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.

	Colorectal cancer is the third leading cause of cancer in both men and women in the United States. Despite improvements in screening that result in detecting this disease in earlier stages, the disease remains the second leading cause of cancer death in men and the third in women. Each year, more than 50,000 people will succumb to the disease.

	Patients with locally advanced or recurrent colorectal cancer are difficult to treat effectively with conventional methods. Accepted levels of traditional external beam radiation treatment (EBRT) are insuffi cient to control advanced disease, and higher doses of EBRT would damage surrounding healthy tissue. EBRT boost is often technically diffi cult to achieve, due to the risk of small bowel involvement. An alternative is intraoperative electron radiation therapy (IOERT), the application of electron-beam radiation directly to a tumor or tumor bed during surgery.  With IOERT, most of the tumor is removed through conventional surgical techniques. Radiation is then directly applied to the area immediately surrounding the tumor, while still exposed during surgery.

	For locally advanced rectal cancer, IOERT is particularly effective as a precision boost—a high dose of radiation therapy at the time of surgery&mdash;because, in the pelvis, surgery is confi ned to natural boundaries that often make it impossible to achieve a total resection. By using IOERT, radiation can be delivered to the area of highest risk, while healthy tissue&mdash;that might normally surround the target structure when delivering externalbeam boost or external-beam dose escalation&mdash;is displaced and/or protected during surgery, which signifi cantly enhances the therapeutic ratio. In the case of rectal cancer, the small bowel, bladder, and ureters can be excluded from the radiation field.

	IOERT is delivered at the time of surgery, when residual tumor cells from the surgery are most vulnerable, so that a tumorcidal dose can be delivered to the tumor bed before tumor cells have the opportunity to re-implant, proliferate, or migrate. Because IOERT replaces two to three weeks of conventional fractionated radiotherapy treatments, the number of EBRT fractions that must be delivered prior to the surgery can be safely reduced, thereby minimizing gastrointestinal complications that sometimes occur from higher EBRT doses. A precision IOERT boost, combined with a smaller number of precisely delivered EBRT fractions, achieves the goal of precision radiotherapy dose delivery with the added benefi t of reducing complications from the EBRT component of the treatment.

	Studies demonstrate that IOERT improves local control and survival rates in locally advanced cancer. A pooled analysis of 649 locally advanced rectal cancer patients showed a 5- and 10-year local control of almost 90% and a fi ve-year survival of 67%. Without IOERT, typical local control and survival at fi ve years is less than 60% and 40%, respectively. For recurrent rectal cancer, IOERT is one of the few treatments off ering any hope to patients who otherwise face a grim prognosis.  Mobile linear accelerators:

	The size of conventional linear accelerators and the shielding required make it prohibitively expensive to install them in most operating rooms. To combat this, mobile electron linear accelerators have been developed that allow IOERT to be delivered in almost any unmodifi ed hospital operating room. For example, the 

, a mobile linear accelerator manufactured by IntraOp Medical, weighs only one-eighth as much as a conventional linear accelerator and requires no supplemental shielding. The Mobetron can be installed in virtually any operating room, and because it is mobile and motorized for transport, it can conveniently be used in more than one operating room, providing fl exibility in the scheduling of the IOERT treatment.  Colon and rectal cancers are among the most common cancers in the United States. If not diagnosed at an early stage, these cancers can be diffi cult to treat with conventional methods. Treatment for colorectal cancer has improved over the last 10 years, resulting in more eff ective options for people with this type of cancer, including IOERT, which helps fi ght cancer at its source with a more precise radiation beam, shortens treatment cycles, and provides fewer side eff ects.  Dr. Goer is the chief scientist at 

Articles

Despite improvements in screening that result in detecting this colorectal cancer in earlier stages, the disease remains the second leading cause of cancer death in men and the third in women. 

Medical Devices: IOERT for Colorectal Cancer

The recent FDA accelerated approval for Avastin (bevacizumab), in combination with paclitaxel chemotherapy for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer, has sparked larger discussion about the approval of pharmaceuticals that may improve quality of life but do not necessarily extend life. Below are the thoughts of three 

Unfortunately, the discussion regarding the utility of bevacizumab has failed to differentiate between benefit defined by evidence-based (randomized phase III) clinical trial data and the actual cost of that therapy. While the highly statistically significant improvement in the time to clinical disease progression demonstrated in this trial will certainly not be of relevance to all patients in this setting, it will be to many—and perhaps most&mdash;individuals.

