Will this be a game-changer? It very well might be. It comes on the heels of other incentives the feds have used to get hospitals to lower their CLABSI rates, so the new effort could create a tipping point. Here are the previous initiatives:

* In October 2008, the federal Center for Medicare and Medicaid Services (CMS) ceased reimbursing hospitals for a number of hospital-associated conditions, including CLABSIs, that it considered preventable.

* CMS lowered the financial boom again about two years later. As we reported here, CMS mandated that to get full Medicare payments, hospitals had to report CLABSIs and certain other healthcare-acquired infections (HAIs) on the CDC’s National Healthcare Safety Network (NHSN).

The reporting to NHSN began in January 2011, and it is that data that is being shared on Hospital Compare. Although the reporting is voluntary, most hospitals participate for obvious reasons – it would be unthinkable to suffer lower Medicare payments. By the way, much of the credit for these government crackdowns goes to Consumers Union, which for years has been pushing for action on HAIs through its Safe Patient Project.

Of course, Hospital Compare is going to keep some hospital CEOs up at night.

Undoubtedly, savvy patients will penalize facilities with high CLABSI rates when they go hospital hunting. Some CEOs complain that a simple comparison of CLABSI rates puts their institutions at an unfair disadvantage. We’re sympathetic to that claim in some cases. We’ve worked with several hospitals whose patient populations are unusually vulnerable to CLABSIs.

For example, we’ve written about one well-regarded children’s hospital that nevertheless has much higher-than-usual CLABSI rates because many of its patients suffer from short bowel syndrome and also receive total parenteral nutrition. Both issues significantly increase CLABSI risk.

But note that this hospital was still able to lower its CLABSI rates dramatically by taking several preventive steps, including implementing an alcohol-dispensing disinfection cap called SwabCap® that improves disinfection of IV connectors. Disclosure: (We represent SwabCap’s maker, Excelsior Medical.)

Numerous hospitals that were struggling to reduce their CLABSIs achieved sharp reductions when they adopted the disinfection cap, which smartly addresses the problems with the traditional approach to disinfecting connectors.

So, yes, Hospital Compare will sometimes compare apples to oranges, but hospitals can and should reduce infections by implementing best practices and evidence-based technologies like the disinfection cap.

Average hospital CLABSI rates have dropped some over the years, thanks in part to campaigns by the feds, Consumers Union, and other concerned organizations. Consider, though, that many experts believe CLABSIs can be completely eliminated. If they’re right, there’s still room for improvement.

Update: The transformation is here, and it places a premium on efficient sharing of healthcare information.

That’s the word from Paul Grundy, M.D., MPH, a presenter at the 2012 CHIME/HIMSS CIO Forum in February. Grundy, who is president of the Patient-Centered Primary Care Collaborative and director of healthcare transformation at IBM, pointed to the growing percentage of healthcare that is now delivered via the patient-centered medical home (PCMH) model – and also the growing share of payments from private and government payers now going to PCMHs.

A PCMH is a team of providers led by a personal physician who coordinates the patient’s care with various sub-specialists. As Grundy noted, no one provider in a PCMH completely owns patients or their data, so data has to be shared with all relevant team members – smoothly, quickly, and reliably.

Cloud-based medical info exchange has a role to play in this process. Where imaging files are concerned, no method better fits the PCMH scenario than a cloud-based service like eMix that almost instantly moves medical files and reports to any provider’s Web-connected computer, including tablets and smart phones.

Moreover, today’s Facebooking, tweeting patients expect new types of interactions with their providers, including virtual interactions.

As one sign that medical manufacturers have already geared up for this new reality, consider VGo, a new, remote-controlled “telepresence” robot that, among other uses, enables providers to see and interact with patients as if they were in the same room.

To understand the growing potential of patient-centered medical homes, just follow the money.

Two large private payers, WellPoint and UnitedHealthCare, are redoing their reimbursement and delivery approaches. On the government side, the Centers for Medicare & Medicaid Services (CMS) has committed 11 percent of payments to approaches other than fee-for-service. This redirection of payments will drive more and more providers to adopt the PCMH model, Grundy said.

Why the sudden shift? It’s in part because payers are fed up with the inefficiencies of a healthcare system too heavily reliant on unregulated fee-for-service and rescue/specialty care, Grundy said.

