Questioning Surgery for Early Prostate Cancer - NYTimes.com

A new study shows that prostate cancer surgery, which often leaves men impotent or incontinent, does not appear to save the lives of men with early-stage disease, who account for most cases, and many of these men would do just as well to choose no treatment at all.

The findings were based on the largest-ever clinical trial comparing surgical removal of the prostate with a strategy known as "watchful waiting." They add to growing concerns that prostate cancer detection and treatment efforts over the past 25 years, particularly in the United States, have been woefully misguided, rendering millions of men impotent, incontinent and saddled with fear about a disease that was unlikely ever to kill them in the first place. About 100,000 to 120,000 radical prostatectomy surgeries are performed in the United States each year.

"I think this is game-changing," said Dr. Leonard Marks, a professor of urology at the University of California, Los Angeles, who was not involved in the study. "What this study does is call attention to the fact that there are a lot of prostate cancers that are diagnosed today that are not dangerous."

Even so, the research, published Wednesday in The New England Journal of Medicine and paid for by the Department of Veterans Affairs, the National Cancer Institute and the Agency for Healthcare Research and Quality, is unlikely to settle the debate about the best course of care for men with prostate cancer.

An editorial accompanying the report argued that the study of 731 men, while important, is still too small to draw definitive conclusions about the relative benefits of radical prostatectomy. In addition, slightly more men who did not undergo surgery developed bone metastases over the course of the 15-year study. There was no statistical difference in risk of death from prostate cancer or any cause among men who were randomly assigned to surgery or to an observation group. There was also a suggestion that men with very high scores on a prostate cancer screening test were more likely to benefit from surgery.

The study included only men with early-stage disease, about half of whom learned of their cancer as a result of the prostate specific antigen, or P.S.A., screening blood test. About 81 percent of men with prostate cancer have early-stage or localized cancer, which means it has not spread beyond the prostate. But the findings are not relevant to men with more advanced disease, who may benefit from aggressive treatment, said Dr. Ian Thompson, director of the cancer therapy and research center at the University of Texas Health Science Center in San Antonio.

"The real point is that we shouldn't focus on finding every prostate cancer because, as this study and all the screening studies show, the majority that you find don't need to be found,'' said Dr. Thompson, an author of the editorial. "What we should focus our screening on and our testing on are patients who are likely to have more aggressive tumors in which treatment seems to make a difference."

This year, about 242,000 men will receive a diagnosis of prostate cancer, largely because of screening for high levels of P.S.A. in the blood. About 28,000 men die of prostate cancer each year, making it the second-biggest cancer killer of men, second only to lung cancer. Even so, large studies now show that early detection by P.S.A. screening makes little, if any, difference in whether a man dies from prostate cancer.

In May, the United States Preventive Services Task Force issued a controversial recommendation against regular P.S.A. screening. The task force concluded that the test offers little, if any benefit, yet subjects men to anxiety and painful biopsies and often puts them on the course of invasive and risky treatment. But several medical groups have criticized the finding, and P.S.A. testing remains an entrenched part of men's health care at middle age.

The latest research, called the Prostate Cancer Intervention Versus Observation Trial, or Pivot, focuses on what happens after a man receives a diagnosis of early-stage cancer, often as a result of a P.S.A. test. The men in the study were randomly assigned either to surgical removal of the prostate or to an observation group, where a man's cancer was monitored but not treated unless it showed signs of progressing. Although the study originally set out to recruit 2,000 men, the researchers could not reach that goal and revised the research plan to include 731 men.

By the end of the 15-year study, 354 men had died, but most of them had died of from a cause other than prostate cancer. There was no statistical difference in overall mortality rates in the surgical group, which had 171 deaths, compared with the observation group, which had 183 deaths.

During the study, only 52 men, or about 7 percent of the study subjects, died of prostate cancer, but again there was no statistical difference in the prostate cancer mortality rate between the groups.

But in a secondary analysis, the researchers did find an important difference between the groups, suggesting that surgery may benefit men with early-stage disease who have a high P.S.A. score. Among men with a P.S.A. value higher than 10 nanograms per milliliter of blood, surgery lowered a man's risk of dying by 33 percent compared with the observation group. Overall, among men with high P.S.A. scores, there were 13 percent fewer deaths in the surgery group compared with the observation group. No difference was seen among men with a P.S.A. value of 10 or less.

