way in society, one must appreciate the fact that introduction of this kind of technology is paving the way for its future use in mainstream healthcare enterprises. However, there exist significant differences between the consumer and healthcare markets (though I am certainly not denying the fact that a patient is also a consumer).  I have previously discussed issues vital to designing and implementing digital health technologies. I will attempt here to touch on five critical differences between the consumer and patient care markets.

1. There needs to be buy-in by the healthcare provider for patient-facing trackers. There are few physicians these days that roll their eyes when patients tell them they have looked up something related to their complaint or condition on the Internet. Such was not the case 15-20 years ago when online health information was far less reliable.  Today there are websites which are routinely suggested to patients to obtain information, and in fact virtually all physicians and other providers utilize the Internet and apps to obtain information. In order to garner support of providers, the technologies need to: improve efficiency, achieve better patient outcome, and deliver data in either stealth or meaningful ways via utilization of quality analytics within new care delivery processes. This contrasts with the direct to consumer model (see also number 4 below).

2. Consumer-facing trackers need not demonstrate efficacy. There is no burden of proof of efficacy for a consumer item. The sale of the technology is the ultimate goal but adherence is not. It should be noted that the recall of the Fitbit Force was ordered by the Federal Product Safety Commission for an unacceptably high incidence of contact dermatitis (skin irritation) from the device, not because it didn’t perform up to standards.  Hospitals will be places for the critically ill and a place to have procedures performed. This scenario is already a reality in many developed countries. One way to achieve this is with the utilization of reliable proven and unobtrusive technologies. Technologies will be used to monitor patient at home to decrease hospital readmissions, manage chronic disease states, and help people age at home.These technologies will need to prove their worth with outcomes studies. The targeted outcomes might consist of cost efficiency, clinical benefit, or others. Is this too much for patients and providers alike to request?

3. Patient-facing trackers require more than pure data. Lost or ignored data garnered by a consumer fitness tracker has little consequence. What is done with the data in a patient-facing device is the potential of its success. Does it mean the person needs to walk more? Faster? If it suggests bad sleep pattern (a stretch) is it because of obstructive sleep apnea or a noisy neighbor? Does an increased heart rate require the person to drink more fluids, take less insulin, have their blood count or thyroid checked, or increase their diuretic usage?  Therein lays the challenge for companies of these products (or others which process data from different sensors). The product might be the same, but unless analytics and processes for evaluation and management of actionable data (hopefully driven by the user demographics and medical history) are in place, the shift from consumer to patient-focused tech will not be successful.

4. Patient-facing tracking sensors need payer participation. Right now there is no concrete incentive for a consumer to use a heath tracking device.It is already clear that healthcare providers are becoming payers.  In addition, we are also witnessing more payers becoming providers.  Some of the more visible politics of this trend have been seen in the  Highmark versus UPMC battle waged in public media campaigns. Whatever the level of participation, payers are critical to the adoption of these technologies.  The development of new business models is necessary. A wearable sensor has a better chance of being utilized if the patient is incentivized financially vis-a-vis lower healthcare premiums to wear it in the context of an overall treatment program. The data can be used by wellness or chronic disease management coaches already widely used by payers.

5. Consumers are self-managers and patients often depend upon caregivers. While the walking well constitute the majority of consumers of fitness trackers, family caregivers are becoming increasingly more important to the healthcare system. These people also need to be connected to the data derived from sensor trackers of their patients. Most directives arising from algorithmically derived data should be targeted to both the patient and a caregiver to facilitate understanding and adherence. Consumer-facing trackers might focus on trendy language associated with the data, stylish design or graphics. Patient sensor platforms need to deliver understandable and timely simple instructions to them and caregivers.  Caregivers are necessary intermediaries to patients whereby consumers are independent recipients and managers of the data.

There might be some significant differences among financial analysts and others regarding fitness tracking revenue predictions. These predictions often mix the apples of consumers and patients. I believe these technologies will become an integrated part of healthcare. However, the shift from consumer to healthcare markets is not one as simple as some make it sound. It will not be seamless by any means and will require financial, strategic, clinical, and sociological considerations to be incorporated into that transition. I look forward to being both an active participant and observer of this process.


