Challenging Pharma towards Patient Centered Studies

Pharma effectively trains a "Challenger" Salesforce, as described in Harvard Business Review. We recently met with Dr. Molony to discuss the development of a short lunch lecture series at UT-Houston which would better prepare medical students to deal with this type of salesforce. In the long run, pharma will deliver only the evidence that doctors demand. As we begin to demand patient centered studies, leading Pharmas will react by funding more appropriate studies. Then, patient centered evidence becomes a competitive advantage.

Collaborative :: Silos

Recently, our leadership team has been developing a plan to study and improve the ability of our teaching hospital to comply with best practices in the blood pressure management of acute stroke patients. Coincidentally, we will be working with the hospital to implement findings from studies our neurologists acted as reviewers, contributors, or even lead authors.

UT Houston and Memorial Hermann have recognized that it’s not enough to be a thought leader; ideas must be transformed into clinical practice. This goal isn’t accomplished by establishing a separate “Translational” organization, furthered by flashy rhetoric, or supported by a partnership with a neighboring business school. Rather than discuss the need for “bench to bedside” initiatives, quality transformation has been fully integrated into the culture of UT Houston medical school and its main teaching hospitals. The initiative has been championed by our dean, and its vision accomplished through the leadership of our faculty mentor, Dr. Eric Thomas. Today, Quality Improvement physicians are in place as distinct leaders in most clinical departments. In this way, Patient Safety benefits from direct accountability of named individuals and by delegation through well structured responsibilities.

We engaged the QI leader of the neurology department to help us refine our project proposal. He identified several flaws. Additionally, in his role, he had the credibility to request that our proposal be reviewed by the Chief of Neurology and several Stroke Neurologists. Our collaborative effort was further strengthened by his engagement of nursing staff who noted our project required an understanding of admission criteria. We were promptly supplied with that documentation and the nursing Stroke Coordinator was available for follow-up questions. Within a few days we had received constructive comments from several organizational facets. Many we immediately integrated into our proposal; others we sidelined to discuss with our mentors how additional study metrics may overextend our scope.

What’s unique in these efforts is not that medical students are engaged in clinical research. That’s common in any medical school. Fortunately, we attend the rare medical school in which a group of students is able to organize and be counseled by these experts. It is a unique structure that wholeheartedly supports quality improvement. A culture sufficiently pervasive that even its student’s perspective of clinical problems may initiate change.

QI Revolutions Lower Barriers to Improvement

Over the past year, 2directions has met with leading physicians to learn from their successful QI projects. We were most impressed by projects which achieved demonstrable benefits to their patients and to their medical care organization. One such project was Dr. Bela Patel’s success at Memorial Hermann Hospital, in which she essentially eliminated ventilator associated pneumonias (VAP) from her ICU for five years and counting. Review of her achievements highlights patients who experience fewer adverse outcomes and arrive home sooner.

To accountants, those patient-centered results equate to cost savings and increased turnover. Previously, 2directions presented an analysis of how bed turnover is one of the primary drivers of hospital efficiency. Better turnover increases capacity and widens bottlenecks that otherwise limit patient flow. It’s much easier to justify those benefits through a low cost, low risk quality improvement project, than through heavy capital expenditure and disruptive construction of new beds. We estimate her work releases $1.7 million from the annual operating budget and avoids $3 million of capital expenditures.

Her work provides meaningful patient stories and a compelling business case. But even as Bela Patel’s Medical Intensive Care Unit has gone without a VAP for five years, in most hospitals, VAPs remain a monthly occurrence. This observation led 2directions to ask what barriers prevent rapid adoption of such tremendous accomplishment to other healthcare institutions.

Several of us at 2directions have experience outside healthcare. Software, industrial manufacturing, and retail provide reference of successful scale: the explosive growth of social networks, the economics of precision in mass production, and fashion trends. The answer to why scale is not possible in quality improvement is the same reason my former employer, IBM Consulting, has been tremendously successful, even in economic downturn -- QI is a highly customized service. Solutions aren’t simply adopted, they must be adapted. Even if the solution has proven successful elsewhere, adaptation is required, and it is an expensive process that calls upon local heroes to successfully shift the organization to the new clinical approach.

It became our conviction that QI scale is hindered by two cultures. The clinical culture is hesitant to change processes. Physicians are apt to believe in a system in which hard work, by competent people, delivers the best patient outcomes. We need a change agent that will risk reputation and expend great efforts to demonstrate that even better patient outcomes are possible through QI. The financial culture of the hospital is hesitant to invest in projects which disrupt the current model. Reluctance can be overcome by a salesperson who understands the hospital’s financial drivers, and uses those drivers to connect their offering to better business outcomes. We need a similarly equipped salesperson for QI.

Understanding these barriers to scale, and the capabilities needed to surmount them, we considered the equipment which would enable physicians to overcome them. We aim to refine our blueprint and begin to fabricate these tools over the next 8 months. However, ours is not a “if we build it, they will come” type solution. Only participation by QI Physician Leaders will substantiate our vision. Therefore our first step was to garner support for our concept from the American Medical Association. We drafted a resolution which describes the problem we identified and our approach to a solution, and presented it to the AMA medical student section (MSS) to ask for promotional support. The MSS formally adopted our resolution at their national meeting in New Orleans one week ago. It’s a milestone we are excited to share. The next step will be for physicians to debate this resolution on the floor of the House of Delegates, at the AMA meeting in Chicago this summer. Passage would be a strong catalyst to improve collaboration between QI leaders.

Social Coordination of Healthcare

The whole costs less than the sum of the parts.