Dr. Timothy J. Wilt, the study's lead author and professor of medicine at Minneapolis Veterans Affairs Center for Chronic Disease Outcomes Research, said he hoped the results would give patients with early-stage disease more confidence to choose watchful waiting as an option.

About 90 percent of men with early-stage disease choose immediate treatment with surgery or radiation, he said.

"Many men, when they hear about a diagnosis of prostate cancer, become fearful," Dr. Wilt said. "They think if they aren't treated they will die from it. Our results clearly demonstrate that's not true. The overwhelming majority will not die of their disease if it's left untreated."

http://well.blogs.nytimes.com/2012/07/18/questioning-surgery-for-early-prostate-cancer/?nl=todaysheadlines&emc=edit_th_20120719

Are Warnings About the Side Effects of Drugs Making Us Sick? | NeuroTribes

Your doctor doesn't like what's going on with your blood pressure. You've been taking medication for it, but he wants to put you on a new drug, and you're fine with that. Then he leans in close and says in his most reassuring, man-to-man voice, "I should tell you that a small number of my patients have experienced some minor sexual dysfunction on this drug. It's nothing to be ashamed of, and the good news is that this side effect is totally reversible. If you have any 'issues' in the bedroom, don't hesitate to call, and we'll switch you to another type of drug called an ACE inhibitor." OK, you say, you'll keep that in mind.

Three months later, your spouse is on edge. She wants to know if there's anything she can "do" (wink, wink) to reignite the spark in your marriage. She's been checking out websites advertising romantic getaways. No, no, you reassure her, it's not you! It's that new drug the doctor put me on, and I hate it. When you finally make the call, your doctor switches you over to a widely prescribed ACE inhibitor called Ramipril.

"Now, Ramipril is just a great drug," he tells you, "but a very few patients who react badly to it find they develop a persistent cough…" Your throat starts to itch even before you fetch the new prescription. Later in the week, you're telling your buddy at the office that you "must have swallowed wrong" — for the second day in a row. When you type the words ACE inhibitor cough into Google, the text string auto-completes, because so many other people have run the same search, desperately sucking on herbal lozenges between breathless sips of water.

In other words, you're doomed. Cough, cough!

What's going on here? Just medicine-as-usual in a world where valuable drugs have annoying side effects and conscientious health professionals do their best to protect their patients from unpleasant (and potentially litigious) surprises? Sure. But aprovocative new report by Winfried Häuser, Ernil Hansen, and Paul Enck in the journal of the German Medical Association suggests that the side effects of some drugs, and the discomfort of certain medical procedures, may be inadvertently intensified by doctors and nurses trying to keep patients fully informed of the consequences of their medical care. The culprit behind this phenomenon is the nocebo effect.

You can think of the nocebo effect as the evil twin of the placebo effect — the body's healing response to the act of taking a pill or receiving medical care, even if the pill itself is inert. The most familiar example of the placebo effect is what happens in trials of experimental drugs. One group of volunteers is randomly assigned to take the drug in question; another group is assigned to take placebo — a fake drug designed to look just like the real one. Neither the volunteers nor the staff know which group is which. If the drug group improves significantly more than the placebo group, the drug is judged to be effective. This kind of test — thedouble-blind, placebo-controlled trial — has been the gold standard of drug development in medicine for half a century.

In real life, gauging the effectiveness of a new medication is not quite that easy. In 2009, I wrote a widely-circulated article in Wiredmagazine about a mysterious increase in placebo effects in trials in recent years that is making it harder for Big Pharma to bring new drugs to market. I explored some of the reasons that might be happening in the article.