Of great importance in this discussion, cost is not defined by “scientific evidence,” but rather by the “marketplace.” As a society, we absolutely must deal with the issue of the staggering costs of oncology drugs. But in this discussion, we should not permit these legitimate concerns about cost to negate the documented benefits to quality of life as revealed in well-conducted, evidence-based clinical trials. It is absolutely acceptable to declare, “We can’t afford this drug at its current cost.” Conversely, it is inappropriate to state, “This drug did not impact a meaningful clinical outcome in women with breast cancer.”

Lately, disease-free survival, or progression-free survival (PFS), has sometimes worked and other times not worked when it comes to predicting survival. My feeling is that in today’s marketplace, in which drugs and medical oncology are so expensive, it’s very difficult to approve a lot of drugs. My personal preference is that metastatic disease survival should be the endpoint, rather than PFS. The pro to that is that you’ll get drugs that show survival differences. The con is that it’s going to take some drugs a long time to reach that endpoint.

PFS had, in a number of cases, predicted survival differences. Now that we’ve seen a number of drugs in which there were survival diff erences but no PFS, it creates a big question mark. It’s going to be more expensive to reach survival diff erences and thereby possibly drive the prices of those drugs up when they do get approved, but they will also eliminate a lot of drugs that might have been approved based on PFS that don’t reach survival diff erences. Another way to do it would be to approve drugs based on PFS but withdraw the approval if they don’t show survival diff erences. That way, patients can get earlier access to drugs that look like they are going to show a survival difference and also avoid those drugs being on the market long-term if they don’t. 

 missed its mark of PFS by 0.07; in two trials, it did show a survival diff erence, and the 

 advisory board advised that the FDA approve it. But then a month later, it was not approved. So, the FDA gave an approvable letter saying that “as soon as you show us a survival difference” in the 

 that they’re doing now, “we’ll approve you.” Many cancer patients were upset that they couldn’t get access to the drug. A lot of people could have benefi ted from it, but they didn’t because it wasn’t approved. Now, you take Avastin, and for one reason or another, that was approved based on PFS, but no survival diff erence was shown in breast cancer.

 that does not show a survival diff erence be approved? My feeling is that it’s too expensive, there are toxic eff ects from it, and I’m not sure it’s the right thing to do. I wouldn’t prescribe it to my patients with metastatic breast cancer. I think that the approval of Avastin sets a precedent. How can you tell one company for whom you approve a very expensive drug based on PFS and not survival diff erence “yes” and tell another company “no”?  I think we’re spending way too much on the last three months of life and that we’re going to have to ration healthcare.  So, if you have a 25- or 30-year-old woman who could use something like Avastin to improve PFS, we can consider that if we can stop having secondary and tertiary lung cancer patients, let’s say, who are 85 years old getting chemotherapy when we’ve shown that there’s very, very little chance of helping them.

But our health system isn’t set up to ration care yet. We’re going to have to cut back someplace in this economy and this environment, and nobody seems to be able to come up with the answers. I think symptomatic, supportive, and palliative care for comfort is the way to go. But most families in this country aren’t prepared to make the decision for such care, and we’re spending healthcare dollars on such patients and not allowing those dollars to go to younger patients who really need them. We have 47 million uninsured who can’t even aff ord healthcare. We have to begin to set standards and get palliative care to prevent people from getting drugs that won’t help them.

The standards for FDA approval of a drug are already fairly well defi ned and established. First of all, the drug should be safe, meaning it has a toxicity profile that’s within the range of what we’re willing to accept in medicine and oncology. And, of course, it has to have proven, measurable, clinical activity and benefit. I believe that is why Avastin was approved, even in the absence of improvement in survival. I personally believe that if a drug has demonstrable clinical activity, even if it doesn’t prolong overall survival, the benefi ts may nonetheless be valuable to many patients. I think it’s important that, as a profession, we look beyond the standard five-year overall survival marker as the primary determinant of whether a drug or treatment is meaningful and valuable to patients and their family members. 

Anyone who has gone through cancer—personally or with a loved one&mdash;understands this immediately; survival is not the only issue that matters. I believe that part of our job as oncologists is not only to add more years to our patients’ lives, but more life to their years. And based on the data that we presently have for Avastin, it appears that it may in fact do just that. I can assure you that, for many patients, it matters greatly to them to have CT scans that show no disease progression&mdash;even for a period of six months. For some, those six months may be the most important of their lives, and the relief of knowing that their disease is stable, even temporarily, can be immensely meaningful.

