Research Ethics Review for EMR Systems?

This article by Wes Fisher found on the KevinMD.com news captured my interest because what I think the author is saying is that we should have Research Ethics Boards (REB) or Institutional Review Boards (IRB in the United States) to review implementations of Electronic Medical Record systems. It is interesting because I am a research ethics professional and I have a graduate degree in eHealth. He compares developing and use of EMRs to human experimentation, and as we know today, no human research experimentation can be done without clearance by an REB or IRB.  He uses quotes from the Belmont Report, which is one of cornerstone research ethics policies, to make comparisons for the need for human participant protection from possible harms from EMRs.  In the United States there is a technology push for EMRs and a lot of money mandated for development of EMRs. This could and probably does lead to the development of systems that are not going to be successful, and possible pose harm for patients. The ethics discussed in the article is also more about economic ethics, or the ethics of pushing a technology in advance of knowing net benefits, user acceptability, user satisfaction.

I have recently been thinking that EMR systems should not only have Privacy by Design principles built into their conception, development, and implementation, but also Evaluation By Design. We know that IT systems are notorious for high failure rates - up to 70% of them. It is no different in Health IT. In Canada, Health Infoway does have a certification system for EMRs, which costs about $100,000 and several companies have obtained that certification. This is not same as having an REB review the system.  As well, Health Canada can define some EMRs as class II Medical Devices, which require a certification. Class I medical devices only display or transport data.  Class II devices manipulate the data for decision support purposes, and thus, act more like humans - prone to making error. This Health IT failure website has great case studies.

From what I have studied, a lot of private companies are developing innovative healthcare applications to help people with chronic conditions. Often these applications are tested with patients without having gone through an REB review, unless the companies are working directly with university or hospital researchers who have requirements for REB review. At minimum, the clinical efficacy of these systems needs to be proven in such things as controlled clinical trials, before governments and businesses decide to spend vast sums for patient healthcare. As Dr. Norm Archer in the McMaster School of Business says, the return on investment (ROI) in Healthcare has to be improvement in quality of life.

I have been doing some research lately on information system success models, such as the DeLone and McLean model. This model for IS success has been well tested and measure in information systems studies, but I don't know how it has been applied to healthcare. I have seen the Technology Acceptance Model (TAM) used, but I am told this model is overused and many journals don't accept articles anymore using it. I am going to look into how the Delone and McLean model is used in Healthcare, because it could be one of the cornerstones for an Evaluation by Design model for EMR systems.  I also want to think more along the lines of this article by Dr. Fisher, and think about how the Canadian policy for research ethics, the Tri-Council Policy Statement, could apply to the review of EMRs.

The ethics of EMR: How unproven technology affects patients

WES FISHER, MD | TECH | FEBRUARY 4, 2013

The implementation of the electronic medical record (EMR) in American medicine gained a powerful foothold in medical care with the passage of the American Reinvestment and Recovery Act (ARRA) in 2009. With the passage of this act came the promise of improved efficiencies, safety and ultimately reduced cost delivery for health care. Also, some $18 billion dollars in financial incentives were offered to physicians to offset costs to deploy these systems nationwide. To assure adoption, if the systems were not implemented by 2015, doctors and care providers will suffer payment penalties from the government. For physicians who care for Medicare patients, there was no alternative than to deploy these systems.

In 2010 alone, the EMR market was pegged at $15.7 billion dollars, a cost that is ultimately passed to all Americans. In addition, despite all of the changes that health care reform has brought to date, people in some states continue to see their insurance premiums mushroom over 20% in 2013 from the preceding year. Simply put, patients are finding health care anything but “affordable.”

We should acknowledge that there might be cause, ethically, to deploy a technology that truly benefits patients at some cost. After all, you have to break a few eggs to make a good omelet. If interoperability of EMR systems between facilities were commonplace and clinical data were shared with ease while patient privacy was vigorously upheld flawlessly, the cost of these systems might be ethically justified.

But the promise of improved efficiencies to our health care system, improved patient safety and (especially) reduced cost for our health care system remain elusive. More importantly these goals remain unproven. In fact, examples that the opposite is occurring abounds as doctors struggle to enter ever-increasing amounts of information of no relevance to the patient’s presenting problem just to prove they’re using the EMR in a “meaningful” way, health data security breeches continue, data-mining of patient information is occurring not just for patient care, but for marketing purposes, and the direct costs of health care for patients continues to rise, not fall. Proponents of these systems will argue these issues are nothing more than “growing pains” of these novel systems.

So should we step back for a moment and ask ourselves if we are being ethical to patients with the deployment of this technology? Does the ends of presumed cost savings to our national health care system justify the deployment of poorly integrated, difficult-to-use systems? Are patients being subjected to new risks heretofore never considered with the adoption of this technology? Could a tiny programming error occur that negatively impacts not just one patient, but millions? If so, what are the safeguards in place to prevent catastrophic error? Who will be responsible? Who is the oversight body that assures the guiding principles of the Belmont Report (respect for persons, beneficence and justice) with respect to EMR deployment are followed? The Secretary of the Department of Health and Human Services or a more nebulous body like Congress?

