Outpatient infusion therapy and diabetic foot infections

A review on diabetic foot infections and other soft tissue infections with emphasis on outpatient infusion therapy is presented here as a Medscape CME activity. It contains a world of information on the practical and administrative aspects of outpatient parenteral antibiotic therapy.

Given the recent controversy about Medscape CME I’ll offer my take regarding any commercial bias for this activity and others from Medscape that I link to. This activity was supported by Wyeth pharmaceuticals, the makers of Tygacil. Although listed among alternatives for outpatient infusion therapy for soft tissue infections, Tygacil was given no favorable comments over other alternatives. If anything the article was somewhat favorable to daptomycin (Cubicin) which is not a product of the sponsoring company. The favorable comments regarding daptomycin appropriately reflect new concerning evidence about vancomycin and infusion related concerns. This activity was scientifically rigorous and free of commercial bias.

Bob Wachter’s Knol on the hospitalist model of care

Bob Wachter’s Knol is one of the better overviews on hospital medicine I’ve seen. The section on the history of hospital medicine is particularly good in that it explains the profound but underappreciated impact of Medicare’s Prospective Payment System, (PPS) enacted in 1983, on hospital economics. While not talked about much today the PPS was clearly one of the antecedents of the hospitalist movement. That fact dawned on me in a new way after I read Wachter’s Knol. What also dawned on me was an irony: I owe my hospitalist career in part to this manifestly unfair PPS, a system I’ve always loved to hate.

Wachter devotes considerable attention to the emerging subspecialty hospitalist movements (pediatric, surgical, neuro and obstetrical) thus establishing “hospitalology” in its various forms as subdivisions of parent specialties rather than a single specialty which cares for all inpatients regardless of illness. That’s as it should be, I think.

Apart from a few quibbles about how he handles the evidence regarding the efficiency of the model I agree with Wachter’s perspective and consider this piece a must read for anyone seeking a better understanding of hospital medicine.

Perioperative statin use in cardiac surgery

A meta-analysis has demonstrated that perioperative statin use is associated with a decrease in atrial fibrillation, all cause mortality and stroke following cardiac surgery. Almost all of these patients should already be on statins but an alarming number are not. Is this an area where hospitalists can help?

Via Medscape/Heartwire

Bob Wachter introduces Google’s Knol

A Knol is a “unit of knowledge” according to his description. Google rolled out its Knol project, which has been branded as “Google’s answer to Wikipedia”, Thursday. Wachter, who is an advisor to the project and helped assemble some medical articles for the launch, compares and contrasts Knol with Wikipedia (there are some differences) and addresses the larger question of how Knol, Wikipedia, blogs and other Web 2.0 media will affect the world of medical publishing, particularly traditional journals.

How does Knol differ from Wikipedia? Wachter explains:

Unlike Wikipedia’s anonymous, collaborative writing/editing process, Knols have authors, with names, faces, and reputations. (Authors can choose to have their identity verified, through a cross-check on their credit card or phone records.) Google provides Knolers a tool; authors enter their content and click “publish.” And poof, there it is, on the Web. Users can rate and comment on Knols, send them to friends, and suggest changes. But the author remains the sole owner of the content, able to update and modify it (or remove it) at any time.

Some skeptics, according to Wachter, are already criticizing Knol as being “less pure” than Wikipedia due to Knol authors’ opportunities to partake of Google’s ad revenue. If financial incentives were the only perverse incentives in the world of publishing that would be true. But, as has been pointed out time and time again (and as I pointed out here and here) many other questionable agendas have played out on Wikipedia’s pages.

It strikes me that Knol’s principle weakness may be a failure to define its audience. Wachter notes:

The Knols are layperson oriented: I asked authors to write the Knol that they’d want their mother or best friend to read if they had just been diagnosed with the illness.