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Point of Engagement Business Models for Digital Health Technology

          One of the biggest challenges globally that patient-facing digital health technologies face is finding ways to gain traction and to generate revenue within traditional reimbursement systems. In a previous post, I discussed best practices for adoption of technology by the healthcare enterprise. But the introduction of technologies is dependent upon other best practices. Many technologies offer tools which address singular technical or clinical issues. They might even prove to produce better outcomes (though precious few have done). Success in the marketplace however, hinges on a combination (some of which are interdependent) of proven results, access to the C-suite door, being attractive to the user (provider and/or patient), and providing a comprehensive approach to a clinical problem. Instead of focusing on how a technology can obtain reimbursement, I submit that a vision of becoming part of a total solution translating to better outcomes will undoubtedly ‘show the money.’ The phrase ‘point of care’ is popular now. I think that the technology version of this is ‘point of engagement’ (POE), where the opportunity for adoption of the tool lies. The POE is dictated by the clinical or workflow need. It might be the office visit, the hospital admission or discharge, or the time at home when the need for such a tool arises.

           Business models which are designed with the POE in mind will find the best chances of success. It is where the shared desire of a patient and provider for a better outcome is greatest. It is where the highest concentration of empathy and resources are found. Combining the concepts of partnering and point of engagement is a recipe for both new care and business models in this sector.

           A cardiac patient at the time of discharge from the hospital might be given an interactive app which has been shown to decrease readmission rates, blood pressure, and weight. The app contains educational content and tracking of vital signs. There might be other apps which are connected wirelessly to vital sign monitors and might also contain specific disease state educational content offerings. The content might originate from pharmaceutical or medical device companies (furnishing instructions about how to optimally use a product within the context of a comprehensive treatment approach), from one of a number of third-party digital health content providers, or the healthcare enterprise itself which might customize and/or brand provided content. Best of breed sensors (a combination of wearable and environmental) might be combined to monitor the patient. Both content and data can then be incorporated in the patient’s EHR or third-party portal.

            Patient portals are themselves POE tools. They are accessed by patients and caregivers at a time when information is needed to be obtained or transmitted.

            At the pharmacy, a patient or caregiver presents to fill a prescription. At the same time, an app describing how that drug is to be used is digitally transmitted by the pharmacist at checkout.

            The patient visits the physician’s office for a follow-up appointment. In the waiting room a tablet is given to the patient to complete a patient satisfaction survey. Virtual glasses are given to the patient through which an educational video is transmitted about the discharge diagnosis. A login might be provided to an online patient support group.

           See the pattern? A specific part of the matrix of the ‘usual technology suspects’ is relevant at different points of engagement. The matrix involves disease state education and management tools (via apps, digital content sent via email or patient portal), social media, the EHR, and peripheral devices (remote monitoring sensors/devices, smartphone, tablets, Internet). The ideal digital health business model involves the partnerships of technologies which are relevant and additive (either in a clinical or operational way). Consideration of the POE is critical for business development of tech tools in healthcare, both from introduction as well as adoption standpoints. A clinician team member or advisor is therefore imperative in the formulation of strategies built around points of engagement. I believe that thinking of this matrix in the context of clinical settings is paramount to success. ‘Build it and they will come’ is possible only with the POE in mind.

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Transforming a Digital Health Technology Tool into a Solution

I always pay attention to the reaction I receive from an audience at a talk or individual I encounter when I discuss the difference between a tool and a solution. Marketing a technology as a solution before it has been trialed, integrated into clinical workflow or even an EHR can even be met with legitimized skepticism by an educated purchaser. I offer a few thoughts on the subject which are critical for the development, adoption, and success of digital health technologies. These have been discussed in various other pieces I have written, but are focused here on the issue of technology as a solution.

1.    Solve a specific problem. The Merriam-Webster dictionary definition of solution is: “Something that is used or done to deal with and end a problem : something that solves a problem.” It might seem obvious that a technology touted as a solution would solve a problem. Addressing specific concerns, whether they are workflow-related, clinical should be the driving force behind a technology. The problem should be one which requires bidirectional input so that metrics can be tracked and evaluated. This will facilitate identifying potential pain points from technical or human perspectives requiring improvement.

