Testing, Testing… $, $$, $$$

If doctors knew the exact price of expensive medical tests would they order fewer of them?

That’s exactly what Johns Hopkins researchers wanted to know.

The answer has just been published in the Journal of the American College of Radiology, and it’s a resounding: No!.  According to the investigators, revealing the costs of MRIs and other imaging tests up front had no impact on the number of tests doctors ordered for their hospitalized patients.

“Cost alone does not seem to be the determining factor in deciding to go ahead with an expensive radiographic test,” says the study’s senior author, Daniel J. Brotman, M.D., director of the hospitalist program at The Johns Hopkins Hospital. “There is definitely an over-ordering of tests in this country, and we can make better decisions about whether our patients truly need each test we order for them. But when it comes to big-ticket tests like MRI, it appears the doctors have already decided they need to know the information, regardless of the cost of the test.”

Some earlier studies have suggested that much of the expense of laboratory tests, medical imaging and prescription drugs is unknown or hidden from providers and patients at the time of ordering, leaving financial considerations largely out of the health care decision-making process and likely driving up costs. Other studies have shown that doctors ordered fewer laboratory tests in some cases when they were given the price up front.

But, imaging tests appear to be “a different animal.”

Although there are certain inherent disincentives, aside from cost, to ordering some major tests, such as the potential danger of radiation used, physicians also need to learn how to explain to patients why they may not need them.

For the six months of the study, Brotman and his colleagues identified the 10 imaging tests most frequently ordered for patients at The Johns Hopkins Hospital. Five of these were randomly assigned to the active cost display group and 5 to the control group. During a 6-month baseline period from November 10, 2008, to May 9, 2009, no costs were displayed. During a seasonally matched period from November 2009, to May  2010, costs were displayed only for tests in the active group. At the conclusion of the study, the radiology information system was queried to determine the number of orders executed for all tests during both periods.

And, when they compared the ordering rates to the rates from a six-month period a year earlier, when no costs were displayed at all, they found no significant difference in ordering patterns.

Is this a good or a bad thing?

Certainly there are many instances when expensive tests are justified. When a key diagnosis is needed there are limited options for comparison shopping.  For example, when a patient appears to have had a sub-acute stroke, an MRI is needed regardless of cost.

That is not to say there aren’t times when physicians need to look more closely at whether too many imaging tests are being ordered. Do ventilated intensive care unit patients really need a daily chest X-ray to look for potential lung problems?  Especially when there is good medical evidence that outcomes aren’t compromised if X-rays are ordered only when the patient’s condition appears to be worsening.

“For too long, there has not been enough attention paid to the bottom line in health care,” Brotman says. This isn’t about rationing care to hold down costs, he says, but about choosing tests a little more wisely.

Even though price transparency didn’t influence the way physicians ordered imaging tests in this study, financial considerations may play a role in other circumstances if tied to clinical evidence.

If you show a provider that he or she is ordering four times as many CT scans as a colleague whose patients have similar outcomes, it could change the decision-making calculus for the better.

“Cost transparency must be part of the solution to solving fiscal challenges in medicine,” Brotman says. “Providers have no idea how much they’re spending. Patients don’t know either. Having everyone understand more of the economics of health care is a great place to start cutting costs in medicine.”

Seems logical to us.

Which Is Worse, Hepatitis B or Hepatitis C?

Chronic hepatitis B and chronic hepatitis C, while caused by different viruses are clinically indistinguishable. Both affect the liver and both are potentially fatal.  Over years or decades, chronic HBV and HCV infection can progress to severe liver diseases including cirrhosis, liver cancer, and ultimately end-stage liver failure.

However, until now, few head-to-head comparisons of clinical outcomes have been attempted.

So, we were really interested to read a new study published in the Journal of Clinical Infectious Diseases.  This study is the first in which the effects of hepatitis B and hepatitis C virus infections were compared in a relatively homogeneous population.

Researchers from Johns Hopkins, led by Oluwaseun Falade-Nwulia, studied almost 7,000 American men included in the large Multicenter AIDS Cohort Study (MACS) prospective database of men who have sex with men.