So, are the medical Knols primarily aimed at the lay audience? Not necessarily. Some authors, Wachter suggests, may be apt to choose Knol as an alternative to traditional journals, suggesting that the scientific community is in the scope of Knol’s readership. Will the health articles be segregated into professional and consumer oriented material? Apparently not. Therein may lie the weakness. An important rule of writing is to define your audience. An article I’d choose to read on diabetes would probably not be understandable to most patients. Writing effectively for an audience encompassing both lay and professional readers is difficult to pull off and, for some highly technical subjects in medicine, next to impossible.

Wachter wonders whether Knols and other Web 2.0 formats will upend traditional medical publishing. I doubt it. I see more of a gradual adaptation in the medical publishing world, one which has been underway for several years as journals adopt more open access, increasingly rapid submission procedures and rapid reader response capability. Meanwhile the different Web 2.0 media will increasingly complement one another. I think it’s all for the good.

Via Kevin M.D.

Procalcitonin: not ready for prime time but promising

Procalcitonin is the prohormone for calcitonin. It is modified in the parathyroid gland to the active hormone and not normally released into the circulation. It is, however, present in the blood in certain inflammatory states.

Studies in patients with various infections indicate that it is a useful marker. Major areas of investigation have been in patients with sepsis and pneumonia. Lack of immediate availability in many community hospitals limits its usefulness at present.

In patients with pneumonia it is a useful prognostic indicator. It also shows promise in differentiating bacterial pneumonia from viral infections. Consequently it has shown promise in guiding antibiotic therapy. In this study patients whose antibiotic therapy was guided by procalcitonin measurements were able to be treated with fewer instances and shorter courses of antibiotic therapy than controls with no difference in outcomes.

With further research and eventual availability at the point of care procalcitonin measurement is likely to emerge as a useful tool for management decisions in patients with pneumonia and sepsis.

Activated protein C for severe sepsis: evidence summary

Since its initial approval for severe sepsis recombinant activated protein C (apC) was beset by controversy stemming from questions about PROWESS design and subsequent concerns from additional studies about the risk versus the benefit. Following the new evidence, the Surviving Sepsis Guideline authors, despite accusations of undue influence by Eli Lilly, substantially downgraded their recommendation for apC.

A comprehensive evidence review published as part of Critical Care’s supplement on apC addresses these controversies and suggests the best current approach, pending additional evidence:

In light of the various clinical trials evaluating the efficacy and safety of DrotAA in severe sepsis, we can conclude that DrotAA can reduce mortality in patients with severe sepsis at high risk for death. We can define this risk using severity scores, such as high APACHE II score or multiple organ failure, but probably also by sustained organ dysfunction that is not improving or worsening despite optimal care and adequate source control. However, this survival benefit is achieved at the expense of a slight increase in the risk for bleeding events, which can be minimized by adequate patient selection. If indicated, the drug should be used within the first 24 hours of sepsis-induced organ dysfunction.

The authors go beyond the simple formulaic approach of using APACHE II scores and number of failing organs as suggested in the original labeling. The response to a trial of optimal therapy with antibiotics, source control and other evidence based modalities is suggested as an additional criterion for selection. Rapidly improving organ function in patients who initially “qualify” might exclude patients from treatment. The observation of initial response would need to be brief, as initiation of treatment within 24 hours is important for better outcomes.

Medical blogosphere subject of Journal of General Internal Medicine study

A paper in the Journal of General Internal Medicine set out to examine the content of medical blogs for appropriateness and professionalism. Pharmalot commented on it here and provided a link to the full text. Kevin commented here.

From the abstract:

Over half (56.8%) of blog authors provided sufficient information in text or image to reveal their identities. Individual patients were described in 114 (42.1%) blogs. Patients were portrayed positively in 43 blogs (15.9%) and negatively in 48 blogs (17.7%). Of blogs that described interactions with individual patients, 45 (16.6%) included sufficient information for patients to identify their doctors or themselves.