A large part of the controversy around Avastin, of course, is its high cost. It points a very sharp spotlight, frankly, on many of the complex, and at times even agonizing, issues that oncologists, patients, and family members face and struggle with every single day. Th e economic realities of medicine in this country often force heartbreaking choices and decisions regarding the distribution of resources and care. As a society, we have to ask, “Is it appropriate to administer Avastin at $7,700 per month to a woman with breast cancer who happens to be insured, even though we know we’re not going to extend her survival … and to struggle to provide the most basic, minimum care to another woman with breast cancer, sitting in the very next room, who doesn’t have insurance?” I think that the degree to which we can openly and respectfully talk about these issues will benefi t not only oncologists, but also our patients and their families, and ultimately society as a whole.  Unfortunately, there aren’t easy answers or solutions, because these issues can be argued very strongly and legitimately from different perspectives.

It seems that the approval of Avastin will open the door for approval of other anticancer drugs that don’t necessarily extend life but do have some positive eff ects. I personally think that’s a good thing—with the caveats mentioned above. We’re in an era in which Pandora’s box has been swung wide open because of the extraordinary costs of these drugs and the complex issues involved in their use. It raises very profound questions about what we are doing as a profession and as a culture&mdash;such as spending $92,000 per year on a single patient for a drug that doesn’t extend survival while there are 47 million people in America who are uninsured and struggling to get just the most basic healthcare services. There is overwhelming data about the compelling needs of underinsured people in this country, and the widening gap in life expectancy based on income. Th is raises agonizing questions&mdash;medical, social, economic, and ethical&mdash;for which there are no easy answers. My hope is that this preliminary approval of Avastin might actually accelerate a deeper and more open discussion of what our goals and objectives are in oncology and how we’re going to handle the exploding costs of medical care in this country.

The discussions raised in this controversy—which highlight issues regarding the value of quality versus quantity of life, and how we evaluate and make decisions about them&mdash;is decades long overdue, and I welcome the process.  I believe that everyone will be served if we, as a profession and a society, would consciously embrace the notion that quality of life is indeed an important and worthy marker of the value of what we’re doing, and in many cases, is as important as survival. I think it would be a great step forward. 

The recent FDA approval for Avastin has sparked discussion about the approval of pharmaceuticals that may improve quality of life but do not necessarily extend life.

Sounding Board: Controversy Surrounding the FDA Approval of Avastin

enormous and growing impact of the internet

 on healthcare in general, and cancer in particular, has been well described in medical literature. In additionto the truly vast quantities of information about cancer available to patients, caregivers, and other healthcare consumers (searching Google on February 19, 2008 using the term “cancer” retrieved more than 232,000,000 results), Web-based approaches have begun to revolutionize communication between providers, providers and patients, and patients themselves. Infrequently discussed in the existing literature is the specific influence of the Internet on global cancer communication, particularly in countries of the developing world and other environments where access to more 

traditional sources of healthcare information

 (eg, medical journals, newspapers, television) remains quite limited. The issue is profoundly relevant in light of the potential for cancer-related information to be easily disseminated, and for communication to be rather dramatically enhanced, in any setting where Internet access is available.

, access to the Internet varies greatly based on geographic location, in one estimate (December 2007) ranging from as high as 71% of the population of North America to less than 5% in Africa. Of considerable interest is the recent growth in the use of the Internet, even in regions of the world where the overall availability remains far behind that of the United States. For example, in one analysis, although only 17% of the population in the Middle East was reported to currently have access to the Internet, growth in Internet users in this region increased 900% between 2000 and 2007.

Web-based communication strategies can serve roles in international communities that are similar, or identical, to those now routinely observed in the United States. For example, the Internet can be used to provide quantitative data regarding the experience of individual physicians and hospitals with particular cancers or procedures, including how successful these entities were in achieving objectively measured quality of care standards. Also, information regarding individual drugs to be administered in specific clinical settings, their side effects, and rational therapeutic options can be presented in a variety of languages. Further, Web-based, cancer-related support groups may also be helpful to patients and their families throughout the world.

