Archive for the ‘New Technology’ Category



Researchers are reporting that they have developed a new way to help doctors and parents make some of the most agonizing decisions in medicine, about how much treatment to give tiny, extremely premature infants.

These are infants at the edge of viability, weighing less than 2.2 pounds and born after 22 to 25 weeks of pregnancy, far ahead of the normal 40 weeks. About 40,000 babies a year are born at this very early stage in the United States.

The new method uses an online calculator developed for such cases factoring in traits like birth weight and sex and generating statistics on chances of the baby’s survival and the likelihood of disabilities (www.nichd.nih.gov/neonatalestimates).

The statistics are not a personal prediction. They estimate risk based on data from similar infants in a large study being published on Thursday in The New England Journal of Medicine.

Certain factors gave babies an advantage. At any given gestational age, they were more likely to survive and escape serious disability if they weighed more than others, if they were singletons rather than twins or multiples or if their mothers had been given steroids before birth to help the fetal lungs to mature.

Girls also fared better than boys of the same age, a factor doctors have known a long time without being able to explain.

Any of those factors was about as good as being a week older, which makes an enormous difference in development from 22 to 25 weeks’ pregnancy, the researchers said. The finding means that a girl at 23 weeks could be as strong as a boy at 24.

“If you could take what the girls have and give it to the boys, we’d be one step ahead of the game,” said Dr. Rosemary D. Higgins, an author of the study and a program scientist at the Neonatal Research Network of the National Institute of Child Health and Human Development.

Although some extremely premature infants do well, many die, sometimes after weeks or months of painful invasive procedures in the intensive care unit. Survivors often suffer brain damage, behavior problems, vision and hearing loss and other disabilities.

Outcomes are nearly impossible to predict at birth. Doctors and parents struggle to decide when aggressive treatment seems reasonable — and when death or severe disability seems so likely, even with treatment, that it would be kinder to avoid painful procedures and provide just “comfort care,” letting nature take its course and letting the child die.

These decisions, made every day in hospitals around the country, are “heart wrenching and passionate,” Dr. Higgins said. “No one ever thinks they’re going to be in this situation, and it’s difficult, for families and also for physicians.”

Dr. Higgins said the study and the calculator were part of an effort to give doctors and parents more solid evidence to make decisions. She said people might be misled by occasional reports of tiny “miracle babies” who beat the odds and wrongly imagined high rates of survival and good health.

Dr. Higgins said she had no idea what overall effect the study and calculator might have on medical practice or whether they would lead to more or less treatment of extremely premature infants. Two families in the exact same situation could easily make opposite decisions about whether to pursue treatment.

Currently, decisions about using respirators, intravenous feeding and other forms of intensive care are mostly based on estimates of a baby’s gestational age — how far along the pregnancy was. Intensive care is often given to infants born in the 25th week, but not the 22nd. The hardest judgment calls are for babies in the 23rd and 24th weeks.

Plugging numbers into the calculator shows that two infants with the same gestational age, the usual criterion to decide treatment, can have quite different odds of survival and disability.

For instance, a 24-week-old two-pound male twin whose mother did not receive steroids has survival odds of 69 percent and a 50 percent chance of having a severe impairment. A female twin the same age and weight has survival odds of 86 percent and a 23 percent chance of severe impairment.

In theory, at least, the calculator would seem to favor treating girls, because, all else being equal, their odds for survival are better.

The study included 4,446 infants born at 22 to 25 weeks at 19 hospitals in the Neonatal Research Network; 744, generally the smallest and most premature, did not receive intensive care, and all died. The babies were assessed at birth, and the survivors were examined again shortly before turning 2.

Over all, half the infants died, half the survivors had neurological impairments, and half the impairments were severe.

Many survivors spent months in the hospital, at a typical cost of $3,400 a day. The researchers estimated that if all babies born at 22 to 23 weeks received intensive care, for every 100 infants treated there would be 1,749 extra hospital days and zero to nine additional survivors, with zero to three having no impairment.