That implies that unless you’re anonymous any case discussion is problematic in terms of patient privacy. The last sentence lumps all medical bloggers who discuss cases and are not anonymous. Since many open bloggers provide more than adequate disguise of patient identity the statement tells us little about how many bloggers actually divulge inappropriate detail.

The authors send a vague and confusing message regarding confidentiality. While appearing to recommend anonymity, at least one of the sources they cite as a standard bearer (Clinical Cases and Images) posts clinical content and explicitly recommends against anonymous blogging.

Why couldn’t the authors have told us how many case discussions were appropriately stripped of the 18 HIPAA identifiers? Moreover, we know nothing about how many bloggers in question got permission from patients.

The authors did not gauge their findings concerning patient postings against any agreed upon standards of confidentiality (e.g. HIPAA regs). Readers are left with the authors’ opinions on how often bloggers inappropriately divulge patient data.

The discussion section of the paper contains what may be a factual error:

Even when the author is anonymous, detailed descriptions of patient interactions and conversations have the potential to be recognizable by the parties involved. For example, the anonymous blog author “Flea” revealed details of a patient’s death after a malpractice case was brought against him. The lawyer for the plaintiffs recognized the description of the case, and shortly thereafter, the case was settled out of court and the author removed his blog from the Internet.

I followed the Flea case closely and that is not what happened as I recall. Bloggers build disguises into their posts and I have never seen reported an instance of anyone recognizing a patient from a case description. The authors’ only citation regarding the Flea case is a Boston Globe piece which gives no indication as to how the blog was discovered. Unfortunately, Google’s cache of Flea’s blog has been deleted, but my distinct recollection is that clinical information had nothing to do with the discovery of Flea’s blog. Rather, what tipped off another attorney (who subsequently contacted the plaintiff attorney) was not a detail of the case, but an image Flea reproduced from one of plaintiff attorney’s PowerPoint presentations. It was that image that the other attorney (who had apparently viewed the presentation) recognized!

The paper covered other aspects of professionalism besides confidentiality. From the conclusion of the abstract (italics mine):

They also risk revealing confidential information or, in their tone or content, risk reflecting poorly on the blog authors and their professions.

(Translation: They show their human side). More from the conclusion:

The health professions should assume some responsibility for helping authors and readers negotiate these challenges.

(Translation: Look out for the Thought Police and their agenda to sanitize our blogs). Finally, from the discussion section:

Physician-leaders and medical educators should consider curricular development and educational forums that address the challenges, opportunities and responsibilities that medical blog authors face, and the place of this new medium within norms of medical professionalism.

The norms of medical professionalism these days are increasingly defined based on public perception. Conformity of medical blogs to a sanitized notion of physicians runs counter to an essential purpose of blogging, articulated more than once by Kevin MD: “The whole purpose of blogging is to be open and pull back the curtain to talk about how it really is…”

Clinical Cases and Images weighs in with an excellent post here.

Activated protein C for sepsis: Can protein C levels guide therapy?

Evidence which has accumulated since the original approval of activated protein C for severe sepsis suggests that patient selection is more difficult than originally anticipated. Patients with lower levels of endogenous protein C have worse outcomes in sepsis and might stand to benefit more from treatment. Could measurement of endogenous levels help select patients and guide treatment? RESPOND, a phase II study, aims to find out.

Want to be a hospitalist?

Read this before you sign up. It’s all too typical.

Via Kevin M.D.

Reaction to Thomas Stossel’s Medscape commentary on commercial influence

---consisted of a rebuttal by Dr. Howard Brody, Professor of Family Medicine at the University of Texas, Galveston along with two comment threads. Dr. Brody’s arguments, it seems to me, were directed at a straw man as he repeatedly accused Stossel of positions he didn’t hold. From one of the opening paragraphs:

Dr. Stossel has generally expressed surprise and dismay that anyone could imagine that commercial influence in medicine has had any negative consequences. From his vantage point, commerce is an unalloyed good.

