This issue (in my mind at least) retains the number one spot it held in last year’s top ten list. And, like last year, the skeptics are still winning. As Bob Wachter has said in so many words on more than one occasion, we have a long way to go before we get this thing right. Here’s a roundup of some of this year’s buzz.
The Optimize study found no benefit associated with most heart failure core measures.
The four hour antibiotic rule was found to be associated with over diagnosis of pneumonia (and consequently overuse of antibiotics).
"Ditto" said another study in Chest.
Pain management “quality” initiatives were found to have unintended consequences.
Bob Wachter made a convincing argument that core quality measures may be distracting from more important matters.
A systematic review failed to validate rapid response teams.
Pneumococcal vaccination in adults was again shown to have modest effects at best.
A poll of an audience at a popular hospital medicine course revealed skepticism.
Friday, December 28, 2007
Top ten issues in hospital medicine for 2007, issue 2: hospitalists and the interface with primary care
Two facets of this issue were on the radar screen this year. One concerns what may be the biggest downside to the hospitalist model: the information gap between the hospitalist and the primary physician. An important paper in JAMA this year which I linked and discussed a few months ago demonstrated poor communication between hospitalists and primary care physicians following hospital discharge. As I was finishing this post I found an excellent commentary by Bob Wachter. He believes every health care system need a transitions officer; I couldn’t agree more.
The other facet is the controversy over what effect the hospitalist movement is having on the primary care shortage. The primary care shortage is creating a larger and larger niche for hospitalists. On the other hand the hospitalist movement has created an attractive career choice for internists, thus perpetuating the shortage of primary care physicians. It’s a self reinforcing cycle. Internists who flock to the hospitalist career are looking for professional satisfaction. It’s not just about money. As I blogged before, General Internal Medicine has lost its identity thanks to economic forces and the American College of Physicians which merely defines internists as “doctors for adults.” About a year ago Retired Doc spoke volumes with the title to one of his posts: Is being a hospitalist the only way to still be an old time internist?
Bob Wachter summarized the issue nicely with posts here and here.
The other facet is the controversy over what effect the hospitalist movement is having on the primary care shortage. The primary care shortage is creating a larger and larger niche for hospitalists. On the other hand the hospitalist movement has created an attractive career choice for internists, thus perpetuating the shortage of primary care physicians. It’s a self reinforcing cycle. Internists who flock to the hospitalist career are looking for professional satisfaction. It’s not just about money. As I blogged before, General Internal Medicine has lost its identity thanks to economic forces and the American College of Physicians which merely defines internists as “doctors for adults.” About a year ago Retired Doc spoke volumes with the title to one of his posts: Is being a hospitalist the only way to still be an old time internist?
Bob Wachter summarized the issue nicely with posts here and here.
Top ten issues in hospital medicine for 2007, issue 3: does the hospitalist model of care improve efficiency and outcomes?
Two papers in 2007 weighed in on this debate. First was this study from the Archives of Internal Medicine showing a statistically significant reduction in length of stay (5.01 vs 5.87 days) associated with an academic hospitalist model in comparison with non-hospitalist care at Albert Einstein College of Medicine.
Just out is this paper from NEJM comparing hospitalitalist care with that of non-hospitalist internists and family practitioners. Hospitalist care was associated with a shorter length of stay than traditional care by internists and FPs (0.4 days for both comparisons), a reduction in cost per case of $268 compared with traditional internal medicine care and no significant difference with family practice care. (Maybe that means family practitioners order fewer or less expensive tests than internists).
How can we interpret these results in light of what was already known? There have been too many papers for me to link here, so I’ll offer an oversimplified timeline. Early in the movement, small studies suggested that the hospitalist care model was associated with reduced charges and length of stay. A study presented at the 2005 meeting of the Society of Hospital Medicine, however, burst the bubble. That largest to date study showed no superiority of hospitalist care in terms of outcomes or efficiency. To my knowledge that was the largest study conducted until the NEJM study linked above. Bob Wachter, commenting on the Archives paper, said there were more than 20 studies with results favoring the hospitalist model. (I didn’t know there were that many!).
From the varied blog reactions to the NEJM paper it seems there are a gazillion ways to interpret the evidence. Dr. Wes is skeptical of the results, seems to question the meaning of $268 per case and laments the discontinuity of care that is built into the hospitalist model. The Happy Hospitalist has a happier spin, doing a little math to suggest how $268 per case translates into real money over multiple admissions and comments on some intangible benefits of hospitalist care. Retired Doc offers a nice summary of the blog reactions here and concludes with perhaps the only statement we can all agree on: the hospitalist movement is here to stay. Bob Wachter weighed in here (did I miss anybody?).
Wachter has some interesting observations on how the fallout from this study may affect the hospitalist looking for a job or jockeying for better compensation. As I see it, it could play out in any number of ways. Wachter suggests that this study, which shows a smaller resource saving than some older studies, could prompt hospital administrators to tighten their budgets for hospitalist compensation:
But I could see it play out another way. Given that the economic value of the hospitalist model was in dispute at least in the minds of some, administrators who look at this paper as having settled the issue once and for all may now say “Hospitalist care is supposed to save money. Why aren’t you doing better than your non-hospitalist peers?”
No matter how you slice it, you’re better off if you can convince folks that there are non-economic and intangible benefits of hospitalist care. As Wachter said,
Just out is this paper from NEJM comparing hospitalitalist care with that of non-hospitalist internists and family practitioners. Hospitalist care was associated with a shorter length of stay than traditional care by internists and FPs (0.4 days for both comparisons), a reduction in cost per case of $268 compared with traditional internal medicine care and no significant difference with family practice care. (Maybe that means family practitioners order fewer or less expensive tests than internists).