If we accept that the benefits of the EMR are at least uncertain to patients in terms of risk and cost, we should demand they be studied before deploying them. The guiding medical ethics tenets would demand nothing less. So, would not such study qualify as human research? After all, we should remember that the United States and other countries have a precedent of human research programs performed by government agencies that were usually highly secretive, and in many cases information about them was not released until many years after the studies had been performed.

From a sentinel paper in 1966 by Henry J. Beecher, MD on Ethics in Research:

I should like to affirm that American medicine is sound, and most progress in it soundly attained. There is, however, a reason for concern in certain areas, and I believe the type of activities to be mentioned will do great harm to medicine unless soon corrected. It will certainly be charged that a mention of these matters does a disservice to medicine, but not one so great, I believe, as a continuation of the practices cited.

Experimentation in man takes place is several areas: in self-experimentation; in patient volunteers and normal subjects; in therapy; and in the different areas of experimentation on a patient not for his benefit but for that, at least in theory, of patients in general.

While Beecher’s paper was addressing ethical research errors in general, his words are oddly prescient for EMR development. Ethical errors, as he pointed out, “are increasing not only in numbers but in variety.” He points to one of the biggest drivers of ethical conflict: money.

Of transcendent importance is the enormous and continuing increasing in available dollars for research, as shown below:

Money Available for Research
Year	Massachusetts General Hospital	National Institutes of Health
1945	$500,000	$701,800
1955	2,222,816	36,063,200
1965	8,384,342	436,600,000

These data, rough as they are, illustrate vast opportunities and concomitantly expanded responsibilities.

Taking into account the sound and increasing emphasis of recent years that experimentation in man must precede general application of new procedures in therapy, plus the great sums of money available, there is reason to fear that these requirements and resources may be greater than the supply of responsible investigators.

The need for “responsible investigators” remains significant; funding for all of the National institute of Health in 2011 was $142.5 billion dollars. Annually, EMR companies have received the equivalent of 11% of the entire NIH annual research budget from US citizens without having to prove their safety or value to patients.

Again, from Beecher’s paper:

The ethical approach to experimentation in man has several components; two are more important than others, the first being informed consent. The difficulty of obtaining this is discussed in detail. But it is absolutely essential to strive for it for moral, sociologic, and legal reasons. The statement that consent has been obtained has little meaning unless the subject or his guardian is capable of understanding what is to be undertaken and unless all hazards are clear. If these are not known this, too, shall be stated. In such a situation the subject at least knows that he is to be a participant in an experiment. Secondly, there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.

Because EMR deployments are cloaked in intellectual property, non-disclosure and restrictive hospital employment agreements, doctors are often prohibited from voicing specific concerns about an EMR system publicly. In addition, by adopting EMR systems as cornerstones of the American health care system, Congress, the President and the ARRA side-stepped patients’ informed consent regarding the short-comings of these systems, advertising only their desired benefits instead. Furthermore, rather than Congress turning to “conscientious, compassionate, responsible investigators,” they turned to lobbyists when deciding to fund the deployment of unproven EMR systems. As a result, doctors were relegated to becoming nothing more than stewards of data entry subject to new, ever-evolving documentation requirements as these systems evolve for cost-saving benefits and care “efficiencies.”

Patients and doctors alike understand the need for improved efficiencies and value in our era of exploding health care costs. We must strive to find a solution to our health care cost crisis that is transparent, cost-effective and ethical. Without such an effort, our health care system will collapse. Only recently has the Office of the National Coordinator of Health Information Technology recognized the problem and opened their Health IT Patient Safety Action and Surveillance Plan for public comment. This plan asks the EMR companies and interested stakeholders to develop their own methods to assure patient safety and reporting systems – a move that approaches the same ethical standards as equivalent of asking the foxes to watch the henhouse. Nonetheless, we should acknowledge their efforts.

But we should be cautious of EMR systems as we move forward. After all, these clinical systems have not been subjected to the same cost-benefit and ethical scrutiny as other clinical tools we use in health care. The scrutiny of EMRs should be no different than that found with pharmaceutical or medical device research where Institutional Research Board approval and proof of no conflict of interest is demanded. Why should clinical EMR systems be any different?

Given the profit motives and market consolidation occurring amongst the purveyors of these EMR systems and the potential for lethal EMR errors both from software and human interface issues, doctors and patients must especially question the ethics of the movement to deploy untested, novel technology on our patient population under restrictive covenants. As part of informed consent, patients should have full understanding of how and where their clinical data are used, including when it will be used for direct-marketing campaigns, prioritizing care delivery, or for research. Patients should be able to opt out of the use of their clinical data for these or any other purpose if desired, without restricting payment for care. Finally, physician and patient concerns about EMR systems should be allowed to be vetted publicly and without threat of professional or personal reprisal or the withholding of payments for care rendered, especially and particularly if these disclosures are performed in the best interest of patient care.