Dr. Eric C. Eichenwald, medical director of the newborn center at Texas Children’s Hospital in Houston, said that the study was important and that its most striking finding was how large the benefits of the various factors could be.

Dr. Eichenwald said the calculator was “a way in which we can provide more accurate information to the process of counseling parents as to what the burdens of intensive care might be.”

Dr. Nehal A. Parikh, another author of the study, from the University of Texas Medical School at Houston, said he thought the statistics would help doctors in advising families.

“We lay out the facts, rather than our own opinions,” Dr. Parikh said, “because we’re not the ones taking these babies home.”

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It is a phone call that women dread. Something is not quite right on the mammogram: come back for another one. But don’t worry, the script goes, most repeat tests wind up normal.

Still, most women know someone who has breast cancer, and even the calmest, most rational minds may think the worst when summoned back to the clinic.

At many centers, these nerve-racking calls are on the rise, at least temporarily — the price of progress as more and more radiologists switch from traditional X-ray film to digital mammograms, in which the X-ray images are displayed on a computer monitor.

Problems can arise during the transition period, while doctors learn to interpret digital mammograms and compare them to patients’ previous X-ray films. Comparing past and present to look for changes is an essential part of reading mammograms. But the digital and film versions can sometimes be hard to reconcile, and radiologists who are retraining their eyes and minds may be more likely to play it safe by requesting additional X-rays — and sometimes ultrasound exams and even biopsies — in women who turn out not to have breast cancer.

Digital is growing fast. In the United States, 32 percent of mammography clinics now have at least one digital machine, up from only 10 percent two years ago. Eventually, film will be phased out.

The rush to digital is occurring in part because for certain women — younger ones and others with dense breast tissue — it is better than film at finding tumors. Digital is especially good at picking up tiny calcium deposits, or calcifications, which are sometimes — but by no means always — a sign of cancer. In the long run, radiologists say, digital technology will make mammograms more accurate for many women.

There have been no studies yet to measure what happens during the transition period, but many radiologists say they do find themselves calling more women back. About 35.8 million mammograms a year are done in the United States, including those for screening and follow-ups for problems. The National Cancer Institute recommends mammograms every year or two for most women over 40 (women at high risk may be advised to start earlier). Mammography is not perfect — it can miss tumors — but even its critics say it has helped to lower death rates from breast cancer, which is the second leading cause of cancer deaths in women, after lung cancer.

There are about 178,000 new cases of breast cancer each year in the United States, and 40,000 deaths.

Of 10 radiologists interviewed for this article, eight said that during the transition from film to digital, recall rates went up in women who were ultimately found to have nothing wrong. Normally a recall rate of 10 percent or less is considered desirable. But during the transition period at their clinics, the doctors estimated that callbacks of women who turned out to be healthy increased by a few percentage points to as many as 10. Only one radiologist reported no problems: Dr. Etta D. Pisano, a professor of radiology and biomedical engineering at the University of North Carolina.

“I don’t believe it,” Dr. Pisano said. “I question that there’s a problem with the transition.”

But Dr. Mary Mahoney, a professor of radiology and the director of breast imaging at the University of Cincinnati Medical Center, said, “I am living through the pain of this transition period on a daily basis.”

Dr. Mahoney’s center recently opened an entirely digital clinic for breast cancer screening.

“Our whole group is kind of pulling our hair out some days,” she said. “You struggle and you struggle. It’s just so much harder. These are really experienced, qualified radiologists who are wringing their hands. It’s where the increase in callbacks and biopsies is coming into play. It happens every day. Many times we’re able to bring the woman back, do additional views and feel comfortable we can follow that area.”

Regarding the higher callback rates, Dr. Mahoney said: “I know it’s not a small thing, the anxiety. Patients are practically in tears because they’re so worried. But I think in the long run it’s going to be to everybody’s benefit.”

