OncologyLive® is the flagship publication of OncLive®. Each issue delivers expert insights and clinical oncology news and updates, which impact the day-to-day clinical practice of oncology professionals who work tirelessly to help improve patient outcomes.

Two key intimately related factors that influence favorable outcomes when administering radiation therapy are delivery of a therapeutic dose to malignant tissue while minimizing doses to normal tissue and delivery of a cytotoxic dose commensurate with dose-response data. Recent technological advances in radiation therapy have been designed to help achieve both of these goals. Some newer modalities that facilitate isolation of the tumor to allow delivery of a high dose of radiation to the target tissue include 3D conformal radiotherapy (3DCRT), intensity-modulated radiation therapy (IMRT), and image-guided radiation therapy (IGRT). 

 information on the dose delivered is essential to successful treatment but presents challenges. These may be addressed by applying advanced sensor and engineering technology to an implantable device. Designing such devices can prove difficult because of the need for power generation and efficient telemetry. Sicel Technologies (Morrisville, NC) has been involved in the development and commercialization of an implantable device considered to be platform technology. This device, called the Dose Verification System (DVS), is currently the only commercially available method for verifying that the planned dose is delivered to its target. 

DVS is based on MOSFET (Metal-Oxide-Semiconductor Field Effect Transistor) technology, which has been used in radiation therapy dosimeters for several years. DVS employs wireless technology, and the dosimeter is permanently implanted in the target site, allowing verification of the actual dose delivered to the target. The device is interrogated after each fraction of radiation is administered, and the measured dose is compared with the planned dose to ensure the prescribed treatment plan is being received. The dosimeter is intended for use with standard external beam radiation treatment energies (photons of 6-18 MV), and, until recently, for a dose range between 150 and 250cGy per fraction; however, the dosimeter has now also been cleared for use with the hypofractionated radiation schemes of 340 to 400cGy twice daily for 10 fractions and 600 to 900cGy daily for five fractions. 

 the FDA cleared DVS for use in patients receiving radiation therapy for prostate and breast cancer. This study was conducted at four institutions, including Rex Cancer Center, Duke University Medical Center, Wake Forest University Baptist Medical Center, and the Texas Cancer Clinic. The objective was to evaluate the safety (migration and frequency of adverse events) of the device after implantation and its ability to measure the daily delivered dose at the implantation site. Generally, two dosimeters were implanted in each patient, one at the tumor site and one in nearby normal tissue, allowing the difference between measured and planned radiation dose to be observed. The study showed a difference of 7% or greater between planned and delivered cumulative dose in 20% of patients receiving whole breast or large field prostate radiation and in 42% of patients receiving IMRT for prostate cancer. Importantly, all 18 patients treated with IMRT boost also had IGRT with B-mode acquisition and targeting, gold seed markers with MV portal imaging, and on-board imaging (OBI). 

Achieving a favorable therapeutic ratio and delivering the planned dose are inexplicably linked. The latter requires localizing the target and verifying the dose delivered. The implantable dosimeter can serve the dual role of acting as a fiducial marker while verifying that the planned dose has been received.

 This dual function of the dosimeter becomes even more appropriate during delivery of hypofractionated radiation schemes, which use fewer fractions and a higher dose per fraction, as one aberrant fraction can result in a significant under dose to the tumor or overdose to normal tissue, leading to an unfavorable therapeutic outcome. By imaging and verifying the location of the dosimeter prior to each fraction of radiation being administered, DVS allows verification of the dose delivered to the patient as well as assessment of the dosimetric impact secondary to patient set up error or organ or patient movement. 

Charles W. Scarantino, MD, PhD, is a radiation oncologist at the UNC Rex Department of Radiation Oncology, Raleigh, NC, and co-founder of Sicel Technologies, Inc.

1. Scarantino CW, Prestidge BR, Anscher MS, et al. The observed variance between predicted and measured radiation dose in breast and prostate patients utilizing an in vivo dosimeter. 

2. Kry SF, Price M, Wang Z, Mourtada F, Salehpour M. Investigation into the use of a MOSFET dosimeter as an implantable fiducial marker. 

Articles

A new way to ensure your patients receive the proper radiation dose where they need it. 

Wireless Dosimetry

 conducted by the Institute for Health Policy (IHP) between late 2007 and early 2008 found that only 4% of physicians are using a fully functional EHR, with an additional 13% using only portions of a basic EHR. Although EHRs have been available for the past 10 years, and recent incentives have been provided to incorporate EHRs into practices nationwide through HITECH (Health Information Technology for Economic and Clinical Health Act), the adoption rate has stalled. Why is this? There appear to be two major obstacles: (1) the lack of electronic patient information embedded into the EHR when a practice goes live; and (2) the amount of time it takes to enter information compared with dictation or handwriting. Let’s examine these issues in greater detail and evaluate which steps can be taken to minimize or remedy them.

When evaluating data entry methods, we need to consider electronic data transfer from other sources. Let’s start with very basic information, such as a patient’s demographics and insurance information, which are the easiest data to enter. Because most practices already have a practice management system (PMS), physicians should require their EHR vendor to transfer all patient demographics and insurance information over to the EHR. Additionally, since the PMS application maintains visit dates and CPT and ICD-9 codes, physicians should require their EHR vendor to convert visit-level data into identifiable, discreet data showing patient visit dates tied to the appropriate diagnosis codes and any procedure codes not related to the office visit level. Using this methodology, a patient’s clinical record could be pre-populated with dates of service, problem lists, and medical history. 