Approximately 5% of participants entered the study with each type of chronic hepatitis.  At the end of an 8 year follow-up, all-cause mortality was similar in both groups, but liver-related mortality was significantly higher for those with chronic hepatitis B infections. This finding held true for both HIV-negative and HIV-positive participants, including those who were severely immune-compromised.

Excluding the few men in the study who underwent treatment for hepatitis C, infection did not change the pattern. However, liver-related deaths among participants who were co-infected with hepatitis B and HIV and who were enrolled after 2002 were markedly lower than among those who were enrolled earlier, possibly reflecting use of newer antiviral drugs that are active against both HIV and hepatitis B virus.

These results are worth noting for a number of reasons.  First, they underscore the need for expansion of HBV screening and vaccination to protect against HBV infection. Second, they suggest individuals co-infected with HIV/HBV should be treated with dually active drugs.

And lastly, despite the recent surge of public health advertisements that have brought hepatitis C screening and treatment into the public eye, clinicians should remember that hepatitis B is still out there, and that effective oral treatment can save lives.

Hope for hard-to-match kidney patients

The first (unsuccessful) human-to-human kidney transplant took place 75 years ago.  Some 16 years later, the first successful human transplant took place. Now, according to the United Network for Organ Sharing (UNOS), there are currently 111,714 people in the US awaiting organ transplantation.  Approximately 20,000 of these are so called “hard-to-match” kidney transplant patients.

In other words, their immune systems will reject most kidneys because of antibodies circulating in their blood that react to proteins known as human leukocyte antigens (HLA). These proteins are found on most cells and are used by the immune system to recognize what is foreign to the body.

In HLA-sensitized patients, the body has been exposed to foreign HLA in the past, either through pregnancy, blood transfusion or previous kidney transplant. As such, it immediately recognizes most donor organs as unfamiliar. And, unless these antibodies can be removed, they will result in severe antibody mediated rejection (AMR) and early loss of the transplanted organ.

Apart from the scarcity of donor kidneys, the biggest barrier to kidney transplant is the percentage (nearly 1:3) of patients on the waiting list whose immune systems make them likely to reject most kidneys available to them. Highly HLA-sensitized patients are very difficult to match with less than 7% receiving transplants each year.

SRxA’s Word on Health was therefore interested to hear of a new study from Johns Hopkins which showed that desensitizing such patients with a combination of therapeutic plasmapheresis and intravenous immunoglobulin (IVIG) doubled their chance of survival eight years after transplant surgery, as compared with those who stay on dialysis awaiting compatible organs.

Additionally, the protocol enabled a dramatic 98% transplant rate rather than the traditional 7%.

“The results of this study should be a game changer for health care decision makers, including insurance companies, Medicare and transplant centers,” said lead investigator Robert A. Montgomery, M.D., D. Phil. “There’s a dramatic survival benefit, so people should take note. If this were a cancer drug that doubled chances of survival, people would be lined up out the door to get it. It’s really extraordinary to go from 30 percent survival to 80 percent survival after eight years.”

Widespread use of the pre-surgery protocol developed at Johns Hopkins could potentially lead to 3,000 more kidney transplants from living donors each year. The protocol uses plasmapheresis to remove the HLA from the blood before the transplant, then the patient receives low-dose intravenous immune globulin (a human plasma protein) to replace the problematic antibodies and prevent their return. This process is performed every other day for several days before transplant and then for up to 10 days following the surgery.

Although the protocol has great benefit in living donor transplants, it cannot be used in patients receiving cadaver organs – where time is of the essence,  because several days of plasmapheresis and IVIG are needed before surgery can take place.

Additionally, the patient will still to take the same anti-rejection drugs as all other organ transplantation patients.

The desensitization protocol also makes kidney transplants more expensive, However, the cost savings when compared to remaining on dialysis are enormous. Better still, the patient no longer has to endure the difficulties of dialysis, a process that takes about five hours a day, three days a week, and which often makes the tasks of daily life from working to caring for children nearly impossible.

“This treatment increases survival, ensures a better lifestyle and saves the health care system money,” says Montgomery. “There aren’t many things like that.”

Let’s hope healthcare insurers are reading this and taking note.

The Doctor Will See You All Now!