The goal of the PCMH is to improve outcomes and reduce costs through coordinated care. Grundy described several studies showing that the PCMHs studied were already resulting in fewer hospital readmissions and shorter hospital stays.

What does it all mean? A new model of healthcare and provider compensation is here to stay. At the same time, robots at patients’ bedsides and imaging files shared via the cloud are carving a place for themselves in contemporary healthcare. The convergence of these new arrivals could be beneficial for all parties.

Among the leaders in this field is eMix, a client of ours. Florent Saint-Clair, eMix general manager, recently led an On-Demand Education Session of Virtual HIMSS12 titled “Cloud-Based Medical Data Exchange: What We’ve Learned So Far.” Virtual HIMSS 12 was held online from Feb. 20-24. To see Saint-Clair’s post on the HIMMS blog, click here.

HIMSS provided the virtual sessions as a way to take part in activities related to the HIMSS 2012 Annual Conference & Exhibition, other than attending the event in person. Attendees were able to participate from any location in the world. Virtual HIMSS12 included both interactive activities and on-demand sessions such as the one on cloud-based medical data exchange.

Saint-Clair’s session described the evolution of cloud-based medical data exchange from its introduction in 2010 to its increasingly wide use today. He discussed why the technology is a giant leap forward from such troublesome, limited workaround solutions as exchanging files on CDs and sending them via virtual private networks (VPNs).

CD and VPN file exchanges are plagued by such issues as time delays, reliability, and security. Cloud-based medical data exchange has created a sharp, and welcome, break with this troubled past. Thanks to the new technology, a hospital can now securely send an imaging or other medical file to a radiologist’s EHR, PACS, or mobile device – indeed, any computer with a broadband connection – in just minutes.

The technology is similar to using email and just as reliable. It is also vender-neutral, which means it neatly hurdles the fact that medical information technology systems are often proprietary and don’t easily “talk to” each other. This was the problem that created workarounds such as CD- and VPN-mediated file exchanges in the first place.

Saint Clair’s presentation detailed the various ways that patient care has been improved by the increased reliability and speed brought about by services like eMix. He also noted the adjustments that adopters of the services face with respect to their workflow, protocols for handling images, and business processes. For those who couldn’t make it to HIMSS, the session provided an opportunity to get updated on an important new advance in medical data exchange with the depth and sophistication that HIMSS attendees expect.

Having worked previously for the Association for Vascular Access (AVA), last year we began supporting the efforts of AVA’s research and education arm, the Wise Foundation.

AVA and the foundation ended the year on a high note, with the announcement of a major grant from AVA to the foundation. The $50,000 grant, given in honor of AVA’s membership, underlines AVA’s support for the foundation’s mission. The grant also strengthens the foundation’s outreach to other major funders.

For more on the grant and the foundation’s work, see Wise Foundation Grant from AVA. Additional info on the foundation and a current grant opportunity available at www.wisefoundation.net.

Consumers’ gaze always seems pointed toward the next big thing, needed or not. Over the years, interest has shifted from desktop computers to laptops to tablets and mobile devices.

The situation in medicine is not so unidirectional. In fact, right now, attention appears focused on an old, invaluable favorite: the picture archiving and communication system (PACS).

According to a recent report from market researcher KLAS, the PACS replacement market seems to be gathering momentum.

Large hospitals are leading the parade. Of hospitals and health systems with more than 1,000 beds, nearly one in six told KLAS they are in the planning process of replacing their PACS.

One of the reasons that the PACS replacement market is heating up again: The early PACS were strictly radiology systems. They were used to store, access, and distribute digital imaging files.

The current PACS generation encompasses radiology information systems (RIS) and cardiovascular information systems (CVIS), too. A RIS is a computerized radiology database with functions that include results reporting, patient tracking and scheduling, and image tracking. Interfaced with PACS and in many cases a hospital information system (HIS), the RIS plays a central role in radiology workflow, from radiology practices to hospitals. In a similar way, a CVIS is a workflow solution for cardiology departments and practices.

But the large hospital/health system decision makers who responded to the KLAS survey don’t want just any PACS/RIS/CVIS. They said they wanted innovative technology from a new PACS vendor with in-depth clinical and radiological expertise. They demand reliability, scalability, interoperability, mobility and accessibility, as well. Finally, they want their vendor to be a strategic partner.