A placebo, you might say, is an ersatz drug that makes you feel better, while a nocebo is a fake drug that makes you feel worse. Of course, in both cases, it's not the pill that's doing the work; it's your own body, responding to the social context in which you take the pill. If a skilled doctor with kindly bedside manner tells you that drug X will reduce the inflammation of a minor injury, it often will — even if the drug itself is nothing but a capsule full of lactose, milk sugar. One of the astonishing things we've discovered about the placebo effect in recent years is how wide a range of ailments can be ameliorated by it, at least temporarily — from chronic pain, to high blood pressure, to inflammation, to depression and anxiety, to sexual dysfunction, to the nausea and vomiting caused by chemotherapy. Perhaps unsurprisingly, it turns out that the nocebo effect is equally capable of making you feel more miserable, in a similarly broad range of ways.

One of the most interesting findings in the new report from Germany is about the underappreciated — and under-studied — role of nocebo effects in clinical trials.

If you tell a group of trial volunteers that they're testing a new drug that may relieve the pain of migraines, a significant number of volunteers will experience pain relief after taking the drug — even if they've been randomly assigned to the placebo group and are receiving nothing but sugar pills. The placebo effect in action.

But here's where it gets interesting. If you tell the volunteers that the side effects of this new medicine may include dry mouth, tingling in the hands and feet, and slight dizziness, some volunteers will experience precisely these side effects — in bothgroups. In fact, some volunteers who are taking nothing but sugar pills will be made so uncomfortable by these symptoms that they will choose to drop out of the trial early.

The relevance of the nocebo effect is not limited to clinical trials. A particularly nasty demonstration of its power can be provided by patients who are being treated for Parkinson's disease with small doses of electrical current delivered to certain structures in the brain. This technique, known as Deep Brain Stimulation (DBS), has been shown to be effective in controlling tremor and other motor issues in patients who are resistant to drugs. But if you tell a DBS patient that the current has been switched off — even though it remains on — their coordination and other motor functions will abruptly decline until you tell them that the juice has been switched on again. Classic nocebo.

The German researchers cite many other examples. In one study, 50 patients with chronic back pain were randomly divided into two groups before a leg flexion test. One group was informed that the test could lead to a slight increase in pain, while the other group was instructed that the test would have no effect. Guess which group reported more pain and was able to perform significantly fewer leg flexions?

Another example from the report: Patients undergoing chemotherapy for cancer treatment who expect these drugs to trigger intense nausea and vomiting suffer far more after receiving the drugs than patients who don't. That's not to say that this nausea is imaginary, purely psychological, or "all in their heads." Like placebo effects, nocebo effects are physiological, not just mental. Researchers like Franklin Miller at the National Institutes of Health and Tor Wager at the University of Colorado are learning that nocebo effects are mediated by neurotransmitters like dopamine, endogenous opioids, and cholecystokinin. Telling a volunteer that the scented Vaseline you're slathering on their arm is a pain-intensifying gel triggers a cascade of chemicals in the body that magnify sensations of discomfort.

How evil can the evil twin of the placebo effect get? Even setting aside anecdotal accounts of evil eyes and "voodoo death" (first reported by a doctor named William Cannon in 1942), nocebo effects can kill, or at least accelerate the progress of disease. In traditional Chinese astrology, some potentially fatal maladies like cancer are associated with certain birth years. A 1993 study of Chinese-Americans who came down with these diseases found that they were more likely to die faster if they were born in an "ill-fated" year associated with the disease — but only if they believed in traditional Chinese astrology. (In these tragic cases, a dose of skepticism could have at least staved off the inevitable for a little while.)

In recent years, the phrase "informed consent" has become a mantra in public health, which is good news for many reasons. But what if the lengthy litanies of side effects we've become accustomed to skimming over — on printouts at the pharmacy, in ads for the latest antidepressants — are self-fulfilling prophecies? What if our well-intentioned desire to prepare patients for the worst increases the probability that the worst will happen?

Even the specific words employed by a doctor can influence the course of a patient's treatment. Some particularly dreadful word choices cited by the German researchers include doctors telling patients:

You must strictly avoid lifting heavy objects — you don't want to end up paralyzed.

You are a high-risk patient.

We're putting you to sleep now. It will soon be all over.

Though the German report focuses on clinical practice and bedside manner, it's hard not to think about the broader implications of nocebo effects in daily life. If you're ever been told twice in one afternoon that you "look a little worn out," you know that it's a miracle if you don't feel utterly exhausted – if not physically ill — by the end of the day. Knowing about nocebo has made me much more careful when making observations about a friend's physical condition.

