Archive for the ‘Medical Studies’ Category
Friday, February 15th, 2013
Fascinating study about missing obvious findings on CT studies, based on another study about selective attention. In the cited study, 83% of radiologists missed the abnormal findings on the first CT image.
Don’t ruin it for anyone else, but how many of you caught all the abnormalities on the CT scan below? For those who aren’t used to looking at chest CT scans, I included a fairly “normal” CT chest cross section (except for the small nodule) at approximately the same level on the bottom for comparison (credit here).
 Abnormal CT 
Posted in Medical Studies | 5 Comments »
Tuesday, December 11th, 2012
Does ED overcrowding affect patient outcomes or costs?
This study from Annals Emergency Medicine (.pdf) suggests so.
However, the study used times that hospital was on ambulance diversion as a measurement of overcrowding. When a hospital diverts ambulances, that action may demonstrate overcrowding or may also be due to CT scanner being down or other non-volume-related reasons. And just because a hospital is not on diversion doesn’t mean that there aren’t beds lined up in the hallways to cope with overcrowding. So the study is trying to draw associations between metrics that may be only marginally related.
In addition, the study excluded many rural hospitals that did not keep ambulance diversion data. There are many studies showing that mortality in rural areas is higher than mortality in urban areas. Had rural hospitals been included in the study data, it is conceivable that the rural hospitals which tend not to go on bypass may have decreased or eliminated the difference in death rates between “overcrowded” times and “normal” ED volumes.
I certainly don’t agree with the authors that their data “support the perception of ED crowding as a marker of poor quality of care.” I’m all for decreasing ED overcrowding and I agree that ED overcrowding should be viewed as an important public health priority … but using cost, mortality, and length of stay as measures of “quality” care? Seriously?
That’s the Kool-Aid that CMS is trying to get us to drink. Sorry, I’m not thirsty.
Just because you call a pig a cat doesn’t mean it’s going to start meowing.
Watch all the unintended consequences that occur if we adopt cost, deaths, and length of stay as surrogates for “quality.”
Posted in Medical Studies | 2 Comments »
Wednesday, December 5th, 2012
It has been a few years, but the FDA’s war on antiemetics (medications for vomiting) continues.
To review …
Bendectin was the first antiemetic to be taken off the market after famous plaintiff attorney Melvin Belli sued Merrell Dow Pharmaceuticals. No credible evidence was ever found that Bendectin caused birth defects as the plaintiff attorneys alleged, yet Merrell Dow removed bendectin from the market to avoid further lawsuits.
Droperidol was another great nausea medicine that got the FDA’s dreaded “black box” because it allegedly caused QT prolongation. See commentary here.
Then the FDA went after Tigan suppositories. Remove them from the market, it demanded.
Compazine was next to get the dreaded “black box” kiss of death.
Then came Reglan, which joined the “black box” club due to a risk of tardive dyskinesia. Interesting that one of the medications that has been used to treat tardive dyskinesia is another antiemetic … Zofran.
Phenergan was next. In Wyeth v. Levine, a Vermont jury decided that drug labeling warning against intra-arterial use wasn’t strong enough. The resulting black box warning struck fear into the hearts of hospital risk managers everywhere. By the way, how many of you knew that Phenergan is an antihistamine and, like Benadryl, can be used as a local anesthetic?
It appears that not enough people were scared off by the previous FDA warning on Zofran, though.
Now, the FDA has decided the 32 mg IV dose of Zofran has the “potential for serious cardiac risks” and is demanding removal of all 32 mg IV Zofran doses from the market. Those same cardiac risks – QT prolongation – were used to get droperidol black boxed, so it is only a matter of time until Zofran gets its scarlet letter from the FDA.
Personally, I would like to see the FDA’s studies on Zofran … and all the other antiemetics for that matter. I seriously doubt many of the claims.