2.    Give as much importance to processes as to technology. Technologies do not operate in a vacuum.  Many digital health technologies (if not most) involve staff education, restructuring workflows, and perhaps rethinking human resource requirements. All of these considerations translate into new processes within which the technology will operate. Certainly this has been illustrated in the area of electronic health records. Some processes built around the technology have had both negative impacts (decreased physician/nurse efficiency and time with patients) and positive ones (billing, scheduling, e-prescribing). Given time, both the technology and processes will likely arise to improve upon the negatives. Many of the pain points experienced in the implementation and use of EHRs are borne out of the fact that they were not developed with provider-patient workflow in mind and therefore do not offer a good user experience. This is due to the development addressing needs to satisfy regulatory requirements, not clinical issues. Other technologies will not be strapped with as much regulatory restrictions and have the freedom to create friendly and effective processes. It is up to many of us to demonstrate to physicians that EHRs are not representative of the rest of the digital health technology sector which holds much promise for achieving positive and honorable goals from both the provider and patient perspective.

3.    Demonstrate positive outcomes.  Most digital health technologies need not undergo long clinical randomized trials to demonstrate outcome. However, prospective studies looking at time efficiencies, user satisfaction, and eventually clinical impact are what a purchaser of a technology would not only demand but expect. The development process must include small trials in order to result in quality cost-effective outcomes for the company itself.The best time to collect data is from the beginning of implementation, even if it is a minimal viable product trial. This will be the best way to identify weaknesses and strengths of the product and processes. Until data is collected and the ROI (whether it be clinical, financial, or other type) demonstrated, a technology should not be called a solution. Business impact can be measured on strategic, operational, and tactical levels. According to the excellent book Measuring ROI in Healthcare, effective measures are: important, complete, timely, visible, controllable, cost-effective, interpretable, simple to understand, specific, collectible, team-based, and credible.

4.    Create partnerships (doing whatever it takes) to solve the problem. Sometimes this is the most difficult part of the vision and execution of the project. Budgeting resources, whether they be financial or human is best accomplished by partnering with other entities which can contribute to the solution in ways otherwise not achievable. The partnerships might be in technical, clinical, or business development areas. They sometimes might involve strange business bedfellows. The production of a more robust offering (whether it be from a technical or strategic standpoint) is going to make it easier to get into a C-Suite or perhaps result in better process or clinical outcomes.

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Five Ways Patient Engagement Can Start in the Office

There are over 58 million references to ‘patient engagement’ if one conducts a Google search. The term has been diluted and changed in the past couple of years and has become a buzz phrase, used more from a business than clinical benefit perspective.  The Center for Advancing Health defines patient engagement as “actions individuals must take to obtain the greatest benefit from the healthcare services available to them.” This implies that the engagement is generated by the patients themselves, not received from others or technology which is often implied. Engagement is a process which, as I have stated before, will require a change of the culture of healthcare, morphing the adversarial provider-patient relationship into a shared decision-making one. This process cannot result from the adoption of technology, regardless of how ‘patient-centric’ it might be. In a previous post I discussed how patient empowerment must precede patient engagement.  I think the process is a slow one which can be accomplished.  Patients who do not have smartphones, who have been non-adherent, who are skeptics of physicians all can become engaged. It starts with baby steps which I will offer here and which I participate in every day in my office with patients. There are countless mobile apps which monitor patients’ vital signs, activities, symptoms and thoughts with diary logs. The use of mobile health apps is something I feel is a beneficial and inevitable and important part of the future healthcare landscape. I have spent a considerable part of my time in this arena both as a paid and volunteer consultant. The premise of apps is to make a process more convenient. If patients do not do these things in other ways, the convenience factor is lost.  The app itself becomes a tool which might be less appreciated. In addition, those patients without smartphones (estimated to be 20% of the population over 65 years old in the USA), mobile apps will not be adopted immediately.

1.    Have patients start to monitor their health metrics with pen and paper.   One example in which I as a cardiologist engage patients initially is to have them start to manually keep track of their blood pressures (if a diagnosis of hypertension is suspected but not made, if medications are changed which might affect BP, or to attempt to correlate symptoms with BP). I observe a compliance rate of 100% with a request for a two-week log.  At follow-up (either via the patient portal or in person) I review the record (I supply the patient with a pre-printed chart to fill out), reaffirm the importance of the data, and then perhaps move to discussions about monitoring via simple apps that they or their caregiver might use (even if unrelated to blood pressure).