The German report also points out that nocebo effects deserve much more study. One promising avenue for research might be examining the role of negative messaging in large-scale social phenomena like the apparent increase in food allergies in recent years, or the surge in popularity of gluten-free diets. Having friends with celiac disease and autism, I'm fully aware that some people are truly gluten intolerant, and that banishing the dreaded protein from the menu can avert serious medical problems. But the new report makes me wonder if the flood of anti-gluten "awareness" messages on social networks isn't lengthening the lines for pricey GF pasta, crackers, and doughnuts at my neighborhood Whole Foods Market.The conflict between the need for informed consent in medicine and our bodies' propensity to take social factors into consideration when calculating our own health status is not an easy problem. In recent years, the pendulum has swung so far in the direction of more-bad-news-is-better that it seems almost like heresy to suggest that some of this paternalistic advice may actually be making us sicker.

The new generation of placebo and nocebo research is teaching us that how we feel is highly dependent on the feedback we get from the people around us, particularly from trusted health professionals. The next time I get a headache, you'll forgive me if I don't re-read the label on the aspirin bottle warning me about the possibility of hives, facial swelling, asthma, shock, Reye's Syndrome, nausea, vomiting, severe stomach bleeding, allergic reactions, and distressingly vague "changes in behavior."

I'll just take two and hope for the best.

http://blogs.plos.org/neurotribes/2012/07/16/are-warnings-about-the-side-effects-of-drugs-making-us-sick/

Signs of Cognitive Decline and Alzheimer’s Are Seen in Gait - NYTimes.com

The way people walk appears to speak volumes about the way they think, so much so that changes in an older person's gait appear to be an early indicator of cognitive impairment, includingAlzheimer's disease.

Five studies presented at the Alzheimer's Association International Conference in Vancouver this month provide striking evidence that when a person's walk gets slower or becomes more variable or less controlled, his cognitive function is also suffering.

Thinking skills like memory, planning activities or processing information decline almost in parallel with the ability to walk fluidly, these studies show.

In other words, the more trouble people have walking, the more trouble they have thinking.

"Changes in walking may predate actually observable cognitive changes in people who are on their way to developing dementia," said Molly Wagster, chief of the National Institute on Aging's behavioral and systems neuroscience branch. Experts said the studies could lead to developing a relatively simple tool that doctors could use to forecast, if not diagnose, possible Alzheimer's disease.

"You can probably just watch them walk down the hall in your office and look for people who are starting to show deterioration in their gait and have no other explanation for it," said William Thies, the chief medical and scientific officer for the Alzheimer's Association. "If gait begins to deteriorate, we begin to have a conversation about how is your memory."

While scientists have studied gait changes after a heart attack or stroke and in diseases like Parkinson's, they have only recently begun studying connections between walking and cognition. For decades, people thought slower walking was just part of getting old, but research shows some changes in gait signify problems that go beyond normal aging.

"It's like driving a car — you need an engine, a chassis and steering," said Dr. Stephanie Studenski, an expert on walking who was not involved in the dementia studies. The engine of walking is the heart, lungs and blood, she said. The chassis is the muscles, joints and bones.

And the steering is "the wiring — the nervous system," said Dr. Studenski, a geriatrician at the University of Pittsburgh and the Pittsburgh Veterans Administration.

"People who are focused on cognition largely never watch people move," Dr. Studenski said. "The tests are all done sitting down. But damage to the wiring is an important shared problem of difficulty with thinking and difficulty with moving."

The new studies were larger and more detailed than previous research, and involved sophisticated measures of changes in gait. Some used an electronic walkway, a long mat outfitted with sensors that measure small differences in walking speed, cadence (the number of steps per minute), the width of the stride and variability (how often the person's stride changes).

The studies screened out people with arthritis or other physical problems, and adjusted for height, age, weight and sex.

One study involved more than 1,100 elderly people in Basel, Switzerland. About a quarter of them were cognitively healthy, while the others had mild cognitive impairment, considered a precursor to dementia, or were in various stages of Alzheimer's.