Those are not unreasonable expectations. In fact, they are all qualities, according to KLAS voters themselves, of the company they chose as 2011′s top PACS vendor in the large hospital category: DR Systems (San Diego) (a Dowling & Dennis client).

Besides DR’s industry-leading technology, KLAS voters cite the company for working extremely well with customers. A PACS is not – or at least should not be– be an off-the-shelf product. Customers should have access to executives and product designers at the vendor company so they can customize and even help evolve the product to better fit their needs.

Which is why we think hospitals may be better off purchasing from “best of breed” companies like DR Systems, rather than from large corporate vendors that have a medical division but also divide their attention among many other divisions.

While it’s mainly large health systems that are planning PACS replacements now, it probably won’t stay that way. The KLAS analysts believe the wave the big institutions are starting will eventually envelop smaller hospitals, too.

– END –

On December 13, 2011, four of the world’s leading clinical researchers in breast brachytherapy gathered to provide statements and discuss a controversial new study on APBI presented at the 2011 San Antonio Breast Cancer Symposium.

Featuring:
• Robert Kuske, MD, (Scottsdale, AZ) Co-Principal Investigator, NSABP B-39 study comparing five-day APBI to six-week whole breast irradiation
• Peter D. Beitsch, MD, FACS, (Dallas, TX) Co-Principal Investigator of the American Society of Breast Surgeons’ MammoSite Registry
• Jayant Vaidya, MD, (London, U.K.), pioneer of targeted intraoperative radiotherapy (IORT)
• Rakesh Patel, MD, (Pleasanton, CA), Chairman, American Brachytherapy Society

Stream audio of teleconference

Background:
The study was based on Medicare billing claims for more than 130,000 patients over the age of 66 who were diagnosed with early stage breast cancer between 2000 and 2007 and received a lumpectomy and radiation.

Many members of the medical community have spoken out against the study since it was presented. In particular, many physicians object to mastectomy being considered a validated surrogate for local failure, contending that there are many indications for mastectomy unrelated to APBI, such as a new primary cancer or elsewhere failure, and that claims data do not provide sufficient clinical information to draw such conclusions. In addition, the study claimed brachytherapy was associated with higher rates of infection and increased toxicity which is contrary to results of several published clinical trials on brachytherapy.

Read statements of concern from the major medical societies involved in the research and use of APBI – American Society of Breast Surgeons, American Brachytherapy Society (PDF) and American Society of Radiation Oncology.

Below are statements by three of these internationally know experts, prepared for a Dec. 13, 2011 teleconference they organized to challenge the study findings.

“Shortcomings of the New Study on Breast Cancer

Brachytherapy (APBI): What Women Need to Know Now”

  Robert Kuske, MD, FAACE:

 – Co-Principal Investigator, NSABP B-39 study comparing five-day APBI to six-week whole breast irradiation.

Partial breast irradiation (PBI) was begun in New Orleans in 1991 by myself and colleagues at the Ochsner Clinic, and has been one of the most studied treatments for breast cancer over the past 20 years.  Numerous publications have shown PBI to be safe and effective for select early stage breast cancer patients. As a result of promising phase 2 clinical trials and two favorable randomized prospective clinical trials (scientifically the “Gold Standard”), there has been growing interest in using PBI. Accelerated PBI (APBI) treats only the part of the breast affected by cancer and the treatment time is decreased from several weeks to four or five days. For decades, whole-breast irradiation (WBI), where radiation is delivered every day for five to eight weeks, has been the standard treatment for patients with early breast cancer treated with breast conserving surgery.

APBI has several benefits, including a decreased overall treatment time and a decrease in the radiation delivered to healthy tissue and adjacent organs.  To document its long-term safety and effectiveness compared to WBI, we await the results of the other 7 randomized trials comparing APBI with WBI.

I am concerned about the potential misinterpretation of data presented last week at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium regarding breast cancer patients who received brachytherapy, or accelerated partial breast irradiation (APBI). These data have serious limitations, and should not influence current treatment recommendations for women with early stage breast cancer fitting current eligibility criteria for PBI.

