Still think screening for breast cancer doesn’t matter?  In this country there is a lot of debate about that very topic.  Opponents of screening suggest that it results in over-treatment for “lumps” that may be benign cysts or nothing at all.  What is over-treatment?  Sometimes simple referral for ultrasound [...]]]> Source:  BBC Health; Journal of Medical Screening

Still think screening for breast cancer doesn’t matter?  In this country there is a lot of debate about that very topic.  Opponents of screening suggest that it results in over-treatment for “lumps” that may be benign cysts or nothing at all.  What is over-treatment?  Sometimes simple referral for ultrasound or MRI and sometimes referral to a breast surgeon for aspiration (withdrawing cells through a needle), biopsy (cutting out a portion of the lump) or excision (removal of the lump).

Well the latest study, out of England, focused upon 80,000 women aged 50 and over.  (Women in England between 50 and 70 receiving screening every 3 years under the National Health System).  The results?  Over a period of 20 years,  5.7 (yeah, I don’t know what a .7 person is either) breast cancer deaths were prevented for every 1,000 women screened.  2.3 of those 1,000 women were told they had a lump of unclear significance.  Okay, that’s raw numbers, what does it mean?  Well, for every 28 cases diagnosed, 2.5 women had their lives saved and 1 woman was over-diagnosed.

According to the authors of the study, “The benefits in terms of numbers of deaths prevented are around double the harm in terms of over-diagnosis.”  Projecting forward leads them to believe that, “A significant reduction in breast cancer deaths in association with mammographic screening.”

Because of research such as this the NHS plans to extend mammography to women 47 to 73 by 2012.  Meanwhile, here in the United States and with the possible implementation of a National Health Care Service we appear to be going in the opposite direction.  Here we debate the costs of screening women under 50.  Whether or not it’s prudent.  Economically effective.  And whether or not too much screening, rather than resulting in more diagnosis and lives saved, results in over-treatment (read more money).

And back across the pond, a spokesperson for Cancer Research UK, Sara Hiom, was quoted saying, “What we need to remember is that detecting cancers earlier generally means improved survival.  And we know through trials and through research that breast cancer screening can save lives.”

Deputy Directer of the NHS cancer screening programmes (thats Brit for programs) adds, “There is a risk of over-diagnosis and possible subsequent over-treatment associated with any screening programme” and that, “The latest independent study shows that the risk of over-diagnosis is very much lower than some other recent estimates have claimed and that the benefits [of mammography screening] far outweigh the risks.”  Well put.

~Posted by D.M. Schwadron, Esquire

A Duke University study published in the American Journal of Roentgenology (that’s x-rays) found that plain x-rays miss a surprising amount of fractures compared with MRI.  How many?  Out of 92 patients undergoing x-ray and then checked with MRI, 35 fractures were missed.  That’s more than 1/3 of fractures [...]]]> Source:  American Journal of Roentgenology; BBC Health

A Duke University study published in the American Journal of Roentgenology (that’s x-rays) found that plain x-rays miss a surprising amount of fractures compared with MRI.  How many?  Out of 92 patients undergoing x-ray and then checked with MRI, 35 fractures were missed.  That’s more than 1/3 of fractures for the slow at math.  Oh and 11 patients had a fracture suggested by x-ray that wasn’t on the MRI (a false positive).

The problem? Well outside of the obvious, is that a negative finding read on an x-ray will not result in any additional study.  In a Hospital Emergency Room Setting, the goal is to rule out traumatic fractures and move on to other diagnoses.  Which means that patients are getting sent home with fractures that could potentially result in greater injury (ie. risk of fall, accident, extension of fracture, etc).

The suggestion of the authors was to use MRI in addition to x-rays, where doctors have doubts -particularly in the frail or elderly patient population.  (Like you, I was looking to see if the study was funded by the MRI Manufacturers Association, but I could neither confirm nor deny that.) Hip and pelvic fractures are common among this group.  (Who else thinks putting the call back upon the doctor is an inherently good idea?)  Maybe I’m missing something (no pun intended) but if ER doctors are using x-ray to rule out fracture, why would they go any further once they get a negative result.  Further, won’t the hospital administration and the Insurance Companies question the diagnostic rationale of obtaining an additional study when the first study was negative?

Okay, here is the point where I go off on an associated tangent, but a tangent, nonetheless.  The point of this study was to use MRI as a back up where there were questions about an x-ray finding.  Maybe the better practice would be to simply use MRI as the first study and do away with conventional and, apparently out-dated, x-ray technology?