To fully understand the truly unique capabilities of the Internet when it comes to global cancer communication, it is relevant to discuss 

. Following cardiovascular and diarrheal diseases, cancer is the third leading cause of death in developing world countries. Of the approximately seven million deaths due to malignant disease worldwide in 2007, nearly five million were predicted to occur in regions of the developing world. In these countries, the leading cause of cancer-related mortality in males is (as expected) lung cancer (500,000 deaths), while cervical cancer (275,000 deaths) is the most common fatal malignancy in females.

 are believed to be related to tobacco use, and this percentage is certain to increase as the epidemic of cigarette smoking advances in these countries. Recognizing the role played by tobacco and preventable infectious disease (eg, human papilloma virus, H. pylori, hepatitis B virus, human immunodeficiency virus, etc) in the pathogenesis of 

 could be prevented by implementing systemic health initiatives and reforms (eg, effective tobacco control, infection prevention initiatives, active vaccination programs). Considering the morbidity, mortality, and substantial costs associated with malignant diseases in developing world countries with extremely limited funding available for all health-related initiatives, the profound importance of educational and other public health eff orts focused on cancer prevention simply cannot be overemphasized.

Internet-Based Cancer Communication in the Developing World

Developing world countries will likely have major, and often quite distressing, limitations on the availability of oncology specialists, opportunities for consultative services, medical libraries, and educational materials directed to cancer patients. It is realistically possible that Web-based strategies can assist in a highly meaningful manner in overcoming some of these serious deficiencies.

 can be organized that permit physicians in remote regions to receive advice on patient management from cancer experts in regional centers, or major cancer centers in different parts of the world, who might agree to provide this educational service. It is also reasonable to suggest that consultations conducted through this mechanism could assist local physicians in the developing world in their eff orts to provide adequate, even if clearly not “state-of-the-art,” treatment for cancer patients in a setting where facilities (eg, linear accelerators) and medications (eg, targeted anti-neoplastic therapy; bone marrow supportive factors) are not available due to cost or geographical considerations (eg, rural clinic). Cancer experts, working together in an Internet-coordinated community, may be able to design rational and innovative strategies to deal with complex management issues.

For individuals in the developing world with access to the Internet, sites focused on cancer patients can serve an important role by providing relevant information (eg, treatment options, strategies to manage complications of therapy). As with global Internet-based tumor boards that can enhance interactions between physicians, this method of communication can serve a unique role in the developing world (again, assuming access to the Internet) and enable patients to share their experiences and strategies to optimize quality of life during and following treatment.

It is relevant to note that the Internet can also serve as a valuable source of data regarding differences and similarities between 

cancer patients in various locations throughout the world

. This information may permit cancer-related educational and support programs to be designed that fulfi ll unique needs of specific patient populations, based on factors other than socio-economic status (eg, language, education, religion, culture).

Global Communication Related to Clinical Trials

It is recognized that the revolution in our understanding of the molecular events that control the establishment and progression of cancer has led to the development of a large number of exciting novel anti-neoplastic drugs. In an eff ort to examine these agents as effi ciently as possible, many oncology-oriented pharmaceutical and biotech companies have elected to conduct an ever-increasing proportion of their clinical cancer research eff orts outside the borders of the United States. Klitzman and colleagues note, in the January 2008 issue of 

, that it is reasonable to speculate that the Internet can serve as an important source of information for cancer patients in specific sites around the world where such studies are being conducted, both for the purpose of recruitment and to assist in the process of providing adequate informed consent. This informed consent process, which will require input from local investigators and governmental regulatory bodies—and organizations focused on ensuring the ethical conduct of research involving human subjects&mdash;should include discussions of possible benefi ts and risks for study participants that are specifically relevant to unique characteristics of the population (eg, language, education, culture).

Ensuring adequate quality-control for the information provided while obtaining “informed consent” is a process particularly suitable to the Internet. Each step in the process (eg, discussion with patient, “signature” of the patient and a witness not involved with the study team or study sponsor) can be documented and audited. Finally, it is critically important to recognize in any 

discussion of the use of Web-based strategies

 for global cancer communication that the fundamental openness of the Internet also means that considerable effort must be undertaken to ensure that the information being viewed is objectively valid and not potentially harmful to the welfare of individual patients or the general public.

The Internet has the potential to serve a truly unique role in global communication regarding cancer and its management. Th e successful attainment of widespread international access to the Internet may be a key step in filling a serious void in the provision of quality information that is highly relevant to both individual cancer patients and all members of the world community.

 Physician Editor-in-Chief Maurie Markman, MD, is vice president of clinical research at the MD Anderson Cancer Center in Houston, TX.

According to Internet World Stats, access to the Internet varies greatly based on geographic location, in one estimate (December 2007) ranging from as high as 71% of the population of North America to less than 5% in Africa.

Global Cancer Communication and the Internet

In the coming months, you will probably hear and read a lot about personal health records, as two technology heavyweights roll out initiatives designed to spur the mass consumerization of health information. The race between Google and Microsoft to apply the resources of the Internet to personalized healthcare might be great for consumers, but how will physicians benefit, if at all?