This study, based on Medicare claims data, demonstrated a small 1.8% increase in the rate of mastectomies in patients treated with APBI compared with those treated with conventional whole breast external beam irradiation. Note that the rate of documented recurrences of breast cancer after treatment is not reported.  In either case the rate of mastectomy is still very low (2.2 to 4%), and should be contrasted with the 35 to 40% recurrence rate after lumpectomy without any radiotherapy.

The data presented in San Antonio was drawn from records of patients varying risk factors and stage treated between 2000 and 2007. Doctors choose treatments for their patients based on cancer extent, grade, surgical margins, and other factors such as obesity, diabetes, and age.  This study failed to take these important tumor and patient issues into account, and is therefore biased. This study is a good example of why it is important to be selective in choosing which patients receive the accelerated treatment.

The PBI treatment given in this study is an antiquated balloon catheter with a single channel. Since that time, technology has dramatically improved including the use of newer multichannel applicators with tighter dose constraints. The side effects and toxicity seen with these modern technological advances are far better than the results presented in this study.

This study should encourage enrollment in clinical trials, especially NSABP B-39/RTOG 0413, a National Cancer Institute-sponsored, randomized prospective phase 3 trial. In the meantime, doctors and patients should not limit their options, and should continue to consider a 5-day alternative to conventional 6-7 weeks of whole breast irradiation to conserve the breast.

Peter Beitsch, MD, FACS:

– Co-Principal Investigator of the American Society of Breast Surgeons’ MammoSite Registry.

The study presented by at the San Antonio Breast Cancer Symposium has garnered a tremendous amount of print and Internet media attention. After reading the abstract (paper not in press yet), seeing the talk live in San Antonio, and discussing the study with many colleagues in breast surgery and radiation oncology, I want to try to clarify the data on APBI, and discuss the “information” in the abstract and the hyperbole in the lay press that is distressing our patients.

First and unequivocally, accelerated partial breast irradiation is a safe and effective form of treating the breast after appropriately performed lumpectomy in patients over age 45-50 with early-stage invasive (typically <3cm primaries and lymph node negative) and non-invasive breast cancer.  Numerous retrospective studies and two prospective randomized studies (the gold standard) have shown no difference in survival, local-regional cancer recurrence rates and complications between APBI and whole breast irradiation (WBI).  The American Society of Breast Surgeons’ MammoSite Registry has published more than 16 papers showing the safety and efficacy (comparable to WBI) of MammoSite APBI.

The San Antonio abstract and presentation were drawn from the Medicare claims-SEER database, which is a large database with cancer-patient data linked to Medicare claims data.  The database is managed by the National Cancer Institute and sold to institutions to do research.  The linked database has information about cancer type and treatments, but it has no specific data on margin status, prognostic factors such as estrogen receptor/progesterone receptor (ER/PR) and HER2/Neu receptor — or even local, regional or distant recurrence.

The study stated that “subsequent mastectomy” is a “validated surrogate for local failure,” but I am unaware of any literature that states this.  The “two-fold increased risk for subsequent mastectomy” is misleading and inaccurate. (It s 4.0% for APBI vs. 2.2% for WBI in their study).  Both of these rates are quite small, and it is questionable whether there is any clinical significance between the two.  Not emphasized but equally important are the overall survival rates for APBI vs. WBI, which were equivalent.

The study also stated that infections were higher for APBI (not surprising since it involves the insertion of one or more catheters in the breast), but there is no statement regarding severity (were the APBI patients just placed on prophylactic antibiotics and is that how an infection was defined?).  Fat necrosis and breast pain were also significantly higher in the APBI group, although there is absolutely no uniform definition of what fat necrosis is nor a statement about the severity of the fat necrosis or breast pain.

Lastly, the researchers state there was a 9.6% hospitalization rate for APBI patients vs. 5.7% for WBI patients.  This is puzzling since no diagnosis was given for hospitalization nor was there information on the time period over which patients were hospitalized. Was hospitalization APBI-related (doubtful) or related to first chemotherapy cycle (perhaps) or other unrelated health issues? (It’s worth noting that APBI is often used in older, sicker patients who may not be candidates for six to seven weeks of WBI).

In summary, this retrospective study of an inherently inaccurate database (no data on tumor characteristics and margin status — both known to be significant determiners of local recurrence), with questionable outcomes (admission rate) and non-validated “surrogate endpoints” (subsequent mastectomy=local recurrence) should be looked at with appropriate skepticism in the face of 20 years of retrospective studies and two prospective randomized trials to the contrary.

