Lab Soft News

DPA Visions: Free Resident Registration for Posters & Travel Awards

The Digital Pathology Association (DPA) is offering complimentary membership and discounted registration to its annual conference, Pathology Visions, to all residents, fellows and PhD students interested in digital pathology (see: Digital Pathology Association Offering Complimentary Membership and Discounted Pathology Visions Registration to Residents). Pathology Visions 2013, the DPA’s annual conference, will be held September 29 through October 1, 2013, at the Grand Hyatt San Antonio in San Antonio, Texas. This year, pathology residents and fellows have two opportunities to attend Pathology Visions at no cost:

• The first opportunity is through poster presentations. The DPA Program Committee is now accepting abstracts for poster presentations. Residents can submit an abstract for review until August 1, 2013. If their poster presentation is chosen, their registration to Pathology Visions 2013 will be complimentary.
• The second opportunity is through resident travel awards. The DPA is making available up to four conference travel awards ($2,000 value each) for pathology residents and fellows. Recipients will be chosen based on their understanding of the impact of digital pathology and whole slide imaging on the specialty of pathology, merit of application, and the value of the award to the applicant. Applications are due July 1, 2013. 

South Georgia Medical Center Chooses RelayHealth for HIE Deployment

When I see the term health information exchange (HIE) used, I tend to think primarily about the exchange of health information among unaffiliated hospitals on a regional or state basis. However, the Wikipedia defines the term in the following way: the mobilization of healthcare information electronically across organizations within a region, community or hospital system (see: Health information exchange). A recent press release about the deployment of RelayHealth at the South Georgia Medical Center therefore caught my attention (see: South Georgia Medical Center Chooses RelayHealth for Patient-Centric Health Information Exchange (HIE) Project aims to seamlessly connect hospital clinicians, area physicians, and patients for data exchange). Below is an excerpt from it:

South Georgia Medical Center is implementing RelayHealth’s patient centered Health Information Exchange (HIE) platform as part of its strategy to meet Stage 2 Meaningful Use requirements and facilitate the fluid exchange of data between physicians and patients.....In the past 18 months, South Georgia Medical Center (SGMC) has evolved from a community hospital into a four-hospital system that includes a 25-bed critical access hospital about 25 miles from the main Valdosta campus. The growth meant that HIE was critical to the organization’s success....Phase one of [of a system integration project for the enterprise] includes populating the RelayHealth HIE with the hospitals’ information and making it available to physicians....The second phase involves connecting five physician practices’ EMRs to the HIE so physician orders and test results can flow between the two. More practices will be added to the HIE later. The final phase involves a patient portal that will allow individuals to communicate electronically with their physicians and view their health records. 

The RealyHealth web site, linked to above, suggests to me that the company is focusing on enterprise integration encompassing one or more hospitals in a system, the offices of physician admitting to the hospital(s), and affected patients. This makes perfect sense as a business model because a single hospital system will readily fund such initiatives before they are interested in integrating data across health systems,, some of which may be competitors. The RelayHealth web site refers specifically to Enterprise HIE Solutions and refers to the need to "Build a Longitudinal Patient Record Across Your Community." This is a little ambiguous but I will assume here that community refers to the "community" of a single hospital system and the physicians and patients it serves. Here's some additional information from this same web page:

Redundant tests, hospital readmissions, medical errors, and other inefficiencies caused by a lack of access to patient data are costing your health system.  Sharing a longitudinal patient record (LPR) across different settings of care is critical to removing waste within your health system, and delivering the right care to your patients.  Creating a usable LPR comes with challenges: (1) Patient data is trapped within disparate technologies; (2) Disparate technologies utilize differing patient identity schemas and data dictionaries; and (3) Providers require efficient, workflow-integrated solutions.

