Lab Soft News

Radiofrequency Ablation of Lung Cancer Found Effective

I came across a recent article that discusses a non-surgical means for ablating malignant lesions of the lung for patients who cannot tolerate surgery or other therapeutic approaches (see: Non-Surgical Approach Can Treat Lung Cancers). It's called radiofrequency ablation (RFA), Below is an excerpt from the article with boldface emphasis mine:

A minimally invasive procedure normally used to treat liver cancer also holds promise for lung cancer patients, according to a new study. In the study..., 88 percent of lung cancer patients responded well to treatment with percutaneous image-guided radiofrequency ablation (RFA). RFA is performed in less than an hour and is a non-surgical procedure that targets large tumors with no harm to surrounding healthy tissue. After one year, 70 percent of patients survived at least one year with few side effects; none that impaired lung function, the researchers report....Lung cancer is the leading cause of cancer death in both men and women. Surgery is the standard treatment for early-stage, non-small-cell lung cancer (NSCLC), which constitutes about 80 percent of most malignant lung tumors. Unfortunately not all patients are eligible due to other health reasons. The alternatives, radiotherapy or chemotherapy, do not have good survival rates. The study...involved 106 patients with malignant lung tumors that were smaller than 5 cm in diameter. Thirty-three patients had NSCLC; 53, metastatic lung cancer from the colon; and 20, metastatic lung cancer from other sites in the body. All the patients had been turned down for surgery, radiotherapy or chemotherapy. The major post-RFA complications were pneumothorax (27 instances) and pleural effusion (4 instances) which needed drainage.

Here is a more detailed description of RFA from RadiologyInfo:

In radiofrequency ablation, imaging techniques such as ultrasound and computed tomography (CT) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, creating heat that destroys the abnormal cells.

Basically, this technique is analogous to "cooking" the primary or metastatic lung lesions in a microwave oven. This approach would seem to bypass both the thoracic surgeons and pathologists unless fine needle aspiration (FNA) is used to diagnose the NSCLC lung lesions. In the case of those patients with metastatic disease, biopsies may have been obtained previously to diagnose the primary lesions. This seems to be an excellent approach for patients who are not candidates for other therapies. It also effectively demonstrates the expanding scope of practice of interventional radiology.

Epic Systems and Its Corporate Culture

Anyone deeply involved in lab computing needs to understand the companies supplying  LISs and EMRs to this market. Part of this understanding involves the "culture" of these companies. The term corporate culture is complex and incorporates a number of variables. As one measure of the complexity of the term, a Google search for it yields 4,450,000 hits. As only one example, some HIT companies are technology-driven whereas others are more marketing-driven. Probably no company is as interesting culture-wise as Epic Systems, currently the market leader in the EMR market. A recent article (see: Behind the Curtain) discusses the company in great detail. For me, the most interesting part of the article was the list of the differences between Epic and its competitors. Below is that portion of the article:

• Epic almost never advertises, and relies almost entirely on word-of-mouth recommendations to market itself.
• Epic does retain salespeople, but they make no commissions on sales, and act more like advisers and consultants than traditional salespeople.
• Epic turns away potential business. Indeed, prospective customers meeting with Epic representatives find they are being evaluated as much as they are evaluating.
• Epic executives have evolved a very specific implementation process over time, one that involves intensive pre-implementation analysis and planning, but then focuses very strongly on meeting go-live dates.
• Rather than seeking experienced healthcare IT professionals, Epic relies on hiring a large corps of the brightest young, just-out-of-college IT professionals for its programming and implementation positions.
• Epic never grows through acquisition, but rather relies on internal development, in extreme contrast to all its competitors among the largest clinical IS vendors.
• Most of all, Epic has a very unusual corporate culture, one that intrigues and sometimes puzzles those who encounter it or hear about it....That culture emanates to an extraordinary degree from the personality of the company's visionary, media-averse founder and CEO.

The true test of the value of any corporate culture is the success of that company in the competitive market. There are clearly no rigid rules. And by this test, the Epic culture has been, and continues to be, a successful one. My guess is that its competitors may  review this list and then probably decide that their own cultures will triumph in the end.