To do otherwise is unethical for our patients and the public at large.

Wes Fisher is a cardiologist who blogs at Dr. Wes.

Image credit: Shutterstock.com

TAGGED AS: HEALTH IT

Another McMaster Study about Health IT: The Renaissance Version!

So, I enjoy reading posts on the Kevin Pho MD newsletter, and I am not even an MD. The ehealth stories are often very interesting, like the one I am posting here. Now this article has 3 main characters:

1. The article by James Salwitz entitled "Why IT is the core of the healthcare renaissance".
2. An article mentioned by Dr. Salwitz by Stephen Soumeri and Ross Koppel on the online Wall Street Journal called "A Major Glitch for Digitized Health-care Reform".
3. A paper by McMaster University researchers entitled "The economics of health information technology in medication management: a systematic review of economic evaluations".

Please draw your own conclusions! My conclusion would be that the McMaster researchers uncovered a need for better economic assessments of healthcare technology, in order to really make a realistic appraisal. And I agree with Dr. Salwitz that looking back 5 decades is too long.

And this isn't the only research that has cast aspersions on the benefits of eHealth technology. A study on PLOS last year, that was almost polemical in tone, blew the doors off of that "The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview"
"http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387

Why IT is the core of the healthcare renaissance

JAMES C. SALWITZ, MD | TECH | DECEMBER 11, 2012

Warning!  I am a practicing doctor who sees real patients using an electronic medical record (EMR).  My sole agenda is to provide the best patient care.  I have no financial stake in information technology (IT).  However, unlike the editorial board at the Wall Street Journal, Mr. Stephen Soumerai of Harvard or Mr. Ross Koppel of the University of Pennsylvania, I have actually used digital patient records for over a decade and I have news for them;  EMRs work.

In a reactionary opinion in the WSJ entitled “A Major Glitch for Digitized Health-Care Records,” the authors expanded to the point of silliness the conclusions of a review of healthcare IT by McMaster University.  The McMaster analysis abstracts data from 36000 studies over five decades of healthcare IT and concludes that computerization has yet to save dollars nor improve health care.  WSJ editorialists proposed that the concept of a common medical database has “already failed” as is “common knowledge.”  While they portend to “fully share the hope” in the success of a computerized healthcare system they express doubt as to “why are we pushing ahead to digitalize.”

The question is so ridiculous as to barely require an answer.  We are pushing ahead to digitalize because the healthcare industry, which is 18% of our GDP, is the last major industry to go electronic.  Despite how critical medicine is to our citizen and nation’s vitality, health care is most often documented with paper and ink.  Can you imagine any other industry where this would be acceptable?  Would you go to a bank where they use a hand-written ledger?  Travel on an airplane without GPS, fly by wire technology or a minimum of three computers?  Do you yearn for rotary phones?  Credit cards left paper money behind decades ago and will soon move on to the next phase, pay by smart-phone. The world is digital and one of the core problems with medical care is its failure to follow.

The average doctor writes his notes on parchment and scribbles orders on contact paper.  He wastes time writing prescriptions by hand that cannot be read and will produce unneeded drug interactions and side effects.  The data on billions of health care events cannot be mined, monitored, analyzed or improved, because it is not digital.   Millions of hours are wasted, billions of dollars vanish and tens of thousands die because of preventable medical complications, the result of massive variation in quality and safety.  We are doomed because we cannot access or evaluate most medical care data; “If you can not measure it, you can not manage it.”

Taking health digital is key to fixing and affording care.  Standard, unified medical records will significantly decrease the risk of providing unneeded or dangerous medical care.  Massive efficiencies will result by reducing duplication, speeding communication and reduction in waste (and fraud).  Critical improvements will follow the use of guidelines to study clinical databases and drive quality. This means that whether one lives in Manhattan, in the mountains of Tennessee or potentially deep in Africa, the finest care will be possible.

How do I know this to be true?  Our practice of seven doctors and three nurse practitioners was an early EMR adapter.  We put in our first basic system in 2000, upgraded three times and have been fully electronic for four years.  This has resulted in marked efficiencies and obvious quality improvement. Encrypted electronic records cannot be lost, are unlikely to be stolen and are always available from anywhere.  Ordering tests is instantaneous, as is reviewing results, organizing treatments, scheduling appointments or communication with outside health providers. On the cost side we reduced non-clinical staff by more than 50% and in an account receivable analysis our billing cycle dropped more than 60% and bad debt fell to low single digits.