The participants walked normally on the electronic walkway, and again while performing a cognitive task: counting backward by two's from 50, or naming animals.

One 72-year-old woman's first walking test betrayed no problems. But when she walked while counting backward from 50, her gait worsened dramatically, said Dr. Stephanie Bridenbaugh, head of the Basel Mobility Center.

"She teetered and wobbled on one foot," Dr. Bridenbaugh said. "She almost tipped to the side." And "she didn't notice any of it," she added. "She was mad that she didn't remember more numbers."

Dr. Bridenbaugh referred her to the memory clinic, where cognitive testing showed the woman already had mild cognitive impairment.

Asking people to simultaneously perform thinking and movement tasks revealed "deficits that you can't see with the naked eye," Dr. Bridenbaugh said. It may be that the brain is already so compromised that it cannot coordinate its circuits to efficiently manage such "dual tasks."

"A lot of times normal walking looked normal, even in people with moderate Alzheimer's, but if you look at dual tasking, I can detect these problems," said Dr. Bridenbaugh. Her research consistently showed that people who walked more slowly or inconsistently did worse on cognitive tests; the worst walkers had the most severe Alzheimer's.

A large study at the Mayo Clinic involved basic walking, not dual-tasking, but found a similar relationship, said Dr. Rodolfo Savica, a neurologist at the clinic. Most of the 1,341 participants did not have dementia. They were evaluated twice, 15 months apart, with tests of cognitive ability and walking.

Dr. Savica and his colleagues found that on average a person who walked one meter per second slower on their second test scored half a point lower on cognitive tests.

Slower walking was mostly strongly linked to declines in "executive function," the ability to plan and organize activities. A study led by Dr. M. Arfan Ikram, a neuroepidemiologist at Erasmus MC University Medical Center in Rotterdam, tried to connect particular changes in gait with specific cognitive impairments.

More than 1,200 people with no signs of dementia were asked to walk normally, to walk and turn around halfway through, and to "tandem walk," in which the heel of one foot is placed directly in front of the toe of the previous foot. The subjects also were given cognitive tests.

People with poor tandem walking scored low on tests involving fine motor skills. People with lower cadences, who took fewer steps per minute, did worse on tests of thinking speed. And people whose walks were slower and more variable showed poor executive function.

Dr. Ikram said no specific aspect of walking was correlated to memory problems, perhaps suggesting "that memory is purely a brain function which expresses itself only in cognition."

Aside from suggesting that walking may provide early clues that dementia is on its way, the studies may reinforce the possibility that physical activity could help stave off dementia. If slower and more erratic walking signifies neurological damage, could exercises to improve fitness and coordination not only help people walk, but also by help them think?

"Those are the ultimate questions," Dr. Ikram said. "Right now, we are really at the first step."

Next, said Dr. Bridenbaugh, "what we need is to use the information we have here and find a screening tool that physical therapists and doctors can use to red flag those who have a mobility problem. This should be basic. When your patient is in your office and you listen to their heart, it should be basic to see how they walk."

http://www.nytimes.com/2012/07/17/health/research/signs-of-cognitive-decline-and-alzheimers-are-seen-in-gait.html?_r=1&src=me&ref=general

The Couch Potato Goes Global - NYTimes.com

Last month, researchers affiliated with the World Health Organization and the London School of Hygiene and Tropical Medicine reported that, worldwide, people's waistlines are expanding, with the total combined weight of human beings on Earth now exceeding 287 million tons. A third of that global human biomass exists in North America, although we account for only 6 percent of the world's population.

The study was widely publicized, especially after the BBC used its findings to develop a diverting online tool that lets users compare their biomass to that of people in other nations. (I learned that I have the B.M.I. of your average, middle-aged Eritrean.)

The study, however, did not address possible underlying causes of the ever-growing weight of nations.

But a group of groundbreaking new reports, being published online as a series today in The Lancet, suggest that voluntary physical inactivity, a practice once confined mostly to North America and parts of Europe, is spreading rapidly to the rest of the world and likely contributing materially to global gains in tonnage and declines in health.