How can we interpret these results in light of what was already known? There have been too many papers for me to link here, so I’ll offer an oversimplified timeline. Early in the movement, small studies suggested that the hospitalist care model was associated with reduced charges and length of stay. A study presented at the 2005 meeting of the Society of Hospital Medicine, however, burst the bubble. That largest to date study showed no superiority of hospitalist care in terms of outcomes or efficiency. To my knowledge that was the largest study conducted until the NEJM study linked above. Bob Wachter, commenting on the Archives paper, said there were more than 20 studies with results favoring the hospitalist model. (I didn’t know there were that many!).
From the varied blog reactions to the NEJM paper it seems there are a gazillion ways to interpret the evidence. Dr. Wes is skeptical of the results, seems to question the meaning of $268 per case and laments the discontinuity of care that is built into the hospitalist model. The Happy Hospitalist has a happier spin, doing a little math to suggest how $268 per case translates into real money over multiple admissions and comments on some intangible benefits of hospitalist care. Retired Doc offers a nice summary of the blog reactions here and concludes with perhaps the only statement we can all agree on: the hospitalist movement is here to stay. Bob Wachter weighed in here (did I miss anybody?).
Wachter has some interesting observations on how the fallout from this study may affect the hospitalist looking for a job or jockeying for better compensation. As I see it, it could play out in any number of ways. Wachter suggests that this study, which shows a smaller resource saving than some older studies, could prompt hospital administrators to tighten their budgets for hospitalist compensation:
Since most hospitalist groups get (and require) hospital support, and much of that support has been predicated on a Return-on-Investment drawn from earlier findings of 15 percent LOS and cost reductions, expect some skirmishes at budget time, with hospitals trying to tighten the screws on their hospitalist groups (“why should we raise your support – you only save us $200 per patient!”).
But I could see it play out another way. Given that the economic value of the hospitalist model was in dispute at least in the minds of some, administrators who look at this paper as having settled the issue once and for all may now say “Hospitalist care is supposed to save money. Why aren’t you doing better than your non-hospitalist peers?”
No matter how you slice it, you’re better off if you can convince folks that there are non-economic and intangible benefits of hospitalist care. As Wachter said,
The hospitalist group that has not convinced its CFO that the true ROI doesn’t hinge on pure cost reduction – but rather on systems improvement, QI, patient safety, and more – may be in for a bumpy ride.
Thursday, December 27, 2007
Top ten issues in hospital medicine for 2007, issue 4: evidence based management of sepsis---is it time to unbundle?
The Surviving Sepsis Guidelines (SSG) are now over 3 years old. I’m going to look into the crystal ball of recent evidence and make some predictions about what the next version will look like, realizing, with apologies to Yogi Berra, that “predictions are risky, especially when they’re about the future.”
The SSG recommendations were put forth as a “bundle” by the Institute for Healthcare Quality (IHI) and other organizations. Recently some key components of the bundle are being challenged by new evidence.
Perhaps the most contentious measure in the guidelines is the recommendation for Drotrecogin Alfa (activated protein C). Drotrecogin Alfa was controversial from the time of its original FDA approval because that approval was based on a subset of patients in a single RCT. Nevertheless, at the time of publication of the SSG this was the best and most current evidence available. Although recent evidence calls the use of Drotrecogin Alfa into question the loudest criticism, a perspective piece in NEJM (really more of a rant containing little in the way of perspective) which preceded this evidence, was not based on evidence at all. As I pointed out in posts here and here it seemed more like an ad hominem attack on the guideline authors for their association with Eli Lilly.
But recent disturbing evidence on Drotrecogin Alfa has surfaced including this paper which raised concerns about real world use of the drug and called for additional clinical trials to assess the risks in relation to the benefits. There was also a meta-analysis I linked to and discussed here which suggested a lack of mortality benefit.
The NEJM perspective authors launched another salvo in a recent letter to the editor of Critical Care Medicine, reported by Hooked: Ethics, Medicine and Pharma and Health Care Renewal. I can’t access the letter, so I don’t know whether it’s another exercise in Pharma bashing, a “see I told you so” or a sober assessment of the new evidence. Nevertheless the new evidence calls into question the efficacy, safety and cost effectiveness of Drotrecogin Alfa. If the letter writers made an appeal to this evidence they’ve gained my respect. If the writers of the next version of the SSG moderate their recommendation for Drotrecogin (and I expect they will) it should help put to rest concerns about marketing being disguised as evidence based medicine.
The use of corticosteroids in stress doses, another component of the bundle, took a hit with the release of CORTICUS (discussed here) which showed no mortality benefit. The study was underpowered, having been halted early due to enrollment difficulties, but showed no signal of benefit. It contained less ill patients than those in earlier smaller studies which showed benefit. Although critical illness related corticosteroid insufficiency (CIRCI) is real, the results of CORTICUS tell us that, while some patients need to be treated, a blanket recommendation is not warranted. Patient selection is now unclear. The best candidates for steroid treatment may be those among the more severely ill (matching the populations evaluated in older studies) who fail to respond to cortrosyn. Expect a more restrictive corticosteroid recommendation in the next version of the SSG.
Glycemic control has been challenged by evidence published since the release of the guidelines. There is little question that glycemic control is important in critical illness but the targets are unclear. Glycemic control recommendations will remain in the guidelines but I expect some refinement in the next update.
Early goal directed therapy, timely initiation of appropriate antibiotics, source control and other components of the bundle remain intact, having withstood the test of time.
The SSG recommendations were put forth as a “bundle” by the Institute for Healthcare Quality (IHI) and other organizations. Recently some key components of the bundle are being challenged by new evidence.
Perhaps the most contentious measure in the guidelines is the recommendation for Drotrecogin Alfa (activated protein C). Drotrecogin Alfa was controversial from the time of its original FDA approval because that approval was based on a subset of patients in a single RCT. Nevertheless, at the time of publication of the SSG this was the best and most current evidence available. Although recent evidence calls the use of Drotrecogin Alfa into question the loudest criticism, a perspective piece in NEJM (really more of a rant containing little in the way of perspective) which preceded this evidence, was not based on evidence at all. As I pointed out in posts here and here it seemed more like an ad hominem attack on the guideline authors for their association with Eli Lilly.