According to data collected till 2009 for the 100,000 Homes Campaign, about half of our nation's hundreds of thousands of homeless people have either a medical, mental, or substance abuse problem, and one quarter have all three. Unfortunately, their healthcare provider of choice--emergency departments--is the most expensive one.

Providing regular housing to homeless people on its own decreases their per-capita health care cost from $28,436 to $6,056, according to Boston's Health Care for the Homeless program. However, just as five percent of our country's population uses fifty percent of our healthcare resources, there is a similar stratification of need among the homeless. Patients with a cluster of chronic needs, or a debilitating condition that can be improved with a few weeks or months of treatment can be channeled away from acute care, if given assistance in navigating the healthcare system. Coordination of care by nurses and social workers connects them with primary care and this team combats the mental health, substance abuse, and social issues. Developing a first-name relationship and giving tailored, ongoing support, makes the difference in these successful programs.

Communities from Portland to Philadelphia are identifying and partnering with these homeless patients. In one success story, Portland's Recuperative Care Program has been taking high-need patients from the ER into a 30-day medical home and assigning them care coordinators, and has reported rates of 74% medical recovery and 61% discharge to stable housing. Oregon Health and Science University hospital leaders report that since 2005, they paid $500,000 to the program and thereby saved $3.5 million in costs, by reduced retreatment visits in the ER. At the heart of these results are care coordinators who know the patients personally, and help them execute primary-care centered, long-term plans.

System-level healthcare integration is not only important for the homeless. Disjointed, high-cost, acute care for the homeless is reminiscent of our broader system. Truthfully, few of us find a medical home. Perhaps these programs are the first stones to be thrown in a Copernican Revolution which recasts the patient at the center of our medical system. Patient health at the bottom line is the organizing principle, and primary care is the organizer. Without them, specialty interventions become so many soldiers without a general or a plan.

Craig C, Eby D, Whittington J. Care Coordination Model: Better Care at Lower Cost for People with Multiple Health and Social Needs. Institute for Healthcare Improvement white paper.

Electronic Access vs. Safety

I was listening to public radio cruising north on 59 toward LBJ when I heard Dean Sittig discussing a new study on privacy in electronic health data. A study by PriceWaterhouse Coopers suggests that privacy standards are not keeping pace with access to health care information. Health care workers are gaining increased access to protected health information (PHI) on mobile devices at the risk of these devices not having sufficient privacy standards to prevent security breaches.

This was fascinating to me because Memorial Hermann just released Care4 access to iphone and ipad users. Is this access necessary and reasonable to allow doctors to treat their patients appropriately and effectively? To be sure, handheld electronic devices are commonplace among physicians, residents, and students alike. I have been using my ipod touch (because I refuse to pay the outrageous data fee for any smartphone) consistently to look up dosages on epocrates. Similarly, one of my residents rarely uses paper for rounds, but rather his ipad for access to Epic. Would it be more convenient for me to look up a patient’s recent BMP while walking without having to sit down and log into a computer? Probably, but I’m unsure whether the benefits outweigh the risks.

The trouble with the study is that it doesn’t seem to offer any answers, similar to much of the research done so far in electronic health records. I’m left with an uncanny feeling of uncertainty about current policy regarding handheld devices and access to PHI.

You can listen to Dean Sittig’s 1 minute NPR clip right here.
http://app1.kuhf.org/articles/1316724294-Study-Suggests-Healthcare-Industry-Falling-Short-In-Protecting-Digital-Records.html

Rural Research

A recent article in the British Medical Journal, by Perry, et al., presented evidence that a CT scan within 6 hours of symptom onset yields 100% sensitivity in the diagnosis of subarachnoid hemorrhage (SAH), when read by a trained radiologist. The results suggest that in this setting the need for lumbar puncture (LP) is greatly diminished. If this data is trusted, and physicians use the CT scan as the Gold Standard, then an invasive procedure may be avoided. Currently, when a CT scan doesn’t highlight any blood, physicians are likely to order an LP to be certain that SAH is safe to rule out.
Citation: BMJ 2011; 343:d4277

However, this study is concerned with the utility of CT, not making LP obsolete. In 2008 I detoured from a cross country move, to drive through a small Kentucky town, after a sign for a hospital drew me off the road. Banners hung across the hospital’s entrance to celebrate its recent implementation of a smoke-free campus. I wonder whether the benefits of CT or smoking cessation was the first to affect the practice of those physicians.

Even without the evidence demonstrated in the Perry study, hospitals in the Texas Medical Center have long been using CT to aid the diagnosis of SAH. This study justifies ordering a CT scan to identify subarachnoid bleed when there is a suspicion of SAH. While its data is not game changing along Fannin Street, it does reinforce CT scans’ legitimacy as a covered diagnostic test, even by the stingiest of health insurer.

As the indicated uses for CT broaden, perhaps rural hospitals are more likely to purchase the advanced equipment. However, in the near term, it’s critical that research begin to focus on the way medicine is practiced in these rural areas. To do so requires dedicated NIH grants stipulating funds be spent in a rural setting.
Conducting research in this manner would inform us of the methods rural physicians use to make a diagnosis when using a less technologically advanced toolbox. Likely, we’d learn something from their practice, or maybe we’d remember things our profession has largely forgotten. But more importantly, we’d face a reality that medicine must be practiced differently by people living in rural areas.