Consider the findings of perhaps the most sobering of the new studies, which looked at the extent to which sedentary lifestyles are colonizing the world.

Led by Pedro C. Hallal, a professor at the Federal University of Pelotas in Brazil, the researchers turned to a large body of data about activity that the W.H.O. has been collecting in recent years. To gather the data, the W.H.O. provides questionnaires to people in various nations that ask, in effect, how much they exercise and otherwise move in their daily lives, an admittedly inexact way to measure activity (people misremember or, for cultural or other reasons, prevaricate). But it's the best global information currently available.

The latest figures suggest that the world's population has become disturbingly inactive. According to the researchers' calculations, 31.1 percent of the world's adults, or about 1.5 billion people, are almost completely sedentary, meaning that they do not meet the minimum recommendation of 150 minutes of walking or other moderate activity per week, or about 20 minutes a day.

Teenagers are faring even worse. More than 80 percent of young people ages 13 to 15 worldwide are not getting the hour a day of vigorous exercise recommended for their age group.

Unsurprisingly, North America and Europe lead the world in not exercising, with 43.3 percent of Americans and 24.8 percent of Europeans not reaching the low recommended threshold. But the world is catching up or, rather, joining us in sitting down. More than 30 percent of Russians are inactive nowadays; ditto in the Middle East; and about 27 percent of Africans are sedentary.

(Although in general, the richer the nation, the less active it is, the most sedentary nation on Earth is the tiny island of Malta, population 419,000, 72 percent of whom almost never voluntarily move around much.)

The consequences for global and personal health are punishing and likely to grow more so, reports another first-of-its-kind study in the Lancet series. In it, the authors conclude that sitting around most of the day has become as deadly as smoking or obesity.

Specifically, using data from W.H.O. and other large population studies worldwide, the researchers determined that inactivity is linked to about 6 percent of all instances of heart disease on Earth; 7 percent of Type 2 diabetes cases; and 10 percent of all breast and colon cancers, including among people who don't smoke and are of normal weight.

About 5.3 million people a year die from diseases tied to physical inactivity, the authors calculated.

By comparison, about 5.1 million die annually because of smoking, as an accompanying comment article points out.

"It seems clear from our data that physical inactivity, on a global scale, is at least equivalent to smoking and obesity," in terms of its deleterious impact on people's health, says Dr. I-Min Lee, a professor of epidemiology at the Harvard School of Public Health, who led the study.

Here, too, the United States is among global leaders, with 10.8 percent of all premature deaths in the United States now related to too little exercise. But other nations are outstripping us. More than 18 percent of deaths in Saudi Arabia are likely linked to physical inactivity, Dr. Lee's group concluded; the same goes in Serbia. In Britain, where the Summer Olympic Games next week will showcase the glories of the human body in motion, almost 17 percent of the nation's deaths are linked to a lack of exercise.

What can be done globally to slow or reverse the trend toward physical inertia? Other studies and comments in the Lancet series propose both governmental and personal action, including building more parks, promoting bike commutes and providing financial incentives, like lower insurance premiums, to encourage exercise, as well as using cellphone apps and other technologies to nudge people toward more movement.

But perhaps the most intriguing and potentially viable suggestion in the Lancet series is to start emphasizing just how deadly physical inactivity can be. "I don't think most people really understand that not exercising," even if someone is otherwise healthy, "appears to be just as unhealthy" as smoking or being severely overweight, Dr. Lee says. A sedentary life is shorter than it should be.

On the other hand, inactivity is easier for most of us to combat than a nicotine addiction or intransigent obesity, she adds. "It only takes a 20- or 30-minute walk most days of the week," she says. "With rare exceptions, everyone, everywhere can manage that," and five million lives around the world could be extended.

http://well.blogs.nytimes.com/2012/07/18/the-couch-potato-goes-global/?pagewanted=print

C. difficile rates dropped after Ontario hospitals released infection rates to the public - thestar.com

Rates of C. difficile dropped by more than one quarter in Ontario after the province made it mandatory for hospitals to publicly report cases of the deadly hospital-acquired infection, according to a new study on the patient safety problem.