In the meantime there’s always Aprepitant. That’s only $100/dose (in 2004). Plus … the FDA won’t determine that it’s bad for your health for at least another 10 years – about the time it goes off patent.
Posted in FDA, Medical Studies | 18 Comments »
Thursday, October 25th, 2012
 Attribution: http://www.everystockphoto.com/photographer.php?photographer_id=12419 It seems as if some members of the American Academy of Pediatrics have determined that emergency physicians aren’t performing enough useless tests on teenage girls.
According to a study presented at this year’s AAP conference, only 19 percent of the 77 million girls between ages 14 and 21 that were examined in emergency departments between 2000 and 2009 received pregnancy testing. Subgroup analysis showed that only 42% of those patients complaining of abdominal pain received pregnancy testing and only 28% of those patients exposed to radiation that could cause birth defects received a pregnancy test.
In an American Academy of Pediatrics news release, the researchers, including study author Dr. Monika Goyal, found it “particularly concerning” that rates of pregnancy testing were low even among females with potential reproductive health complaints or with exposure to “potentially teratogenic” radiation (i.e. may cause birth defects) such as chest x-rays or CT scans.
First, note how Dr. Goyal and company mention nothing about the indications for performing pregnancy testing in the emergency department. In other words, they’re bashing emergency physicians for failing to order a test when they haven’t even described when the test should be ordered.
I’m sure that Dr. Goyal’s study didn’t look at repeat visits or specific patient histories. If they’re reporting on 77 million patient visits, they must be using aggregate data. Another problem with the study is that aggregate data doesn’t take into account all of the instances in which a pregnancy test may not be indicated in a female teen.
If the patient had a negative pregnancy test in the doctor’s office two days prior to her current visit, another pregnancy test probably isn’t warranted. If a patient who is known to be pregnant is also having abdominal pain, a pregnancy test is probably a waste of time and money. Patients with epigastric pain or “heartburn” probably don’t need pregnancy tests. Should we get pregnancy tests on every patient with classic UTI symptoms? I don’t.
It’s pretty ridiculous to call the lack of pregnancy testing “particularly concerning” without saying what the “concerns” were. Did the researchers find any cases of bad outcomes due to lack of pregnancy testing in the 77 million cases that they reviewed? I’m sure there will be a few, but then a thorough researcher would then analyze thoses cases to determine whether the bad outcome was due to a failure to perform a pregnancy test. This study did nothing of the sort.
I was also surprised by the specious logic that patients having a chest x-ray performed should have pregnancy testing performed because chest x-rays “may” cause birth defects. The amount of radiation in a chest x-ray is equivalent to the amount of background atmospheric radiation people experience just being alive for 10 days. It is also equivalent to the amount of radiation that someone taking two roundtrip flights from Washington DC to Los Angeles would absorb. Read more about it on Wikipedia if you’re interested. Calling for more pregnancy testing because chest x-rays may be “teratogenic” is like demanding that all women take a pregnancy test before taking a cross-country flight on an airplane because the increased radiation exposure in the upper atmosphere may be just as “teratogenic.”
Whoops. Better not give the TSA any ideas.
Another practical issue is that lead aprons block x-ray radiation. Often x-ray techs and/or doctors will just have a potentially pregnant patient put a lead apron over her abdomen while an x-ray is performed rather than obtaining a pregnancy test. Of course such actions would be “particularly concerning” because no pregnancy test was done.
In the AAP news release, the study’s author stated that the “findings underscore the need to develop quality improvement interventions to increase pregnancy testing in adolescent girls in the emergency department, especially among those with higher risk of pregnancy complications.”
Translation: This study has failed to show that failure to perform pregnancy testing has any relation to quality of care or that it has caused harm to even one patient.
Conclusion: This study was a complete waste of time and money.
Posted in Medical Studies, News Commentary | 3 Comments »
Thursday, August 16th, 2012
Get ready for more governmental regulation of opioids and maybe even some black box warnings added to the prescribing information for c0deine-containing drugs … just for everyone’s safety, of course.