Today’s rhetoric favors preventative medicine and seems to delight in our failure to prevent disease. Politicians introduce the topic as if they originated the idea of prevention, and admonish physicians for not participating in their unnamed solution. The natural reaction is to parry, "Society as a whole fails to take the responsibilities necessary to prevent disease; this is not the fault of physicians." Rather than join in meaningless debate, the physician profession must lead improvement. One action is the research of Primary Care methods, with aims to determine how to better prevent disease.

Today, it’s not uncommon that complicated patients in rural, East Texas be transported to Houston for higher level care. A tenet of Quality Improvement is that transportation is waste. While the patient is moved, the standard of care is temporarily lowered. Currently, the vast majority of research is conducted at tertiary care referral centers. Broadening our focus of research to include rural areas, in addition to tertiary care centers, would bolster the quality of care provided in the rural setting. Where academic researchers travel, medical residents and fellows follow, in search of training. As the government begins taxing Graduate Medical Education programs, the already meager resident salaries will thin further. A number of medical school graduates are likely to appreciate the opportunity to train in a location where their salary offers a higher standard of living.

Several factors may converge to favor the development of rural medical care. By studying the patient populations in the primary setting we’d learn more about prevention.

Heads Down, Thumbs Up

Acute ischemic stroke patients may benefit by simply lowering the head of their bed. An inverse relationship was demonstrated between bed angle and residual blood flow to ischemic brain tissue. Similarly, Jugular Venous Distension becomes clearer when a patient is reclined. Therefore, this finding is not totally surprising. What is compelling is that the improvement is distinct and occurs even across small gradients: 15 degrees is preferred to 30 degrees even if not as ideal as a patient laying flat.

Clinically implementing the finding still requires a bit of common sense judgement. Patients with dysphagia are at an increased risk of choking which is greater when they lay flat. Because the same patient who has suffered a midbrain stroke is often dysarthric, they are at risk to silently aspirate. A real risk of choking must be weighed against the perfusion benefit described in the study. Occupational therapy can help in the management of these stroke patients.

While the hospital bed controls which set head angle are simple, keeping a patient's head down can be more complex. Patient compliance is required. Those short of breath when laying down (orthopnea from Congestive Heart Failure), and those prone to choking (dysphagic after a midbrain stroke) desire to sit up. Many stroke patients spend the first hours after the diagnosis of stroke in the ER. Therefore, the ER staff must also understand the importance of heads down just as well as the specialized staff of a dedicated stroke team. Even once admitted to a stroke unit, visitors may raise a patient's head earlier than is desired. Technicians who perform cardiac echos may raise the bed or ask the patient to prop themselves up, into positions which obtain a better ultrasound image. A well-meaning family member will often raise the head of a patient's bed, allowing the patient to more easily see and interact with family, at the expense of critical perfusion.

The heads down study has encouraged neurologists to emphasize a seemingly small detail to physicians and practitioners outside their specialty. It can be found by referencing: Neurology. 2005 Apr 26;64(8):1354-7.Heads down: flat positioning improves blood flow velocity in acute ischemic stroke. Wojner-Alexander AW, Garami Z, Chernyshev OY, Alexandrov AV.

"Ischemic stroke is a potentially reversible process that is dependent on restoration of arterial blood flow within a window of cellular viability that varies according to the severity and duration of the flow deficit. Measures that promote blood flow during the acute phase of ischemic stroke may directly impact the subsequent development of brain infarction and associated clinical deficit. One such measure may be flat head-of-the-bed (HOB) positioning to promote a gravity-induced increase in arterial flow to ischemic brain tissue; however, patients with stroke and other neurologic diagnoses are routinely positioned using 30° HOB elevation by paramedics and emergency room personnel."

Source: Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX 77030, USA

Photo by Flickr user: chimothy27

Fishbone Diagram: Promotion Category

Product Place and time Price Promotion Process People Productivity Purpose

There are many strategies for well run promotions. The AMA employs a promotional strategy to gain members by allowing medical students to join at greatly reduced rates. The AMA follows a strategy that uses elements of discounts, limited time offers, and versioning.

Hopefully, for the individual medical student, the discounted rate is a limited time offer and they are eventually eligible for the more expensive physician rate. The experiences available as a Student differ slightly from those enjoyed by a Physician. The distinction between these two versions is most evident during the National Meeting when two separate House of Delegates are maintained in a fashion similar to a House of Lords (Physicians) and House of Commons (Student section).

Versions work best when different tiers more closely approximate the individual needs of users. For example, only the most gunner Medical Student would think that they benefit professionally from spending time in the Physician House of Delegates. While the pomp and circumstance of that venue is an enriching experience, the small talk with physicians that ensues is unlikely to make a lasting impression. Working with peers has more peripheral benefits. The versions employed by the AMA appropriately assign members to work with their colleagues and are priced accordingly.

Simplifying the Square

A goal of 2directions is to help physicians win the corner office at the hospital and to begin making business decisions in the best interest of the Patient-Physician relationship.

To weigh interests, business schools teach a simple method: ask two dichotomous questions and plot the answers on a 2 X 2 square. Along one side, are the responses to the effect of the action on customers as either Good or Bad. On the other, the same consideration is made, this time regarding the effect of an action on the business itself. Answering these two questions allows quick analysis of whether a project should be pursued, weighed, or rejected. The resulting grid is reminiscent of the Punnet Square. Homozygous recessive is akin to the elusive win-win, while the Heterozygotes fall in the more common grey areas.

While you wouldn’t always think so, MBAs prefer projects which are good for both the customer and the business. However, the MBA doesn't shy away from actions which are unfavorable to one of the two parties so long as the actions are strategic and maximize the long term value of the firm. Mixed responses to the two questions introduced above lead the MBA to consider options, with an eye for the long run, the MBA attempts to maximize profits without losing its best customers.