	Apersonal health record (PHR) enables individuals to keep track of their own health and medical history. Th is information can be stored online and can be accessed by anyone who has the necessary electronic credentials to view the information. Content can range from simple identifi cation and demographic data to a complete medical history, physical fi ndings, and test results, gathered from multiple sources.  In theory, this makes great sense. It empowers consumers by allowing them to provide doctors with valuable information that can help improve the quality of care they receive. The PHR can help reduce healthcare expenditures by eliminating duplicate tests and also allow people to receive faster and safer treatment in an emergency.  Consumers have several choices when it comes to PHRs. Some are paper-based, some are PC-based, but most use the Internet to collect, store, and share health information. 

 was one of the first companies to off er a free online PHR.

, currently in beta testing, is a free Web-based platform claimed by Microsoft to have enhanced security and privacy measures. However, given Microsoft’s poor track record with first-release software and security, I would advise patients to stay away from this service until the kinks have been worked out.

	Perhaps the biggest player will be the last one to the party: Internet search giant Google. Rumors about the launch of Google Health have been swirling for months, and a beta version is expected to arrive this spring. Google has a very strong track record of releasing easyto-use, powerful software with an uncluttered interface that appeals to consumers.

	It remains to be seen whether any of these online services will gain serious traction with consumers. So far, very few people have actually signed up for an online PHR, mainly due to a lack of understanding about their potential benefi ts and concerns about privacy and security.

	In my mind, however, the most serious problem with the entire concept of the consumer-focused personal health record is that it will create more work for physicians. More importantly, who is going to pay for the time, energy, and legal risk involved? Are we truly going to take on yet another task without adequate compensation? If so, it means we are about to allow ourselves (yet again) to get “shafted” by the healthcare system.

	Agreeing to uncompensated support for PHRs would be worse than naive, given the way physicians are consistently treated by thirdparty payers. If we make PHRs part of our patient care regimen it will soon become the standard of care, and we will have lost another opportunity to receive adequate compensation for our time and eff ort. While we certainly want to support our patients in taking more control of their healthcare decisions, we must demand that it be done in a way that doesn’t just add to our workload.  Simply put, patients need to begin paying physicians directly for our time and knowledge. And while it is too late to easily make this happen for E&M offi ce visits, it is not too late for us to refuse to adopt new technologies that will just end up being more work and just another expected piece of healthcare required by insurers. 

	So while PHRs will (and should) end up being a critical part of the medical record, we must say “No, we are not willing to participate” until we fi nd a reasonable solution to the payment problem.  One solution might be that physicians share in PHR-related revenue.  Surely Google, Microsoft, and others see the advertising dollars and other associated revenue in PHRs, hence the reason for their foray into the fi eld. We should demand a piece of that revenue be paid to us before we agree to play any role in this new technology.  A modest payment from revenue the PHRs will surely generate for many of these profi table businesses, over thousands of patients, can add up to a signifi cant dollar amount for struggling small practices, and provide a valuable incentive to physicians. In this model, consumers win, doctors win, and PHR companies win. So what could be better?

Dr. Bertman is Physician Editor-in-Chief of

. He is also a Clinical Assistant Professor of Family Medicine at Brown University and president of 

, a leading developer of electronic health record (EHR) software. He also is the founder and president of 

, a consumer website focusing on personal medical topics. He is in private practice in Hope Valley, RI.

Personal Health Records: Just Say No

	HRs, as well as public awareness and attitudes regarding them, have been rapidly evolving. A

 titled “Electronic Personal Health Records: A Survey of Consumer Attitudes and Usage” revealed that more than 50% of the respondents had never heard of PHRs; after a PHR was described to the respondents, 82% were unsure if they would use it. A survey conducted by the Markle Foundation in the same year demonstrated that only 60% of respondents supported the creation of 

	With the field of PHRs now significantly expanding to include providers, payers, employers, and information technology industry giants, such as Microsoft and Google, public awareness and attitudes regarding PHRs have changed. More than 95% of respondents to a 

 said it is important for physicians to be able to access to all of a patient’s medical records in order to provide the best care. A similar number of respondents wanted individuals to be able to access all of their own medical records to manage their own health.  A November 2007 

 Online/Harris Interactive Health-Care Poll

 found that, “A sizable majority of Americans believe electronic medical records have the potential to improve US health care and that the benefits outweigh privacy risks.” The poll also revealed that a vast majority of Americans want access to their health information, with 91% of those polled saying “patients should have access to their own electronic records maintained by their physician.”