According to this FDA Special Bulletin on Safety Information, three pediatric deaths and one case of respiratory depression were documented in the medical literature after children took codeine-containing compounds. The etiology for the deaths was allegedly because the children had a variation in their cytochrome P450 enzyme that caused the codeine to break down faster into morphine, high levels of which, according to the FDA, “may be fatal.” If your child or your patient is an “ultra-rapid metabolizer” of codeine, he or she could DIE.
The FDA also published a “Drug Safety Communication” that disclosed the studies on which its recommendations were based.
One case cited by the FDA as “proof” that codeine can kill you involved a 2 year old child with sleep apnea who underwent tonsillectomy and adenoidectomy and who died three days after surgery. At autopsy, the child had elevated levels of codeine and morphine in his system, had aspirated food particles, and also had bilateral pneumonia. No mention of how much codeine the patient’s parents gave the child, only of the dose that was prescribed. No mention of how bilateral pneumonia or aspiration in a young child can be deadly. The researchers concluded that the elevated morphine levels “may” have contributed to the child’s death. The FDA wants you to believe that there was a causal connection there.
Another article cited by the FDA was from the same authors who now found three additional cases of children who died after having tonsillectomy/adenoidectomy and were prescribed codeine. I didn’t purchase the article, but I also am assuming that there were no controls for dosing of the medication, only for prescription of the medication. In other words, I doubt that the researchers would be able to tell whether the parents accidentally just gave the child too much medication as opposed to whether some genetic variant caused higher than normal blood levels of the medication at normal doses.
I also did a PubMed search for “children codeine p450” and also “pediatric codeine p450“.
There was one Canadian case report of a mother who was an “ultra rapid metabolism phenotype” whose breastfed child had fatal opioid intoxication after the mother used codeine.
There was another case report from Canada of a 5 year old girl who died from hydrocodone overdose when she was taking both clarithromycin for an ear infection and valproic acid for seizures. The medications decreased metabolism of the drug and she also had a genetic defect that decreased the metabolism of the drug.
None of the other articles that I found mentioned pediatric death due to an interaction between opioids and cytochrome P450.
Now, based on 4 deaths out of likely hundreds of millions of codeine prescriptions, the FDA is “currently conducting a safety review of codeine” and is recommending that doctors use low doses of codeine for patients in pain or that doctors just use another medication completely for children in pain. The FDA also recommends that caregivers monitor patients for signs of opioid toxicity. These recommendations are already in the prescribing information for Tylenol with Codeine.
Oh, and the FDA also notes that doctors can always perform “FDA approved” genetic testing to see if children have the gene responsible for rapid metabolism of codeine.
I can’t help wonder what motivation the FDA has to issue this warning about 4 deaths in tens or even hundreds of millions of prescriptions that were hypothesized to have been caused by this mechanism. It’s not like codeine is a new drug or that the cytochrome P450 pathway is a new discovery. Why now?
Trying to justify the FDA’s existence/budget? Getting a cut of the fees for approving the genetic testing? Getting fees for some new pain medication so that it can be approved for use in pediatric patients? Something just doesn’t make sense.
Of course, now if sometime in the future a young patient dies from an alleged codeine overdose, there will be some newspaper article published and some lawsuit for millions of dollars in damages filed alleging that if only the negligent doctor had paid attention to the FDA warnings and performed CYP2D6 genotyping, the patient would probably still be alive today.
And people wonder why doctors practice defensive medicine.
UPDATE
Congratulations to the Wall Street Journal, NY Times, Washington Post, ABC News, Bloomberg News, NPR, and the Boston Globe for feeding into the hysteria. Hat tip to EM Today from ACEP for the links.
Posted in Defensive Medicine, FDA, Medical Studies | 7 Comments »
Sunday, May 20th, 2012
Two interesting studies were published recently.