Dr. Margarita Zuley, the director of breast imaging at Magee-Women’s Hospital at the University of Pittsburgh Medical Center, said it could take six months to a year to learn to interpret the new images.

Lecturing in Manhattan recently about the transition to digital, Dr. Zuley told an audience of radiologists: “When you first start out, you may feel a little anxious and recall more patients because everything looks like a cancer to you. It’s O.K. Just bring the patients back. It’s part of the learning curve.”

Regarding higher recall rates during the transition, Dr. Zuley said: “Everybody sort of knows it, but it’s anecdotal. There are no numbers.”

Meanwhile, patients or their insurers are paying for the extra tests. Fees for mammograms vary around the country. A clinic in Manhattan recently billed an insurer $387 for a digital mammogram and then $336 for extra images of one breast — needed because of confusion between the old films and the new digital pictures — and was paid about half of those fees. Fees for film-based mammograms are usually $45 to $120 less.

Nancy Liber, a radiologic technologist at Dr. Mahoney’s center, was called back by her own colleagues at the center after her mammogram last month.

“I thought exactly what every woman does,” Ms. Liber said. “Immediately you panic and think, ‘Oh my gosh, what if something is really wrong?’ ”

She found herself worrying about what would happen if she became ill and unable to take care of her children. She did not even tell her husband what had happened until after the second test, which turned out normal. The concerns were due entirely to the difference between film and digital images. Despite the stressful experience, Ms. Liber said that from what she had seen in her work, digital mammograms were the way to go.

“The inconvenience it may cause is worth it,” she said. But, she added, “I definitely know what these women are going through.”

Radiologists say one of digital’s advantages is that it lets them adjust features like contrast and magnification, and see things that were blurry or maybe even invisible on film. In the long run, doctors say, the increased clarity of digital mammograms may lead to fewer callbacks of healthy women — but it takes time to learn the ropes.

Dr. Constance D. Lehman, the director of breast imaging and a professor of radiology at the University of Washington, said she was not sure whether more women were called back during the transition. But describing the two technologies, she said, “In some areas it’s like comparing apples and oranges.”

When looking at a woman’s first digital image, Dr. Lehman said, radiologists must ask themselves whether a seeming change in the breast is truly new, or was it there all along but just not visible with earlier techniques.

Once a woman has had enough digital mammograms, the comparisons should be easier, radiologists say. But the first few may raise questions because when radiologists compare, they often go back to images from two or three years before. And in some clinics that have a mixture of film and digital machines, if a woman is switched between the two types from year to year, ambiguities may crop up again and again.

Many women do not know the difference between film and digital, or notice which is being used, and clinics may or may not inform them of potential problems during the changeover.

Digital mammography got a boost from a large study in 2005 that showed it was better than film at finding tumors in women under 50, or women of any age who had dense breasts, meaning a lot of glandular and connective tissue in proportion to fat.

A buzz grew around digital after the study. Some radiologists use the technology as a selling point, and others feel they must follow suit. Now there is such a demand for digital machines that there is a six-month wait for certain types, Dr. Zuley said, even though they cost $350,000 to $600,000, about three to five times as much as units that use film.

Dr. Leonard M. Glassman, who practices at Washington Radiology Associates, said that his practice in the Washington, D.C., area, which performs 85,000 mammograms a year, converted to digital about two years ago.

“There’s an increase in the rate of things you think are abnormal for about three months, and then you get used to it,” Dr. Glassman said. “You take more extra pictures, of things that six months later you would dismiss. It happened probably 5 to 10 percent of the time right at the beginning, so it’s a significant amount, and then it tails off.”

When questions first arise, Dr. Glassman said, he does not warn women that the imaging may be the culprit because he cannot be sure what the problem is until he sees the second set of X-rays.

“At the end I tell patients, ‘You were a victim of technology,’ ” he said. “They give me a blank stare. I say: ‘Your last one was film; this one was digital. They look different, and we just didn’t know that.’ ”

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