International Organ Trafficking Ring Broken Up in Costa Rica

In a note about a year ago, I commented on the black market for transplant organs, particularly kidneys (see: Black Market for Transplant Organs Becomes Global Phenomenon). People in less developed countries essentially "sell" one of their kidneys through a black market network to a recipient in a more affluent country. This note mentioned the frequent source of such kidneys as China, India, Brazil and the Philippines. Below is an excerpt about an international organ trafficking ring that sold kidneys to patients in Israel and Eastern Europe and was broken up by Costa Rica police and Interpol (see: Israeli doctors, patients accused of involvement in trafficking kidneys):

An international organ trafficking ring that sold kidneys to patients in Israel and Eastern Europe was broken up by Costa Rica police and Interpol. The ring also worked with Israeli doctors who have not yet been named, according to Haaretz. Israel’s Health Ministry denied any knowledge of the organ trafficking ring. The Costa Rican Attorney General’s Office said last week that Israeli doctors had performed kidney-removal operations on some Costa Ricans who sold their organs, according to Haaretz. Israeli patients have paid up to $20,000 for a black market kidney. The organs were removed both in Israel and Costa Rica. Under Israel’s New Organ Transplant Law passed in 2008, health maintenance organizations and supplemental insurance companies in the country stopped funding most organ transplants for Israelis abroad if the origin of the organ could be at all suspect.

It thus appears that the black market in kidneys is continuing in Israel despite the 2008 law and a 2012 amendment designed to stop the traffic (see: Israel: Amendment to Organ Donation Law Passed). As the excerpt above indicates, this illegal market would not exist without the complicity of surgeons who function to both harvest the organs from donors and then transplant them into the paying recipients.

Israel has developed some very innovative programs for organ donation programs, perhaps spurred on by some of the bad press it has received (see: Extra Points in Israeli Organ Donation System for Signing a Donor Card). Here's an excerpt from that note:

[A relatively] simple scheme to increase the number of organ donation cards in Israel [has been developed]. Similar to the process in this country and when you need a kidney transplant, you are assigned a priority score on the basis of a points system. Under the Israeli donor incentive system, you receive bonus points if you or your first-degree relatives have signed organ donor cards or actually donated organs.

I came across an excellent web site of the U.S. Department of HHS relating to organ donations. Here's a quote from the home page:

During your visit to organdonor.gov, someone may have been added to the [transplant organ] waiting list. It happens every 10 minutes! Each day, about 79 people receive organ transplants. However, 18 people die each day waiting for transplants that can't take place because of the shortage of donated organs. Organ transplantation has become an accepted medical treatment for end stage organ failure. The facts prove it! But only you can help make it happen!

Employers Cap Payments for Selected Surgical and Diagnostic Procedures

Large hospitals have a distinct advantage over smaller ones in that they often perform common surgical procedures more often than smaller ones. Some of them are now beginning to leverage this advantage by learning how to reduce the cost of these procedures (see: The Transition to "Big Med": Need for Emphasis on Standardization and Cost). They achieve this goal by standardizing processes and wringing out the wasteful steps. Because of these lower costs, large, self-insured companies are providing incentives for their employees to choose these hospitals for surgery. Here's an article about how some employers are placing caps on coverage for certain procedures (see: Employers Test Plan to Cap Medical Spending). Here's an excerpt from the article:

Hoping to cut medical costs, employers are experimenting with a new way to pay for health care, telling workers that their company health plan will pay only a fixed amount for a given test or procedure, like a CT scan or knee replacement. Employees who choose a doctor or hospital that charges more are responsible for paying the additional amount themselves. Although it is in the early stages, the strategy is gaining in popularity and there is some evidence that it has persuaded high-priced hospitals to lower their prices. In California, a large plan for public employees has been especially aggressive in using the tactic, and the results are being watched closely by employers and hospital systems elsewhere. Under the program, some employees are being given the choice of going to one of 54 hospitals, including well-known medical centers like Cedars-Sinai and Stanford University Hospital, that have agreed to charge no more than $30,000 for a hip or knee replacement. Prices for the surgery normally vary widely in the state, with hospitals billing from $15,000 to $110,000 for the same operation, a spread that is typical for much of the nation.....

[California Public Employees’ Retirement System, known as Calpers] worked with the insurer Anthem Blue Cross, a unit of WellPoint, to introduce the program. Overall costs for surgeries under the program fell 19 percent in 2011, the program’s first year, with the average amount it paid hospitals for a joint replacement falling to $28,695, from $35,408....The hospitals may have been willing to drop their prices because Calpers has such clout....Using a technique called “reference pricing,” the employer sets a cap, based on what can be an average price for the service or a price that allows employees to select from a wide group of hospitals or doctors but still excludes the very high-priced providers. The idea is to exert pressure on prices for certain procedures without limiting the individual’s choice of hospital or doctor for all kinds of care.....Last year, WellPoint [also] worked with the Kroger Company, a large grocery chain, to start a similar program in which payments for certain M.R.I.'s and CT scans were capped at around $800, and employees were given a list of places that would charge that amount or less. Kroger picked services that had a significant variation in price but did not vary in quality from provider to provider....The company also chose to set the price the plan would pay at a point where employees would still have a wide range of choices, she said.