Jayant Vaidya, MD:

– Pioneer of targeted intraoperative radiotherapy (IORT).

We have performed a prospective randomized phase III trial, which is considered the highest level of scientific evidence.

We have shown with the TARGIT approach (risk-adapted partial breast radiotherapy with a single dose of radiotherapy during breast conserving surgery) that the local recurrence rate is very low (about 1% after 4 years). This rate is non-inferior to the standard approach, which was used in half of the more than 2000 patients.

This supports the concept of PBI in selected (e.g., older) patients with small tumors.

Also important was that the toxicity was not higher with the new approach. The rates of clinically relevant toxicity were about 3% in both treatment arms.  Toxicity is highly dependent on how radiation is delivered, i.e. treatment device, dose, dose rate, fractionation and target volume concept.

- End -

What Women Need to Know Now

Tuesday, Dec. 13, 2011

Noon EST

Call-in number:  1-480-629-9712

Please join us via teleconference to hear statements and discussion by four of the world’s leading clinical researchers in breast brachytherapy (accelerated partial breast irradiation, or APBI).

These experts will highlight their concerns about a controversial — and potentially misleading — new study on APBI presented at last week’s San Antonio Breast Cancer Symposium. They will also provide perspective on what women need to know now about breast cancer radiation therapy.

The teleconference will feature:

Robert Kuske, MD, (Phoenix) Co-Principal Investigator, NSABP B-39 study comparing five-day APBI to six-week whole breast irradiation

Peter D. Beitsch, MD, (Dallas) Co-Principal Investigator of the American Society of Breast Surgeons’ MammoSite Registry

Jayant Viadya, MD, (London, U.K.), pioneer of targeted intraoperative radiotherapy (IORT)

Rakesh Patel, MD, (Pleasanton, Ca.), Chairman, American Brachytherapy Society

This event is open to the first 50 participants, including media and other interested parties.

(Note to media: To ensure your place on the call, please contact Liz Dowling, tel. 415-388-2794; Liz@dowlingdennis.net.)

The study said women who got an older form of breast brachytherapy appear to have slightly higher rates of complications and subsequent mastectomy. Presented at this week’s San Antonio Breast Cancer Symposium, it was a “look-back” at Medicare records.

The MDA conclusions have prompted unusually strenuous objections from physicians who support and perform breast brachytherapy.

Breast brachytherapy, a form of accelerated partial breast irradiation (APBI), is increasingly popular because of its clinical efficacy for appropriate patients, and because it takes just 5 days.

By comparison, the standard course of external-beam, whole-breast irradiation (WBI) takes six or seven weeks. Many early-stage breast cancer patients increasingly express a preference for the far more convenient approach of APBI.

Follow-up radiation is recommended for women who have a lumpectomy as part of breast-conservation therapy. APBI now accounts for an estimated 13% of patients undergoing treatment in 2007, according to MDA’s Dr. Benjamin D. Smith, lead author of the study.

But are the study’s conclusions valid? And what are doctors saying to their patients about breast cancer treatment – especially given that the study data covers a period before more sophisticated APBI became available? (After all, even MD Anderson isn’t changing the way it offers APBI.)

“Criticism of the study surfaced almost immediately,” noted the respected radiology website AuntMinnie.com. “One critique was that the study is based on an analysis of Medicare billing codes rather than actual clinical outcomes.” Medicare claims data is often not a reliable measure of clinical effectiveness.

Also weighing in was the American Society of Breast Surgeons, which represents physicians who place the catheters that deliver breast brachytherapy.

ASBrS maintains a registry of 1440 patients treated by APBI with the balloon catheter device through 2004. It statement said numerous published studies have shown:

– A 5-year local cancer-recurrence rate of <5%, comparable to that of WBI;

– A low rate of other complications with APBI; and

– Good or excellent cosmetic results in approximately 90% of patients.

ASBrS noted that several randomized and nonrandomized studies using another technique of APBI — multiple interstitial catheters — have also seen rates of local cancer recurrence comparable to WBI.

For the record, Dowling & Dennis represents a company that makes one of those multiple interstitial catheters. It’s called SAVI – and it was developed to address the shortcomings of earlier brachytherapy technology, the one examined in the MDA study.