First was a study in NEJM showing that the beloved ZeePack that so many people think will clear their boogers and resolve their cough instead increases the risk of death. During the 5 days that they took Zithromax (azithromycin), patients had almost a threefold increase in risk of cardiovascular death and almost a twofold increase in death from any cause. Patients who took Levaquin (levofloxacin) had the same increased risk of death as those who took Zithromax. The risk for death was significantly higher in patients who had preexisting heart disease.
Perhaps this may be related to the increase in death associated with higher patient satisfaction scores?
Also interesting that there was not an increase in death for patients using amoxicillin and Cipro. Makes me wonder whether “atypical” bacteria (which aren’t killed by amoxicillin or Cipro but are killed by Zithromax and Levaquin) provide some beneficial effect in the human body.
Which serves as a good segue to the second study.
A study in JAMA showed that probiotics significantly decrease the incidence of diarrhea that occurs when taking antibiotics.
I happen to be a proponent of probiotics for a number of medical problems. A couple of weeks ago I was offered the opportunity to review a new book about probiotics and will put up a review in the near future … when I finally get the time to read it.
Posted in Medical Studies | 2 Comments »
Wednesday, May 9th, 2012
Any patient who demands a ZeePack for a runny nose, who wants amoxicillin for sinus congestion, or who wants Levaquin to “keep this bronchitis from developing into pneumonia” needs to read this Bloomberg article.
We are heading toward a situation where people die from infections that no antibiotics can treat. The article discussed one infant in a pediatric ICU that died because the infection that the child developed was resistant to all antibiotics used for treatment. Six similar incidents occurred during the course of 16 months. Estimates are that 100 million people in India have been colonized with organisms carrying the genetic mutation. Medical tourism in India is decreasing as a result.
Even the director of the CDC cites the situation an example of why we have to limit antibiotic prescriptions: “We are looking at the specter of untreatable illness.”
Oh, and remember how the Centers for Medicare and Medicaid Services assert that if hospitals don’t give antibiotics to every single pneumonia patient within 6 hours of arrival – even though a large proportion of pneumonias are viral in nature – that the hospitals are falling outside of “quality” guidelines? Our government’s own “quality” guidelines may be contributing to the looming microbial Armageddon in this country.
Posted in Medical Studies, Medicare, Policy | 19 Comments »
Friday, March 16th, 2012
A study just published in the Annals of Emergency Medicine shows something that many people suspected: Patients with Medicaid (i.e. government “insurance”) tend to use the emergency department much more often than patients with private insurance.
After studying 230,000 participants in the National Health Interview Survey, the researchers found that Medicaid patients were more than twice as likely to use the emergency department as their privately-insured counterparts. When barriers to timely primary care were added into the picture (including difficulty reaching doctor on telephone, difficulty obtaining timely appointment, long waits in the physician’s office, limited clinic hours, and lack of transportation), emergency department utilization increased significantly. 40% of Medicaid patients had used the emergency department more than once in the prior year. 51% of Medicaid patients with one barrier had more than one ED visit in the prior year and 61% of patients with two or more barriers had more than one ED visit in the prior year.
I’m sure that there are other reasons for the higher than normal emergency department utilization, the biggest one being lack of a disincentive for using emergency departments versus primary care physicians.
The article concluded that “Expansion of Medicaid eligibility alone may not be sufficient to improve health care access.”
Insurance doesn’t equal access. Wonder where I’ve heard that before ….
Posted in Medical Studies, News Commentary | 10 Comments »
Wednesday, March 7th, 2012
A few interesting topics caught my eye in the literature lately.
From the Journal of Emergency Medicine (full article on Medscape): Tessalon Perles can be dangerous in an overdose. This case report shows how a teenager who took 10 pills in a suicide attempt presented in cardiac arrest, was successfully resusciatated, then ended up losing her eyesight and developing permanent psychiatric problems.