Reference pricing is a strategy by which a product is sold at a price just below its main competing brand (see: Reference pricing). If the value of the price cap placed on the product is set according to (i.e., in reference to) the price for one version of the product, it’s a reference price. (see: Is reference pricing a good deal?) 

Surgical procedures and MRI/CT scans are not branded items but, for healthcare consumers in the Los Angeles area, hospitals such as Cedars-Sinai and Stanford University Hospital, would be highly respected. What's interesting about this capped approach to reimbursement for various procedures such as total hip replacement is that there should be no diminution in quality in the face of these price caps. Put another way, the discounted price paid by the employer may well result in a higher quality result than having undergone the procedure in a smaller hospital. This point is emphasized in the last two sentences of the excerpt above:

• [The employer] picked services that had a significant variation in price but did not vary in quality from provider to provider.
• [The employer also] chose to set the price the plan would pay at a point where employees would still have a wide range of choices....

This strikes me as a very intelligent way for the health plans to cut costs. Less is spent by the company for a surgical procedure but the employee-recipients of the care do not suffer any deterioration in quality and may actually be better off. 

Assessing the Value on "Water Cooler" Conversations; Micropayments for Blogs

In response to my blog note of yesterday (see: Jason Lanier Theorizes about How to Fix the Digital Economy), Ajit Alles submitted the following comment:

I think this desire to pay for everything erodes the social values of neighborliness and altruism - the desire to do things out of the goodness of one's heart. I, for one, would not read your blog if I had to pay for the privilege. The information and ideas are enjoyable, interesting and provocative, but not essential to my wellbeing. Your blog is like a water cooler discussion, and who would pay for that. I suggest that you read "Predictably Irrational" by Dan Ariely in which there is a chapter dealing with this topic. He states the case much more fluently and elegantly.

The major point of my note, quoting Lanier, was that the belief that web-based information should be free may be harming the economy. Some industries, notably print newspapers and the music industry, are suffering financially as a result. These effects, according to Lanier, are contributing to the hollowing-out of the middle class.

In his comment, Ajit compares the content of this blog to "water-cooler" discussions at work and says that "the information and ideas are enjoyable, interesting and provocative, but not essential to my wellbeing." I take no offense at this and suggest that he is generally correct. My goal for Lab Soft News has always been to predigest information for my readers. The blog then becomes an efficient means by which readers acquire information about lab medicine, lab software, and healthcare. I have always assumed that many of the readers scan the blog during coffee breaks at work.

The problem with Ajit's analogy to "water cooler conversation" is that it trivializes blog content and minimizes its intrinsic value. I would prefer an analogy to "hallway conversations" which I think is far more accurate. Every pathologist knows that "hallway conversations" with colleagues about patients or current news about lab medicine can be extremely important although often brief. Let me also suggest that the most important criterion for assessing the value of brief conversations at work, be they in the hall or around the coffee pot, is the extent to which they cause positive changes in diagnoses or plans.

Let me also say that the type of remuneration we are discussing here for blogs would be micropayments -- perhaps pennies per day. To use an e-book example, an author who auto-publishes and sells 100,000 copies of an e-book at $2.00 a copy is far better off than one who sells 5,000 hardcopy versions of a book $25.00 and shares the lesser profits with a publisher. We need to seriously ask why consumers will readily pay $4.00 for a Starbucks latte and balk at paying pennies for the useful information that may be contained in a blog.

Jason Lanier Theorizes about How to Fix the Digital Economy

A recent op-ed piece in the NYT by Jason Lanier discussed how to fix the digital economy (see: Fixing the Digital Economy). I have been blogging for more than seven years and access to this blog, as is usually the case, is free. I have always believed that this is a good idea but now I am not so sure. Below is an excerpt from his article:

Two big trends in the world appear to contradict each other. On the one hand, computer networks are said to be disrupting centralized power of all kinds and giving it to the individual....But then there’s the other trend. Inequality is soaring in rich countries around the world, not just the United States...The job market in America has been hollowed out; unpaid internships are common and “entry-level” jobs seem to last a lifetime, while technical and management posts become ever more lucrative....Technological change might sometimes seem to be an automatic threat to the middle class.... In this century, however, we have forgotten that wisdom and decided that when it comes to digital networks, more and more people will not be paid for what they do even though what they’re doing is needed. Jobs involving communication and expression ...are suddenly much harder to come by, because information is now held to be free....