"Promotions" are actions which benefit the customer more than any harm done to the business. When judged correctly, promotions have a high transaction value even though they may be unfavorable to the business. Groupon capitalizes on this strategy by helping business to generate awareness and goodwill. The business shares with customers the majority of the value it creates. Actions which benefit the customer but aren't necessarily good for the business accumulate Goodwill. Later, the business will have an opportunity to take actions which favor the business at the expense of the customer.

A recent example of cashing in on Goodwill is Netflix upsetting customers by raising its rates and enacting separate billing for postal delivery of DVDs and streaming video. Undoubtedly analysts demonstrated the move is good for Netflix, despite the fact that customers will be lost. Clearly, those customers who stick it out receive less value now that the same product carries a higher price. In the future, greater customer value may return if many more movies are available to stream. Should that happen, customers who are satisfied by streaming alone might discontinue postal DVD delivery, a choice they would otherwise not give much thought to without separate billing. Since the cost to Netflix is greater to ship a DVD than to stream a movie, Netflix will benefit when consumers change their behavior. By billing separately, Netflix encourages customers to drop DVD delivery so that in the future Netflix might discontinue its postal service with less guilt. Despite the fact that customers don’t benefit by this path, the decision supports Netflix’s long term goal to yet again revolutionize the way we watch movies at home.

Should physicians give in to perverse incentives, they breach their fiduciary duty to patients. Whether motivated by greed or the practice of defensive medicine, these actions increase the cost of care without adding value. On the other hand, an action which is not in the best interest of the physician and benefits the patient should be taken. Indeed, a criteria of a profession is to only take actions which benefit the customer. Currently, many hospitals are run by CEOs who approach decisions as an MBA would. To maintain service, and ensure it stands for future generations, physicians must be mindful of when actions harm the business. On average, most decisions the Physician CEO makes would need to benefit the business. However the MBA's approach could be simplified by omitting any option that is not good for patients:

Price doesn't equal Value (Fishbone Diagram)

Product Place and time Price Promotion Process People Productivity Purpose

When setting prices, a business avoids going too low. Of course, we understand this fails to maximize profit. More importantly, consumer behavior demonstrates that a product which is sold for a lower a price than its competitors, is first considered a value. Eventually, the price difference becomes too great. Then the discount is no longer judged to be a better value, and begins to suggest that the product is inferior. For many consumers, the product which they believe has the most value is the second most expensive. For this reason, a business will develop a luxury version of their product. While it may manage to sell a few of these highest end items, more benefit is derived by the now second most expensive item being perceived as a better value.

The price schedule for the AMA is cheap when compared to other professional organizations such as that for trial lawyers. Could the low cost lead many physicians to question how relatively inexpensive professional organizational fees can return value? What if the annual dues were doubled? Would physicians anticipate more value and respond by joining the AMA?

Zane highlighted that much of the cost of participating in the AMA is incurred by traveling to the national meetings. His recognition again raises the question whether a national organization is needed. Or, perhaps Annual and Interim meetings are not regularly required. More productive work may be invested in local improvement, rather than preparing for the next national meeting. When the total cost of participation is largely related to travel expenses, then the disconnect between price and value widens further.

Reviewing the price we find a lot of wasted value. This concept of waste, arises repeatedly in medicine. In the case of the AMA annual events the waste takes the form of travel. Going to Chicago is a fun time, no doubt. However, many physicians would just assume take a legitimate family vacation. Travel to Chicago for CME and professional development workshops allows value to dribble away as hotel receipts, cab fares, and hasty lunches.

Instead, physicians could receive more value by attending regular meetings at which local financial consultants educate attendees on choosing a medical equipment loan from options locally available. They would attend such conferences with neighboring physicians and discuss the local problems they face. Rather than mulling over what they'd like to do about those problems, then only delivering their decision as a single vote to a national legislative body, they could take action--locally and immediately. Of course there are national problems physicians face which require a national organization. One such problem is how to best adopt EMRs to achieve the furtively defined, "meaningful use." Perhaps a local forum in which physicians can offer lessons learned from their adoption of EMR would be more beneficial. As more and more small clinics merge to grapple with increasing overhead, the need to know local fellow physicians increases.

Now, we'll put more meat onto our Fishbone Diagram. The new problems identified:



By picking apart price, we have noted additional problems with Place. Creating a fishbone diagram should allow this sort of active brainstorming. We can quickly categorize this newly identified problem under its appropriate Place label as we fill in the Fishbone Diagram.

Political or Practical (Fishbone Diagram)

In his recent post, David shared reactions to the recent AMA Annual Meeting in Chicago. Its dwindling membership has led us to question the direction the organization is heading. While we at Two Directions agree there are numbers in healthcare which should not rise, we look to reduce costs and would prefer to increase participation.

To analyze the problem we’ll use the Fishbone Diagram tool, and hope to accomplish the aim of this blog: to demonstrate how QI tools are used so they can be more widely applied to healthcare. In doing so, we also hope to consider solutions to the AMA’s dwindling membership. Given that several of us writing are members, we hope this process can inform our own engagement with organized medicine.

Fishbone Diagrams are a tool to conduct root cause analysis. Here, we’ll look for the root cause of the problem: why do so many doctors not participate in their main professional organization? To analyze this problem, we will organize our brainstorming into categories. This structured approach to problem solving is a technique for physicians to approach QI. To be not only creative, but effective, brainstorming often needs to follow a method; especially when working with a group. Because the AMA is essentially offering services to members, we will seek root causes by organizing our thoughts into the following service oriented groups.