2.    Introduce mobile health apps for wellness first. When discussing diet, medication adherence (especially when prescribing a new one), disease state education, or perhaps smoking cessation, I make it know that there are apps to assist in those areas. I give a list of the best ones and suggest that their caregiver if needed help with the download or use of the app. I show sample snapshots from the app store on my own phone.  I believe that wellness apps are easier to introduce as engagement tools than specific disease apps (at least to the less digitally literate).

3.    Discuss your philosophy as a physician. After I introduce myself to a new patient (with the same degree of attention to the caregiver in the exam room), I discuss my practice philosophy of only recommending the minimal degree of testing and prescriptions (many patients mistrust physicians as prescribing testing or drugs because of financial incentives).  I then go on to stress shared decision making which requires a partnership of honesty and listening. I believe this to be imperative as it not only sets the tone in a positive manner but establishes the importance of patient participation.

4.    Learn about the patient as a person. Knowing the caregiver support (or lack thereof) around a patient gives a physician the milieu in which shared decision-making is to play out. Critical barriers might exist which will ever prevent success without adjustments by the provider and/or the patient. Caregivers should be involved whether it is a near or distant interested relative, friend, acquaintance or other professional involved with the patient. A patient’s former or present occupation or hobby might impact treatment plans or give insight into educational and levels, and degree of independence.

5.    Create buy-in from physician colleagues. Discussing patient engagement within the context of everyday professional interaction is a great way to change culture one person at a time. In correspondences or conversations regarding a patient, “The patient, family and I have decided”, “I found the BP diary the patient filled out for me very useful” or “I recommended that the patient consider using such and such diabetes app” are non-threatening or proselytizing ways to convey how I view positively and embrace engagement.

While none of these methods are unique or innovative (to utilize some even more overused terms), they work. I truly see, in that first encounter, a reaction of pleasant surprise, time after time. Something must be clicking. Happy trails!

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Completing the Puzzle – Mobile Survey Results Shape the Direction of mHealth

There have been a few excellent surveys regarding mHealth.  One report commissioned by PwC and published in 2012, was a combination of two separate surveys conducted in Brazil, Denmark, the UK, the USA, Turkey, Germany, India, China, South Africa, and Spain. One survey was directed at 1027 patients of various backgrounds. The second survey targeted physicians and payer executives. Some takeaways from this report are impressive. One half of patients and 60% of physicians and payer executives felt that mobile health technology adoption is inevitable in the near future and patients in addition, believe that mHealth will positively affect convenience, cost and quality of care. One  interesting contrast seen in the surveys point to different viewpoints of patient empowerment with patients viewing mHealth as a way to increase their power over their health, while doctors expressed a resistance to this loss of control over patients.  With regards to geography, the report states that emerging markets are much more receptive to mHealth than developed countries. More physicians there offer mHealth technologies and more payers reimburse for it (I have previously described why payers are critical to mHealth adoption).

Another report published in 2012 by Ruder Finn found that one in three consumers of all ages want their providers to have access to remote health monitoring data. The study “found that 40% of mature adults (55 and older) listed remote monitoring devices as one of the top tools that would help healthcare professionals verse 31% of millennials”, though interestingly, 36% of these ‘seniors’ would rather speak with their physician in person versus 19% of millenials.

While these surveys are important as they furnish us with a perspective on the market landscape, they do not answer the questions as to what is actually needed and how to best prioritize and implement mobile health technologies. These issues are critical to technology developers, payers, providers, and industry analysts.  A recent survey of HIMSS members, I believe, is the most ambitious, practical, and relevant collection of market data from the’ inside’ of the healthcare enterprise.  This data will compliment the information furnished in the surveys mentioned previously, and complete the strategic puzzle.