For more information on the experiences of women who’ve had SAVI treatment, see SAVI Sisters. Study data on SAVI is available here. In particular see the peer-reviewed, published results in the respected Red Journal (abstract available here.)

Other concerns about the MD Anderson study include:

– “Patients in this study received antiquated technology,” according to Robert Kuske, M.D., the principal investigator in a landmark trial comparing breast brachytherapy to traditional WBI. “Single-lumen balloons are being replaced with newer multichannel devices that allow much greater control of the radiation dose received by skin or ribs.”

– Said Dr. Frank Vicini, “All this study tells us is that when billing codes are analyzed, there appear to be differences in outcomes based upon billing-code surrogates for clinical outcomes. You can’t turn something nonclinical into clinical.”

Dr. Vicini is a Michigan radiation oncologist who publishes outcomes data comparing 199 APBI patients to 199 patients getting conventional treatment.

“Although the authors acknowledge the flaws in their study, these are not trivial,” he told AuntMinnie. “In my opinion, they are huge.”

So how should women and their families regard the controversial new study?

In urging breast cancer patients to participate in clinical studies when possible, the American Society of Breast Surgeons had this to say:

“The evidence in the MD Anderson study should be considered in pre-surgical counseling — but is not strong enough to preclude the use of APBI in properly selected patients.”

Which is the conclusion Gregory Schears, M.D. of Rochester, Minn. reached about his study of 12 diverse hospitals that trialed SwabCap®, a disinfection cap that is used to passively disinfect the top and threads of needleless IV connectors. Excelsior Medical, SwabCap’s maker, is a Dowling & Dennis client.

Speaking at the annual meeting of the Association for Vascular Access (AVA) – and in a follow-up clinical webinar Dr. Schears said that a disinfection cap should be considered as part of best practice protocols for eliminating central line-associated bloodstream infections (CLABSIs), which kill some 30,000 U.S. patients a year according to the CDC.

You can see Dr. Schears talking about the study here: disinfection cap video. There’s also a free webinar by Dr. Schears that provides more detail on his research, available under “Videos,” here.

How did Dr. Schears reach his conclusions?

Traditionally, nurses disinfect a needleless IV connector manually before accessing the catheter line to draw blood or administer medications or nutrition. The usual method involves scrubbing the connector with an alcohol wipe for 15 seconds, then waiting another 30 seconds for the alcohol to dry before entering the line.

Because the method has several steps, takes at least 45 seconds to do correctly, and often must be done many times a day, busy nurses often cut short the time or skip it entirely. Compliance with 45-second “scrub the hub” protocol is also almost impossible to monitor: What hospital can afford to have someone trail every nurse as she goes about her rounds?

The potential for slip-ups with this method is widely believed to be an obstacle to reaching zero CLABSIs.

The SwabCap disinfection cap, which dispenses alcohol when it is pushed and twisted onto the connectors’ threads, addresses the problems with manual disinfection. It goes on in a few seconds. It twists on just one way, like a lid on a jar, which eliminates variance. Its bright orange color handles the compliance issue, because when it is observed in place, compliance is verified.

It also does two things manual disinfection cannot. Because it creates a seal at the base of the threads, the connector top and threads are continually bathed in alcohol between line accesses. Also, prolonged contact with alcohol is proven to improve disinfection. Moreover, when the cap is in place, it is protecting against touch and airborne contamination.

The hospitals that trialed the disinfection cap in Dr. Schears’ study wanted to test whether it could produce lower CLABSI rates than with manual disinfection alone. The cap’s effectiveness was measured by comparing CLABSI data from the eight-month span prior to the cap’s implementation to the eight months following implementation. This retrospective overview encompassed some 92,000 catheter days – a large number for this kind of study.

The cap made a remarkable difference. The average CLABSI rate reduction at the twelve institutions was 61.6%, which is statistically significant (p<0.0020). The hospitals in the study covered the gamut, from medical to surgical to intensive care in both community hospitals and tertiary care facilities.

For years, a nationwide public-private effort has focused on diminishing CLABSIs, but progress has been spotty. The Schears study suggests that a far greater impact might be achieved if more hospitals adopted disinfection caps. Everything we’ve seen about this device – and the study is just the latest in a constant flow of strong results – points in the same direction.

You can see Dr. Schears talking about the study here: disinfection cap video.

-      END –