Product Place and time Price Promotion Process People Productivity Purpose

As a happy coincidence, each group starts with P. A few notes about them:

• The first 4 P’s listed above are the classic 4 P’s of marketing
• While QI analysis usually considers “Process” in the scope of a product delivery or manufacturing, in this post we want to focus on the AMA’s legislative process. In a sense, it is a manufacturing process for crafting its organizational objectives
• Since the AMA acts as an advocacy organization, its Purpose is an important factor in determining its quality

To begin filling out this bare-bones diagram, consider how the AMA’s products alienate or fail to meet the needs of potential physician members. As we begin to fill an empty white board, we'll recognize that the product faults we identify are better categorized into another group, such as Place and Time.

CPT Codes. The use of the Current Procedural Terminonology codes to bill insurers is responsible for a large part of back office overhead. Physicians are often required to use these codes to receive reimbursement. Since the coding system changes often, physicians must hire employees who maintain this specialized skill.

Yet, the process adds no value to the Patient-Physician relationship nor does it improve patient health. Sometimes regarded as a cozy monopoly fostered by the AMA and insurers, CPT codes complicate the relationship between physicians and patients. The complexity of the coding system edifies the overhead expense of a medical coder, and facilitates the insurer practice of holding up or denying legitimate claims. Despite this detriment to physicians and the practice of medicine, CPT licensing generates annual revenue on the magnitude of tens of millions of dollars for the AMA.

Advocacy. Many physicians feel the AMA advocates for positions which they don’t agree with. Rather than advocate, the AMA may do better to inform. Individual physicians could then better assess how the actions of Congress fit with their personal views. Rather than pay professional lobbyists millions of dollars, the AMA could further shift its focus towards empowering physician's to use their voice in public forums. Again, the AMA's current approach fails to add value for physicians but does reward the lobbying firms the AMA retains. (Product)

Development.The AMA purports to be a professional organization, but has been overtaken by physicians with a fetish for politics. My own experience at A-11 had few opportunities for professional development. The main event was the legislative process. Medical students were exposed to JAMA, AMPAC, pomp and circumstance, but essentially no guidance on the transition from medical education to medical professionalism. A review of the AMA website points to some professional guidance. However, much of it seems to reinforce other AMA products such as the CPT codes. Google is appreciated by its users because the new technologies it offers are designed with the intention of making Google more useful. The AMA is unappreciated as its products seem to only reinforce its necessity.(Product)

The AMA does provide a generous experience to get involved with politics. Participation would likely bolster professional skills; politics and marketing have much in common. However an intensive course, set in Washington, D.C. is impractical to the demands of medical training and practice. (Place/Time)

Continuing Medical Education is a component of a physician's ongoing training which does have the potential to add value to the Patient-Physician relationship. CME offerings compete in a crowded market. The AMA offers CME credits through JAMA and via its Annual and Interim Meeting. Overall, a physician's specialty is typically more successful at meeting educational needs by offering more relevant CME topics. (Product & Place).

A fishbone diagram could capture and portray this analysis as:

The Many Faces of Organized Medicine

Two weeks ago, the AMA met for its 160th annual meeting in Chicago; this year with 12,000 fewer members than during the 159th annual one year ago. At the meeting, I heard many physicians express a growing concern: the membership of this national professional organization has dwindled recently, and now represents less than 10% of the physician voice in America.

Speculation has suggested two reasons for the loss of membership. First is the controversial position of “support” that the AMA gave two years ago to the PPACA. Second is the inconsistency between AMA policy voted upon by its House of Delegates (HOD) and the actions taken by AMA’s Board of Trustees on the organization’s behalf. Rather than leveraging the election and legislative processes to reign in these problems, 12,000 doctors have chosen not to renew membership in their national professional organization.

What would happen if our national legislators decided not to participate in the democratic process because they disagreed with an election or policy vote? Arguably, it would be quite counter to effective democracy. Having observed the policy creation process in the AMA’s HOD, it is clear that the process makes great efforts to entertain the minority opinion prior to a vote. Perhaps for dissenters, the more effective approach to strengthening representation would be to recruit like-minded physicians to pledge membership and run for elected office, rather than leaving the table all together.

Medical politics, like those of our federal government, continue to grapple with unwavering and polarized points of view. Many AMA southern delegates proclaim freedom from government regulation of any kind, while northern delegates are generally more comfortable complying with some terms of the PPACA in order to achieve greater access to healthcare. During debate on more benign policies, like the one requiring physician excuses from physical education in grade school, southern doctors dogmatically proclaim freedom from exercise mandates, while northern states judged such colleagues as holdouts to fighting our nation’s obesity epidemic.

One of the most contentious votes during the last four national meetings of the AMA has been on the healthcare mandate prescribed by PPACA. Prior to the A-11 meeting, the vote in the HOD has been evenly split 50/50 along state and ideological lines. In this meeting, however, almost 60% of the House passed a resolution with language endorsing current AMA policy D-165.966 (find it on AMA policy finder). This policy will provide state governments the freedom to decide how to best cover the uninsured. A state-by-state implementation is already enacted by PPACA, but will not take effect until 2017. The Wyden-Brown Senate bill, currently under debate, would move this deadline to 2014 if adopted by the US Congress.