What do I mean by “outdated?”  A quick history lesson.  It was 11/08/1895 when Wilhelm Conrad Röntgen accidentally discovered an image cast from his cathode ray generator.  A week after his discovery, Rontgen took an X-ray photograph of his wife’s hand which clearly revealed her wedding ring and her bones. The photograph electrified the general public and aroused great scientific interest in the new form of radiation. Röntgen named the new form of radiation X-radiation (X standing for “Unknown”).  Wilhelm’s wife, who served as chief tester would later die of radiation over-exposure.  In 1913, William Coolidge invented the X-ray tube which then revolutionized the generation of X-rays and is the model upon which all X-ray tubes for medical applications are based.  I’d consider that outdated.  Hey, what do I know, I’m a lawyer, not a doctor.

~Posted by D.M. Schwadron, Esquire

The FDA just announced a potential patient safety issue with perfusion CT imaging of the head.  The issue? overexposure to dangerous levels of radiation.  Where is this test most prominent?  For imaging to diagnose stroke and to determine treatment for stroke.

Over an 18 [...]]]> Source: US Food & Drug Safety Administration (FDA) and The Wall Street Journal

The FDA just announced a potential patient safety issue with perfusion CT imaging of the head.  The issue? overexposure to dangerous levels of radiation.  Where is this test most prominent?  For imaging to diagnose stroke and to determine treatment for stroke.

Over an 18 month period, 206 patients at an unidentified hospital received radiation doses 8x the level expected. The maximum recommended dosage for the head is 0.5 Gy.  Patients in the investigation received 3-4 Gy.  So what’s a little hair loss and erythema (redness of the skin), right?

Well the Wall Street Journal was kind enough to “out” the facility under investigation as Cedars-Sinai Medical Center in LA.  According to a spokesperson for Cedars-Sinai, there was a “misunderstanding about an embedded default setting.” No sh*t, Sherlock.

The reason any of this matters to you? One, it proves that even we trial lawyers are correct about medical errors every once in a while. Two, the FDA has suggested that the incident, “May reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure.” Government speak for, “OMG! WTF?!”

According to their official statement, the FDA is, “Working with the parties involved to gather more data about the situation and to understand its potential public health impact.”

Oh good. I feel safer already.

Posted by David Marc Schwadron, Esquire

Okay, some advice and some terms.  First, women should be performing self breast exams (minds out of the gutter, or enlist a friend, whichever).  The studies referenced compare physical exams by a doctor with current mammography.  So what [...]]]> Source:  Journal of the National Cancer Institute, Chiarelli, A., 2009; 101: 1236-43; Barton M., 2009; 101: 1223-25; www.breastcancer.org

Okay, some advice and some terms.  First, women should be performing self breast exams (minds out of the gutter, or enlist a friend, whichever).  The studies referenced compare physical exams by a doctor with current mammography.  So what are “false positives?” Apart from a really poor usage of language, “false positives” in the medical world occur when a benign (non-cancerous) abnormality is felt to look like a malignant (cancerous) one. Like what you ask?  Suspicious calcifications; architectural distortion, a cyst or a lump, to name a few.

Why is this important? I will slow down for those of you in the back rows.  If  an otherwise healthy patient has a “false positive” on a breast exam by a physician, certain protocols, which may include a needle biopsy or other invasive study are performed. Okay, so you require additional testing and a small incision in your breast, big deal, right?  Right.  Because “subtle findings” are not always detected on diagnostic studies, the breast self examination (BSE) and office physical exam remain useful tools in the diagnosis of breast cancer.  Too many “false positives” and expensive insurance dollars used on follow up testing for “false positives” and protocols have a way of changing.  Funny how that works.

So what are the numbers?  The study of some 290,000 Canadian women (No their breasts aren’t colder children), found that physical breast exam and mammogram combined were 95% accurate in detecting breast cancers. Mammography alone was 89% accurate. Combined there was a 12% rate of “false positives” while Mammograms alone only had a 7.4% rate of “false positives.“  In other words, for every cancer detected by a doctor breast exam, there were 55 “false positives.”  Mammography Centers appear to be in the forefront of pushing for the primary reliance on mammograms.  Again, funny how that works.  It’s an apportionment thing.