Another key set of patient data are laboratory values. Because laboratory organizations in most regions are required to maintain patient clinical laboratory results for 2 years, physicians should require their EHR vendor to download specific patient clinical laboratory results from local and nationwide labs. If these data are downloaded following LOINC matching criteria, 27% of the necessary clinical data could be available electronically on the first date of going live, 

 the average practice more than 156 hours of data entry time per physician. 

This same methodology would work for “active and prior medication history.” Using the 

 network, EHR vendors can obtain a patient’s medication history, assuming the medication was paid for by the patient’s local health plan. Given the number of prescriptions maintained in the SureScripts network, it is likely that more than 70% of prior medications could be electronically entered into a practice’s EHR database before going live, which could save the average practice more than 141 hours of 

When a patient checks in at the front desk, the registration clerk usually asks the patient to fill out numerous forms that cover family, social, and medical history. Instead of asking every patient to fill out the forms when they are in the waiting room, practices could ask patients to fill out the same information via the practice’s Website or a kiosk located within the practice. Enabling a patient to electronically enter this information eliminates the costs normally associated with entering these data in practice. By using an electronic program like Instant 

, which interfaces with more than 40 EHR products, the practice can direct the patient to a site where discreet data can be captured and seamlessly imported into the practice’s EHR without anyone in the practice touching a keyboard. Each practice could customize their patient clinical questionnaires based on clinical protocols and physician-specific guidelines. Once the patient has filled out the practice’s questionnaires, a nurse or medical assistant can capture information on the chief complaint, allergies, medical conditions, vital signs, active medications, recent medical and social changes in the patient’s life, and other key information. 

A survey conducted by the AC Group in May 2008 that included 137 practices found an 83% higher EHR implementation success rate when the practice assigned a nurse or medical assistant to entering Review of Systems (ROS) and History of Present Illness (HPI) data for patients into the EHR. These findings indicate that once the clinical data entry template has been approved by the physician, entry of ROS and HPI data could be assigned to a nurse or medical assistant, who would be trained to follow the physician’s clinical protocols and guidelines. This single 

 in data entry methodology could save physicians more than 100 hours of data entry time per year. 

Of course, one of the best methods for discreet data collection is use of the Electronic Health Exchange (EHX). If discreet patient data have been collected by one provider, why should another provider need to re-enter these data into their EHR? We must move toward an integrated-community EHR (ICE) in which data can be collected once and seamlessly transferred to all providers who have the right to access the patient’s clinical information. Can EHR vendors accomplish this? The answer is a resounding “yes.” Following the government’s continuity of care document (CCD) data exchange standard, vendors can provide discreet data sharing between products and between practices, saving the average practice more than 200 hours of data entry work annually per 

. While all of these options will save time and money, the best method may be to combine an EHR with a new functionality that the AC Group has coined DRT (Discreet Recordable Transcription). 

The concept of a DRT-enabled EHR is simple. Physicians would be allowed to continue to dictate their findings and clinical assessments in their own words, but the transcribed output would be entered directly into the EHR as discreet recordable data. Using this methodology, physicians would not have to change the way they practice medicine or the manner in which they interact with patients. Instead of reviewing a paper chart, the physician reviews electronic clinical data that have been created via the aforementioned data entry methods (eg, data conversions, data interfaces, data entered by the patient or nurse, and ICE) before entering the room with the patient and then follow their usual workflow. The physician talks with the patient, performs the required physical examination, and then discusses their clinical interpretation and treatment plan as per their usual protocol. After the physician dictates their findings, they plant it directly into the EHR as an electronic wave file, which would be transmitted to a local or remote transcriptionist for electronic transcription. Since 63% of the typical transcription is already gathered electronically via the various data collection methodologies, the 

 for the creation of the final note is cut by more than 50%—an average of $6,000 annually per physician who has elected dictation over handwritten notes. More importantly, the transcription comes back into the EHR as discreet clinical findings, thereby improving clinical documentation, coding, and outcomes. A DRT-enabled EHR allows physicians who have elected to dictate in the past to continue this practice while cutting their transcription costs in half and generating a clinical note via the EHR. 

Two companies that are pioneering DRT-enabled EHRs are 

. Both of these companies have embraced the concept of extracting discreet clinical data from dictations. Using this novel method of data entry, physicians can use an EHR without having to perform any data entry. Although the concept of a DRT-enabled EHR is quite new, numerous physician focus groups have shown that a high percentage of physicians (87%) are extremely interested in the 

 concept; thus, it may be an answer to boosting adoption rates. Regardless, if the EHR marketplace is not revolutionized by 2012, we might still be looking at EHR adoption rates of less than 20% across the nation. 

Mark R. Anderson is the CEO and founder of AC Group, a market research and consultative company specializing in the Healthcare IT marketplace.  

• The record must be totally collaborative to allow anyone in the office to open and chart without regard to others having the chart open. 

• There must be security (an audit trail). 

• It must be very customizable for the practice. No EMR company in the world has all the medical expertise to have the latest and greatest 

templates for every specialty. Customizing must be simple and intuitive, but a template that is customized now cannot in any way harm the documentation done previously with that template. Just think of the new procedures, treatments, lab tests, medications and more that arrive daily. 

• It must be capable of collecting that information, slicing and dicing it with great discrimination, and conveying that information to other health systems software. 

• It must be capable of running off a client-server or be self-contained on a laptop. 

• It must be affordable; $25,000 or more per user is ridiculous. A government-funded EMR should be affordable out of cash flow—that is, no upfront purchase of the software, but rather, turnstile pricing. 

• It must be “graded” in its operational capacity. A new user can use obvious features, but as they mature in their EMR awareness, more features can be accessed. There is nothing like “need” to inspire to user to learn another step. That is, filling out a lab form is too slow and so if the user wishes to switch to a bidirectional lab interface, it should be available. If they don’t care, then at least give them the option of the software filling out the lab request form. 