Overcrowded waiting room and endless wait times may soon  be a thing of the past. At least for patients with Parkinson’s disease.

According to a  study published in the online issue of Neurology, group appointments may be feasible for patients with Parkinson’s disease. Group visits  allow patients more time with their doctor, provide more opportunity for disease management education and allow patients and their caregivers to share their experiences and learn from one another

The study compared patients who received normal care from their physician with patients who had underwent group visits. The “normal care” group had 30-minute appointments with their physicians every three to six months. Group visits lasted 90 minutes and were held every three months and included introductions, updates from patients, and an educational session on a topic chosen by the participants. Time was allotted for questions from patients or caregivers, and individual 10-minute appointments with the physician were scheduled for before or after the group visit for individual concerns.

Of the 30 study participants, 90% completed the 12 month study, along with 93% of the 27 participating caregivers. At the end of the study, there was no difference between those receiving normal care and those participating in the group visits in how they rated their overall quality of life.

Participants were also asked whether they preferred the group visits or usual care. Of those receiving group visits two thirds said they preferred them. Among the normal care group, opinions were roughly divided.

“While both support groups and traditional visits have clear benefits, a survey of people with Parkinson’s showed that they desire more information for them and their caregivers about their disease,” said study author E. Ray Dorsey, MD, MBA, of Johns Hopkins University School of Medicine.

Group visits can give physicians the opportunity to observe their patients for a longer period of time and appreciate disease characteristics such as fluctuations in their symptoms and daytime sleepiness that may not readily be appreciated during a routine 20- to 30-minute office visit.  However, they may also pose logistical issues, such as scheduling difficulties and the need for a large room. Additionally, there is a potential risk that the lack of a one-on-one examination could lead physicians to miss subtle problems and also some concerns about patient confidentiality.

Perhaps what is needed is a hybrid model – where patients alternate between group and individual appointments.

Have you experienced a group appointment?  Would you be willing to have a group appointment? Please share your thoughts with us.

Clinical Research under scrutiny?

If you watched the news at all over the past week you probably saw CNN‘s Sanjay Gupta‘s confrontation with disgraced doctor Andrew Wakefield.  He, as you may recall was the author of the 1998 study that linked autism to some childhood vaccines and set off a worldwide scare for parents.

In the intervening years there have been countless lawsuits against vaccine manufacturers and millions of children who, perhaps needlessly, have gone unvaccinated.  Recently,  an investigative report published in the British Medical Journal called the original study an elaborate fraud.

So, is Dr Wakefield alone in manipulating clinical trial data?  Can we rely on other clinical studies to provide us with the truth?

No, not according to researchers at Johns Hopkins.  In a report published January 4th in the Annals of Internal Medicine the authors concluded that the vast majority of published clinical trials of a given drug, device or procedure are routinely ignored by scientists conducting new research on the same topic.

Trials being done may not be justified, because researchers are not looking at or at least not reporting what is already known.  In some cases, patients who volunteer for clinical trials may be getting a placebo for a medication that a previous researcher has already determined works or may be getting a treatment that another researcher has shown is of no value. In rare instances, patients have suffered severe side effects and even died in studies because researchers were not aware of previous studies documenting a treatment’s dangers.

Not surprising then that they go on to say, “the failure to consider existing evidence is both unscientific and unethical.”

The report argues that these omissions potentially skew scientific results, waste taxpayer money on redundant studies and involve patients in unnecessary research.

Conducting an analysis of published studies, the Johns Hopkins team concludes that researchers, on average, cited less than 21% of previously published, relevant studies in their papers. For papers with at least five prior publications available for citation, one-quarter cited only one previous trial, while another quarter cited no other previous trials on the topic. Those statistics stayed roughly the same even as the number of papers available for citation increased. Larger studies were no more likely to be cited than smaller ones.

“The extent of the discrepancy between the existing evidence and what was cited is pretty large and pretty striking,” said Karen Robinson, Ph.D., co-director of the Evidence Based Practice Center (EPIC) at the Johns Hopkins University School of Medicine and co-author of the research.  “It’s like listening to one witness as opposed to the other 12 witnesses in a criminal trial and making a decision without all the evidence. Clinical trials should not be started — and cannot be interpreted — without a full accounting of the existing evidence.”