But recent disturbing evidence on Drotrecogin Alfa has surfaced including this paper which raised concerns about real world use of the drug and called for additional clinical trials to assess the risks in relation to the benefits. There was also a meta-analysis I linked to and discussed here which suggested a lack of mortality benefit.
The NEJM perspective authors launched another salvo in a recent letter to the editor of Critical Care Medicine, reported by Hooked: Ethics, Medicine and Pharma and Health Care Renewal. I can’t access the letter, so I don’t know whether it’s another exercise in Pharma bashing, a “see I told you so” or a sober assessment of the new evidence. Nevertheless the new evidence calls into question the efficacy, safety and cost effectiveness of Drotrecogin Alfa. If the letter writers made an appeal to this evidence they’ve gained my respect. If the writers of the next version of the SSG moderate their recommendation for Drotrecogin (and I expect they will) it should help put to rest concerns about marketing being disguised as evidence based medicine.
The use of corticosteroids in stress doses, another component of the bundle, took a hit with the release of CORTICUS (discussed here) which showed no mortality benefit. The study was underpowered, having been halted early due to enrollment difficulties, but showed no signal of benefit. It contained less ill patients than those in earlier smaller studies which showed benefit. Although critical illness related corticosteroid insufficiency (CIRCI) is real, the results of CORTICUS tell us that, while some patients need to be treated, a blanket recommendation is not warranted. Patient selection is now unclear. The best candidates for steroid treatment may be those among the more severely ill (matching the populations evaluated in older studies) who fail to respond to cortrosyn. Expect a more restrictive corticosteroid recommendation in the next version of the SSG.
Glycemic control has been challenged by evidence published since the release of the guidelines. There is little question that glycemic control is important in critical illness but the targets are unclear. Glycemic control recommendations will remain in the guidelines but I expect some refinement in the next update.
Early goal directed therapy, timely initiation of appropriate antibiotics, source control and other components of the bundle remain intact, having withstood the test of time.
Top ten issues in hospital medicine for 2007, issue 5: therapeutic hypothermia and early goal directed therapy
Hospitals, scrambling for good public report cards, have implemented various core “quality measures” promulgated by Joint Commission, CMS and others. Unfortunately these measures have suffered from lack of evidence, ill conceived implementation and unintended consequences. Among the unintended consequences is distraction from other measures which may be better supported by evidence and which really matter.
Early goal directed therapy for sepsis and the application of hypothermia to promote neurologic recovery after cardiac arrest are examples of evidence based therapies that matter, but which are currently being ignored by the core measure police. In addition the detailed planning, organizational requirements and expense involved in the implementation of these therapies constitute institutional barriers.
This year I found and posted links to several papers which addressed practical aspects of implementation. Articles on therapeutic hypothermia are linked here and here. Implementation issues for early goal directed therapy are discussed here and here.
Early goal directed therapy for sepsis and the application of hypothermia to promote neurologic recovery after cardiac arrest are examples of evidence based therapies that matter, but which are currently being ignored by the core measure police. In addition the detailed planning, organizational requirements and expense involved in the implementation of these therapies constitute institutional barriers.
This year I found and posted links to several papers which addressed practical aspects of implementation. Articles on therapeutic hypothermia are linked here and here. Implementation issues for early goal directed therapy are discussed here and here.
Top ten issues in hospital medicine for 2007, issue 6: Medicare, CMS and hospital “mistakes”
This year the Centers for Medicare and Medicaid Services (CMS) revamped the prospective payment system and diagnosis related groups (DRGs). Among other provisions starting in October of 2008 (and this is the part that sparked the most controversy) when certain adverse events and conditions occur in the hospital (or aren’t documented to be present on admission) they can no longer be coded to enhance the DRG payment.
The language of the CMS regs implied that events such as hospital falls and hospital acquired decubitus ulcers were avoidable mistakes. Worse, the popular media simplistically spun the new regulations as “Medicare no longer paying for mistakes.” I wrote a series of posts (here, here and here) about unintended consequences and why the newspaper spin was wrong. The short version of my remarks is that a) Medicare hasn’t really paid for the care patients actually received, irrespective of “mistakes”, since 1984 and b) most falls, decubitus ulcers and many infections acquired in the hospital are not the result of mistakes.
The language of the CMS regs implied that events such as hospital falls and hospital acquired decubitus ulcers were avoidable mistakes. Worse, the popular media simplistically spun the new regulations as “Medicare no longer paying for mistakes.” I wrote a series of posts (here, here and here) about unintended consequences and why the newspaper spin was wrong. The short version of my remarks is that a) Medicare hasn’t really paid for the care patients actually received, irrespective of “mistakes”, since 1984 and b) most falls, decubitus ulcers and many infections acquired in the hospital are not the result of mistakes.
Wednesday, December 26, 2007
New concerns about cefepime
Cefepime (Maxipime) is one of the big gun beta-lactams we reach for in serious infections such as health care associated pneumonia and fever with neutropenia. Two recent papers suggest we need to rethink our choice of big guns.
A meta-analysis of trials comparing anti-pseudomonal beta-lactam antibiotics for treatment of febrile neutropenia concluded that cefapime was associated with increased mortality compared with other beta-lactams.
More recently a meta-analysis was done comparing cefipime with other beta-lactams for a variety of indications, again finding an increased mortality with cefipime. The increase in mortality could not be attributed to treatment failure, superinfection or specific adverse events. The authors speculated that discrepancies between in vitro and in vivo results or unidentified adverse effects may have explained the increase in mortality. Possible adverse effects include encephalopathy and non-convulsive status epilepticus, which have been noted in post marketing reports.