As this century unfolds, technology will continue to evolve....There is no magical “artificial intelligence.” When a big, remote computer translates a document from English to Spanish, for instance, it doesn’t understand what it is doing. It is only mashing up earlier translations created by real people, who have been forgotten because of the theater of the Internet. There are always real people behind the curtain. The rise of inequality isn’t because of people not being needed...it’s because of an illusion that they aren’t even there. Dissect almost any ascendant center of power, and you’ll find a giant computer at the core.....Now to be powerful can mean having the most effective computer on a network. In most cases, this means the biggest and most connected computer, though very occasionally a well-operated small computer can play the game, as is the case with WikiLeaks....

The new class of ultra-influential computers come in many guises....Siren Servers can function profitably only if people aren’t paid for the data that is used to calculate their statistical schemes. Siren Servers drive apart our identities as consumers and workers. In some cases, causality is apparent: free music downloads are great but throw musicians out of work. Free college courses are all the fad, but tenured professorships are disappearing. Free news proliferates, but money for investigative and foreign reporting is drying up....Keep track of where information came from. Pay people when information that exists because they exist turns out to be valuable, no matter what kind of information is involved or whether a person intended to provide it or not. Let the price be determined by markets.

The gist of what Lanier is saying is that we need to begin to begin to pay people for generating information or adding value to existing information. Here's a link to an article that provides additional analysis about Lanier's ideas (see: GoogleMart).  Here's the key quote from it:

Lanier's suggestion is everyone gets paid, via micro-payments, linked back to the value they helped create. These payments continue so long as people are using their stuff, be it a line of code, a photograph, a piece of music, or an article.

This kind of tracking that is required for micropayments to all of the people who generate information on the web is complex but certainly within the realm of possibility. Unless we take some rapid corrective action, other knowledge industries may suffer in the same way as the newspaper and music industries and, soon, higher education. To put this bluntly, giant computers (i.e., siren servers) are contributing to the hollowing-out of the middle class, particularly in the the information-based industries. In order to correct this imbalance, we need to compensate the people who generate the information that is the basis for the earnings of companies like Google.

Cervical Cancer Screening with Vinegar in Less Developed Countries

In an earlier note about two years ago, I discussed how vinegar applied to the uterine cervix could be used as a simple test in developing countries to detect dysplasia (see: Replacing the Pathologist and Gynecologist with Vinegar and CO2). Here's a quote from that note:

Nurses using the new procedure, developed by experts at the Johns Hopkins medical school in the 1990s and endorsed last year by the World Health Organization, brush vinegar on a woman’s cervix. It makes precancerous spots turn white. They can then be immediately frozen off with a metal probe cooled by a tank of carbon dioxide, available from any Coca-Cola bottling plant. 

I have just come across another reference indicating that this technique can reduce mortality from the disease (see: Cervical Cancer Screening With Vinegar Reduces Mortality). Below is an excerpt from it:

A simple screening technique using an inexpensive agent dramatically reduced deaths related to cervical cancer in a population of Indian women. Visual inspection with acetic acid or vinegar (VIA), conducted by nonmedical personnel trained to deliver basic healthcare, cut the death rate by 31% [according to a recent study]. This strategy is effective and can be implemented on a broad scale in low-income countries...."There is no cervical cancer screening program in India because it is not feasible," explained [an Indian physician working with the technique]. "There is inadequate infrastructure, a lack of trained human resources, logistic difficulties, and a relatively high cost." Therefore, the researchers looked at VIA, which is a simple visual test that can be done without laboratory support....[Another physician in the study] pointed out that there are several take-home messages from this study; namely, that the VIA method has been validated, has been accepted, is inexpensive, can be use in low-resource areas, and can save lives.....Compliance was high, with 89% participation in screening and 79% compliance with postscreening diagnostic confirmation. The researchers note that the quality of screening performed by the primary health workers was comparable to that of an experienced gynecologist....On the basis of these results, the Indian health officials in Maharashtra state, where the trial was conducted, are preparing to train primary health care workers to provide VIA screening to all women 35 to 64 years of age at 24-month intervals. In addition, the Indian government is working to implement nationwide VIA screening, and is planning to reach out to other low- to moderate-income countries to share these results and offer assistance with training.