Some New Insights into "Bypass Brain"

The cognitive and behavioral aspects of bypass brain are now in the news as a result of the presidential political campaign and Bill Clinton's behavior. Read more about this in a recent blog note (see: 'Bypass Brain': How Surgery May Affect Mental Acuity). Below is an excerpt from the story with boldface emphasis mine:

Aides to Bill Clinton last week vehemently denied speculation that the former president's intemperate remarks on the campaign trail were due to mild cognitive damage from his quadruple-bypass surgery in 2004....But the condition dubbed "pump head" or "bypass brain" has long been recognized by doctors, even if they seldom warn patients about it....Symptoms include short-term memory loss, slowed responses, trouble concentrating and emotional instability....[R]esearchers at Duke University Medical Center tested 261 patients before and after bypass surgery and found that 53% of them had significant cognitive decline when they were discharged -- and 42% still suffered from it five years later....One explanation is that when a patient's blood is pumped through a heart-lung machine during bypass, tiny air bubbles, fat globules and other particles may enter the bloodstream. The pump can also damage platelets, which form clumps, and clamping the aorta loosens bits of plaque. That debris can travel to the brain and clog tiny capillaries, forming microscopic strokes....There's little dispute that heart surgery does cause short-term cognitive problems -- anesthesia alone can do that, particularly in older patients. But recent studies suggest that the cognitive decline years later may be due more to the underlying artery disease than to the effects of surgery.

I don't think that it's fair that the cardiac surgeons need to bear the brunt of Clinton's off-the-cuff remarks on the campaign trail. I also understand that more research is needed to further delineate the true nature of bypass brain. Nevertheless, I suspect that all of us have grown far too complacent about the inherent risks of any surgical procedure and general anesthesia. Here's some food for thought from the U.K. (see: 'Care flawed' in many bypass ops):

Coronary artery bypass graft operations, the focus of their latest project, has approximately a 2% death rate, and over the three year period checked, there were 1,198 deaths reported....There were problems found in every step of the process, from delays after referral, to the way tests were carried out, doctors communicated with each other, and the way patients were cared for after their operations. Overall, they concluded that in two-thirds of cases which ended in the death of a patient, some aspect of care was flawed, due to poor organisation, communication or teamwork.

If the time comes, I guess that I will opt to have a cardiologist snake a catheter into my heart, steer the tip into the ostium of one of my coronary arteries, and drop off a small spring-like device to keep the vessel open. This seems to be the safest course of action.

Sometimes Consultants Surprise You with Their Reports

Reports from healthcare consultants can sometimes be warmed-over pap or merely external validation of decisions already made by hospital executives. On occasion, however, reports from consultants can surprise you. This was obviously the situation described in the following article with boldface emphasis mine (see: WVU dumps its consultant):

West Virginia University officials fired a $75,000-a-month consulting firm Friday, saying the consultants' scathing report about WVU's health science division and affiliated hospitals was full of errors and misunderstandings. The nine-page report, by R&V Associates of Pittsburgh, alleged that "serious," "intolerable" and "alarming" problems at WVU hospitals put patients' lives at risk.  The consultants cited the unexpected deaths of two children and an adult. They also criticized WVU for serious shortages of general surgeons, anesthesiologists and heart surgeons that forced hospitals to send patients to facilities in Columbus, Ohio, and Pittsburgh. WVU said R&V reached false conclusions, in some cases, and the university already was working to fix other problems brought up in the report....[The interim vice president of health sciences] said the university plans to hire another outside consultant that "has experience with academic medical centers." R&V Associates, which has been paid $321,789, plus expenses, for its work since March, has said the report is accurate.

What in the world is going on here? A consulting firm accuses the hospital that engages it of putting "patients' lives at risk." It then adds insult to injury by inserting this claim in only a nine-page report. However, the interim vice president of health sciences at WVU hospitals seems to be heading in the right direction when he says that the organization is now seeking another consultant with "experience with academic medical centers." The web site of R&V Associates describes the discharged firm as specializing in "business consulting and crisis management." It's not clear from the article whether the officials at WVU hospitals anticipated that the consulting firm that they first engaged would precipitate the crisis that now apparently needs to be managed by yet another set of consultants. 

Who "Owns" PACS: Radiology or Central IT in Hospitals?