• It must be easy to assist users who experience difficulty. This is one of the most important items by far. The ease of assisting a user will make or break many EMR installations. My preference is to have the ability of the user, with a single click, to show their desktop to technical support, whether that technical support is in their large facility or in another prearranged site. 

• It must be easy to update, including all the SQL schema changes, executable versioning, new clinical content, and so much more without the use of IT staff. If for every update, someone in the practice must go from computer to computer to update it, updates will never get dispersed. Already the bar is too high. 

• It must be relatively simple to install, not requiring a dedicated IT professional. 

• It must be capable of allowing the practice to be paperless. To design it short of that would ignore a significant percentage of the market. That means document management in the many forms of documents tif, jpg, doc, txt, pdf, Outlook e-mails, html, and even CCR. Additionally, it should be capable of outputting all those scripts, excuses, referrals, letters, and more. It should handle telephone triage (as it’s called in pediatrics) without generating a sticky note for the chart. It must have a forms feature. 

• It should have alerts, messaging, and reminders for those who wish to use them. 

• It must be fast. You want no one complaining of speed. 

A survey conducted by the Institute for Health Policy between late 2007 and early 2008 found that only 4% of physicians are using a fully functional EHR.

Overcoming the Hurdles to EHR Adoption

The initial capital outlay for transitioning to an electronic health record (EHR) is not small. In fact, cost is one of the main reasons practices have been slow to adopt EHRs. These systems can cost tens of thousands per physician to set up and maintain; thus, the smaller the practice, the more economically daunting the endeavor. While adoption rates at the smaller practices are understandably low, even larger ones aren’t adopting these systems as quickly as the government would like, resulting in some recent incentives being offered, along with some potential penalties if an EHR is not implemented by 2015.

At RadAmerica II, LLC, a wholly-owned, for profit subsidiary of MedStar Health, Inc, which is currently the largest provider of technical radiation oncology services in the Baltimore—Washington region, the decision to adopt an EHR was based on the long-term benefits, including improved care coordination, compliance with impending regulations, and to improve efficiencies in personnel and operating costs. After performing a comprehensive review of the available products, we chose Impac. Our primary driver in the selection process was the company’s breadth and depth of services in the field of radiation oncology; however, multiple vendors have products available for oncology, and, specifically, radiation oncology. Other practices have used different EHR products successfully, so deciding on an EHR really depends on a practice’s needs and means. When we rolled out the Impac EHR, this was done in several phases, and while it was largely successful, we did learn some key lessons along the way. 

Improved care coordination and increased patient safety

—First and foremost, successful implementation of an EHR improves communication and care coordination among providers. In the radiation therapy field, the EHR will aid in care coordination on two levels&mdash;improved communication with outside clinicians and all in-house care providers and time saved in identifying and reviewing patient records. Radiation therapy is one of the major treatment options for cancer patients. It can be used alone or in conjunction with surgery and/or chemotherapy; thus, in many cases, numerous other specialists are involved in caring for these patients. 

Radiation therapy itself also involves numerous care providers, including clinicians, nurses, radiation therapists, physicists, dosimetrists, and schedulers. Because so many people are involved, and a patient’s radiation treatment can range from one treatment up to 40, it is important for everyone to be on the same page to prevent errors. This requires constant communication among the many people involved. We’ve found that our EHR has increased communication between different providers, ensuring each patient’s unique needs are addressed and that the best treatment options are identified. Care within the radiation therapy department has also been improved because time is no longer wasted looking for paper charts, allowing more time to be spent with patients. 

—Federal and state regulations are moving to convert all patient records to an electronic format over the next several years. While we do not know exactly what this will ultimately entail or look like, our approach is to be proactive and not reactive with compliance, especially because these regulations will ultimately benefit the patients we serve. 

—Over the past five years, there have been major advancements in the technology and complexity of treatments delivered. EHRs take these advancements and regimens into account, affording various efficiencies, including: 

. Imaging, such as CT scanning and MRI, is essential to treatment planning and is needed before radiation therapy can be initiated. Our EHR allows us to import and fuse images, enabling us to create the best plans possible for our patients. These plans are then readily available in the EHR for future reference.

. Our EHR enables automated customizable patient treatment prescriptions. The physicians begin with a template and can modify the template to fit their needs.

. As part of the EHR, validation of a patient’s treatment plan occurs in a separate component of the electronic system; thus, only after the dose is validated and actually delivered, does it become recorded in the patient’s medical record.

. Positioning technology is built into our EHR to assist with patient positioning during treatment. We can also perform trend analyses across multiple patients and modes of technology.

Clearly, implementing an EHR is an investment in the future; however, several benefits can be quantified at the outset, some of which have monetary value. What follows are some of the immediate benefits: 

(1) Reduced costs in purchase of analog films, as these images are now being digitally obtained, and in the film jackets that used to house the analog films. 

(2) Using the “Record and Verify” system within the EHR ensures all aspects of a patient’s treatment are verified before treatment is implemented, reducing the possibility of errors. 

(3) Implementation of advanced technologies is enabled, such as Intensity Modulated Radiation Therapy (IMRT), Image Guided Radiation Therapy (IGRT), and Stereotactic Radiosurgery (SRS). RadAmerica II implemented IGRT and SRS at one site in 2007 and at another in 2009. 

Implementation process for a multi-site practice 

We required many functions at our practices, and these are now a part of our EHR. These functions include scheduling (patient and provider), transcription, treatment planning, order entry, charge capture, and treatment delivery. When implementing the EHR, we decided to proceed in a stepwise fashion, both at the function and site level. 