From an eMedHome.com Clinical Pearl: Aggressive diuresis in patients with neurogenic pulmonary edema may worsen outcomes. Delayed cerebral ischemia is the most common cause of secondary neurologic injuries in patients with aneurysmal subarachnoid hemorrhage. By reducing preload through diuresis, the resulting hypovolemia may decrease cerebral perfusion pressures and cause additional neurologic injury. Recommendations are instead to maintain normovolemia and use positive pressure ventilation to maintain respiratory status. References here and here. Has any one tried this?
The constipation may be nasty, but the treatment can kill you. Retrospective review shows that Fleets enemas in standard doses can cause renal failure, severe electrolyte abnormalities, and even death in elderly patients. Back to the ol’ “high, hot and helluva lot” soap suds enemas?
Posted in Medical Studies | 1 Comment »
Friday, February 17th, 2012
An older gentleman comes in because he has a “sinus infection” for the past couple of days.
As soon as the triage nurse brings him back, she’s already whispering to the other nurses. Later, I learned that she told them to make sure that I get the patient. She’ll get her paybacks later.
The man was upset because the ZeePack he got from his primary care physician wasn’t working after he had taken a couple of doses. He wanted some stronger antibiotics “like Augmentin or some Levaquin 750s” to make sure that his sinus infections went away. Triage nurse is really going to get her paybacks.
I examined him. He had no sinus infection. He had sinus congestion at best, but even that was questionable.
I dutifully explained that even if he did have sinusitis, studies show that antibiotics confer little or no benefit on patients with uncomplicated sinusitis. In fact, the best things for sinus congestion/sinusitis are topical decongestants and nasal irrigation. I even printed out a copy of the JAMA study and handed it to him. Then I gave him a couple of squirts of Neo-Synephrine in each nostril. Ten minutes later, he was much less congested and felt much better. He thanked me and promised to go home and use the nasal rinses.
That was about 7PM.
At 2AM, he shows up again and he is hot under the collar. I walked into the room and asked him what happened.
“That Neo-Synephrine makes my blood pressure go too high and I read that those nasal washes can give you brain infections, so I’m not taking them. I haven’t slept yet tonight and I want some Levaquin NOW!”
Whoa.
I told him that Levaquin wouldn’t help and that I wasn’t going to prescribe it for him. I started to mention that he could use sterile water in the nasal irrigation and try some Benadryl for his congestion/sleep problems, but he interrupted me.
“Well then, this was a complete waste of time.”
And with that he got up and walked out of the door.
Or at least he tried to walk out the door.
Only problem is that the doors are locked and patients have to be buzzed in and out of the department. When you’re angry, there isn’t an exception to that rule. He went to the regular exit, tried to open the door, pounded it a couple of times and walked back in the department toward the ambulance bay. People ran after him calling “Sir! Sir! This way, sir! Wait!”
He would have none of it.
He got to the ambulance bay doors and tried to pull them open with his bare hands. Nope. You have to use a button to open those, too. Then he started shaking the doors. Nope. They still won’t open.
We have cameras all over the place, so while he’s freaking out and people are trying to help him, everyone else is watching his antics in the camera and admiring his technique. It’s like a new reality TV series.
Then the patient makes one final mighty effort to pull the ambulance bay doors apart. And in the camera he looks just like an angry mime straining against an immovable object. His body shakes ever so slightly. His face gets red. Then … the doors open.
Waaait a minute. We looked across the nurse’s station to the control panel. The respiratory tech stood there smiling.
“Hey, he was going to break the door if he kept it up.”
And with a one-finger salute, the patient stormed out of the emergency department and into the ambulance bay, in further search of the holy grail of mucous sterilants: Levaquin 750s.
Doesn’t it figure that now he’s twice as likely to get a Press Ganey survey.
This and all posts about patients may be my experiences or may be submitted by readers for publication here. Factual statements may or may not be accurate. If you would like to have a patient story published on WhiteCoat’s Call Room, please e-mail me.