The 2013 HIMSS Mobile Technology Survey results will be announced at the 2014 HIMSS Annual Conference. Areas of the survey mirror the sections of the mHIMSS Roadmap which include: New Care Models, Technology, ROI/Payment, Legal and Policy, Standards and Interoperability, and Privacy and Security.  Issues addressed include prioritization of mobile technology, maturity of the technology environment, impact of the technology on patient care, integration of devices with EHRs, mobile app development strategies, and many others. The survey population was noted to be more diverse than in past HIMSS surveys. Mobile device technology deployment is seen as an important part of the healthcare enterprise by most respondents.

There are many potential benefits of the survey. It provides insight into what similar stakeholder HIMSS members are presently implementing and strategizing for the future. It might serve as crucial information for developers to determine best how to present their technology into the healthcare enterprise itself. The survey can be seen as a type of mini premarketing consulting project in this regard. Investors and financial analysts can glean valuable information about rates of adoption and relative areas of interest by customers. I look forward to being a part of the announcement of the survey’s results. There will be much to digest and discuss.


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Introduction vs Adoption of #mHealth Technology

Before the adoption of new technologies which will undoubtedly improve healthcare (as it has the retail and finance sectors), it must be introduced in ways which are digestible, scalable, and subject to rapid iteration. Is mobile technology different from the adoption of any other change in healthcare delivery? I think not. The culture of care certainly requires change as care models are changing. The point of care is shifting to the home, professionals other than physicians are delivering most of the care, and digital technology is becoming a fact of daily life.  With this care shift is the shift of daily tasks to mobile technology. Most mobile tools utilized today by physicians is related to reference or other resources geared towards them, not the patient or care. I suggest a few ways in which the introduction of mobile healthcare tools to physicians will itself lead to adoption. Baby steps are needed in this process contrary to what I see as industry’s ‘Build it and they will come’ philosophy, with its predictable disappointment.  The following suggestions are predicated on good medical app development practices.

1.    Involve physicians in clinical pilots.  This accomplishes three things: It introduces physicians to mobile health tools and processes involved in using them. It serves an avenue for user experience feedback from both clinicians and patients, and might provide some outcomes data.

2.    Establish a network of key opinion leaders. Peer to peer education has a successful track record in both the Pharma and medical device sectors. The ‘in the trenches’ experience provided by these KOLs is invaluable in conveying information and addressing concerns of physicians.  It speaks to pain points, benefit to patients, and healthcare and business models.  These KOLs using digital tools themselves via closed professional social networks is a model I would look forward to being useful.  KOLs have impact via presenting data at professional society meetings, discussing new technologies via traditional media outlets as well as social media.

3.    Payers incentivizing physicians to use good tools (portal, diabetes tools).  The use of mobile health apps and other tools (communications, delivery of educational content, and interoperability of data with EHR) might promote or even necessitate the use of robust patient portals. This therefore accomplishes two things which will benefit patients. Payers are in the unique position to incentivize both patients and providers to take advantage of these mobile tools. In what way can payers incentivize physicians? How about having a physician directory which spotlights those who utilize mobile health technologies?  Like-minded patients who desire to become more participatory in their care will gravitate towards these providers, thereby potentially fostering good relationships even before they meet.

4.    Patients introducing technology. Changing behavior in the doctor-patient relationship can be a bidirectional process. Just as physicians can change patient behavior, patients can exert influence as consumers on physicians by asking questions about the use of digital technologies by their physicians. These inquiries might get physicians thinking. Patients who suggest medications based on DTC marketing ads often receive them. Patients who are proactive are better patients.

5.    Medical school courses for students. Digital natives (or close to them) are now medical students. There is much enthusiasm by students for the use of mobile technologies in healthcare.  Many are designing apps or anxious for others to do so. There are many reasons why medical schools are at the forefront of mobile medical apps. A ‘bottom up’ approach seems logical  in this arena because of the slow pace of the change in healthcare culture by the establishment. Mentors in medical school might not be champions of mobile health tools for many reasons. As often is the case in politics of many sectors of society, the new generation is the source of execution of the dreams of others.

Though none of these points are revolutionary, they should provide sources of consideration for starting points of those interested in this sector. There needs to be a distinction made between introduction and adoption of technology, as I believe they are considerably different. Thinking about the process this way might result in less frustration by the industry, investors, and create a different model for implementation and sales.