Veteran readers of this blog will probably know that I am a strong proponent of having laboratory professionals "manage" their own LISs. Lab tests results are a strategic asset in hospitals, underlying about 70% of hospital diagnoses and constituting about 70% of the data contained in electronic medical records. How does one determine who manages (i.e., owns) the LIS? Easy! Who makes the decisions regarding access to lab information? Who formats that information? Who has the final word on policy issues regarding that information. Who has both de jure and de facto control (i.e., stewardship) over it? If you need to pull out an org chart to answer these questions, you are in trouble. Needless to say, I was interested in a recent article (see: Who owns PACS -- Radiology or IT?) about this same question as it applies to radiology information and images. Below is a longish excerpt from the article with boldface emphasis mine:

Should radiology or the IT department take responsibility for managing PACS in a hospital? It depends on the facility's corporate culture and the level of sophistication of the IT department, an animated "debate" at the 2008 Society for Imaging Informatics in Medicine (SIIM) meeting concluded. The premise of the argument presented by Dr. Paul J. Chang on behalf of IT department ownership is that PACS technology has become a component of the entire hospital informatics enterprise rather than its own unique entity. In an increasing number of hospital infrastructures, dedicated networks for PACS are unnecessary. Thick-client workstations are facing obsolescence....Modern healthcare IT should be structured as a matrix, according to Chang, who straddles both worlds as vice chairman of radiology informatics and director of pathology informatics at the University of Chicago Pritzker School of Medicine....Because PACS is the multimedia component of an electronic health record (EHR), the EHR must be optimized to support radiology workflow. Not only is this a complex undertaking, but it logically fits as the responsibility of the IT department -- as long as the IT department has a global vision and a progressive philosophy, Chang said.

Dr. David Channin, chief of imaging informatics at Northwestern Memorial Hospital and the Feinberg School of Medicine in Chicago, disagreed. "Radiology has led informatics technology innovation in hospitals and will continue to be the source of informatics leadership in healthcare," Channin said. "Domain expertise must take precedence over IT expertise. Tools don't drive domain innovation. If controlled in a central manner, such as a matrix structure, the priorities of a radiology department will be subjected to control by an IT department juggling priorities representing multiple domains in a hospital," he said. "If you don't have budgetary control of your bucket of allocated capital dollars, you have lost control. Your critically needed PACS upgrade will be competing with acquisition of a new laser doodad for OR." Radiology departments should wield the power they have as cash cows for hospitals, define their IT domain borders, provide access to them with standard interfaces, and demand autonomy, according to Channin. He recommended that radiology departments contract with IT departments for "commodity services" such as networks, virtual operating systems, and data storage.

Well, no one can say that Drs. Chang  and Channin did not speak their minds in this spirited exchange. There is too much interesting material here to cover at one time. Here are some of my initial reactions:

• Matrix shamtrix. You either own the LIS/RIS/PACS or you don't. See my discussion above about system management/ownership. Pathology owns (or should own) lab information and pathology images and radiology owns (or should own) radiology information and images. Central IT + clinical personnel should then negotiate with pathology and radiology for access to the information managed by the latter two groups.
• According to Dr. Channin, "radiology has led informatics technology innovation in hospitals." LISs were developed and commercialized in the late 1970s and thus preceded RISs by at least five years in hospitals. AIMCL, the LIS conference that preceded Lab InfoTech Summit, was launched in 1983. Radiologists are the acknowledged leaders in hospital image management and storage. Let's call it a draw.
• I agree with Dr. Channin regarding the IT capital and operating budget for the LIS and RIS. If you don't control the information system budget, you don't control the information system.
• I have no problem with the central IT departments providing "commodity services" to pathology and radiology. They are best able to provide institution-wide services like networks and generic data storage for the entire institution. However, I believe that the latter is now a commodity and best provided via a vertical cloud (see: A Closer Look at the Vertical Cloud in Healthcare Computing; The Potential for "Sereverless" Healthcare Computing).

IT Budget Allocation Categories for Healthcare CIOs

John Moore at the Chillmark Research blog introduced one of his recent blog notes (see: Tradition Grapples with Insatiable Demand) in the following way:

Dan Nigrin, the CIO from Children’s Hospital Boston ...is struggling with the insatiable demand for HIT among care providers ...at Children’s while concurrently dealing with an industry that is so bound by tradition. On one hand he must prioritize spending across any number of categories that he characterized as infinitely long (healthcare still spends a woefully low 1-3% of revenue on IT, as a comparison, manufacturing is spending between 4-6% and financial institutions spend even more). Yet on the other-hand, he needs to find new ways to more effectively leverage this spend to insure effective adoption occurs. Not an easy task in this tied to tradition industry.

Moore then goes on in the note to provide a detailed list the following HIT spending priorities that had been enumerated by John Halamka, the other CIO on the panel. John publishes his own excellent blog (Life as a Healthcare CIO) and is chief Information Officer of the Caregroup Health System and Chief Information Officer and Dean for Technology at Harvard Medical School, among many other things. CareGroup includes Beth Israel Deaconess Medical Center. Below is Halamka's list of high level priorities in addition to the obvious support for business and clinical applications.