A meta-analysis of trials comparing anti-pseudomonal beta-lactam antibiotics for treatment of febrile neutropenia concluded that cefapime was associated with increased mortality compared with other beta-lactams.
More recently a meta-analysis was done comparing cefipime with other beta-lactams for a variety of indications, again finding an increased mortality with cefipime. The increase in mortality could not be attributed to treatment failure, superinfection or specific adverse events. The authors speculated that discrepancies between in vitro and in vivo results or unidentified adverse effects may have explained the increase in mortality. Possible adverse effects include encephalopathy and non-convulsive status epilepticus, which have been noted in post marketing reports.
Top ten issues in hospital medicine for 2007, issue 7: new developments in perioperative medicine
The buzz this year was about perioperative beta blockers, statins and stents. Perioperative beta blockers were already being questioned in 2006. In response the American College of Cardiology (ACC) issued a focused update which recommended a much more restrictive strategy for perioperative beta blockers. In July of this year I discussed the new concerns, linked to the ACC focused update and cited the MaVS and DIPOM trials, both of which demonstrated no benefit from perioperative beta blockers.
In September the ACC released its 2007 updated guidelines for perioperative evaluation and care which incorporated the interim focused update on beta blockers. The class I recommendations were to continue beta blockers in patients already receiving the drugs for a cardiovascular indication and to administer them in patients undergoing major vascular surgery who had ischemia demonstrated on preoperative testing. Class IIa recommendations were to administer beta blockers to patients undergoing vascular surgery who had known CAD or risk factors (with certain caveats about the level of vascular surgical risk in relation to the number of risk factors).
Barely a month after the release of the ACC guideline update came the announcement of the disturbing results of the POISE trial at an American Heart Association meeting. As reported in Med Page Today (H/T to Wachter’s World):
Does this make the ACC guidelines obsolete concerning beta blockers one month after publication? The class I recommendation for continuation in patients already taking beta blockers still seems sound. The class IIa recommendations are now problematic. For an analysis of what it all means for real world practice Wachter’s follow up post on this issue is worth reading in its entirety.
Clinical Cases and Images blog weighed in about beta blockers here.
Statins are increasingly making news in the arena of perioperative medicine. I have blogged several times about possible beneficial effects of statins in the perioperative period, including this post from last September. Will statins replace beta blockers as a beneficial perioperative medication? The new ACC guidelines linked above contain recommendations for statins which, for the first time, give them virtually equal status with beta blockers, including a class I recommendation to continue statin drugs in patients already receiving them.
Patients with cardiac stents who require non-cardiac surgery provided fodder for intense discussion this year. How should we manage patients who require urgent or emergency surgery soon after implantation of stents? How long should we wait to do elective surgery after stent implantation? The guidelines address these questions. (According to the guidelines if the patient has a drug eluting stent, wait a year! You can read the rest in the guidelines linked above, which are available free in full text).
In September the ACC released its 2007 updated guidelines for perioperative evaluation and care which incorporated the interim focused update on beta blockers. The class I recommendations were to continue beta blockers in patients already receiving the drugs for a cardiovascular indication and to administer them in patients undergoing major vascular surgery who had ischemia demonstrated on preoperative testing. Class IIa recommendations were to administer beta blockers to patients undergoing vascular surgery who had known CAD or risk factors (with certain caveats about the level of vascular surgical risk in relation to the number of risk factors).
Barely a month after the release of the ACC guideline update came the announcement of the disturbing results of the POISE trial at an American Heart Association meeting. As reported in Med Page Today (H/T to Wachter’s World):
Perioperative metoprolol (Lopressor, Toprol-XL) started two to four hours before surgery prevented 15 MIs, three revascularizations, and seven atrial fibrillation events per 1,000 treated patients compared with placebo, according to a large prospective trial presented here at the American Heart Association meeting.
But this came at the expense of eight deaths, five severe strokes, 42 cases of significant bradycardia, and 53 significant hypotension events per 1,000 patients, reported P.J. Devereaux, M.D., of McMaster University in Hamilton, Ontario, and colleagues.
Does this make the ACC guidelines obsolete concerning beta blockers one month after publication? The class I recommendation for continuation in patients already taking beta blockers still seems sound. The class IIa recommendations are now problematic. For an analysis of what it all means for real world practice Wachter’s follow up post on this issue is worth reading in its entirety.
Clinical Cases and Images blog weighed in about beta blockers here.
Statins are increasingly making news in the arena of perioperative medicine. I have blogged several times about possible beneficial effects of statins in the perioperative period, including this post from last September. Will statins replace beta blockers as a beneficial perioperative medication? The new ACC guidelines linked above contain recommendations for statins which, for the first time, give them virtually equal status with beta blockers, including a class I recommendation to continue statin drugs in patients already receiving them.
Patients with cardiac stents who require non-cardiac surgery provided fodder for intense discussion this year. How should we manage patients who require urgent or emergency surgery soon after implantation of stents? How long should we wait to do elective surgery after stent implantation? The guidelines address these questions. (According to the guidelines if the patient has a drug eluting stent, wait a year! You can read the rest in the guidelines linked above, which are available free in full text).
Top ten issues in hospital medicine for 2007, issue 8: new guidelines and evidence for diagnosis and treatment of venous thromboembolism
This year saw the publication of new guidelines for the diagnosis and treatment of venous thromboembolism which can be accessed as free full text, which I linked in a post here.
Just out a week or two ago was this randomized trial comparing CT with V/Q scanning for the diagnosis of pulmonary embolism. The results were equivalent. Neither method emerged as the clear diagnostic modality of choice. This was consistent with previous evidence.
Just out a week or two ago was this randomized trial comparing CT with V/Q scanning for the diagnosis of pulmonary embolism. The results were equivalent. Neither method emerged as the clear diagnostic modality of choice. This was consistent with previous evidence.