During phase I of the rollout, we first examined office and practice management functions. We started by transitioning patients’ schedules and then addressing transcription and document handling related to dictated notes. The final part of the rollout phase consisted of transitioning charge capture paper copy to electronic. Once all of these functions were successfully implemented at our pilot site, we then moved them to the remaining sites. Thereafter, we transitioned from using analog film to using the electronic portal imaging device (EPID) that is integrated with our linear accelerators, and our radiation therapists and physicians started reviewing patient treatment imaging electronically. This migration to electronic portal imaging was also rolled out one center at a time. At this point, we evaluated next steps and made two important decisions. 

First, we decided that we wanted a fully functional EHR at our practices. Despite some glitches and lessons learned along the way, our pilot was successful at the centers we implemented; thus, our goal was to become completely paperless over the next five years. Second, after talking to all involved parties following implementation, we amended some of our initial decisions regarding the EHR. We realized that all of our disciplines needed to be involved in making process decisions related to our EHR components, and we formed a company EHR steering committee to facilitate this. 

Two project managers were selected to co-chair the EHR steering committee: the technical director and the manager of information systems. The rest of the committee was comprised of the clinical department managers, administration, and quality management. Each department was required to conduct a workflow  analysis. This allowed us to evaluate all positions in the organization and how each individual would use the various functionalities in the EHR software. Each department was also responsible for evaluating the paper chart to see where documents placed in the paper chart would be located in the EHR software and to develop policies and procedures for the EHR. 

One site was selected to pilot the full conversion from paper records to the EHR. After three months of testing, members of the EHR steering committee met with the staff at the site selected for the pilot to get their input on the value of the EHR and whether other sites should move forward with the conversion. The entire staff indicated that transitioning from a paper chart to an EHR presents an opportunity in which the positives outweigh the negatives, and they recommended moving forward. 

After the first office was fully converted, an implementation schedule with timelines was established for the other practices. One month before an office went live, the project managers and members of administration would meet with the entire office staff to give a presentation on the workflow and implementation schedule. With staff input, a start date was selected at each site, ensuring that all new patients moving forward would have an EHR. The technical director and IT staff were on site for a full week when an office started transitioning. 

There are countless things we did right, including much deliberation and proactive planning; however, there is always room for improvement, and we learned some important lessons along the way. Some of these are as follows: 

(1) At our pilot site, we tested each department separately. Feedback from the staff revealed that they would have preferred if all departments tested the EHR at the same time. This would have tested the interactivity of the system, minimizing the tweaking that was required once we were in a live environment.

(2) It is important to include all levels of staff , not just clinical managers, because this provides different perspectives from individuals who work with the system daily and can provide suggestions that could be incorporated to make for a better end product. It also obtains buy-in from all users, which is critical in moving users toward adopting the system rather than obstructing its implementation.

(3) Hardware should be considered. While we incorporated hardware in our planning eff orts, our predictions fell short in some cases. In the future, we will solicit more feedback in the planning stages on the extent and type of hardware needed, including desktops, monitors, scanners, and other equipment used with the EHR.

(4) It is best to install hardware in advance of implementation or before going live. This allows the staff to become proficient in the new hardware, preventing them from having to learn new hardware, software, and processes at the same time, which can be daunting.

(5) Computer literacy of the staff should not be overlooked. Performing an assessment up front, if time permits, is desirable. Then, if supplemental training is needed, it can be incorporated into the rollout schedule.

(6) It is more difficult to pull records out of the EHR to send to other physicians, and it is not possible to make the EHR look like the paper chart. Although staff may feel that it would be easier for them to use paper over the electronic format in such instances, this makes the transition harder in the long run. We find that analyzing software capabilities along with existing processes and amalgamating with best practices moving forward is the best approach.

(7) It is important to remember that working With an EHR will initially take longer than working with a paper chart; however, this investment is worth the return, as eventually time will be saved with the new system.

We will be taking several important steps in the near future. First and foremost, we will be upgrading to the new EHR platform. We will also start e-faxing reports to the referring physicians, thereby reducing mailing costs and improving office efficiency. Finally, we will be looking to interface with other hospital systems regarding lab results and document importing. 

Linda Rogers, RN, MBA, CPA, is Vice President, RadAmerica II, LLC, and Christopher J. Osik, A. A. R.T. (R)(T), is Technical Director, RadAmerica II, LLC.

The initial capital outlay for transitioning to an EHR is not small. In fact, cost is one of the main reasons practices have been slow to adopt EHRs.

Our Move to an EHR

Most people know that eating a diet rich in fruits, vegetables, low-fat dairy, and whole grains and restricting consumption of unhealthy fats and red meat can help prevent chronic illness, yet few people eat accordingly. Studies have also shown that diet and exercise help prevent breast cancer, yet obesity rates in women continue to rise. New information suggests women with early stage breast cancer can prolong their lives by following a prudent diet. Will they get the message?  

Kathy Allen, MA, RD, LD/N, CSO, is a registered dietician with board certification as a specialist in oncology nutrition. She is also manager of nutrition therapy at Moffitt Cancer Center in Tampa, FL. She noted that eating a diet high in fruits and vegetables and low in animal protein appears to reduce the risk of breast cancer. This is because a plant-based diet is naturally rich in phytochemicals, compounds believed to help ward off cancer. Ms. Allen said studies show that people who consume these cancer-fighting foods have a lower incidence of cancer, including breast malignancies. 