An interesting follow-up study for a developed country would be to correlate the exact histologic changes that cause the cervical mucosa to turn white. Here's some more information about the science behind the test (see: Using Vinegar to Thwart Cervical Cancer in the Developing World):

Dr. Bandit Chumworathayi, a gynecologist at Khon Kaen University who helped run the first Thai study of VIA/cryo, explains that vinegar highlights the tumors because they have more DNA, and thus more protein and less water, than other tissue. It reveals pre-tumors with more accuracy than a typical Pap smear. But it also has more false positives — spots that turn pale but are not malignant. As a result, some women get unnecessary cryotherapy. But freezing is about 90 percent effective, and the main side effect is a burning sensation that fades in a day or two.

Neonatal Diagnosis by Whole Genome Sequencing in Only Two Days

For me, the two most important current uses of whole-genome sequencing in clinical care relate to patients with malignant neoplasms and critically ill newborn infants (see: Neonatal Diagnosis by Whole-Genome Sequencing in 2 Days). This latter process was detailed in a recent article an excerpt of which is provided below:

In a pilot clinical study in the U.S. researchers have applied whole-genome sequencing (WGS) to diagnose genetic diseases in critically ill newborns in under two days, rather than the 4-6 weeks turnaround time needed for genetic analysis using current methods. The approach, called STAT-Seq by its developers at Children’s Mercy Hospital in Kansas City, combines WGS sequencing of blood DNA, with a newly developed bioinformatics platform that marries the clinical symptoms of the patient with a list of possible diseases, so that analysis of the genome sequence is narrowed down to those regions harboring the mutations responsible for the candidate diseases. Taking just 50 hours to complete from sample to diagnostic result, the technology could dramatically improve the speed of diagnosing genetic disorders in neonates, potentially saving lives and reducing the numbers of unnecessary tests carried out. About 20% of infant deaths in the U.S. are caused by congenital birth defects and chromosomal abnormalities....In the case of genetic diseases, it’s imperative that a correct diagnosis is made as soon as possible so that the infant can be treated, if a suitable therapy is available. And for those neonatal genetic diseases for which there are no treatments, a fast diagnosis avoids inappropriate therapy, means parents can swiftly be given counselling, and is critical for research to develop management guidelines.

Unfortunately, diagnosing a suspected genetic disorder isn’t always possible just by looking at symptoms, and newborns might not yet exhibit the full clinical phenotype. On top of this, neonatal screens are currently only available for a handful of genetic disorders, and serial gene sequencing is too slow to be clinically useful in a neonatal intensive care unit (NICU) setting. To speed diagnosis of genetic diseases in the NICU the Children’s Mercy Hospital team have developed and trialled an approach that combines WGS carried out on Illumnina’s HiSeq 2500 system....with a new bioinformatics platform called symptom-and-sign-assisted genome analysis (SSAGA). The clinicopathological correlation tool effectively maps the clinical features of nearly 600 genetic diseases, and how they present in infants, to phenotypes and genes known to cause the same types of symptoms. Effectively, the clinician inputs the patient’s symptoms according to specified terminology, and the software identifies a set of possible diseases.

 All of this strikes me as a sophisticated initiative to rapidly apply state-of-the art genomic science to the rapid diagnosis of critically ill newborns using WGS. However and for editorial balance, here's a more negative perspective about this new diagnostic approach to newborns (see: Genome Sequencing For Babies Brings Knowledge And Conflicts):

"In theory it sounds absolutely fantastic," says sociologist Stefan Timmermans, who studies newborn screening at UCLA. "The reality is that there's a lot of uncertainty about each of the data points you receive. So if people start making health decisions or life-or-death decisions based on information that is so tenuous at this point, I think this could indeed be a nightmare scenario. "A nightmare, because parents could easily become overwhelmed with confusing or ambiguous information about the health of their baby during one of the most sensitive times in their lives." There's plenty of evidence that parents already often overreact to the relatively small amount of data that they're getting from little spots of blood collected at birth. 