There are many medical associations representing specialty medicine, regional interests, and national politics within medicine; but only one association - the AMA - purports to represent ALL physicians. Arguably, based solely on membership numbers, the AMA is already a long way from that claim. What’s undeniable, however, is that for this professional organization to continue, new ways to connect new members are required. What are the best strategies for doing this? And how can the AMA empower physicians such that they feel like their concerns are addressed? Is our nation so polarized and the practice of medicine so regionally variable that no one organization can truly represent all US doctors?

We look forward to exploring these questions more in coming weeks. In the meantime, we look forward to reading your input and ideas.

Quality Lessons from Humira Lawsuit

A suit was filed against Abbott Laboratories regarding its top-selling arthritis drug, Humira. The plaintiff, a patient with Rheumatoid Arthritis (RA), alleges the drug caused a life-threatening fungal infection, histoplasmosis. A rough chronology of the case as described by Bloomberg's report of the patient's complaint:

1. The FDA orders Abbott to "warn patients and doctors of an increased risk of potentially fatal Humira-induced histoplasmosis"


2. About a month later, the patient is prescribed Humira, as therapy for RA, allegedly without any notification of the risk of histoplasmosis


3. Months later the patient is diagnosed with disseminated histoplasmosis


4. Over a year after originally receiving notice to send a warning, Abbott finally does so

Specifically, the FDA identified patients living in the Mississippi or Ohio River valleys (endemic areas) and taking methotrexate as having the greatest risk of infection. The lawsuit was filed in Memphis, where the patient was diagnosed. Additionally, reports state that the patient was taking methotrexate, which is a common component of RA therapy. The patient appears to fit the full risk profile of geographic region and use of methotrexate.

A systemic fault. While casual reporting would make this appear to be a clear case, key facts point to the need to improve the timeliness of the Risk Evaluation and Mitigation Strategy (REMS). The FDA approved the Humira REMS in April of 2010, over a year after the patient was diagnosed with disseminated histoplasmosis. By comparison, Abbott was speedy, and seems to have required a little over a month to distribute letters. A REMS for Enbrel, Pfizer's competing TNF-alpha inhibitor, was approved nearly 3 months before the original FDA notice. Piecing together how that document fits into the timeline of this case was obscured when the Enbrel REMS was updated shortly after the debut of the Humira REMS. Regardless, the process for releasing the REMS was inadequate to help this patient.

The information finally provided by the REMS was also inadequate. To treat RA, Humira calms an immune system that is attacking the patient's joints. Therefore, physicians would expect a person taking the drug to have an increased risk of acquiring a disease which non-immunosuppressed people easily shake off. The key consideration to determine whether Humira is the appropriate treatment for a patient requires weighing benefits against risk. To properly assess those trade-offs requires data. The REMS reads as if it was pieced together from my medical school syllabus and lacks clinical data which would allow a practicing physican to reconsider risk. A separate notice on the FDA's site reports case numbers of those who developed histoplasmosis while prescribed various TNF-alpha inhibitors. However, missing are the respective histoplasmosis case rates which would allow comparison between those RA patients who are prescribed a TNF-alpha inhibitor and those RA patients who receive other therapy.

These shortcomings fail to meet the objectives that data be timely, transparent, comparable and understandable. By these standards the REMS developed by Abbott Labs and approved by the FDA was a failure for physicians and patients.

Missed Diagnosis? The immune system responds to histoplasmosis by sending macrophages to engulf the fungus-its common histological presentation is described as clusters of small yeast within macrophages. TNF-alpha, which Humira inhibits, is released primarily by macrophages with the effect of coordinating and enhancing their ability to consume pathogens. T-cells are believed to release a chemical which amplifies the macrophage's ability to digest the pathogens it has consumed.

Current microbiology and immunology could have led a physician to theorize that patients taking TNF-alpha inhibitors may be more susceptible to histoplasmosis. With a heightened suspicion, the physician's gut may have connected the dots even before post-marketing surveillance of TNF-alpha inhibitors provided data to corroborate the theory. However, the Veterans Affairs medical team, as alleged by the compliant, failed to make an earlier diagnosis. Does a need to justify costs, when pursuing a diagnosis, lower a physician's index of suspicion? As a result, are important diagnoses being missed? Among many measures, Evidence Based Medicine (EBM) considers the sensitivity of a diagnostic test. Has an over reliance on data lowered the sensitivity of the physician's gut, which is now weary to act in the absence of data?

This patient’s health seems to have grown worse in the absence of timely and useful data. If the REMS had been made available earlier, the VA physicians may have made the diagnosis. However, EBM will likely never reach its full potential and instead forever remain in a pubescent phase, always a bit ungainly. Therefore, when EBM fails to place sufficient data at clinicians’ fingertips, clinicians must remain prepared to heighten their own index of suspicion and fill the gaps with their expertise and consultations.

Possibly the VA team requested a consultation, as reports indicate an infectious disease specialist later successfully diagnosed and treated the patient. The current chatter within health policy generally demands and applauds greater reliance on primary care. It is regarded as more affordable by many pundits. However, the forward march of scientific discovery continues to require experts in specific fields. Generalists will continue to rely on those specialists for their valuable knowledge. Improving quality requires better teamwork amongst clinicians; maximizing quality continues to require individual excellence.

A certainty of this case is that REMS system is flawed-from the development of its content to the timeliness of its delivery. We hope physicians and other healthcare professionals will join 2directions in discussing its improvement.

Stakeholder Tables (Thursday)

To quickly recap, there are two types of tables in stakeholder analysis:

1. Effect versus Impact
2. Support versus Influence

The effect-impact table qualitatively assesses the contribution of a particular stakeholder to a quality improvement goal. The vertical axis represents the impact of the stakeholder, in measurements of "low", "medium", or "high". The horizontal axis represents the effect of the stakeholder's impact, in measurements of "negative", "neutral", or "positive".