John P. Pierce, PhD, Sam M. Walton Professor for Cancer Prevention and director of Cancer Prevention and Control at University California San Diego (UCSD) School of Medicine and USCD Moores Cancer Center, believes advances in breast cancer diagnosis and treatment partially account for the growing role diet plays in cancer survival. Breast cancer has evolved from a fatal disease to a chronic one, Dr. Pierce explained, and patients often survive 20 years or more after a breast cancer diagnosis. Many patients with cancer are dying from causes unrelated to the disease, like diabetes or heart disease. As a result, the benefits of maintaining a healthy diet and exercising regularly are increasingly evident. 

The Women’s Healthy Eating and Living (WHEL) trial followed the eating habits of more than 3,000 survivors of early stage breast cancer to determine whether a healthy diet reduced their risk of recurrence. In 2007, researchers concluded that, overall, eating a diet consisting largely of fruits, vegetables, and fiber did not reduce the likelihood that their cancer would return. 

Researchers conducted a secondary analysis in 2008 that looked at a subgroup of women who did not experience hot flashes. Those who ate a prudent diet were 31% less likely to experience cancer recurrence. Investigators hypothesized that the diet reduced estrogen levels, thereby reducing cancer risk. 

Dr. Pierce, the principal investigator of the WHEL study said, “Women who have hot flashes are having them because their hormone levels are low.” Women with higher levels of estrogen do not experience hot flashes. Estrogen is associated with tumor development in some patients, which is the reason many breast cancer treatments involve inhibiting estrogen. In other words, where breast cancer risk and recurrence are concerned, having hot flashes may be a positive sign. 

In an earlier statement about the study’s findings, Dr. Pierce noted that some women are genetically resistant to endocrine therapy, and he said it was possible they were the ones who benefited most from eating a prudent diet. His research team is proceeding with studies to determine why and how the diet appears to lower recurrence risk in some women and not in others. 

Ms. Allen listed excess weight as another concern for women with cancer. “We have suspected for years that lifestyle was an important factor in the incidence of many types of cancer, but more recently, there have been studies that have borne that out,” Ms. Allen said. Recent data demonstrate that women who maintain a healthy body mass index are less likely to develop breast cancer, she added. 

Silvia Herszkopf, RD, CDN, an ambulatory oncology nutritionist at the Montefiore-Einstein Cancer Center, said many women with breast cancer that she counsels are overweight. In addition, many are postmenopausal. After menopause, a woman’s metabolism slows, making it difficult to shed extra pounds and easy to gain them. Ms. Herszkopf said diet is not enough, and exercise needs to be part of any weight loss program. “If you decrease your calorie intake, your metabolism slows down,” she explained. “But, by increasing your physical activity, you’re helping to increase your metabolism.” 

Exercise has other protective benefits for postmenopausal women with breast cancer. Bone loss is a frequent complication of many breast cancer treatments. A proper exercise routine that includes load-bearing or strength-training exercises can help women maintain bone mineral density, staving off osteoporosis. Women with cancer should speak with their physician before beginning an exercise program. Some exercises could be harmful to women whose bone mineral density is already compromised. 

Although the benefits of eating healthy have been touted for some time, Ms. Allen said some people seem to have a “disconnect” between knowing something and implementing it. While a handful of women who receive a cancer diagnosis adopt healthier lifestyles and improve their eating habits, Ms. Allen said others do not. One reason, she theorized, is that “women tend to be the caregivers, so they tend to neglect caring for themselves, in general.” 

In light of what has been learned about the relationship between diet and cancer over the past few years, Ms. Allen emphasized the need for oncologists to talk to their patients about the benefits of maintaining a healthy diet with fruits, vegetables, and fiber, and engaging in regular exercise. “I think when physicians endorse that and recommend it to patients, the patients are more likely to embrace it.” 

Dr. Pierce agreed. He said oncologists used to assume the breast cancer was going to kill their patients with this disease. “Now, we don’t know...They are going to live long enough that they’ve got to worry about other diseases. So, they’d better watch what they eat and start exercising,” 

Even though the studies have not yet proven that adopting a prudent diet reduces the risk of death from breast cancer, there is ample evidence that it helps stave off diabetes, heart disease, and other chronic illnesses and helps to prevent obesity. For women with cancer, these comorbid conditions can further erode their quality of life and complicate treatment. When treating obese women with breast cancer, a referral to the nutritionist may be another important step toward recovery. 

Ed Rabinowitz is a veteran healthcare writer and reporter. He welcomes comments at 

Studies have also shown that diet and exercise help prevent breast cancer, yet obesity rates in women continue to rise. New information suggests women with early stage breast cancer can prolong their lives by following a prudent diet. 

Getting Cancer Patients to Eat for Life

“Man is the center of the universe. We stand in the middle of infinity between outer and inner space, and there’s no limit to either.”

In 1959, physicist Richard Feynman gave a talk at Caltech titled “

,” wherein he first introduced the concept of creating devices at the molecular level by manipulating individual atoms and molecules. It wasn’t until years later that the term “nanotechnology” was coined to refer to this concept, yet its principles had invoked imaginations everywhere, including Hollywood, and, in 1966, the film 

 was released. In the movie, a submarine with a medical team onboard is shrunk to become microscopic and injected into a scientist with the intention of treating his life-threatening blood clot. Since its release over 40 years ago, countless references to this film have been made in literature, television, and cinema, and a remake is slated to be released in 2010, which will perhaps spark interest in nanotech among future generations. 