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By the way, completely unrelated, but any time I think of mimes, this video comes to mind. Don’t know why.
Just like any time I think of pipe fitters, this story comes to mind.
Posted in Medical Studies, Patient Encounters | No Comments »
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Stretching the Definition of “Quality”
Thursday, October 25th, 2012Attribution: http://www.everystockphoto.com/photographer.php?photographer_id=12419
It seems as if some members of the American Academy of Pediatrics have determined that emergency physicians aren’t performing enough useless tests on teenage girls.
According to a study presented at this year’s AAP conference, only 19 percent of the 77 million girls between ages 14 and 21 that were examined in emergency departments between 2000 and 2009 received pregnancy testing. Subgroup analysis showed that only 42% of those patients complaining of abdominal pain received pregnancy testing and only 28% of those patients exposed to radiation that could cause birth defects received a pregnancy test.
In an American Academy of Pediatrics news release, the researchers, including study author Dr. Monika Goyal, found it “particularly concerning” that rates of pregnancy testing were low even among females with potential reproductive health complaints or with exposure to “potentially teratogenic” radiation (i.e. may cause birth defects) such as chest x-rays or CT scans.
First, note how Dr. Goyal and company mention nothing about the indications for performing pregnancy testing in the emergency department. In other words, they’re bashing emergency physicians for failing to order a test when they haven’t even described when the test should be ordered.
I’m sure that Dr. Goyal’s study didn’t look at repeat visits or specific patient histories. If they’re reporting on 77 million patient visits, they must be using aggregate data. Another problem with the study is that aggregate data doesn’t take into account all of the instances in which a pregnancy test may not be indicated in a female teen.
If the patient had a negative pregnancy test in the doctor’s office two days prior to her current visit, another pregnancy test probably isn’t warranted. If a patient who is known to be pregnant is also having abdominal pain, a pregnancy test is probably a waste of time and money. Patients with epigastric pain or “heartburn” probably don’t need pregnancy tests. Should we get pregnancy tests on every patient with classic UTI symptoms? I don’t.
It’s pretty ridiculous to call the lack of pregnancy testing “particularly concerning” without saying what the “concerns” were. Did the researchers find any cases of bad outcomes due to lack of pregnancy testing in the 77 million cases that they reviewed? I’m sure there will be a few, but then a thorough researcher would then analyze thoses cases to determine whether the bad outcome was due to a failure to perform a pregnancy test. This study did nothing of the sort.
I was also surprised by the specious logic that patients having a chest x-ray performed should have pregnancy testing performed because chest x-rays “may” cause birth defects. The amount of radiation in a chest x-ray is equivalent to the amount of background atmospheric radiation people experience just being alive for 10 days. It is also equivalent to the amount of radiation that someone taking two roundtrip flights from Washington DC to Los Angeles would absorb. Read more about it on Wikipedia if you’re interested. Calling for more pregnancy testing because chest x-rays may be “teratogenic” is like demanding that all women take a pregnancy test before taking a cross-country flight on an airplane because the increased radiation exposure in the upper atmosphere may be just as “teratogenic.”
Whoops. Better not give the TSA any ideas.
Another practical issue is that lead aprons block x-ray radiation. Often x-ray techs and/or doctors will just have a potentially pregnant patient put a lead apron over her abdomen while an x-ray is performed rather than obtaining a pregnancy test. Of course such actions would be “particularly concerning” because no pregnancy test was done.
In the AAP news release, the study’s author stated that the “findings underscore the need to develop quality improvement interventions to increase pregnancy testing in adolescent girls in the emergency department, especially among those with higher risk of pregnancy complications.”
Translation: This study has failed to show that failure to perform pregnancy testing has any relation to quality of care or that it has caused harm to even one patient.
Conclusion: This study was a complete waste of time and money.
Posted in Medical Studies, News Commentary | 3 Comments »