Are admissions committees subconsciously making effect-impact tables when they predict the effect of an applicant's impact on their program? If so, how easy is it to make an accurate table? If not, what must tablemakers consider to ensure accuracy?

The support-influence table qualitatively assesses the contribution of a particular stakeholder to a quality improvement project. The vertical axis represents the influence of the stakeholder, in measurements of "low", "medium", or "high". The horizontal axis represents the support of the stakeholder's influence, in measurements of "negative", "neutral", or "positive".

Are patients subconsciously making support-influence tables when they evaluate the support of a provider's influence on their health? Since physicians are stakeholders in the quality of patients' lives, what can we learn from putting ourself in someone else's table?

The difference between these two stakeholder tables is subtle. One difference is the ability to specialize the impact-effect table by defining the impact according to the quality improvement goal. For example, when a physician is the target stakeholder, the particular impact may be defined by years of clinical experience, effectively creating a clinical experience-effect table. Or, maybe the impact is defined by average patient-encounter time, effectively creating an encounter time-effect table. Furthermore, multiple definition metrics can be used simultaneously.

-Brian Blaugrund

Fishbone Diagrams (Wednesday)

To quickly recap, fishbone diagrams are a quality improvement tool that identify the causes of a particular problem. They are an excellent way to document brainstorming at the onset of quality improvement projects. Components of a finalized fishbone diagram can be incorporated directly into ensuing process maps and/or checksheets.

Fishbone diagrams, like any form of brainstorming, should be generated by a team. Contributions from multiple perspectives increase the likelihood that all significant causes will be identified.

What are ways to efficiently obtain such widespread contribution?

1. From providers: fishbone-feedback publications might work, since practitioners typically stay well-read (requirement of the field). When appropriate, this may also facilitate long-distance contribution. And how about convincing QI-ignorant practitioners to participate? Is it sufficient to lead only by example?

2. From patients: post-encounter surveys might work (grounds for summer projects, galore). Another way might be purposeful listening, such as prompting feedback during an encounter. Shh, taboo...can providers ask for patient critique?

3. From policy makers: any suggestions for ways to extract ideas across this two-way glass?



-Brian Blaugrund

Proactive Checklists

When implementing new technology, organizations often miss their biggest opportunities for improvement, by attempting to translate existing processes directly into a digital format. Before writing a checklist, the process which is being measure should be understood and reconsidered.

There is a natural union between a process map and checklists. By combining these tools, technology can distribute checklist tasks according to a process map and organizational roles. If the process map were to be updated after a QI Physician identifies a method that better guarantees patient safety, then the technology could respond by promptly updating its workflow.

To fully redefine a process requires role analysis. With regard to the process of providing timely prophylactic antibiotics, could pharmacists own a portion of a pre-op checklist? Currently, the pharmacy appears to maintain a responsive role, waiting on doctors to request drugs. However, we already know these drugs need to be ordered when the surgery is scheduled. Could we provide pharmacists with a view of scheduled surgery and allow them to proactively confirm the need for antibiotics?

We might imagine the pharmacist could initiate a conversation with the surgeon to determine if the case will use standard antibiotics or does it require a variation? Once informed, the pharmacy could proceed with filling the orders and coordinate with anesthesia to deliver the antibiotics and transfer leadership of the checklist.



Process reorganization achieves its best results when its implementers consider the new methods to accomplish tasks that are possible using technology. Implementers may find that such considerations are easiesr when they analyze a process using a Hierarchal Task Analysis method. This way, they can focus on the tasks which must be accomplished, rather than a sequence of events which may no longer be required.

During a pre-operative timeout, before surgery commences, many items read out from the checklist may have been better to ask an hour ago. However, an hour ago each member of the surgery team couldn’t have predicted where they would be. It’s unlikely that they would have been in the OR, anxiously waiting their turn to affirm that their task was completed. More likely, they were across the hospital, out of reach of a paper checklist. How do we construct a checklist which takes flight, to reach them where they are, allowing their tasks to be affirmed, even when they are away?

Ultimately, the surgeon takes responsibility for the patient. In this role, they need to be informed of key milestones and prompted when milestones haven't been achieved on schedule. What type of checklist allows the surgeon to make use of the critical moment, rather than tally the score only after the patient has been intubated? How can we transition from a checklist which avoids mistakes before the first incision, to a checklist that is present along the way, ushering the patient towards a successful outcome?

After these revisions, a surgeon might receive a report that details accomplishments and notes tasks that may have been overlooked. We've connected the checklist to the process, and distributed ownership of the checklist across the organization, based on appropriate roles. So, rather than ask people if they finished a task they completed earlier, the surgeon knows to thank the nurse, Michele, for ensuring blood products are on hand. It’s a pleasant way to make a final confirmation that the system has worked for this, individual patient.

Some of the most valuable decisions a clinician makes regard judgments of evidence and choices to adopt new practices. Such decisions require high level cognition and make full use of their medical expertise. After those decisions are made, faithful execution is best achieved by a team and may be best managed by a process and checklist that the physician has previously defined.

Using Checklists for Measurement (Tuesday)

Today we heard from Kathy Masters about the basics of Six Sigma, a statistical system designed to improve efficiency of outputs by minimizing errors. We focused on measuring these outputs, the “M” in the DMAIC. One of the principal ways to measure is the use of checklists in medicine. Dr. Tsai, a pediatric cardiothoracic surgeon, talked about how checklists in the OR have helped to decrease the rate of surgical site infections.