While the concept of shrinking humans is quite fantastic and unrealistic (at least for the foreseeable future), scientists have already developed tiny vessels that can hunt down diseased cells and deliver precise drug doses. These tiny vessels are called nanocapsules or nanoparticles, and Russell Mumper, PhD, UNC Center for Nanotechnology in Drug Delivery, UNC Lineberger Comprehensive Cancer Center, has used them to overcome chemoresistance in mouse models. Dr. Mumper and his team found that when doxorubicin or paclitaxel were delivered using lipid nanocapsules, the growth of multidrug-resistant ovarian cancer lesions stopped completely in the mouse models that they examined, whereas these drugs were found to be ineffective when administered through conventional means. His 

 is published in the May 1, 2009 issue of 

, and he took the time to answer some of our questions on his findings and share his thoughts on nanotechnology and its medical applications.  

Overcoming chemoresistance: A conversation with Dr. Mumper 

How do you think nanotechnology will impact medicine over the next decade—do you see this as the next frontier? 

Nanotechnology is not new. In fact, it has been around for decades and arguably for much longer; however, it has more recently captured the imagination and interest of scientists and lay people alike. As of 2007, there were about 200 companies focusing on the use of nanotechnology to address medical issues. There are already over 40 nanomedicine products on the market with sales exceeding $7 billion annually. The use of nanotechnology for drug delivery captures the largest percentage of this market, about 78% of sales. I believe it is one of two next frontiers, those being the really small (nanotechnology) and the really large (outer space). 

Our laboratory has been focused over the past decade on trying to put very potent cancer drugs in nanoparticles so that these small carriers can be injected into the body and potentially targeted to tumors. This endeavor has been challenging for many labs, including ours, since the task is multifaceted and there are many obstacles. We have discovered a very simple process to make oil-filled nanocapsules. Unlike nanoparticles that are solid throughout, these nanocapsules have a shell with a liquid oil on the inside. The engineering process to make the nanocapsules is rapid, cost-effective, and can be completed in a few minutes in one vessel. All of the materials used to make them are already in pharmaceutical products. The oil on the inside of the nanocapsules can dissolve the cancer drugs in high concentration, and the drugs remain stable in the vial or when injected into the bloodstream. Over time, the drug is released from the nanocapsules and the oil in the nanocapsules is actually metabolized by the body and used as nutrients. 

What were some of the key outcomes of your study? 

Many types of cancers develop mechanisms to become resistant to otherwise potent cancer drugs. The most well-known mechanism of resistance is where a protein on the surface of the cells or sometimes in the cells can quickly and extensively pump the drug out of the cell. Resistance is a significant problem and leads to recurrence. The only solution is to choose a different drug and hope that the new drug can provide benefit before the tumor becomes resistant to it. 

Our studies have shown that the nanocapsules can significantly enhance the intracellular drug concentrations in resistant cancer cells. We showed that an ingredient in the nanocapsules that is used to engineer them can inhibit the protein pump in several resistant cancer cells and reduce the energy level in the cell. The cumulative effect is that a much higher concentration of the cancer drug gets into the cancer cells, and is therefore able to kill these cells. This has now been shown in resistant ovarian and breast cancers and melanoma, and we are testing it on other types of cancer as well. 

Why do you think the nanocapsules were able to overcome chemotherapy resistance in your mouse model? 

We have shown that the nanocapsules carrying the cancer drug paclitaxel are able to completely prevent the growth of resistant ovarian tumors in mice carrying human ovarian tumors. The nanocapsules are injected into the bloodstream and are able to deliver drug to solid tumors. The commercially available form of paclitaxel, Taxol

, was completely ineffective in reducing tumor growth even at almost lethally high doses to the mice. Even more encouraging was that the mice that failed Taxol treatment had their tumors shrink when they were treated with the nanocapsules. 

What further investigations have your team planned? 

Tumors that do not respond to chemotherapy, or that develop resistance, very often metastasize and spread to other organs in the body. Metastatic cancer, and not the primary tumor, is frequently the cause of death. The ‘holy grail’ of nanotechnology-based drug delivery is to seek out and destroy tumor cells that have metastasized or broken away from the primary tumor; however, if these metastatic cells are now resistant, this may be difficult to do. We think our nanocapsules can be targeted to these metastatic tumor cells and may be able to overcome the resistance when they find these cells. 

Nonmedical nanotech may spawn medical advancements 

While there are numerous medicines on the market that already employ nanotechnology, as noted by Dr. Mumper, some of the advancements on the medical front may come from nanotechnologies that are not specifically focused on the medical industry. Gregory Rutledge, PhD, Lammot du Pont Professor, department of chemical engineering, MIT, Cambridge, has developed unique electrospun nanofibers that may eventually have medical applications. These nanofibers have a diameter roughly a thousand times smaller than that of a human hair, and while they may not appear to be any different (apart from their size) from regular fibers macroscopically, they can be developed to contain unique and highly useful properties. Dr. Rutledge and his team have developed several textiles that incorporate functional materials into the electrospun membranes. One such material, recently described in the journal Polymer, incorporated chlorhexidine, a chemical antiseptic that can kill both grampositive and gram-negative bacteria. This technology holds much promise for a wide range of applications, and one day protective clothing and drug delivery mechanisms may just be comprised of some very unique nanofibers. Dr. Rutledge discussed his work on electospinning and nanofibers with us, including his observations on how these may eventually be applied to medicine. 

Protection at the nanoscale: A conversation with Dr. Rutledge 

How did you come to work on electrospinning and nanofibers? 

I have a long-standing interest in high-performance fibers, dating back to my days as a graduate student. In the mid-90s, I attended a scientific presentation where the author claimed to make 30 nm diameter fibers from a hard-to-process, high-performance polymer. It turned out that those fibers could not be produced continuously, but I was fascinated by the unusual behavior of the electrospinning jet. As a polymer scientist, I knew these fibers had to have very different molecular organization and properties from the more conventional, micrometerdiameter fibers I was familiar with—we just didn’t know what those different properties would be. When we first launched into this area, it was curiosity-driven, “blue sky” research. 