Today in the office, I saw four new patients.  Without assistance of clerical staff and without leaving my desk I reviewed their entire surgical, laboratory, pathological, and radiologic records.  By the time, I entered the room to meet each of them a significant part of their medical history was entered into our EMR, based on outside records, so that the care and observations of previous doctors was not forgotten. Half way through each visit documentation of their history and physical exam was complete, leaving more time to talk with each patient.  Tests were ordered, treatments scheduled, disability letters printed, medications e-scripted, instructions created and follow-up appointments setup.  The patients were given codes to electronically access their records from home.  Letters were sent online to referring doctors, as well as any clinicians we were consulting in that patient’s care.  Billing was complete before each patient got to the parking lot.  Such is the power, efficiency and quality of electronic medical records.

This is just the beginning.  Although EMRs now provide assistance with basic medical care, such as scheduling flu shots, identifying drug interactions, and health screening reminders, future systems will use academic information to assist the doctor in making diagnoses and planning treatments.   Seamless with the EMR will be computer augmentation to create differential diagnoses and recommend treatment alternatives.  In oncology alone there are almost 50,000 articles published each year; Artificial intelligence integration with the clinical EMR will help every doctor penetrate that massive database on a continuous basis as it applies to individual patients.

So, why does the McMaster study not show this obvious benefit? It comes to four factors. The first is the “five decades” of study reviewed by the Canadian authors.  Since most doctors did not start adapting EMRs until 3 years ago, that leaves 57 months of irrelevant data.  Second, we have not reached the critical mass to achieve broad system efficiencies, as hospitals and doctors are still figuring out how to incorporate the technology into their daily practice, and less than 50% of health care providers have converted to EMRs.   Third, we do not yet have a universal common database for medical records. This is a complex technological step, which has been achieved in major industries such as banking, but still must be assembled in medicine.  Finally, as was correctly stated in the WSJ op-ed piece, present EMRs are cumbersome, immature, and several generations short of perfection.  However, these are expected problems when implementing disruptive evolving technology in the complex changing health market. Challenge is a weak argument for giving up and bringing back the fountain pen.

I am not certain what the goal of Sommeri and Koppel was in writing this piece, they offer nothing but “hope.”  The WSJ has been a strong supporter of business technology leading the drive towards quality, and has long recognized the positive contribution of IT to industry.   Those of us in the trenches, putting EMRs in place, ironing out the kinks, know that electronic medical records are now and they are the future.  With IT at the core of the healthcare renaissance we can make medicine cost efficient, producing quality second to none.

James C. Salwitz is an oncologist who blogs at Sunrise Rounds.

Image credit: Shutterstock.com

Tagged as: CANCER, HEALTH IT, PRIMARY CARE

CMA - Docs for Patients & EMRs

I have been seeing this and other spots on TV. Further info leads to the docsforpatients.ca  site and more information on the outspoken advocate for EMRs, Dr. Ewan Affleck. It is great to see more doctors advocate for Electronic Medical Records. Sponsored by the Canadian Medical Association.  This is why I still keep a cable TV subscription!

I’m Ewan Affleck, I’m a GP, and I live and work in Yellowknife, N.W.T.

The North is a remarkable place for those of us who have come to call it home. I’ve been here 20 years and it’s a privilege as a Canadian to get to know the North. It’s a big part of our identity but many of us never get here.

The health care system globally is under stress. In The North we’re in a bit of a fish bowl, which presents us with an opportunity to be creative and try to find solutions. We have this huge place – this vast territory with 42,000 people and 33 remote communities – and we have to provide some measure of equitable, efficient and safe care. That’s a difficulty, a challenge and a gift, all at the same time.

Last year, over a quarter of the population of the Northwest Territories was physically moved for health care purposes. That drives massive cost. We’re moving people over long distances when what we really need to do is share information over long distances.

Last year, over a quarter of the population of the Northwest Territories was physically moved for health care purposes

My work with health informatics systems started with an outreach clinic that I run at a women’s shelter. Obviously you can’t leave charts in an environment like that given security and privacy concerns. I had to transport charts in and out, and so I went and got an old airline trolley and I would take it down the road with this box of charts, and I thought to myself, there has to be a better way to do this.

I went and got an old airline trolley and I would take it down the road with this box of charts, and I thought to myself, there has to be a better way to do this.

I was very committed to making this outreach clinic work, so I thought whatever it takes I’ll do it. That’s how I started with digital charts and the territorial Electronic Medical Record. Now we have over half of the patients in the territory on that system, and the plan is to have the entire territory on this single charting system, and to have as many of the divisions within the health service on the system so we can provide quality care.  We can provide networked care in the patient’s chart.

As told to the CMA, abridged from a longer interview.