• However, why haven’t checklists been adopted in medicine as they have in the automobile construction industry and world of aviation? What are ways for them to gain widespread acceptance?

Checklists also have drawbacks, as Dr. Tsai alluded to in his comment about having so many checklists that you need checklists to remember all the checklists. Many of the interpersonal aspects of healthcare, like establishing a rapport with a patient, being considerate of cultural and religious concerns and caring for a person’s emotional needs are not readily exportable to a checklist. It is important to recognize that checklists have both benefits and limitations and they must be executed appropriately.

Kathy Luther also mentioned how checklists can be adopted in primary care in the treatment of diabetes. Measuring HbA1c, HDL, and LDL should be done annually for diabetic patients, yet this is not being done. Does a checklist solve this problem? Blue Cross Blue Shield recently started a program called Bridges to Excellence, where physicians are financially rewarded for following guidelines for diabetic and cardiac care.

• Are checklists an effective, accurate, and fair way to measure quality improvement in the primary care clinic?

We also discussed the proper implementation of a checklist in an operating room setting. Dr. Tsai mentioned that in Memorial Hermann ER’s the checklist is done by the surgeon, while other operating rooms throughout the country will use residents, fellows, and nurses to run the checklist.

• Who should be in charge of the checklist? Also, continuing on yesterday’s post on technologies involved in process maps, what technologies could be implemented to improve usage? Are there ways to integrate the checklist with the electronic health records?

First, find your way

Athenian heroes do not win quests without a feat of cunning. In the myth of Theseus against the Minotaur, the hero's greatest challenge is to navigate the Labyrinth. If Theseus can only find his way through the maze, then monster slaying is what epic heroes do best, and we know he'll win the day. As he set out into the Labyrinth, Theseus carries not only his sword, but also the unlikely, a fist full of string; something sharp and something shrewd.

The complexity of the healthcare system is aptly compared to a Labyrinth. Today, Dr. Pratik Doshi presented the first lecture in our series on Quality Improvement by introducing us to Process Maps as a method to define the problems we aim to improve. Dr. Doshi presented two methods to design process maps at our Quality Improvement lecture focused on the Define component of the DMAIC process. The first is a sequential map. It outlines key tasks, interactions, and decision points as identified by walking the process.

Plutarch, the Roman author, maps the process for conquering Theseus’ quest as a sequence of events:

1. Sail to the city of a mad king who demands human tribute from your people


2. Avoid being frisked; smuggle your sword into enemy territory


3. Upon arrival, win the love of the king's daughter


4. Feign martyrdom and assume the place of your countryman in the sacrificial ritual


5. Gain inside knowledge of the maze from its architect, passed by the king’s daughter


6. Receive a ball of string from your lover and lay it along your path as you enter the maze


7. Surprise the fell beast and gain the upper hand in battle


8. Follow the string back; flee island

Theseus lacked the omnipotent position of narrator. He was a hero with a task in front of him—forcefully correct King Minos’ cruel judgment that Athens owed him fourteen of its brave and fair citizens. He would have seen the benefit of the second method Dr. Doshi presented, a goal-oriented process map: Hierarchal Task Analysis. This is the method for Theseus, a man who makes a name for himself by stabbing epic beasts in the throat.

For Theseus, approaching his situation as a sequence of events would be less useful than considering his two requisite tasks: slay the Minotaur, return home. As an epic hero, he already had some sense of how to approach killing monsters, but what of this issue regarding a Labyrinth? Hierarchal Task Analysis could direct Theseus to further consider this problem, rather than charge headlong, and lose himself in a maze.

Outside pundits marvel that health care has been slow to adopt business process improvement. Stepping inside our maze, we gain the view that the healthcare system may not always be best defined as a sequence of events. Dr. Doshi provides us with two means to accomplish a heroic quest. Whichever of these two methods we utilize, Process Mapping is our string, laid down as a guide for clear analysis of our system for providing medical care. Able to navigate our Labyrinth, we can seek its challenges.

Process Maps (Monday)

To quickly recap, there are two types of process maps:

1. Sequential flow
2. Hierarchical task analysis

The sequential flow diagram organizes tasks with arrows indicating order of completion. The hierarchical task analysis diagram organizes tasks with arrows associating relevance to an outcome.

There appears to be uncertainty over which approach is more appropriate for healthcare quality improvement projects. I suspect it depends on the nature of the project, and ultimately the process in question. For complicated, multi-faceted processes with many outcomes of interest, it seems likely that the hierarchical task analysis diagram would provide a clear representation. But for single-track processes with minimal stratification, the sequential flow diagram seems a simpler, faster option.


What are some examples of healthcare processes conducive to mapping?

1. Single-track processes, for example, could include things like documenting patient encounters, performing physical exams, or even USMLE preparation (medical students, meet quality improvement).

2. Complex processes, on the other hand, could include rehabilitation regimes, cancer therapy, or new patient intake.


What are some practical implications of using process maps?

1. Construction: the marker-and-whiteboard method was demonstrated today, but technology is more advanced than that. What software exists to ease construction of process maps? Hey, Apple...is there an app for that?

2. Convention: complicated chemistry has rules for diagrams (bonds, elements, reactions, etc.); process maps need rules too. Dashed lines, dashed boxes, block arrows, solid arrows--the graphics need definitions. Do process maps already have standards? Or should healthcare users attempt to establish them as the tool becomes more widespread?

3. What else?



-Brian Blaugrund