“Electrospinning” is a popular term for an electrostatic jetting phenomenon that leads to the formation of solid, continuous fibers. It is closely related to the electrospray technology used in inkjet printers and in ionization methods for mass spectrometry, a technique that earned its developers the Nobel Prize in Chemistry in 2002. Electrospinning works by charging a viscoelastic liquid to a high potential, on the order of 10 to 40 kV. Under such conditions, the free surface of the fluid becomes unstable and emits one or more jets of charged fluid. If the jet is further introduced into an electric field, typically around 1 kV/cm, the charge on the jet accelerates it downfield, causing it to thin as it goes. When the jet become thin enough, it starts to whip back and forth in the electric field; it is this whipping motion that is largely responsible for reducing the diameter of the jet by another 1 to 2 orders of magnitude, to less than 1 micrometer. With such small diameters, these jets dry very rapidly, so that solid fibers can be collected. 

What are some of the most interesting nanofibers that you’ve spun? 

Beauty is in the eyes of the beholder. I am fascinated by many of the nanofibers we’ve made—each is beautiful in its own way. A particularly interesting recent example is a family of nanofibers we’ve made that look, on the inside, like several embedded, concentric cylinders, each about 25 nm thick; in cross-section, the fibers look a bit like a target used in archery. These fibers are made from block copolymers. Each cylindrical domain can be imbued with different properties, and we can vary the number and thickness of the cylindrical domains. This could be useful for a variety of applications, from wave guides to sensors and drug delivery. 

How do you think nanofibers may be used in the future by the medical industry? 

The two most popular applications currently under development are tissue engineering and drug delivery. The nanofibers formed by electrospinning are about the same size as, and have comparable mechanical properties to, the collagen fibrils that make up the extracellular matrix (ECM) of many tissues, so it seems natural to consider them for applications requiring a synthetic mimic of the ECM. In drug delivery, the combination of high surface area, short diffusive length, and ease of handling of the fibrous membrane give electrospun nanofibers a drug-release profile that is difficult to achieve by other methods. In our own work, we have used electrospun fiber membranes as synthetic replacements for membranes used in wound healing and the repair of severed tendons and nerves. 

When do you think nanotechnologies, such as nanofibers, will be commercialized and/or readily adopted? 

As it turns out, in the filtration industry nanofiber technologies have been used in commercial products for decades. However, these were largely practiced as trade secret, so the full potential of these technologies was hardly appreciated. This has been changing in the past several years. Numerous small start-ups have formed around the use of electrospun nanofibers for specific applications or commercialization of proprietary process technologies. Large multinational chemical and medical supply companies have also become involved. I think this trend toward commercialization will continue to grow for years to come. Not all applications are winners, but the unique features of these materials promise to support a broad range of applications beyond filtration. 

Recognizing the vast revenue-generating potential of nanotechnology, the 

United States National Nanotechnology Initiative

 was established in 2001 to coordinate federal nanotechnology research and development to foster the transfer of new technologies into products for commercial and consumer use. In 2007, the 

 for goods incorporating nanotechnology totaled $147 billion, and this number is estimated to grow to $3.1 trillion by 2015. Clearly, nanotechnology is here to stay, and its impact will become more pronounced as research continues and more products incorporating these technologies and materials are produced. The ultimate ramifications of this molecular manufacturing, however, are unclear, as the long-term impact of nanomaterials on human health and the environment is unknown. Even seemingly innocuous nanotechnologies may have a negative effect on health and the environment. One 

 found that silver nanoparticles added to socks and other athletic wear to kill odor-causing bacteria may be released into waste water during washing, resulting in these nanoparticles ending up in waste treatment plants, where they may destroy the very bacteria that are used to render the waste harmless. Furthermore, a 

 found that carbon nanofibers, which are commercially available, mimicked asbestos when injected into mice. This study raises concern that exposure to nanofibers could result in an increased risk of cancer, such as mesothelioma. 

, have arisen to raise awareness about the potential dangers of nanotechnology. These groups have advocated government regulation of these technologies, and on December 10, 2008, the US National Research Council released a report calling for more regulation of nanotechnology. 

Some proponents of nanotech indicate that such regulation would halt scientific research and the development of pharmacotherapies and other innovations that could greatly impact the quality of life for humankind. Although risk is clearly there, so is promise, and nanotech may just help patients with a life-threatening illness such as cancer beat the odds and continue on their fantastic voyage.

While the concept of shrinking humans is quite fantastic and unrealistic, scientists have already developed tiny vessels that can hunt down diseased cells and deliver precise drug doses.

Nanotech in 2009: A Fantastic Voyage

The recently enacted American Recovery & Reinvestment Act (ARRA), commonly referred to as the “stimulus plan,” includes more than $19 billion in incentives for physicians to adopt electronic health record (EHR) technology. This part of the ARRA legislation is known as the Health Information Technology for Economic and Clinical Health Act (HITECH). In essence, HITECH calls for physicians to earn up to $44,000 over five years if they use an EHR in such a way as to comply with yet-to-be-finalized criteria. So, if you are one of the 83% of doctors who have not yet implemented an EHR system, now may seem like the perfect time to do so. But not so fast… 

Now, I’m probably the last person you’d expect to be saying this, but as I investigated the actual details of this law, I came to a startling realization: none of the details have been worked out, and running out to get an expensive EHR system in hopes of recouping the cost through the incentive programs is nowhere near a sure thing.