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Five Ways Physicians Can Change Patient Behavior

It is no secret that one of the best ways towards better health management is a good physician-patient relationship. There needs to be buy-in from both participants to shared decision-making. One might object to the title of this post, stating that it puts the biggest burden on the patient, however when examining how this is achieved, you will, I hope, feel differently.

1.    Establish a relationship. This might sound trite, but the first few minutes of meeting a new patient are critical. From the physician’s perspective, there is the importance of body language and reactions to patient questions. On the patient’s side as well, there are ways to make the encounter more meaningful.  Physicians need not divulge their own personal stories but convey personal touches via empathy, and anticipating patient concerns. This is perhaps the most important of all the five topics discussed here.

2.    Improve the patient and caregiver knowledge base. Much of patient behavior is driven by fear of the unknown. The purpose of each test and what it entails, the overall suggested plan, the possible diagnoses and their probabilities should all be touched upon.  This need not be done in great detail but in a way in which the patient gets the overall picture. The reason for each medication prescribed and its most common potential side effects is something not always done, leaving patients with prescriptions and many questions even five minutes after leaving the office. A well-informed patient is the best patient.

3.    Utilizing digital health technology tools.  Digital health tech tools, whether in the form of patient portals (allowing patients to easily communicate with me and get test results quicker), apps (allowing the patient to keep and upload a diary or use for nutritional, weight loss, or smoking cessation guidance), or reliable websites (for deeper information about their symptoms or diagnosis) should be an important aspect of all medical practices today. The mHIMSS Roadmap is a guide for healthcare enterprises and providers to adopt mobile health apps (as a matter of disclosure I was the Chair of the Task Force that developed this set of papers). A mobile health tech strategy is essential for reaching patients and improving patient satisfaction.

4.    Providing incentives. Incentives for patients to be better participants in their own healthcare need not be overt. It might be in the form of a physician’s conveying sensitivity to costs by prescribing the most economical medications, minimizing tests as well as acknowledging the issue as a concern. Another is to involving decisions and plans with a caregiver who can help achieve established goals along with the patient. In addition, the previous three points will also incentivize the patient via respect and empowerment.

5.    Involve the caregiver. The role of the caregiver cannot be underestimated in the achievement of provider goals. There are many resources for caregivers. The role of the caregiver is variable, depending upon the diagnosis, resources of the patient, proximity to the patient, and relationship itself. There are digital health tools available for caregivers. I see the success of mobile health dependent upon the focus of the caregiver as end-user and customer.

While none of the above are new concepts, they are ways in which I personally have improved my own practice and my patients’ satisfaction. I look forward to comments from others.


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Five Things New Patients Think Which Surprise Me

     Patients now often enter a physician’s office with preconceived notions. All the parties involved are cognizant of one thing: time is limited. The patient is hoping their issue is addressed (hopefully, the provider often fears it is not more than one), the physician hoping that the right targeted information is provided.  These desires are commonly not met by either side. Should there be ‘sides’ to healthcare?  How did this inherently adversarial relationship develop before the parties have even met? In an  earlier post I discuss the importance about navigating the healthcare system.  I would like to discuss here some observations I have made both in practice and as a caregiver for my mother on the initial office visit. They address my sensitivity to issues which are viewed by others who are resigned to a new status quo and accept them as part of healthcare. Perhaps digital health technologies facilitating communication among patients and providers will help in these regards.

1.    Patients see answering their questions as a value added service.  I am amazed at “Is it OK if I ask a question?”  To their amazement, my pat answer is “This is what I am here for.”  Every encounter is concluded by asking “Do you have any (or other) questions?” The look of satisfaction after that is the only thing I need to propel me to my next patient with a sense of satisfaction and purpose.

2.    Patients think they need to provide a diagnosis instead of seeking one.  I have heard countless patients seeking my help (either via referral by another physician or self-referred) that they are sorry they don’t know a diagnosis for the complaints which have prompted my visit. My philosophy is that a patient is only responsible for describing symptoms.  Most physicians are familiar with Sir William Osler, a great pioneer in medicine, who said “Most times it is the patient who will furnish the diagnosis.”  What he meant was that the patient’s narrative, NOT a specific diagnosis would provide adequate information to make said diagnosis. While it is not as easy today, given significant therapeutic implications not present in Osler’s time, the patient’s story remains critical to focusing future investigation and questioning. I allow the patient to furnish the whole story without interruption. In the case of no specific diagnosis found for a non-serious condition, I emphasize that it is just as important in knowing what it ISN’T as what it is, and that this is not a denial of their symptoms.  I encounter this often facing patients with palpitations.