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COACH Privacy Guides now available for Healthcare Organizations from eHealth Ontario

I knew eHealth Ontario was licensing the patient portal guidelines from COACH, because I was working with the COACH Expert Group that was writing them when it was announced. The recent news announcement that all 3 privacy and security of personal health information guidelines are being offered for free to Healthcare organizations in Ontario is wonderful.  I am now working on updates to the 2011 EMR guideline and the special edition of implementing the EMR with a COACH Expert Group again. Unfortunately, I am not as much as an expert this time because a lot of it is about legislation - not my speciality.  I knew more about patient portals at the time.  If you work in healthcare, you can apparently download them for free here.  So far, however, the download has not worked for me.  Not sure what the problem is.  Maybe it recognized my name and somehow knew I already have copies of these:
http://www.ehealthontario.on.ca/en/privacy/guides/

Privacy Guides

The 2011 Guidelines for the Protection of Health Information is an easy-to-use guide that covers topics such as accountability, consent, collection and security safeguards. This guide reflects the core principles of the Canadian Standards Association Model Code for the Protection of Personal Information and the content is aligned with Canada Health Infoway requirements and standards (international and national) such as the ISO 27002 Security Management Standards.

• 2011 Guidelines for the Protection of Health Information
  A comprehensive resource on privacy and security best practices that helps health care professionals protect the PHI that they require to do their day-to-day work. This resource is designed as a stepping stone to help health care organizations address common concerns, avoid confusion and prevent misunderstandings related to the protection of PHI.
• Privacy & Security for Patient Portals 2012 Guidelines for the Protection of Health Information Special Edition
  Developed for use by those designing, implementing and maintaining a patient portal system, this helpful guide is appropriate for organizations of all sizes—from a physician’s office to a large hospital. Topics include: choosing a portal model, Canadian privacy legislation and privacy and security risks/controls related to patient portals.
• Putting it into Practice: Privacy and Security for Healthcare Providers Implementing Electronic Medical Records COACH Guidelines for the Protection of Health Information Special Edition
  Provides health care providers with up-to-date privacy and security considerations and best practices related to the procurement, implementation, setup and maintenance of an electronic medical record system in a community practice setting.

A Pioneer of Medical Records

I found this story on a blog by a Doctor who blogs.  The subject of doctors who blog is an interesting one, but probably for another post.  I watched this video and was very impressed. Dr. Weed is right on. How could anyone audit, let alone make sense of that patients' chart?

The rest of the article by Dr. Wachter I will copy here.  It is an excellent article, the jest of which seems to me to be about usability of the EMR and the EMR not getting in the way of the human person who's digital information is being recorded:

Putting the “A” Back in SOAP Notes: Time to Tackle An Epic Problem

by BOB WACHTER on SEPTEMBER 3, 2012 in DIAGNOSIS/CLINICAL REASONING, HOSPITAL CARE, INFORMATION TECHNOLOGY,MEDICAL EDUCATION/ACADEMIA

4,766 VIEWS TO DATE

A colleague recently sent me a remarkable video – of Professor Lawrence Weed giving Medical Grand Rounds at Emory University in 1971. It’s fun to watch for many reasons: the packed audience composed mostly of white men in white jackets and narrow ties, the grainy black and white images a nostalgic reminder of Life Before High Def.

But the real treat is seeing Weed, then 47 years old, angular and frenetic, a man on a mission. He begins his talk by rifling through a typical medical chart, thick as a phone book. It is filled with garbage, he says disdainfully; “source oriented” rather than “problem oriented.” Weed was promoting his new vision for the medical record – one organized around patients’ clinical problems.

In 1964, in an article in the Irish Journal of Medical Sciences (reprised, rather more famously, in theNew England Journal in 1968), Weed described his new model for patient care records, known as theSOAP note (“Subjective, Objective, Assessment, and Plan”). The idea was to begin with the patient’s history, then to present the objective data (physical examination, and results of labs, radiographs, and other studies), and finally to describe an assessment and plan for each of the patient’s problems. SOAP notes were designed to populate what Weed called the POMR: problem-oriented medical record.

This was revolutionary stuff at the time, and Weed was ready for pushback from doctors who argued that their random jottings were sacred totems of the “art of medicine.” At 51:30 in the video, Weed addresses these objections:

Art… is not a scribble in the middle of the night…. We debase the word art itself when we call what we’ve been doing art… As Stravinsky says, ‘art is nothing more than placing limits and working against them rigorously’ …and if we refuse to place them… you do not have art, you have chaos, and, to a large extent that’s what we’ve had.  

I like Weed’s problem-oriented format – so much so that one of the reasons I’m pleased when my patients leave the ICU (other than the fact that this usually means that they’re getting better) is that my trainees’ oral presentations morph from being organ-system based (“Neuro: sedated, moving all fours, head CT negative for bleed; Cardiac: MAP 75 on 2 mics of Levophed, heart rate 85, lungs clear, 2 over 6 systolic murmur at apex, good systolic function on echo….”) to problem-based (“Problem 1: dyspnea. Patient remains short of breath, O2 sat 92% on 5 liters, lungs clear on exam and chest x-ray negative. Plan is for chest CT to rule out PE…”). When I hear an organ-based presentation, I find myself struggling to translate it into a problem framework, like someone who isn’t quite fluent in a foreign language trying to make sense of a song in that language.