Top 10 issues in hospital medicine for 2007, issue 10: unintended consequences of the 5th vital sign
About a decade ago people began to wake up to the fact that the medical profession was doing a poor job of treating pain. Treatment was all too often irrational and ineffective. Education and quality improvement initiatives were needed. Unfortunately, well-intentioned initiatives were hijacked by activism and pain management became politicized. The scientific rationale of pain management became difficult to distinguish from dogma. As Joint Commission pain management initiatives got into high gear concerns about narcotic addiction, respiratory depression and other adverse effects fell on deaf ears. These were medical myths perpetuated by a culture of undertreatment and underconcern, we were told. Activism really got into high gear and struck fear in the hearts of physicians with the astounding news in 2001 of a $1.5 million verdict against a California internist for undertreating pain. The award was made possible by a novel legal strategy which bypassed California’s malpractice laws and withstood a substantial burden of proof that the doctor had acted with criminal recklessness. This was despite the lack of diagnosis of a terminal condition (only later confirmed to be untreatable lung cancer) and reliance on a nebulous pain scale which had become enshrined as the "5th vital sign." Lacking a firm diagnosis of terminal illness the physician was understandably concerned about the "double effect" of hastening death in the process of providing comfort and was hampered by California’s onerous prescription documentation requirements for strong narcotics.
The case sent shock waves through the media and medical journals. A Western Journal of Medicine editorial about the case was typical:
Indeed they did. Scientific discourse about pain management was now hopelessly tainted by popular debate. An otherwise well appearing patient walking into the emergency department announcing pain at "10 out of 10" was an urgent indication for narcotics. Adverse effects of narcotics administered on the wards were minimized in importance.
Many of us who realized that the teaching about pain management was based more on dogma than science were worried about unintended consequences. This past year the adverse consequences have been brought to light. A JAMA news report earlier this year documents an alarming rising trend in narcotic related deaths which began in 1999, about the time the new pain management initiatives began to be promulgated. Our pain management dogma that "addiction is rare" was challenged by this systematic review of outcomes for opioid treatment of chronic back pain, which showed addictive behavior to be quite common. Thought leaders this year began to question the science behind the rise in opioid use, calling for the same standards of scientific rigor we apply to other treatments. Finally, a paper from the Journal of the American College of Surgeons earlier this year (H/T Aggravated Doc Surg) demonstrated that since the promulgation of recent pain management initiatives we have changed from a culture of undertreating pain to one of overmedication and underconcern for adverse effects of narcotics, resulting in patient deaths.
Perhaps 2007 will be remembered as the year of appreciation of the adverse consequences of pain treatment dogma.
The case sent shock waves through the media and medical journals. A Western Journal of Medicine editorial about the case was typical:
Another message to physicians implicit in these verdicts is that there is a standard of care for pain management, a significant departure from which constitutes not merely malpractice but gross negligence. Even if professional boards might not hold their licensees to that standard, juries will. With the implementation of the new pain standards by the Joint Commission for the Accreditation of Healthcare Organizations, which recognize the right of patients to the appropriate assessment and management of their pain, public expectations will likely increase exponentially.
Indeed they did. Scientific discourse about pain management was now hopelessly tainted by popular debate. An otherwise well appearing patient walking into the emergency department announcing pain at "10 out of 10" was an urgent indication for narcotics. Adverse effects of narcotics administered on the wards were minimized in importance.
Many of us who realized that the teaching about pain management was based more on dogma than science were worried about unintended consequences. This past year the adverse consequences have been brought to light. A JAMA news report earlier this year documents an alarming rising trend in narcotic related deaths which began in 1999, about the time the new pain management initiatives began to be promulgated. Our pain management dogma that "addiction is rare" was challenged by this systematic review of outcomes for opioid treatment of chronic back pain, which showed addictive behavior to be quite common. Thought leaders this year began to question the science behind the rise in opioid use, calling for the same standards of scientific rigor we apply to other treatments. Finally, a paper from the Journal of the American College of Surgeons earlier this year (H/T Aggravated Doc Surg) demonstrated that since the promulgation of recent pain management initiatives we have changed from a culture of undertreating pain to one of overmedication and underconcern for adverse effects of narcotics, resulting in patient deaths.
Perhaps 2007 will be remembered as the year of appreciation of the adverse consequences of pain treatment dogma.
Top 10 issues in hospital medicine for 2007
It’s time again for a year-end wrap up of developments in the field of hospital medicine. What were the defining issues in 2007? Although there are more answers to that question than there are people reading this blog I have a top 10 list, one that reflects my own biases. As I prepare to present it here as a series of posts over the next few days I’m struck by how the list is evolving. Some of the issues (e.g. Natrecor) have gone into dormancy, perhaps to resurface in future top 10 lists. Others, such as quality and safety remain on the front burner with the skeptics still winning the day. Occasional issues (such as sepsis bundles) seem to have come full circle while still others (glycemic control) remain ever-moving targets.
Here are my top 10 lists for 2006 and 2005---
2006:
State of the hospitalist movement.
Surviving sepsis guidelines under fire.
Debates about ALI and ARDS put to rest.
Medication reconciliation.
Outsourcing of hospital services.
Perioperative medicine.
The new C diff.
ER crowding.
EMR and CPOE.
Enthusiasm versus skepticism on the quality movement and core measures.
2005:
Diagnosis of pulmonary embolism.
Inpatient glycemic control.
Quality and accountability.
Combining modalities in treatment of sepsis.
EMR and CPOE.
ACLS, ECC.
Controversies in hypercoagulability.
Emerging infections.
The Natrecor controversy.
State of the hospitalist movement.
Here are my top 10 lists for 2006 and 2005---
2006:
State of the hospitalist movement.