So there appears to be some statistical support for the false positives.  However even a math idiot like me will note that that the difference in accuracy are also better with both clinical breast exam and mammography combined.  And since it’s better to be accurate than good, or something like that, I think we should take this into consideration, but not invest too much consideration.

Posted by David Marc Schwadron, Esq.

A recent Swedish study (Yes, where the candy fish come from) comparing PSA (Prostate Specific Antigent) Test results of 540 men before they were eventually diagnosed with prostate cancer and 1,000 healthy men failed to determine the point where a PSA Test was a diagnostic predictor of prostate cancer.

What [...]]]> Source: BBC Health; British Medical Journal

A recent Swedish study (Yes, where the candy fish come from) comparing PSA (Prostate Specific Antigent) Test results of 540 men before they were eventually diagnosed with prostate cancer and 1,000 healthy men failed to determine the point where a PSA Test was a diagnostic predictor of prostate cancer.

What does that mean?  Okay.  Very low concentrations of PSA (less than 1 ng.ml) basically ruled out a future diagnosis of prostate cancer.  The problem lies in setting the upper ranges. Currently those men with a PSA of 3 ng/ml who are aged 50-59 are candidates for urological follow up.  Men 60 and over with a PSA of 5 ng/ml are also.  But beyond that there is still not enough information.  A viable concern is that over-diagnosis might lead to over-treatment with the attendant side effects of impotence and incontinence.  (Aren’t you glad you don’t have a prostate ladies?)

Prostate cancer has risen to the 2nd most common cause of cancer related deaths in the UK. Rates are somewhat lower in the US with an average mortality age of 80.  Prostate cancer is typically “survivable” if diagnosed and treated early.  Oddly the UK approach of less PSA Testing seems to be the opposite of that in the States.  Time will truly tell on this one.

Posted by David Marc Schwadron, Esquire

A survey led by an associate professor at Weill Cornell Medical College of records of some 5,434 patients at 19 independent primary care and 4 academic medical centers has produced some startling results.

Now before you jump all over the Plaintiff attorney, the Director of Clinical Informatics and Brigham and [...]]]> Source: The New York Times, June 2009

A survey led by an associate professor at Weill Cornell Medical College of records of some 5,434 patients at 19 independent primary care and 4 academic medical centers has produced some startling results.

Now before you jump all over the Plaintiff attorney, the Director of Clinical Informatics and Brigham and Women’s Hospital in Boston, a fine institution in its own right, says the study was “high quality” and utilized “good methodology.”

So what were the results? Glad you asked. More than 7% of abnormal tests results were NEVER reported to the patient. Missed notifications included blood work and imaging studies. Curiously the offices in the survey volunteered to participate, indicating they were fairly confident they would get it right. The implication certainly is that one should not go by the old adage of no news. . .

Bottom line: If you haven’t heard back from your physician on a lab result or study, you might want to call and ask about it. Just a suggestion.

posted by David Marc Schwadron, Esq.

Patient safety experts at Johns Hopkins are pushing for medical providers to give the same attention to diagnostic errors as they devote to drug prescription errors, wrong-site surgeries and hospital-acquired infections.

Drs. Newman-Toker and Pronovost, estimate that 40,000 to 80,000 hospital deaths per year are the result of errors in [...]]]> Source: Johns Hopkins Medical Institutions -Media (3/11/2009)

Patient safety experts at Johns Hopkins are pushing for medical providers to give the same attention to diagnostic errors as they devote to drug prescription errors, wrong-site surgeries and hospital-acquired infections.

Drs. Newman-Toker and Pronovost, estimate that 40,000 to 80,000 hospital deaths per year are the result of errors in diagnosis (missed, wrong or delayed). Perhaps more frightening is the suggestion that such diagnostic errors could be “drastically reduced by simply adopting tools like a checklist to help physicians remember critical diagnoses or by readily available computer programs (which can be used on a mobile device) to calculate risk factors for certain conditions.”

Experience has demonstrated to us that even a slight delay in diagnosis, such as pulmonary embolism, brain aneurysm, or cancer can result in death. The wrong diagnosis or a missed diagnosis has the same potential for harm. We have sued hospitals which have few or no policies and procedures relative to issues such as infection or no mechanism of enforcing the policies which they do have.

The idea that a simple checklist might trigger a series of important studies or tests which could lead to the correct diagnosis sounds ridiculous, but it is accurate, even with advances in modern medicine.

posted by David Marc Schwadron, Esq.