Whatever the method used to divide patients up into manageable chunks, there is always a tension between a reductionist view of a patient’s problems (or organs) and a big-picture view. Just as we are, biochemically, simply the sum of our cells, even atheists know that humans are far more than that. So too are patients more than the sum of their problems.

Note that I’m not being touchy-feely and holistic here, decrying the dehumanizing aspects of modern healthcare. No, I’m saying that even if you are a coot who doesn’t give a damn about what the patient isfeeling, even if you gloss over the social history in a mad dash to the liver function tests, even if you think that “patient-centered care” is mostly an empty slogan, even if you’re the kind of doctor who simply wants to figure out your patient’s problems and deal with them effectively, you must balance the simplicity and practicality of a systematic approach with the need to see patients as more than the sum of their problems.

With paper notes, this tension usually managed to work itself out. Even as we embraced Weed’s problem-oriented approach, there was something about the act of writing things down that made you realize that there was a person attached to the problems, and that each patient needed an über-assessment – a paragraph or two summing up his or her issues. The reason for this was not so much to honor the patient’s humanity (although that’s nice too) as it was to offer a crucial synthesis of what was otherwise a jumble of facts and impressions.

At UCSF Medical Center, we went live with our version of the Epic electronic medical record three months ago. It beats pen and paper, and it beats the EMR system that we traded out (at a cost of a hundred million dollars or so) by a long shot. The implementation went well overall, notwithstanding a few snafus (several thousand missing billing charges, a few patients temporarily unaccounted for, that kind of thing). I’m certain that these glitches can and will be ironed out.

But I’m less confident that we can fix what Epic is doing to our notes, and our brains.

The system, you see, places the problem list at the core of the patient’s clinical world – in a way that goes well beyond what Larry Weed imagined. One really doesn’t “write a note” anymore; rather one charts on each of the patient’s problems, one by one. At the end of a session, the computer magically weaves these fragments into what outwardly appears to be the patient’s progress note. But it’s not really a note, it’s a series of problems (each accompanied by a brief assessment and plan) held together with electronic Steri-Strips. In other words, it takes Weed’s vision of the POMR and hypertrophies it. As with muscle, while some hypertrophy can improve function and be attractive, there comes a point when more hypertrophy becomes constrictive, dysfunctional, even grotesque.

Why did Epic and our UCSF IT gurus structure things this way? The primary virtue is that this charting-by-problem approach allows the patient to be followed longitudinally, since one can track problems such as “hypertension” or “ovarian cancer” over years, seeing how they have been managed and observing the response to therapy. It isn’t a bad conceit, and it probably makes tons of sense when described in a fishbone diagram on an informatics seminar whiteboard.

But the effect I witnessed on patient care and education was less positive. When I was on clinical service in July and read the notes written by our interns and residents, I often had no idea whether the patient was getting better or worse, whether our plan was or was not working, whether we need to rethink our whole approach or stay the course.

In other words, I couldn’t figure out what was going on with the patient.

If Epic was the only thing promoting this kind of reductionist approach, it might be survivable. But it’s not. In the face of duty-hours limits, our trainees are increasingly programmed to operate in a “just the facts, ma’am” mode, to approach patients as a series of problems to be addressed expeditiously and algorithmically. This “if X, then Y” mode of thinking isn’t wrong, per se, but – particularly in the hospital – when unaccompanied by an effort to paint a coherent overall picture, the notes (and accompanying presentations) can become data without information, empty e-calories.

(Note that this problem comes on top of the copy-and-paste phenomenon so cleverly skewered by Hirschtick a few years back in JAMA. While copy-and-paste must be addressed, I’m less worried about it than I am about the impact of the EMR on clinical synthesis and reasoning.)

Larry Weed was acutely aware of another objection to his problem-oriented approach: the concern that each problem would be viewed in a vacuum. In his 1968 article, he wrote:

Fragmentation of single diagnostic entities resulting from listing separately single related findings is not a legitimate complaint against a complete list of problems. If a complete analysis is done on each finding, integration of related ones is an automatic byproduct. Failure to integrate findings into a valid single entity can almost always be traced to incomplete understanding of all the implications of one or all of them.

In the old days, failure to connect the dots between problems 1, 3, and 6 may well have been due to cognitive gaps. But the modern IT system can prevent even smart physicians from performing this essential act of synthesis. The patient with cough, sinus problems, and kidney failure cannot be thought of as the sum of the differential diagnosis of each of these problems. Instead, as Occaminsisted, these problems must be placed in a Venn diagram, accompanied by strenuous attempts to figure out what lives at the intersection. This is damn hard to do when one is electronically charting each problem independently. Monkeys and typewriters come to mind.

Over the past few years, Epic has “won the game” in the competition among IT vendors trying to sell to large teaching hospitals. This is fine – it is a robust system and an impressive company. But something needs to be done to preserve the essential act of clinical synthesis, and soon.