Surviving sepsis guidelines under fire.
Debates about ALI and ARDS put to rest.
Medication reconciliation.
Outsourcing of hospital services.
Perioperative medicine.
The new C diff.
ER crowding.
EMR and CPOE.
Enthusiasm versus skepticism on the quality movement and core measures.
2005:
Diagnosis of pulmonary embolism.
Inpatient glycemic control.
Quality and accountability.
Combining modalities in treatment of sepsis.
EMR and CPOE.
ACLS, ECC.
Controversies in hypercoagulability.
Emerging infections.
The Natrecor controversy.
State of the hospitalist movement.
Tuesday, December 25, 2007
Merry Christmas
Christmas at RW's place was special not only for the kids and grandkids---
but also for the dogs.
It was a day of eating too much, no-brain TV and, of course, a little blogging.
but also for the dogs.
Monday, December 24, 2007
Stem cells: the basics
Think you can understand the stem cell debate? Not if you don’t know the biology. Some resources are here. Compiled by Life Sciences Education.
Dr. RW's online museum of antique drug company freebies
I was cleaning out closets and ran across some very old drug company trinkets. Now, I'm not as old as these images would indicate. Some of them are hand-me-downs!
Sunday, December 23, 2007
CPR and EBM
I was about to cite a couple of new articles and an editorial from Circulation to seize a SITYS (see I told you so) moment when I found that California Medicine Man beat me to it. It concerned predictions I made in a series of posts starting in October of 2005 about changes I thought were overdue in the guidelines for CPR and emergency cardiac care. California Medicine man beat me not only to the SITYS (not that that was his intent) but also to a post back in 2005 which predated mine by several months (back before I started blogging).
The posts concerned data on CPR from a group of Arizona investigators spearheaded by Dr. Gordon Ewy, Chief of Cardiology at the University of Arizona College of Medicine and author of the cited editorial. In it Ewy notes poor survival rates following CPR and asks:
Despite that rationale (and it’s pretty strong pathophysiologic rationale) to adopt compression only resuscitation for certain types of cardiac arrest, traditional CPR with compressions and rescue breathing has persisted through multiple iterations of the guidelines. Ewy, himself an early leader in this field, has been telling us for years that we’ve been doing it all wrong. Why have the guideline writers ignored his pleas? I believe it’s an unintended consequence of evidence based medicine (EBM).
Don’t get me wrong. I’m an advocate of EBM. There’s nothing in EBMs basic principles, which tell us to seek the best and most current evidence available to guide treatment, to stop guideline writers from adopting Ewy’s recommendations. Rather, the problem seems to be a popular distortion of EBM which summarily rejects pathophysiologic rationale, animal studies and "low level" human data, anything, in fact, other than a randomized controlled trial (RCT). I’m a fan of the RCT but I recognize that there are some questions which are extremely difficult to subject to that method of investigation. In such cases we must go with the best available information.
So I have a somewhat different take on CPR and EBM from that of California Medicine Man. He seems to think EBM will come to the rescue and bring about needed guideline changes. That may be true. But I feel EBM (well, not really EBM but the popular distortion of EBM I referenced above) has stalled important updates to CPR protocols. I made that point earlier this year in a Medscape Roundtable piece about EBM controversies:
Ewy expresses a similar view in the editorial even though prospective randomized trials comparing the two methods are finally underway:
So that’s the question. If the RCTs now underway prove that traditional CPR with rescue breathing is superior to compression only CPR for bystander-witnessed primary cardiac arrest the EBM extremists will be vindicated.
What does the evidence show so far? California Medicine Man’s posts summarize it pretty well. Not mentioned is this study of implementation of the changes in a region in Wisconsin, showing that the new protocol is associated with improved survival as well as data presented by Ewy’s group at the American Heart Association meetings in 2006 showing markedly improved survival in Phoenix resulting from compression only CPR. In summary, we have pathophysiologic rationale, strong data from animal studies as well as comparison studies in humans using historical controls which show either equivalency or superiority of compression only CPR for survival and neurologic outcomes.
The zealots of EBM like to trot out the CAST study and trials on estrogen replacement therapy as examples of the hazards of over reliance on low level data. Those are important lessons, to be sure, but one has to wonder whether the insistence on RTCs is always appropriate or, as I asked in my Roundtable, whether we’ve gone too far with EBM.
The posts concerned data on CPR from a group of Arizona investigators spearheaded by Dr. Gordon Ewy, Chief of Cardiology at the University of Arizona College of Medicine and author of the cited editorial. In it Ewy notes poor survival rates following CPR and asks:
Why have survival rates not improved? One possibility is that the guidelines are not optimal. The guidelines advocate the same approach for 2 entirely different pathophysiological conditions: respiratory arrest in which severe arterial hypoxia and hypotension eventually lead to secondary cardiac arrest, and primary cardiac arrest in which the arterial blood is fully saturated with oxygen at the time of the arrest.
Despite that rationale (and it’s pretty strong pathophysiologic rationale) to adopt compression only resuscitation for certain types of cardiac arrest, traditional CPR with compressions and rescue breathing has persisted through multiple iterations of the guidelines. Ewy, himself an early leader in this field, has been telling us for years that we’ve been doing it all wrong. Why have the guideline writers ignored his pleas? I believe it’s an unintended consequence of evidence based medicine (EBM).
Don’t get me wrong. I’m an advocate of EBM. There’s nothing in EBMs basic principles, which tell us to seek the best and most current evidence available to guide treatment, to stop guideline writers from adopting Ewy’s recommendations. Rather, the problem seems to be a popular distortion of EBM which summarily rejects pathophysiologic rationale, animal studies and "low level" human data, anything, in fact, other than a randomized controlled trial (RCT). I’m a fan of the RCT but I recognize that there are some questions which are extremely difficult to subject to that method of investigation. In such cases we must go with the best available information.