Researchers say the drop in rates suggest that public reporting helped to focus hospitals' attention on C. difficile, prompting them to find ways to prevent and reduce the spread of the infectious organism

Prior to September 2008 there were between 5,000 and 6,000 cases annually of C. difficile in Ontario.

After the province introduced mandatory reporting, rates fell by about 26 per cent, which translates to 1,970 fewer C. difficile cases per year, said Dr. Nick Daneman, the study's lead author and infectious disease specialist at Sunnybrook Health Sciences Centre.

"And since about 5 to 6 per cent of patients with C. difficile die directly from the C. difficile or in part from C. difficile, we also estimate this could mean more than 100 lives saved per year in Ontario," said Daneman, who is also an adjunct scientist at the Institute for Clinical Evaluative Sciences.

The study, published Tuesday in the journal PLoS Medicine, is the most rigourous study to date of public reporting on hospital-acquired infections.

Daneman said the results are not only statistically significant, but clinically significant because C. difficile is a common disease that can be fatal. He also said the organism is increasingly becoming more virulent.

Up until September 2008, only hospital administrators and infection control specialists knew the rates of hospital-acquired infections, including rates of C. difficile.

According to the Ministry of Health, there are currently four C. difficile outbreaks in Ontario hospitals, the most recent of which were declared July 5 at the Victoria site of London Health Sciences Centre and July 3 at Mississauga's Trillium Health Centre and The Credit Valley Hospital.

The public release of key hospital data followed a Star investigation into medical secrecy. There are currently nine patient safety indicators reported to the public, including hospital mortality rates and hand-hygiene compliance.

Clostridium difficile is one of the most common causes of infectious diarrhea in hospitals and long-term care facilities and the elderly and those with underlying health problems are most at risk. It has become a problem, in part, because of the over-use of antibiotics.

The study, which relied on an independent data source, found that prior to public reporting, rates of C. difficile increased between 2002 and 2008.

Daneman said the research does not pinpoint the specific mechanisms that reduced rates — that is the subject of further research — but he and his colleagues believe that publicly releasing infection rates motivated hospitals to better adhere to best practices in infection control. These include environmental cleaning practices, hand washing, isolating sick patients and increased surveillance for infection and outbreaks.

Health Minister Deb Matthews said she was pleased with the study's results.

"We know that when you measure and when you publicly report you can really drive change," she said. "People who work in health care really want to do what's best for patients and when they see that they can do better, how they stack up against other hospitals, they can improve their outcomes."

Dr. Michael Gardam, medical director of infection prevention and control at the University Health Network and Women's College Hospital, said

the study, along with anecdotal evidence, suggests that publicly releasing C. difficile rates has had a measurable impact. But he also warned that more needs to be done to control the infectious disease in the province.

Since April 2010, which is when the authors stopped analyzing data, Gardam said C. difficile rates have started to again rise.

"Public reporting has definitely done something, but it's not the only answer," he said.

The need for new hospitals —infection control is more difficult in older institutions — hospital overcrowding, and the continued miss-use of antibiotics continue to lead to C. difficile infections in Ontario, Gardam said.

http://www.thestar.com/news/ontario/article/1227914--c-difficile-rates-dropped-after-ontario-hospitals-released-infection-rates-to-the-public

Don't Get Sick in July - NYTimes.com

It's one of those secrets you normally don't learn in nursing school: "Don't go to the hospital in July." That's the month when medical residents, newly graduated from medical school, start learning how to be doctors, and they learn by taking care of patients. And learning means making mistakes.

There's disagreement in the medical literature about whether a so-called July Effect, where medical error rates increase in the summer, actually exists. But a 2010 article in the Journal of General Internal Medicine and a 2011 article in the Annals of Internal Medicine both found evidence of it. In an interview, Dr. John Q. Young, lead author of the latter review, likened the deployment of new residents to having rookies replace seasoned football players during "a high-stakes game, and in the middle of that final drive."

From what I've experienced as a clinical nurse, whether or not the July Effect is statistically validated as a cause of fatal hospital errors, it is undeniably real in terms of adequacy and quality of care delivery. Any nurse who has worked in a teaching hospital is likely to have found July an especially difficult month because, returning to Dr. Young's football metaphor, the first-year residents are calling the plays, but they have little real knowledge of the game.