	It is likely, therefore, that many practicing physicians will be asked by their patients about PHRs. We’ve prepared a PHR primer to help physicians answer questions from curious patients.

	Although there are many types of PHRs offered on the market, there are several key elements all have in common. PHRs:

		Include comprehensive healthcare data pertaining to the consumer/owner.

		Are universally accessible over the Internet.

		Are managed and controlled by the individual/proxy.

	Are secure and the privacy and confi dentiality of the health information is protected.  Th e Healthcare Information and Management Systems Society (HIMSS) defi nes PHRs as:

		Universally accessible, laypersoncomprehensible lifelong tools for managing health information, promoting health maintenance, and assisting with chronic disease management via an interactive, common data set of electronic health information and e-health tools.

		Owned, managed, and shared by the individual or his or her legal proxy.

		Secure to protect the privacy and confi dentiality of the health information it contains.

		Not a legal record unless so defi ned and therefore subject to various legal limitations.

	The PHR is a lifelong record that includes all health information from all sources for an individual.  Th e secure electronic transfer of personal health information (PHI) is necessary to achieve this. As electronic PHI from providers, pharmacies, payers, and others is made available for electronic exchange with third-party PHRs, individuals may choose to send their information to them. However, it is important to note that these third-party PHR vendors are not covered by HIPAA regulations, and therefore do not have to comply with standardized requirements regarding the privacy, security, and data usage of the PHI that is sent to them under federal or state regulations.

	Healthcare consumers should have the right to control the movement of their data to such third-party PHRs, but they also should have the right to know that currently there are no established federal privacy, security, and data usage standards such as HIPAA governing such entities. Th ere are also no regulations requiring periodic oversight and audits to ensure that such entities comply with their own stated privacy, security, and data usage standards.  Ideally, HIPAA regulations could be extended by Congress to also apply to all third-party PHR vendors. In the interim, or if HIPAA regulations are not extended, it is recommended that:

		The public should be educated regarding any potential implications surrounding the exchange and usage of PHI in the context of a PHR.

		All PHR products should clearly, simply, and concisely list their security, privacy, and data usage policies and make them available in a consumer-friendly fashion.

		Standards be established for the electronic data exchange and the privacy, data usage, and security for PHI with non-HIPAA-covered PHR products.

	There should be disinterested third-party validation and periodic audits to ensure PHR products’ compliance with their stated policies. When patients ask about electronically transferring their personal health information to third-party PHRs, physicians should educate them regarding HIPAA regulations and remind them that third-party PHRs are not covered by HIPAA. Physicians should also advise patients to carefully review the PHR’s terms and conditions of use and encourage them to make their own informed decision regarding proceeding.

Mary P. Griskewicz, MS, FHIMSS, is the director of Ambulatory Health Information Systems for HIMSS.  

editorial board member Holly Miller, MD, MBA, is vice president and CMIO at University Hospitals, a community-based system that serves patients at more than 150 locations throughout northern Ohio. She currently serves as chair of the HIMSS PHR Steering Committee.

With the field of PHRs now significantly expanding to include providers, payers, employers, and information technology industry giants, such as Microsoft and Google, public awareness and attitudes regarding PHRs have changed.

Sounding Board: A Personal Health Record Primer

	Modern medicine has adopted technology and pushed the boundaries of science in impressive ways. We see this in the use of high-tech imaging, advanced pharmaceutical agents, innovative medical devices, and recent advances in proteomics and genetics. However, in the actual delivery of care (how physicians interact with patients, manage health information, and pay for care), we still have paper records, we still hand write prescriptions, and we still have as much as 30—40% administrative overhead. This healthcare delivery “adoption lag” is predictable, and typically averages five to seven years, but may be as long as 

. The automation of financial transactions, the movement toward electronic medical records, or even the adoption of Linux within the healthcare enterprise have all followed the predictable delayed adoption pattern seen in other industries.

	However, this delay can be used to the strategic advantage of astute physicians and healthcare entrepreneurs. By observing the wider technology adoption patterns in fast-adopting industries like financial services, we can reliably predict what trends will soon be impacting healthcare. We can also get a sense of how consumers, traditionally called patients within healthcare, will respond as they adopt—and push their providers to adopt&mdash;the technologies that will simplify their healthcare interactions. This millennial generation of patients will expect to be able to use Internet technology to shop, compare, chat about, purchase, and report their experiences just as they do with nearly all the other services they consume. Welcome to nextgeneration

	healthcare and what I like to call the Millennial patient.