The Hopkins researchers could not say why prior trials failed to be cited, but Robinson says one reason for the omissions could be the self-interest of researchers trying to get ahead.

Want to make sure that your clinical trials stay on track and that your publications are evidence-based?

Contact SRxA for more details.

Pedestrian Struck!

As a volunteer EMT and trainee paramedic, this SRxA Word on Health blogger has seen, all too frequently, the tragic consequences of pedestrian trauma.

These are never good calls. Regardless of the cause or the circumstances, in the battle of man-versus-metal, it’s rarely the car that suffers.  In such circumstances, we do everything we can, and like to think that our interventions play a critical role in the survival of such patients.

However, new research from Johns Hopkins suggests that the victims’ race and economic factors are also crucial determinants of outcome.  According to a study just published in Surgery, even if the injuries sustained are similar, uninsured, minority pedestrians hit by cars are at a significantly higher risk of death than their insured white counterparts.

The death rate disparity is compounded by the fact that minority pedestrians are far more likely than white pedestrians to be struck by motor vehicles.

“It’s a double whammy,” says Adil H. Haider, M.D., M.P.H., an assistant professor of surgery at the Johns Hopkins University School of Medicine and the study’s senior author. “Minorities are much more likely to get injured by this mechanism and much more likely to die by this mechanism.”

Researchers reviewed National Trauma Data Bank information on 26,404 patients hit by vehicles between 2002 and 2006. African-American patients had a 22% greater risk of death and Hispanic patients a 33% greater risk of death than white patients involved in similar crashes. Meanwhile, the researchers said, uninsured patients had a 77% greater risk of death than those who were insured.

“Do we treat minorities and the uninsured differently? I don’t think so, but we’ve got to ask the question,” added Haider.

A greater prevalence of, or lack of treatment for, co-morbidities, such as obesity, diabetes or hypertension, could be factors that raise the risk of death among injured minority or uninsured crash victims.

Since the underlying causes of the disparities can’t be easily answered, Haider says, policy makers need to focus in the short term on better pedestrian injury-prevention programs, particularly in the inner city, where many of these deadly crashes occur.

Here at Word on Health, we say “Be Careful.”   Much as we love our readers, let’s not meet on an ambulance.

A New, Less Invasive Technique for Kidney Donation

Surgeons at a leading US hospital are studying a new way to make kidney donation safer, less invasive and almost scar free for women by using a new technique that removes kidneys transvaginally.

The technique is called natural orifice translumenal endoscopic surgery (NOTES), in which surgeons use a natural opening in the body to minimize pain and scarring, making recovery much easier.

According to the United Network for Organ Sharing (UNOS), more than 60% of living kidney donors are female.

Currently, kidney donors undergo either open or minimally invasive laparoscopic surgery.  During the latter operation the surgeon prepares the kidney for removal by working through three ¼-inch incisions. However, when it comes time to remove the kidney, a larger three- to four-inch incision must still be made for the extraction. The larger incision is the source for most of the pain and scarring. Other complications of current surgical techniques include hernias and wound infection.

Removing the kidney transvaginally, where there are relatively few pain fibers, results in a nearly painless operation with no extraction scar.  The first procedure was performed, to media fanfare in February 2009 at Johns Hopkins University, in Baltimore, MD.  Although deemed a success, there was, at the time, considerable skepticism from other clinicians.

Now, a study is being undertaken at the Methodist Hospital in Houston, TX, which intends to examine some of these concerns.

The investigators will conduct a microbiological analysis of the cervix and vagina of patients undergoing laparoscopic transvaginal hysterectomy. A sterile mock kidney will be placed in the patient’s abdomen and extracted transvaginally at the end of the hysterectomy procedure. They will conduct a microbiological analysis of the mock kidney after the procedure, as well.

If this analysis shows no evidence of contamination, or other adverse effects, this technique may become a future standard, improving donor and recipient safety while reducing pain and recovery time for the donor.  Ultimately, it is hoped, it will also increase the number of donors.

According to UNOS there are, as of today, over 108,000 people in the US awaiting a transplant. For them, and their potential living donors, the results can probably not come soon enough.