This experience deficit plays out in ways large and small, but I remember an especially fraught situation one July when a new resident simply did not know enough to do his job and a patient quite literally suffered as a result.

The patient was actively dying. He was older and his death was expected. He had kept his cancer at bay for several years, but there were no more curative treatment options left and he had opted to die peacefully in his bed, surrounded by family. He had also wanted to die in the hospital, and his death was coming on quickly enough that the hospital decided to allow it. He was grumpy, charming, funny and impressively clear-eyed about the end of his life. During our brief, two-day acquaintance I developed a strong attachment to him.

Death came closer quickly on that second day and as it neared, his pain increased significantly. Dying from cancer often hurts. He needed oxygen to breathe comfortably, and because he was alert he fully felt the intense pain.

I'm a nurse, so legally I cannot decide to increase a patient's dose of pain medication, but I can call a physician and describe the patient's distress. That's part of a nurse's job, but there is also a chain of command for getting medication orders, and another part of my job is adhering to that hierarchy.

I paged the first-year resident covering the patient. Since it was July he was an M.D. on the books, but he was brand new to actual doctoring. I explained things, but he would not increase the ordered dose. I paged him again. We talked over the phone, and I insisted. Then I pleaded. He would not up the dose.

Looking at the situation from his point of view, I understand his reluctance. I was asking him to prescribe a very large dose of narcotic, a killingly big dose if the patient was unused to opioids. The resident might have learned in medical school about pain during dying, but he had not actually been with a patient going through it. Seeing such pain - the body twisting, the patient crying out helplessly - is categorically different from reading about it.

I also imagine the resident had been taught to prescribe narcotics judiciously, perhaps even sparingly, and the amount of drug I was asking for was neither.

The patient's wife was kind; his daughter, a nurse, forthright. They and he deserved better than they were getting, so I decided to take a risk. Ignoring the chain of command, I paged the palliative care physician on call. She and I had talked about the patient the day before.

I described the patient's sudden lurch toward death, the sharp increase in pain and the resident's reluctance to medicate the patient enough to give him relief. "Ah," she said, "I was worried about that," meaning that the patient might begin actively dying sooner than the medical team had expected. She ordered a morphine pump. I got the drug, loaded and programmed the machine. The patient died fairly soon after. He was conscious to the very end, and I can say he did not meet his death in agonizing pain.

A FEW hours later I ended up in the elevator with the new resident. He and I both started talking at once. Looking stricken, he apologized to me for having been busy, overwhelmed with several new patients. Knowing it is never easy to have someone's footprint on your head, I apologized for having called in an attending physician. "I don't usually jump the line," I started to explain, when he interrupted me. "You did the right thing for the patient," he said.

Such an exchange is rare. A nurse who goes over a doctor's head because she finds his care decisions inappropriate risks a charge of insubordination. A resident who doesn't deliver good care risks the derision of the nurse caring for that patient. Nurses aren't typically consulted about care decisions, and this expectation of silence may lead them to lash out at doctors they see as inadequate.

The July Effect brings into sharp relief a reality of hospital care: care is becoming more specialized, and nurses, who sometimes have years of experience, often know more than the greenest physicians. We know about medicating dying patients for pain, but we know a lot of other things, too: appropriate dosages for all kinds of drugs, when transfusions and electrolyte replacements are needed, which lab tests to order and how to order them, whether consulting another specialist is a good idea, whether a patient needs to go to intensive care because his vital signs are worryingly unstable.

The problem can be limited by better supervision from senior residents, fellows and attending physicians, as well as by nurses. We need to acknowledge this fact, because admitting that new residents need help, and that nurses can and do help them, is the beginning of owning up to our shared responsibilities in providing care. For the good of our patients, nurses and doctors need to collaborate.

Theresa Brown is an oncology nurse and the author of "Critical Care: A New Nurse Faces Death, Life, and Everything in Between."

http://opinionator.blogs.nytimes.com/2012/07/14/dont-get-sick-in-july/?src=recg&pagewanted=print