So I have a somewhat different take on CPR and EBM from that of California Medicine Man. He seems to think EBM will come to the rescue and bring about needed guideline changes. That may be true. But I feel EBM (well, not really EBM but the popular distortion of EBM I referenced above) has stalled important updates to CPR protocols. I made that point earlier this year in a Medscape Roundtable piece about EBM controversies:
Sometimes, EBM proponents' insistence on patient outcome-based studies slows the wheels of medical progress. The American Heart Association 2005 guidelines for emergency cardiac care provide a recent example. Investigators at the University of Arizona, Tucson, have been publishing evidence for years in support of changes in emergency cardiac care for adult victims of out-of-hospital cardiac arrest.[8,9] Despite this evidence, the guideline authors, dutifully trying to be evidence-based, failed to adopt the new methods because of a reluctance to base changes on anything other than randomized trials. However, the evidence, although based on "low-level" physiologic rationale, was compelling. More recently, the Arizona investigators were vindicated by direct evidence that the new procedures save lives. This situation represents a failure of EBM, not due to any shortcomings of EBM itself, but due to the misappropriation of its principles.
Ewy expresses a similar view in the editorial even though prospective randomized trials comparing the two methods are finally underway:
Will these reports finally be enough to result in guideline changes in the near future, or as suggested by the authors of the Swedish study, should this decision await the published outcome of randomized trials of CCC and CPR now underway? My conclusion is that guideline changes should be made as soon as possible because they are long overdue.
So that’s the question. If the RCTs now underway prove that traditional CPR with rescue breathing is superior to compression only CPR for bystander-witnessed primary cardiac arrest the EBM extremists will be vindicated.
What does the evidence show so far? California Medicine Man’s posts summarize it pretty well. Not mentioned is this study of implementation of the changes in a region in Wisconsin, showing that the new protocol is associated with improved survival as well as data presented by Ewy’s group at the American Heart Association meetings in 2006 showing markedly improved survival in Phoenix resulting from compression only CPR. In summary, we have pathophysiologic rationale, strong data from animal studies as well as comparison studies in humans using historical controls which show either equivalency or superiority of compression only CPR for survival and neurologic outcomes.
The zealots of EBM like to trot out the CAST study and trials on estrogen replacement therapy as examples of the hazards of over reliance on low level data. Those are important lessons, to be sure, but one has to wonder whether the insistence on RTCs is always appropriate or, as I asked in my Roundtable, whether we’ve gone too far with EBM.
Thursday, December 20, 2007
Transfusion and mortality in acute lung injury
It’s been well known for a while that transfusion can cause acute lung injury (ALI). Now, a cohort study in Chest suggests that red cell transfusion increases mortality in patients with established ALI. The results were adjusted for confounding variables. An accompanying editorial reviews other literature in favor of conservative transfusion strategies and emphasizes the need for controlled trials.
Adverse outcomes associated with RBC transfusion in critically ill patients have driven interest in the use of erythropoietin in such patients. Unfortunately, that strategy has not been shown to be beneficial.
Exceptions to a conservative transfusion strategy in critically ill patients include bleeding, early goal directed therapy for sepsis and coronary artery disease.
Adverse outcomes associated with RBC transfusion in critically ill patients have driven interest in the use of erythropoietin in such patients. Unfortunately, that strategy has not been shown to be beneficial.
Exceptions to a conservative transfusion strategy in critically ill patients include bleeding, early goal directed therapy for sepsis and coronary artery disease.
Wednesday, December 19, 2007
Use of vasoactive drugs in septic shock
The old adage was “levophed, leave ‘em dead.” Now it’s “who’s the dope that started dopamine?” Although current evidence suggests superiority of levophed (norepinephrine) in septic shock the choice is not always simple and must be tailored to specific hemodynamic goals. A head to head trial comparing norepinephrine and dopamine is ongoing.
A review in Chest discusses these issues as well as other pressors, including an update on the adjunctive use of vasopressin infusions.
A review in Chest discusses these issues as well as other pressors, including an update on the adjunctive use of vasopressin infusions.
Tuesday, December 18, 2007
Resolved: “mainstream” medical education is slouching towards quackery
In our recent Medscape Roundtable Discussion Roy Poses and I took the affirmative side of this debate while our colleague Nick Genes argued for the negative. If Nick feels all alone he can take solace in the discussion thread which, so far, seems to be lining up in his favor. It was my hope that this edition of the Roundtable would spark debate and give the controversy exposure beyond the blogosphere.
In a spirit of friendly debate let me answer some of Nick’s objections. He takes a more optimistic view the last decade of medical education, arguing that for some time after the Flexner report medical education remained dogmatic, only in more recent years embracing the rigorous scientific principles of evidence based medicine (EBM). While this popular view of medical education would seem to be in diametric opposition to what I said, it’s not so simple.
He writes:
Unknown? What about antimicrobial agents, vaccines and CPR? Granted, clinical investigation early in the 20th century didn’t meet the standards of EBM as we know it today, but this was not the result of mainstream medicine’s adherence to dogma. According to M.L. Meldrum’s fascinating paper on the history of the randomized controlled trial, efforts were made in the early 20th century to garner evidence on the clinical effectiveness of therapies but they were beset with lack of funding and organization. The American Medical Association, at about the same time it helped commission the Flexner Report, began initiatives aimed at the evaluation of drug effectiveness, including publications such as Useful Drugs. Controlled studies became increasingly common in the 1930s. The publication in 1935 of Fisher’s The Design of Experiments was a landmark development in the progress towards clinical trials. In the late 1940s shortages of streptomycin allayed ethical concerns about randomized trials of this agent in the treatment of tuberculosis. These examples from Meldrum’s paper comprise just a portion of the time line of advances in clinical investigation in the first half of the 20th century.