	Millennial patients can best be defi ned by their behavior, rather than their age, sex, or demographic. Millennial patients are the first generation of Americans to grow up with the Internet as a pervasive part of their lives. They use the Internet in their everyday life to research information, purchase tickets, pay bills, and meet their personal, social, and professional needs. They are amazed, bewildered, and ultimately angry with the inability to access their healthcare services in this way. They cannot understand, and they will not tolerate, this disparity in the ability to manage healthcare transactions as simply as they manage their financial transactions. They are knowledgeable, intelligent, are typically prepared for their appointments, and inherently expect and demand a far higher level of service from their healthcare provider.

 by Dr. Scott Haig, most Millennial patients are not “Googlers” in the derogative way he uses the term. Most do not use this information as a weapon against their physician, but rather use it to become an informed participant in the delivery of their care. They value the trusted relationship with their healthcare provider and want to work together to optimize their health. Having used professional advisors in other areas of their life, they understand the need to have a relationship with their healthcare provider based on trust, mutual respect, and open communication. In order for physicians to most eff ectively engage the Millennial patient, it is import to understand the diff erent types of next-generation patients.

	The days of passive patients cowering under the commanding voice of their all-knowing physician are gone. The outsourcing of medical decision making will continue to wane as the outsourcing of fi nancial responsibility continues to be reduced. As the cost shifting returns back to the patient, the increased fi nancial accountability means that patients will be more involved with decision making, including treatment decisions, because these directly aff ect costs. The notion of “shared medical decision,” pioneered by Jack Wennberg’s team at Dartmouth, describes the collaboration that occurs in reaching an agreement about a healthcare decision. Part of these conversations will include discussions regarding the pricing of services, which will force providers to reconsider what they are willing to accept for payment for their services. How much does that treatment cost? What are the alternative therapies, and how much do they cost?

	It is important for providers to realize that patient consumers are not asking these questions to challenge their clinical judgment. There is no plausible medical tenet or practice bylaw that states the patient “shall not” know the price they are about to pay for a service. Th ey are asking because they need this information to formulate in their own minds the value decision (outcome/ price) that will aff ect what they ultimately decide to do. While providers may believe that the patient will always choose the therapy that potentially leads to the best outcome, patient consumers may not be willing to pay the price to obtain the recommended outcome.

	In addition to getting comfortable discussing pricing, providers will need to be able to complete healthcare transactions at the point of service.  As more consumers pay a higher percentage of their own healthcare costs (consumer payments are about $50 billion today), healthcare providers will need to adopt new technology and business processes. Failure to do so will result in an everincreasing uncollected payment burden. The 

 has documented the need to transform the point-of-service transaction capabilities in several papers. Part of this transformation includes eligibility verifi cation, real-time co-pay/ deductible accumulators, card/reader technology, and fi nancial integration with consumer accounts. In addition, providers will need to become much more transparent with regard to pricing for their services. Retail clinics have led the way in posting cash prices, and physicians will need to learn to not penalize consumers with much higher cash prices. Rather, they’ll need to reward them for the real and tangible savings that cash payments make possible by avoiding the Byzantine insurance payment process. Companies like Recondo, TriHealix, and even practice management companies like Athenahealth are leading the way.

	Physicians will need to realize that pricing information is only the fi rst wave of the oncoming transparency initiatives. Savvy consumers will quickly become interested in outcomes information, wanting to know the specifi c results achieved by a specific physician for specifi c procedures. Furthermore, they are going to want to talk with the “patients like them” who have actually undergone the procedure from the physician to get a sense of experience, service level, and outcomes. Social networking has already signifi cantly impacted this, and companies like HealthGrades, Xoova, Vitals, and others provide basic rating information right now. This will become much more sophisticated and ultimately include relevant outcomes data in consumer-friendly formats.

	Finally, the consumer patient will want to engage their healthcare provider in the convenient ways in which they engage every other service. They will demand the ability to schedule appointments online, check laboratory or radiologic results, and communicate with their physician via “new media” like e-mail, chat, and video. These technologies are all well-established commodities, and they enable providers to meet their patients “where they are” in terms of how, when, and in what manner they would prefer to communicate. New services like American Well, Hello Health! and Organized Wisdom are all representative of enabling technologies that patient consumes will want to utilize to engage their health providers.