Let’s start with what is known. Beginning in 2011, physicians can receive extra Medicare payments for the “meaningful use” of a certified EHR. These payments can total as much as $18,000 in the first year for practitioners who adopt in 2011 or 2012, with slightly lower amounts for those who do so in 2013 and 2014; incentives are gradually reduced and then end in 2016. For physicians with high volumes of Medicaid patients (30% or higher), the law provides subsidies through the Medicaid program as well. Doctors must choose whether to participate in the Medicaid or Medicare bonus program; they cannot receive bonus payments from both.

Thus, eligible professionals demonstrating meaningful use of a certified EHR starting in 2011 could collect $44,000 over five years. Waiting until 2013 would result in a maximum bonus of $27,000 over three years. HITECH also imposes financial penalties to spur adoption. Physicians who are not using EHRs meaningfully by 2015 will lose 1% of their Medicare fees, then 2% in 2016, and 3% in 2017. The bottom line is that 2011 is still 18 months away, so there is plenty of time to wait to make a decision about your EHR, even if you want to collect the maximum $44,000 benefit.

What qualifies as meaningful use of a certified EHR? 

The law states that only “eligible professionals” who “meaningfully use” a “certified” EHR will able to collect the stimulus money. Yet none of these terms have been authoritatively or legally defined. There is much analysis and information about this legislation from various sources floating around the Internet, but none of it has the official seal of government approval. Like most new laws, it will probably take years of regulation, test cases, and interpretations by lawyers and courts before we have definitive answers to many of our questions. We can, however, make some logical assumptions based on the goals of the government.

The biggest issue is America’s high level of healthcare expenditures (compared to the rest of the world). Thus, we can assume that meaningful EHR use will promote the functions that can reduce this cost, such as prescribing generics, sharing lab and radiology findings among physicians rather than reordering tests when the results aren’t readily available, and ensuring that standards of care for community health are followed.

Using e-prescribing, computerized ordering/reviewing of tests, and health information exchange networks all seem to be part of what would be defined as meaningful use; unfortunately, it seems unlikely that tort reform will make it into this discussion to any significant degree, and thus we will continue to practice defensive (and expensive) medicine, ordering questionable tests, procedures, and consults just to reduce our risk of lawsuits.

In terms of a “certified” EHR, it seems reasonable—and it is assumed by many observers&mdash;that CCHIT (Certification Commission for Health Information Technology) certification will suffice in lieu of a formal government certifying body. So, even though CCHIT charges tens of thousands of dollars to apply&mdash;and requires not only the “meaningful” features above, but also hundreds of other “bell and whistle” features that make EHRs less usable&mdash;it looks like that is the future of our EHR choices (Amazing Charts is currently going through the onerous process of getting CCHIT-certified, so watch for a future article describing this experience).

The most important question for physicians is how to get the promised money (before future budget cuts remove it). I reviewed the HITECH legislation and couldn’t find any real details on how the money was to be distributed. I went to the Healthcare Information and Management Systems Society (HIMSS) conference, where everyone was buzzing about the HITECH legislation. I had two basic questions, assuming I used a certified EHR in a meaningful way by 2011:

• Who is an “eligible professional?” An eligible professional appears to be a physician, but does a nurse practitioner or physician assistant count? What if this mid-level practitioner owns his or her own practice?

• How does a physician actually get the money? It appears that you are allowed up to 75% of Medicare payments per physician, but will the payments come in a lump sum, or over time, or piecemeal with each Medicare payment? 

Amazingly, nobody I spoke with—including a number of EHR vendors who were advertising the $44,000 stimulus funds to entice folks to purchase their overpriced systems&mdash;knew the answers. Eventually, I found a booth for the agency tasked with overseeing HITECH, the Office of the National Coordinator for Health Information Technology (ONCHIT). There, I spoke with two representatives (who requested not to be identified). One said they just didn’t know; the other said she “couldn’t answer.” When asked if she couldn’t because she didn’t know, or wouldn’t because she wasn’t allowed, she replied, “A little of both.”

Frankly, I have no idea what that means. It certainly sounds cryptic, but the fact that even an ONCHIT representative couldn’t (or wouldn’t) provide the answers to simple questions is astounding, especially given the way in which this money is being advertised by vendors and agencies with an interest in accelerating EHR adoption.

While it is disappointing that there is, as of yet, no clear interpretation of several fundamental parts of the HITECH legislation, it is unconscionable that vendors and other groups are hyping this money knowing that the details have yet to be defined. I suspect we’ll find, as we did with the promise of P4P, that the actual money delivered is far less than what was implied. A further risk is that the next administration or congress may choose to cut funding for this incentive program due to fiscal constraints. In the end, it is the underpaid and overworked primary care physicians who will be cajoled, enticed, and ultimately forced into spending tens of thousands of dollars for unproven technology.

I will continue to closely follow and report on how these critical issues play out over the coming months. Until then, slow down and try to ignore all the background noise from vendors and other groups with their various agendas, pushing you into an EHR solution before you’re ready.

Dr. Bertman is Physician Editor-in-Chief of 

. He is a Clinical Assistant Professor of Family Medicine at Brown University and president of AmazingCharts.com, a leading developer of EHR software. He is also the founder and president of AfraidToAsk.com, a consumer website focusing on personal medical topics. He is in private practice in Hope Valley, RI. 

The recently enacted American Recovery & Reinvestment Act, commonly referred to as the "stimulus plan," includes more than $19 billion in incentives for physicians to adopt EHR technology.

May 2009 | Oncology Live®

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Nanotech in 2009: A Fantastic Voyage

I will get $44,000 to Use an EHR? Where do I Sign Up?