3.    Patients smile when I tell them that I dispense medications and suggest tests on a minimal basis. Most patients, contrary to many providers’ impression, do not seek or desire a pill, tests or procedures.  Certainly they cannot be avoided in all circumstances. Initially, they want to know if the condition is (or potentially) serious, and why each therapy, test, or procedure is prescribed. Explanations go a long way. Often communication with other providers (especially regarding side effects of meds prescribed by others) is critical. I tell patients that my goal is to decrease medication use, not to increase it. I find that relatively healthy 90 year olds are on minimal medications and tell them that it is in part for this reason that they are doing relatively well. Ordering tests for defensive medicine purposes is largely unnecessary and many do not fall into accepted practice guidelines. Good patient relationships are fundamental to decreasing liability concerns. Minimizing interventions are both important in this regard and appreciated by patients as a sign of patient advocacy.

4.    Patients are relieved when I acknowledge the importance and intent of caregivers.  Many patients are embarrassed when significant others or other caregivers accompanying them to either ask questions, take notes or corroborate the narrative.  I take time to dispel any doubt about the importance of that person. I first ask for the relationship of the person and if it is OK to share all of my thoughts with that person. The extent of caregiver support might very well affect the type of treatment plan I recommend or the need to contact that person to discuss the shared decision plan.

5.    Patients are surprised when I tell them that old age is not a diagnosis.  While many diseases are diseases of old age, a patient’s age itself is not a disease. Someone presenting with fatigue due to anemia should certainly not be written off as having ‘anemia of old age.’  I am not advocating exhaustive workup of elderly patients, merely stating that a discussion regarding shared treatment decisions needs to take place.  Discussions surrounding advanced directives should also include how far one would like to go in testing and therapeutic procedures. This might not preclude an otherwise healthy elderly patient from undergoing a workup for a problem impairing quality of life.


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Why Clinical Trials Need Mobile Health Tools: Can CROs be Replaced?

I have previously written why mobile technologies need clinical trials.  I would now like to discuss why clinical trials need mobile technology.

For readers not familiar with clinical research, a CRO (clinical  research organization)  is “…an organization that provides support to the pharmaceutical and biotechnology  industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical researchclinical research, clinical trials management, and pharmacovigilance. (Wiki)”    CROs as we know them today started in the late 1970s and early 1980s and have grown as a part of Pharma R&D budgets from 4% in the 1990s to close to 50% in the mid 2000s.  In a previous post on why Pharma needs mobile apps, I briefly mention their potential role in clinical trials.  I would like to discuss this in more detail now.  The cost of performing clinical trials is increasing significantly. Technology including mobile technology and analytics can decrease these costs, but the challenge is for both business models and the research processes to adapt around them. This presupposes that the technologies can perform trials well.

In an excellent paper Transforming the Economics of Clinical Trials, the authors discuss the introduction of technology in clinical trials: “Over the last decade, electronic data capture (EDC) has made some progress in transforming this [business] model. In an EDC-enabled environment, paper forms are replaced by electronic forms, whereby sites enter their data into an electronic database. This technology has produced some efficiency gains as edit-checks reduce the cost of the manual data-query process. However, the EDC platform was largely embedded in the traditional clinical research business model, with legacy concepts around site monitoring and validation. New opportunities for central statistical monitoring of data in these systems were not widely embraced)…Patient screening and recruitment costs remained largely unchanged.”  They then suggest the mining of EHRs for data for the screening and recruitment of patient research subjects, and mobile technologies for direct data collection. What is also keenly pointed out is the current absence for a technology-based business model. The report goes on to discuss monitoring of trial sites. Both the European Medicines Agency and the FDA have endorsed centralized monitoring of trials via technology on a real-time basis.

One company providing mobile tools for clinical trials is exco intouchInVentiv Health is a CRO which has recently become active in the mobile side of clinical trials. InVentiv bought a stake in Mytrus, a company that has mobile technology which facilitates obtaining informed consent for clinical trials.