Using Altered Metabolic Pathways to Diagnose Alzheimers Disease

In previous notes, I have touched lightly on metabolomics but have not discussed the relevance of this science for clinical applications (see: Metabolomics, Metabolomic Profiling, and Systems Biology). A recent article made me more aware of some of the diagnostic opportunities made possible by this approach (see: Blood test could diagnose Alzheimer’s in earliest stage). Below is an excerpt from the article:

Blood offers promise as a way to detect Alzheimer’s disease at its earliest onset, Mayo Clinic researchers say. They envision a test that would detect distinct metabolic signatures in blood plasma that are synonymous with the disease — years before patients begin showing cognitive decline. Their study was recently published online in the journal PLOS ONE.Researchers analyzed cerebrospinal fluid and plasma samples from 45 people in the Mayo Clinic Study on Aging and Mayo Clinic Alzheimer’s Disease Center (15 with no cognitive decline, 15 with mild cognitive impairment and 15 with Alzheimer’s disease). They detected significant changes in the cerebrospinal fluid and plasma in those with cognitive decline and Alzheimer’s. Most important, changes in plasma accurately reflected changes in the cerebrospinal fluid, validating blood as a reliable source for the biomarker development. The team uses a relatively new technique called metabolomics, which measures the chemical fingerprints of metabolic pathways in the cell — sugars, lipids, nucleotides, amino acids and fatty acids — to detect the changes. Metabolomics assesses what is happening in the body at a given time and at a fine level of detail, giving scientists insight into the cellular processes that underlie a disease. In this case, the metabolomic profiles showed changes in metabolites related to mitochondrial function and energy metabolism, further confirming that altered mitochondrial energetics is at the root of the disease process.

Here's a link to another related article if you want more information about this topic (see: Identification of Altered Metabolic Pathways in Plasma and CSF in Mild Cognitive Impairment and Alzheimer’s Disease Using Metabolomics).

The basic concept here is that a disease, Alzheimer's disease in this example, causes changes in the body's metabolic pathways. These changes are referred to as "chemical fingerprints" in the article quoted above or, perhaps more clearly, as "altered metabolic pathways." Historically, we have often looked at variations of a single analyte or small sets of them to diagnose disease. For example, serum glucose might be sky-high for a diabetic patient or PSA may be elevated in a patient with cancer of the prostate. Metabolomics allows the diagnostician and labs to look at complex metabolic pathways for a patient and detect the subtle, but significant, changes of common metabolites. Such analyses obviously requires powerful computer support to both identify the subtle changes that are associated with a particular disease and then detect them later in patients suspected of perhaps being in an early state of that disease.

FDA Launches New Patient Network Website; Useful Resource for Clinical Trials

Here is some very big news. The FDA has just launched a patient network website (see: The FDA Patient Network Website - Pretty Darn Patient-Centered). Here are the details: 

The twin goals for this website are promoting the educational mission of the FDA, and promoting opportunities for patient advocacy within the FDA — and earlier in the policymaking process than has been the case historically....[A spokesperson described it in the following way:]“The idea is to engage the patient community, to have the patient voice heard at the FDA....The FDA Safety & Innovation Act (enacted in mid-2012) mandates the involvement of patient representatives in roles beyond those of the advisory committees. Draft procedures for patient involvement are due to be made public in September of this year....Unlike opportunities for patient involvement in other government agencies, the FDA recognizes patient representatives on advisory committees (and in the new roles) as consultants....and this means that patients involved in the FDA processes in an official capacity are paid for their time and expenses. Aside from this new program, the website really just puts a patient-friendly face on an existing set of resources — clinical trials, investigational products, and more — but the improvement is quite welcome.

Long overdue is the feature of the FDA site that provides a much clearer advice for patients regarding participation in clinical trials. Previously, most of this was in the hands of treating physicians. As I was browsing the various links in the clinical trials section of the FDA patient network website, I came across the following information regarding what a patient should think about before joining a clinical trial:

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment. Be sure you understand:

• what happens during the trial
• the type of health care you will receive
• any related costs once you are enrolled in the trial
• the benefits and risks associated with participating. 

Very succinct advice and also very important and relevant. As a former member of an IRB, I can attest to the fact that each of these bulleted points is critical and worthy of extensive conversation before joining a clinical trail. I encourage all patients with serious disease to utilize the FDA patient web site and not remain totally depend on their physicians' advice for consideration and admission to clinical trials. I am also impressed by the fact that the FDA has developed this web site in what seems to be a patient-friendly way and tried to avoid too much bureaucratic and regulatory jargon.