• Getting non-affiliated doctors on-board in using an EMR throughout the New England region
• Addressing the demand for data storage
• Insuring secure communication throughout the network
• Tackling security
• Compliance
• Creating dynamic websites
• Disaster recovery

It's a good idea to take stock of the larger set of challenges facing healthcare CIOs today. However, the list is not much different than that of the CIO of any major enterprise. The only surprise for me in his list was the first point -- getting non-affiliated doctors on-board in using an EMR throughout the New England region. Clearly, getting "outsiders wired" would not be the goal of any corporate CIO outside of the healthcare enterprise. One wonders if John is pursuing such a goal as part of his overarching interest in the improvement of healthcare IT or whether connecting such non-affiliated physicians is a strategic goal to spur admissions at his own hospitals. In a previous note and pertaining to the challenge of data storage (see: A Closer Look at the Vertical Cloud in Healthcare Computing), I discussed how some hospitals are turning to external web-based storage solutions such as InsiteOne for PACS records.

A Call for the Development of Integrated Diagnostic Centers

I will be delivering a lecture to the 42nd annual Congress of the Brazilian Society of Clinical Pathology (Sociedade Brasileira de Patologia Clínica; SBPC) on July 3, 2008, in Sao Paulo, Brazil. The lecture is entitled "Integrated Diagnostics Emerges as a Key Element in Healthcare." The lecture will address the development of integrated diagnostic centers (IDCs) which I believe will play an important role in the future of healthcare delivery. Below is a summary of this presentation that I was asked to write for the SBPC web site.

The general field of diagnostics, with molecular diagnostics and medical imaging at its core, is undergoing an explosion of knowledge providing the potential to diagnose disease in its pre-clinical pre-symptomatic stage before any physical manifestations are present. Such a new approach to healthcare will be very disruptive for clinicians who have been trained to suspect the presence of disease on the basis of a patient history and a physical exam. This new perspective on disease diagnosis sets the stage for the emergence of “integrated diagnostic centers” (IDCs) staffed by pathologists, lab medicine specialists, and radiologists. A patient would be referred to an IDC by a primary care physician, at which time the physicians in the diagnostic center would assume total responsibility for diagnosing the patient’s disease, assessing the prognosis of the disease, and making some therapeutic recommendations. This IDC concept is well known in Brazil where it has already been executed on a large-scale basis.

In order for this IDC concept to gain wider acceptance in the future, a number of changes need to be adopted within the specialties of pathology, laboratory medicine, and radiology. First of all, the distinctions between morphologic observations of diseased tissue and clinical lab analyses need to be blended to provide integrated conclusions about the overall pathophysiology of a disease (also see: Integration of Anatomic and Clinical Pathology). Following this, the specialties of lab medicine and pathology need to merge to form the new and integrated specialty of diagnostic medicine. Finally, a means need to be discovered to enable the reallocation of funds from the current “therapeutic silos” to “diagnostic silos.” This reallocation of healthcare dollars can be achieved by an increased focus on measuring the efficacy of current drug treatment using diagnostic methods. Given that a substantial percentage of drug therapy, particularly in the field oncology, has been shown to have little effect, the executives of health insurance companies and governmental health programs will gladly reallocate funds to diagnostics if the result is a net savings of the cost of drugs and the avoidance of unnecessary side effects by those patients receiving the unnecessary drugs.

Should the Hospital CIO Report to the CFO

Mr. HIStalk recently commented on the topic of whether a hospital experiences better financial performance if the CIO reports to the CFO rather than to the CEO. Below is his note in its entirety (boldface emphasis mine):

A study says that hospitals in which IT reports to the CFO have better financial performance. Actually, I’m reading between the lines since reading the actual lines themselves would set me back $7.95 and I don’t really buy the premise (and therefore the article). I recognize some Florida State University names among the authors, I think. I would think it’s hard to prove that IT reporting influences the hospital bottom line vs. happens to correlate to it in some way. There’s also the question of value and quality, of course.

Here's the "money" quote from the summary of the report that he makes reference to:

Reporting to the chief financial officer brings positive outcomes; reporting to the chief executive officer has a mixed financial result; and reporting to the chief operating officer was not associated with discernible financial impact.

Duh! News flash. Hospital financials are better when the CFO is in charge of IT. Believe me, I have operated in such an environment and you don't want to go there. I started managing an LIS when the hospital "mainframe manager" (pre-CIO days), an IBM retread, reported to the CFO. As one would expect in such a setting, the efforts of the central IT group were largely allocated to business applications. Projecting such a reporting relationship into today's environment, how could be results be any different?