Of course, Dr. Stossel said no such thing. Quite the contrary, her argued for a more scholarly and balanced analysis of the relative risks and benefits of commerce in medicine than has been offered to date.

And---

Dr. Stossel, in conclusion, calls for an apparently simple and defensible outcome -- that "we work in a spirit of mutual respect with our industry colleagues to improve physicians' and physician-in-training's understanding of medical product development." What Dr. Stossel never explains, however, is why such "mutual respect" need require that physicians in academia stuff themselves with free lunches and dinners, and stuff their pockets with consulting and speakers' fees.

An eloquent display of moral outrage, perhaps, but, sorry, straw man again.

The reader comments so far favor Stossel. I like these:

When academics stop cashing their paychecks, we will permit being lectured to by the unbiased.

The pompous arrogance of the morality police is breathtaking. Every sophomoric abstraction, every bit of sophistry is trotted out to bash pharmaceutical companies for being in business, making a profit, and having normal customer relations. I am every bit a scientist as any. I go where the evidence takes me. Abstractions and theory are irrelevant. Conflicts of interest are normal, eternal human behavior. Just be transparent and disclose. I have an excellent BS detector. There is no credible evidence of undue influence. If you can find some, show us. I'll decide for myself. Put up, or shut up.

Background: Dr. Thomas Stossel’s commentary.

Challenging the dogma on conflicts of interest

Although I’ve already linked to Harvard Medical School professor Thomas Stossel’s Medscape commentary a couple of times it’s so rich I just can’t let it rest. Finally the leaders of the grand inquisition of doctors and drug companies have been taken to task, their dogma publicly held to a rigorous standard of evidence. Although Stossel’s article was in response to the AMA Council on Ethical and Judicial Affairs report calling for a ban of industry supported CME he addressed the broader issue of commercial involvement in medicine and its impact on professionalism:

My intention here, however, is to challenge the fundamental beliefs underlying The Report that transcend medical education to affect medical practice and medical research in general. These beliefs are that commerce in general is detrimental to medical professionalism and that "medicine" and "commerce" have sufficiently misaligned interests to justifying their segregation from one another.

He noted that the arguments for these severe claims were remarkably one sided:

Citing both sides of controversial issues is a requirement of serious scholarship. Violating this mandate, Brennan and colleagues not only ignored the benefits of commercial contributions to medicine, but exercised confirmation bias by referring only to publications critical of industry influences on medicine, although others rebutting these criticisms existed when the Brennan paper appeared.[19-23] All of the references that Brennan and colleagues cited were to books, medical journal articles, and newspaper reports supportive of the authors' claims. These references were compilations of anecdotes, purportedly exemplifying industrial corruption of medical research. Not only has follow-up due diligence challenged the interpretation of some of these stories (eg, Shuchman[24]), but, more importantly, considering the enormous expansion of corporate interactions with medicine, the paucity of examples is striking and their frequent repetition is not legitimate evidence.

The Brennan paper, frequently referenced in Stossel’s commentary, argues for severe restrictions in pharmaceutical industry support of education and research, and is one of the most widely cited papers by the critics of Pharma influence.

Although marketing activity does influence doctors there’s no evidence for a net effect leading to patient harm:

Unable to marshal evidence that corporate promotion adversely affects patient outcomes, The Report resorted to indirect arguments intended to convey that industry influence adversely biases physicians' judgment. In one, it mentions 2 notorious cases in which drug companies accused of promoting off-label drug use paid settlement fines to prosecutorial authorities. The obvious intention of mentioning such anecdotes is to imply that all corporations are fundamentally unethical. Considering the vast scope of corporate-sponsored medical education compiled by The Report, such extrapolation from isolated incidents -- meant to insinuate that such conduct is typical -- is grossly extravagant, bordering on slander.

I made the same point in a post from 3 years ago. The advocates for severe policy change should be required to sustain their burden of proof. They cannot.