What would I do? I’d build into each Epic note a mandatory field, and call it “Über Assessment” or “The Big Picture.” Mousing over a little i icon would reveal the field’s intended purpose:

In this field, please tell the many people who are coming to see your patient – nurses, nutritionists, social workers, consultants, your attending – what the hell is going on. What are the major issues you’re trying to address and the questions you’re struggling to answer? Describe the patient’s trajectory – is he or she getting better or worse? If worse (or not better), what are you doing to figure things out, and when might you rethink the diagnosis or your therapeutic approach and try something new? Please do not use this space to restate the narrow, one-problem-at-a-time-oriented approach you have so competently articulated in other parts of this record. We know that the patient has hypokalemia and that your plan is to replace the potassium. Use this section to be more synthetic, more novelistic, more imaginative, more expansive. Tell a story.

All in all, I am pleased that UCSF went with the Epic system and I remain a fan of electronic health records. And Larry Weed was right: we must have a structure to record what is happening to our patients, and his problem-oriented approach remains the most appealing one. (Ultimately, one wonders whether natural language processing will make such a structure less important, in the same way that I no longer pay much attention to filing documents on my Mac now that its search function is so powerful.)

But the time is now – before our trainees build habits that will be awfully hard to break – to recognize that electronic medical records do more than chronicle our patients’ histories, exams, and labs. They are also cognitive forcing functions, ever-so-subtly modifying our approach and language into something that can either improve our clinical care and teaching, or not. Let’s show these computers who’s boss, and put the “A” back in SOAP.

Paging Dr. Watson

I did watch Watson defeat the best Jeopardy players in the world, when - last year or so - and of course as an eHealth student, I knew this would be a fantastic machine to program for medicine, in particular, diagnosis.  I knew about other attempts at artificial intelligence for diagnosis like Isabel.  Isabel is one of the leading "differential clinical decision support" tools for physicians.  There were many early experiments in artificial intelligence for medicine, and I believe the editor our our Biomedical Informatics textbook, Edward H. Shortliffe, was also an early pioneer, as the chapter would attest. The writer on this article on "Paging Dr. Watson" mentions a book called "How Doctors Think".  I read it, and it is excellent.  Another book that is relevent is "Every Patient Tells a Story" by Lisa Sanders, who advised on the House TV series.  One theme of the book is the loss of skill in the physical exam by physicians and the over reliance on technology for diagnosis.  I am just saying. 

 

 

Paging Dr. Watson: artificial intelligence as a prescription for health care

October 18, 2012

(Credit: IBM)

“It’s not humanly possible to practice the best possible medicine. We need machines,” said Herbert Chase, a professor of clinical medicine at Columbia University and member of IBM’s Watson Healthcare Advisory Board, Wired Science reports.

“A machine like [IBM's Watson], with massively parallel processing, is like 500,000 of me sitting at Google and Pubmed, trying to find the right information.”

Yet though Watson is clearly a powerful tool, doctors like physician Mark Graber, a former chief of the Veterans Administration hospital in Northport, New York,  wonder if it’s the right tool. “Watson may solve the small fraction of cases where inadequate knowledge is the issue,” he said. “But medical school works. Doctors have enough knowledge. They struggle because they don’t have enough time, because they didn’t get a second opinion.”

According to Chase, doesn’t fully appreciate Watson’s value in bias-free second opinions. “The machine says, you thought of 10 things. Here are the other five,” he said. “You’ve probably seen Jerome Groopman’s book, How Doctors Think, about the mistakes doctors make. A simple one is anchoring: You get stuck to some diagnosis. We’ve all had that experience. A machine can change its diagnostic profile on a dime based on new information. One of the things a machine is not is biased.”

Graber warned that doctors will need to guard against a new source of bias: over-reliance on Watson. “When I use my GPS too much, I never really learn the layout of a new city,” Graber said. “Same story.”

He and Chase also disagree on the implications for health costs. Chase sees Watson helping doctors and patients reduce eliminate unnecessary tests and treatments, whichnow cost $750 billion per year. Graber fears that Watson’s ability to identify many possible diagnoses will encourage patients to ask for even more tests and procedures, setting off a cost-inflating “diagnostic cascade.”  …

(more)

Topics: AI/Robotics | Biomed/Longevity

eHealth Ontario Diabetes Registry is no more

A variation of this article in whatever edition of the Toronto Star I saw, was headline news.  The story line in the current online edition says"Diabetes Registry obsolete, ehealth tells liberals". The headline I saw on the shelves in the grocery store at around 10:00am this morning was something like "eHealth Ontario Axes Diabetes Registry". The twists and turns in this story are many and varied.  I remember the eHealth Ontario procurement and spending scandal in 2009 mostly because I had just starting working towards a graduate degree in eHealth (or Health Informatics) at the time and I was beginning to feel a lot of regret about the name of my degree. The real concern here should be about people who have diabetes and the epidemic this is now becoming globally - not some provincial political hot potato, or football, or whatever metaphor pleases you.