One small anecdote from these "good old" days around 1985. The mainframe manager was bragging to a hospital IT committee that the computer "up time" was hovering around 98%. Everyone in the room cheered. This was at a time when the mainframe computer had a scheduled "down" of four hours every night for system backup and maintenance. I asked politely how we could achieve a 98% performance given our extended nightly maintenance period. She responded that the "up time" for the hospital computer was calculated using the number of planned available hours per 24-hour period in the denominator. Just my two cents. Hospitals are already too driven by bottom line financial issues. No need to exacerbate this problem even more.

The Big Three in Healthcare: Cardiology, Oncology, and IT

A recent announcement by GE Healthcare about an upcoming conference in Dubai (see: GE Healthcare to focus on emerging healthcare trends at second annual Middle East Media Summit ) reinforced in my mind what I believe are now, and will continue to be, the three dominant fields in healthcare: cardiology, oncology, and IT. Below is an excerpt from the article with boldface emphasis mine:

The aim of this year's Middle East Media Summit is to further assist in promoting healthcare knowledge across the region....Today, the region faces a number of significant and serious healthcare challenges: life expectancy lags behind developed countries, the population is both increasing and ageing, and its citizens suffer some of the highest rates of obesity and diabetes in the world....This is the company's focused response to the projected rise in healthcare costs in the GCC region [six-nation Gulf Cooperation Council] from US$12 billion today to US$60 billion by 2025....This year's summit will address some of the key healthcare challenges facing the region focusing on the shifting trends in healthcare delivery as it relates to the "Early Health" model of care. The summit will include presentations, case studies and lively debates on recent advances in healthcare in the region, specifically in the fields of Cardiology, Oncology, and IT and will provide insights into the future of healthcare in the region.

I have posted a number of previous notes about GE's early health model so I won't discuss the concept again here. I have also previously blogged about the high rate of diabetes in this region (see: Diabetes Epidemic Hits the Middle East Hardest). What interested me most about this article, however, was the special conference focus on cardiology, oncology, and IT. Both in published articles and in my own mind, these fields continue to dominate in technology, research, and healthcare delivery. When asked about the most interesting and challenging areas in healthcare by medical students and house officers, I usually cite these same three fields. To restate the obvious, however, IT is the enabling technology that underlies and supports both research and clinical practice for cancer and heart disease.

Advances in Portable Ultrasound Devices

I have posted a number of previous notes about portable ultrasound devices. The technology has been widely and rapidly adopted in emergency medicine (see: World's Smallest Ultrasound Device Unveiled) because it increases the speed and quality of diagnoses and also generates additional revenue. It's a good example of how technology is causing "leakage" of imaging procedures to specialties other than radiology. I came across another article about this same topic with special emphasis on the increasing sophistication of chip technology (see: Chip Advances Lift Ultrasound Market, Help Save Lives). Below is an excerpt from it with boldface emphasis mine:

Two hours after the patient had a heart attack...doctors at St. Luke's-Roosevelt Hospital Center in New York discovered his heart was being compressed by pooling fluid and rushed him to surgery. The quick assessment was made possible by a portable ultrasound machine from Siemens AG dubbed the P10, the smallest currently on the market....New ultrasound devices like the P10 are possible in large part because of analog chip makers, which are racing to develop electronics that allow portability....By improving quality and shrinking size, component makers are hoping to open new markets from emergency care to emerging economies. Expanded use of ultrasound ...could offer inexpensive improvements in patient care, the companies say....Traditionally, ultrasound has been used by radiologists, cardiologists, obstetricians and gynecologists. Now it is an option for new classes of specialists, including anesthesiologists and emergency-care physicians, and even those in Iraq looking for shrapnel in wounded soldiers. It is also within reach for clinics and hospitals in developing countries.

Two ideas in this article caught my attention. The first was the analogy between the deployment of new chips in portable ultrasound instruments and in cell phones. We are all familiar with how the feature/function set of cell phones has rapidly increased while their cost and size have rapidly decreased. We may see a similar phenomenon with portable ultrasound devices. Continuing with this cell phone analogy, this evolving technology allowed less developed countries to set up a sophisticated telecommunications networks without first installing an expensive land-line infrastructure. Downsized ultrasound devices and the development of other imaging devices designed specifically for third-world countries will allow them to rapidly develop more sophisticated healthcare delivery systems.