Recruitment of patients is another aspect of digital technology in clinical trials. Pfizer used social media to recruit patients for a clinical trial of Detrol  One company hosting 200,000 patients in online communities which gather data on 150,000 disease states, PatientsLikeMe  has signed agreements with pharmaceutical companies to match patients with trials using its clinical trial search tool.

Other advantages of mobile clinical trials, as I see them, include less biased recruitment via crowdsourcing, a dramatic reduction in costs, better medication tracking via pill sensor technology (Proteus Digital Health), and faster reporting of adverse events (which can potentially save lives and stop negative studies earlier via transmission to the Data Safety Monitoring Board),  and more timely analytics and trial reporting. In addition, they might lend themselves to more comprehensive or efficient audits, and will strengthen the assistance of caregivers (who can receive and transmit data with/for the patient) in the trial. 

     While I do not believe that mobile technology will replace CROs, I do believe that it will significantly reduce costs and improve procedural inefficiencies and accuracy. The digitalization of clinical trial data represented a significant step in improving process and quality of trials. Making it mobile will take it to an even more higher level. 

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Takeaways from The #DigitalHealth Conference 2013

I recently attended and moderated at my first Digital Health Conference in New York, hosted by the New York e Health Collaborative. I was impressed with the quality of the speakers but more impressed with how this year, in my view, truly signals the implementation of digital health technologies we have long discussed as technology of the future.

1.    Analytics are the key to the power of Big Data.  Much has been said about Big data. However, Big Data is as useless without good analytics is as weather data is without forecasting models. The keynote speech by Kaiser’s George Halvorson was powerful.  He provided examples of how analytics (retrospective and more so real-time) are powerful in both formulating hypotheses and providing answers needed to drive better patient outcomes. It was the emphasis on outcomes which mesmerized me as a physician and a proponent of the use of digital technology to solve real clinical problems.

2.    Interoperability was addressed at multiple sessions. In one session, standards for interoperability were discussed by speakers from the ONC as well as commercial entities. Representatives from The North Shore-LIJ Health system discussed how interoperability is utilized to facilitate continuity of quality care across different areas (pre-natal, labor and delivery, and post-delivery) in another. Interoperability was also a focus of an excellent session entitled “Freeing the Data: Driving Value from Using Clinical, Claims, and Device Data”, moderated by Dr. Deborah Estrin. The importance of interoperability was highlighted at a session which I moderated as well, “Mobile Health Technology: The Future is Now.” Another big session focused on interoperability as a key component of care coordination where patient hand-offs and care coordination planning were discussed.  It was made clear (and comforting to me) from the conference that interoperability is no longer seen as a luxury but an integral part in the projected success of digital health technology.

3.    Tools of the future were discussed.  The development and potential use for Google Glass and 3D printing in healthcare were artfully presented by early adopters and developers. The enthusiasm of early adopters was infectious and palpable in the crowded rooms.

4.  Presentations relating to the patient perspective made me proud to be a part of the faculty of this conference.  Sessions on the Blue Button Initiative (direct patient access to data) and patient portals from leading experts in the public and private sectors were informative and inspiring.  It is my hope that all healthcare conferences (including professional society meetings) include patient perspectives. Shared decision-making will necessitate such collaborative collective learning.

5.   The role of digital technologies in producing better patient outcomes via new care models was highlighted in a couple of sessions. The value of the use of digital tech by Medicaid patients and their providers and how IT will be critical to ACOs were discussed.  The importance of IT as an engine of efficient and cost-reducing new care models cannot be overstated. Patient and disease tracking, individualized medicine, and patient safety hang in the balance.

I am glad that we are finally talking about how digital heath technology is not a separate silo in the healthcare ecosystem. Not only is it an integral part of the fabric of all silos, but it signals the dissolution of many silos themselves. Patient care is now seen as a continuum with the weight shifting from institutions to the home and from physicians to other providers, heralding the importance of shared decision-making and highlighting the role of the caregiver. I look forward to contributing to other pivotal conferences, namely mHealth Summit 2013 and HIMSS 2014 as well. Bring it on!

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