I was studying the clinical efficacy of using personal health records to manage diabetes, looking for systematic reviews of the literature in the Cochrane Collaboration.  They were not many because they are not many clinical trials involving diabetes and electronic medical records (let alone personal health records).  Yes I looked on the clinical trials registry site as well - clinicaltrials.gov   and found a rare few clinical trials, mostly involving large hospital systems that had electronic health records in the United States. I had learned in my courses that clinical trials present the highest form of medical evidence, exept for meta-analysis or systematic reviews, which is a composite study of all the best clinical trials.

It was when I was studying the project management issues in a mobile application for managing type II diabetes, that I came upon the understanding that clinical efficacy should precede business opportunity. See the COMPETE studies at McMaster. In healthcare, the return on investment is improvement in quality of life, but why spend millions on a system because it is believe to be clinically helpful, when the evidence for the actual efficacy is not in yet.  There were experiments and studies that did show promise for this, and maybe they showed promise because they were all small studies and easy to manage.

We were aware that a smartphone or mobile solution for persons with diabetes tracking and managing their condition always seemed to involve a triage person or nurse practitioner who monitored the data flows from the patients.  York University's Department of Health is now started a course of training for Health Coach Professionals, which was part of the subject of my last blog post on a consortium of academics, business and health organizations to develop the open source OSCAR EMR and it's companion PHR call MyOSCAR.  It is this kind of triage person who I think could really help fill the gap between the patient with diabetes using the smartphone or the computer, and the personal health record or electronic medical record where data measurements and journaling provide the tools necessary to self-manage the condition.  A coach is really needed to get people to exercise, eat well, adhere to regimes of all sorts, etc.

Later in 2011 when I was researching the system architecture of personal health records systems in Ontario and their relationship to the national blueprint architecture of the Canada Health Infoway, that main benefit for using them would evolve in the prescription model that physicians currently have with their patients.  A personal health record system could be prescribed to a patient, because of the clinically proven benefits of using them to manage the condition. Again, this involves the evidence based medicine preceding the business model or expediency.  As well, the prescription model maintains the traditional trust between physician and patient, and as far as I know, diabetes is not something you want to try and handle on your own, without professional guidance and help.

When in 2010 we learned eHealth Ontario was going to create a Diabetes Registry for all Ontarians, I for one thought they really did not know what they were getting themselves into.  It is not that I am proved right, it is just that technology projects are often started for the wrong reasons, and pulling the plug on them, before trying to fix the short comings, is the right thing to do.  Wished it could have turned out better for the eHealth Ontario people, CGI, and I suppose the Liberal government, who I know have the patients in Ontario and their health in mind first.

McMaster Developed OSCAR/MyOSCAR Personal Health Record gets over 5 million from Federal Government

This story is the highlight of my year.  Not only is it another McMaster story, it is one involving the OSCAR EMR and the  MyOSCAR personal health record (PHR) that most M.Sc. eHealth students at McMaster know about.  I used MyOSCAR in an exercise to design a clinical trial for type II diabetes self-managment, a procurement solution for mobile eHealth (again with Diabetes in mind), and as an example of a tethered system.  Tethered no longer by the looks of it!  It looks like it will be developed for an integrated if not interoperable solution for the general public, instead of just the trial projects at Stonechurch Family Medicine in Hamilton, where the McMaster developers work.  Certainly, the clinical utility, effectiveness, etc. has been through many tests.  How exciting for McMaster, and for the general public, to have this service available for them.

This story is big ehealth news, in my mind, and here are some of the links to it, just to get started:

A) The story on the McMaster University Daily News.
B) The Hamilton Spectator.
C) The Federal Economic Development Agency for Southern Ontario (which provided funding)

From news source C) above:

The following is the complete list of partners in this project:

Private sector partners

Post-secondary institute partners

Not-for-profit research partners

• NexJ Systems Inc.
• OSCARService Inc.
• PryLynx Corporation
• Rogers Health Care
• Research In Motion
• Trivaris
• Tyze Personal Networks
• Beth Israel Deaconess Medical Center (an affiliate of Harvard Medical School)

• York University
• McMaster University
• Centennial College
• George Brown College
• Seneca College

• Centre for Global eHealth Innovation (University Health Network)
• North York General Hospital
• Southlake Regional Health Centre

For more details on the project and its partners, please visit: www.chwp.org.

ehealth Saskatchewan public survey on personal health records

Saw this news story:
http://www.canhealth.com/

News2029.html
"eHealth Saskatchewan is polling the public on its website, www.ehealth-sk.ca, to discover whether the residents of the province would like to see development of a Personal Health Record, and if so, what they would like to see in it."

eHealth Saskatchewan Public Message from eHealth Saskatchewan on Vimeo.

This to me is a credible thing to do.  Most surveys of the public attitudes towards electronic health records show a great interest in them.  An equally high percentage are concerned with the privacy and security of their health records. Sounds like Saskatchewan is sizing up the feasibility of a provincial architecture for the personal health record.  I would like to see the results of the survey.