	Enabling new technologies works both ways in allowing patients and physicians to interact in new ways. For physicians, that means the ability to empower patients by helping them become more informed, involved, and in-tune with their own health. Just as the use of mid-level providers served as an eff ective extension of the physician, many of these new technologies can push outsourcing of care all the way down to the patient. In this paradigm, the patient becomes another provider, perhaps a much more accurate and appropriate description of the term primary provider.

	David S. Sobel, MD, MPH, Medical Director of Patient Education and Health Promotion for The Permanente Medical Group at Kaiser Permanente, is responsible for 3.3 million members who interact with the Kaiser system and has a simple mantra for success: “Keep the patients healthy, happy, and at home.” Beyond the trite saying is a powerful philosophy about patient empowerment. Namely, Sobel considers his patients as providers and collaborators in the care process. “Patients are most often viewed as consumers of healthcare, and health professionals are seen as the primary healthcare providers” Sobel says. “In fact, 70 to 90% of all symptoms are self-diagnosed and self-treated without the help of health professionals. The true primary care providers are people themselves.” What would happen if providers considered their patients as colleagues in optimizing health?  How would patients respond to not only an increased fi nancial stake in their care, but also an increased clinical stake as well?

	While we may still be a long way from patients as providers, initiatives like shared medical decision making are helping break the paternalistic perspective and embrace the patient as a member of the care team. Patients can be reliable reporters of treatment regimens, can assist with care coordination, and with appropriate oversight, can serve as outsourced low-level providers. The physician role in this setting is to create an aligned relationship of trust that leads to health optimization; the physician becomes the trusted advisor who guides the partner patient through the labyrinth of healthcare decision making. This is the physician counselor who can facilitate decision making along clinical, fi nancial, and social/cultural lines. Sounds suspiciously like the primary care model, right? What is so novel about the patient as a partner? Get real. Primary care delivered in this way is exceptionally diffi cult to find. You cannot create a trusted, advisory relationship in the 7- to 12- minute patient interval treadmill that most primary care physicians run on every day.  However, there is a growing awareness, perhaps even a growing movement, among the proponents of throwback traditional medical practices, with an updated technology twist.

	Having already defi ned Millennial patients, it would be appropriate to also describe Millennial providers. These are the enlightened physicians who realize that technology can help them in delivering an entirely new range of personalized healthcare services that meet specifi c individual needs. While some remain concerned that technology gets in the way of developing meaningful relationships, Millennial providers use technology in such a seamless way as to abstract it nearly completely out of the relationship. Instead of decreasing the intimacy of the relationship, it actually allows healthcare services to be delivered in a much more personalized way.

	This style of medical practice is allowing a sense of freedom and fulfi llment that had previously been extinguished in the crushing cycle of managed care. “I couldn’t handle the frustration of traditional managed care practice paradigm,” said Jordan Schlain, CEO of OnCall Physicians group in San Francisco. Schlain begin his own on-call, personalized medicine service just two years out of residency.

	“I was not happy, not in control, and not enjoying my patients or myself. I chose to create the type of practice that I wanted to go to, that I would actually use as a busy, young professional.” Schlain discontinued his practice, stopped taking insurance, and instead created an on-call service whereby he would go to the offi ces of his patients to provide care. He adopted an electronic medical record, wireless technology, and several practice innovations that allowed him to coordinate his practice with that of his patient partners. He worked holistically with the patients, to meet their ongoing health, prevention, and wellness needs.  He works reasonable hours, makes more money, and couldn’t be happier practicing medicine on his own terms, using technology-enabled, personalized services that treat the specialized needs of his unique patient population.

	Millennial patients are beginning to demand a higher quality of service and a more meaningful relationship with their provider consistent with their experiences in other sectors of the market.  Millennial providers will create service off erings that will address patients’ specialized needs and help deliver appropriate health services within a personalized context. Th is partnership of care relationship will need to be supported by the very best technology, products, and services associated with the pricing, quality, and eff ectiveness information required of a value-driven system.  When these elements become transparent and aligned with appropriate fi scal incentives, the US healthcare system will approach the effi cient, next generation healthcare system that can continue to serve our countries healthcare needs well into the new millennium.

Scott Shreeve, MD, is interested in the convergence of medicine, technology, and business. He works to design, develop, and distribute healthcare technologies that enhance patient safety, increase clinical efficiency, and improve overall quality of care. His blog, 

is dedicated to ensuring that these technologies are eff ectively applied to healthcare delivery in order to create a true consumer market for optimal health.

Modern medicine has adopted technology and pushed the boundaries of science in impressive ways. 

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