When I was a medical student in the early 70s many randomized clinical trials including the University Group Diabetes Program study, the Coronary Drug Project, the Lipid Research Council trial, several early hypertension trials and the early coronary artery bypass trials, early trials on anticoagulation for myocardial infarction and thromboembolism were completed or underway in planning or implementation. Although the term “evidence based medicine” was not popularized until 1992 history shows that throughout the 20th century medicine was indeed gradually becoming more and more evidence based.
Nick goes on to criticize what he apparently believes to be an over emphasis in 20th century medical education on the basic sciences:
Well, the reason why not should be obvious.
The principal point of his argument is that medical education in the last decade has advanced critical thinking and evidence based medicine, not pseudoscience:
But recent surveys suggest that’s not true. A recent study published in JAMA demonstrated that medical house staff had a very poor working knowledge of the quantitative aspects of EBM. Here’s a link to a study showing a lack of proficiency among medical house staff in EBM searching.
So, there’s reason for concern that while medical schools talk a good game about EBM they’re not very effective in teaching it. But more striking to me is the irony of teaching EBM alongside the uncritical promotion of pseudoscience.
Orac weighs in here about the Roundtable.
In a spirit of friendly debate let me answer some of Nick’s objections. He takes a more optimistic view the last decade of medical education, arguing that for some time after the Flexner report medical education remained dogmatic, only in more recent years embracing the rigorous scientific principles of evidence based medicine (EBM). While this popular view of medical education would seem to be in diametric opposition to what I said, it’s not so simple.
He writes:
So, if you subscribe to Dr. Donnell's narrative, you'd be inclined to believe that for nearly a century, physicians were consistently trained to critically evaluate scientific literature. You would think the tests that they employed, and the therapies that they prescribed, were based on a strong foundation of supporting evidence.
In fact, this was not the case. Medical education was dogmatic after Flexner. However, instead of calling upon the wisdom of the ancients, or their chakras, doctors relied on animal physiology experiments and the observations of a few brilliant, dead clinicians.
The treatments that medicine espoused throughout the 20th century had a basis in science, to be sure, but whether these therapies were really helping patients was unknown -- and often not even properly studied.
Unknown? What about antimicrobial agents, vaccines and CPR? Granted, clinical investigation early in the 20th century didn’t meet the standards of EBM as we know it today, but this was not the result of mainstream medicine’s adherence to dogma. According to M.L. Meldrum’s fascinating paper on the history of the randomized controlled trial, efforts were made in the early 20th century to garner evidence on the clinical effectiveness of therapies but they were beset with lack of funding and organization. The American Medical Association, at about the same time it helped commission the Flexner Report, began initiatives aimed at the evaluation of drug effectiveness, including publications such as Useful Drugs. Controlled studies became increasingly common in the 1930s. The publication in 1935 of Fisher’s The Design of Experiments was a landmark development in the progress towards clinical trials. In the late 1940s shortages of streptomycin allayed ethical concerns about randomized trials of this agent in the treatment of tuberculosis. These examples from Meldrum’s paper comprise just a portion of the time line of advances in clinical investigation in the first half of the 20th century.
When I was a medical student in the early 70s many randomized clinical trials including the University Group Diabetes Program study, the Coronary Drug Project, the Lipid Research Council trial, several early hypertension trials and the early coronary artery bypass trials, early trials on anticoagulation for myocardial infarction and thromboembolism were completed or underway in planning or implementation. Although the term “evidence based medicine” was not popularized until 1992 history shows that throughout the 20th century medicine was indeed gradually becoming more and more evidence based.
Nick goes on to criticize what he apparently believes to be an over emphasis in 20th century medical education on the basic sciences:
Of course, medical school also emphasizes scientifically determined biochemical pathways, with their opportunities for intelligent drug interventions. However, upon entering the wards, a significant student function is to push fluids and dole out cold remedies. Which ones? How much? Until recently, there was little scientific guidance for these decisions; students learned to simply do what their mentors and colleagues were doing.
No wonder CAM gained a foothold. If students were being made to learn arcane trivia and give time-honored but untested therapies, why not invoke energy fields and pressure points?
Well, the reason why not should be obvious.
The principal point of his argument is that medical education in the last decade has advanced critical thinking and evidence based medicine, not pseudoscience:
Students are now trained to critically appraise the literature. They can determine likelihood ratios for a diagnosis on the basis of a test result, and calculate how to properly judge a new therapy. They can point out the inherent biases and methodologic shortcomings in a study. Equipping future doctors with the tools of EBM has encouraged critical thinking about the way medicine is practiced, and has helped expose the inadequate underpinnings of 20th-century medicine's diagnostic and therapeutic modalities.
But recent surveys suggest that’s not true. A recent study published in JAMA demonstrated that medical house staff had a very poor working knowledge of the quantitative aspects of EBM. Here’s a link to a study showing a lack of proficiency among medical house staff in EBM searching.
So, there’s reason for concern that while medical schools talk a good game about EBM they’re not very effective in teaching it. But more striking to me is the irony of teaching EBM alongside the uncritical promotion of pseudoscience.
Orac weighs in here about the Roundtable.
Saturday, December 15, 2007
Another review on noninvasive ventilation
See previous post here.
One of the tricks of noninvasive ventilation is to monitor the patient for signs of failure so that if the patient is destined for invasive mechanical ventilation timely intubation can be carried out before a crisis point is reached.
This is another helpful review of the topic, published in Critical Care Medicine, as free full text via Medscape. Noninvasive ventilation is expanding its niche as new promising indications are explored.
One of the tricks of noninvasive ventilation is to monitor the patient for signs of failure so that if the patient is destined for invasive mechanical ventilation timely intubation can be carried out before a crisis point is reached.
This is another helpful review of the topic, published in Critical Care Medicine, as free full text via Medscape. Noninvasive ventilation is expanding its niche as new promising indications are explored.
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