If you’d like to watch a companion video, Stossel recently gave Grand Rounds on this topic at Dartmouth-Hitchcock Medical Center. He was heckled by the audience although no one could effectively challenge him in the Q&A. You can access the video here.

Talk about conflicts of interest

Mention conflicts of interest and the pharmaceutical industry immediately comes to mind. But there are many other conflicts in day to day practice of medicine which are ignored in public debate. Here are a few that were uncovered in a recent Reader’s Digest interview of two dozen doctors:

Hospitals want physicians to send patients home faster, so some doctors are given bonuses for getting their patients out of the hospital quickly.

Doctors respond to market forces. If the reimbursement system is fee-for-service, that results in more services. If you build a new CT scan, someone will use it, even though having a procedure you don't need is never a good thing.

Doctors get paid each time they visit their patients in the hospital, so if you're there for seven days rather than five, they can bill for seven visits. The hospital often gets paid only for the diagnosis code, whether you're in there for two days or ten.

Not a day goes by when I don't think about the potential for being sued. It makes me give patients a lot of unnecessary tests that are potentially harmful, just so I don't miss an injury or problem that comes back to haunt me in the form of a lawsuit.

In most branches of medicine, we deal more commonly with old people. So we become much more enthusiastic when a young person comes along. We have more in common with and are more attracted to him or her. Doctors have a limited amount of time, so the younger and more attractive you are, the more likely you are to get more of our time.

Are you conflicted? Read the rest. Via Fox News.

Mechanisms of recombinant activated protein C in sepsis

Activation of the coagulation system and inflammatory cytokines are universal in sepsis and are interrelated. Although activated protein C works on both pathways its actions on the inflammatory cascade are less well understood.

Activation of coagulation occurs along a spectrum ranging through asymptomatic laboratory abnormalities, micro thrombosis and overt DIC with diffuse bleeding. In general the more severe the coagulation disturbance the more the patient benefits from activated protein C up to the point where the coagulopathy increases bleeding risk. That point is difficult to define, contributing to difficulty in patient selection. These issues are discussed in a review of the mechanisms of activated protein C, part of a supplement in the journal Critical Care.

Should hospitalists take over the world of inpatient care?

No. A story from the Annals of Family Medicine speaks louder than all the “data” you can marshal about hospitalists and outcomes. The author, Cherie Glazner, M.D., saw the exodus of primary care physicians from her hospital and agonized about whether the old fashioned doctor who makes hospital rounds and sees patients in the office is obsolete. A personal experience provided a compelling answer:

Resolution to my uncertainty came to me most unexpectedly. The next day my mom called; she was taking my 85-year old grandmother, 6 days after receiving a stent in her left main coronary artery, to the hospital. I met them in the strange familiarity of a distant emergency department. The cardiologist, wizened and gray headed, had no explanation for her sodium of 120 mEq/L, her bigeminy, and her low blood pressure. My grandmother, who had raised 4 children on a subsistence dry-land farm with no water or plumbing, explained in her tired and timid voice that the problem was too much medication, but to no avail. The nephrologist would see her in the morning. She wasn’t having a heart attack. Her stent was fine. Dismissed.

The next morning, feeling fatigued, defeated, and fearful of death, my grandmother confided that no one appeared to be in charge. First one cardiologist, then another, had come in without answers. The nephrologist had not yet been in, but she was restricted to 1,000 mL of fluid for the day. She wanted to know why no one had spoken to her family physician. He knew that her sodium bottomed out on hydrochlorothiazide, which the cardiologists, unaware of her history, had started 6 days ago. Her family doctor knew she could not tolerate a blood pressure of less than 120/70 mm Hg, but the cardiologist’s opinion was otherwise. Her family physician knew her passion lay in her rose beds and perennial gardens now that water was freely abundant to her. He understood that for my grandmother to feel too weak to stand up and walk her gardens was a type of death.

We’re not told whether a hospitalist was placed in the middle of this mess, but I suspect so. I also suspect that the hospitalist, steeped in evidence based medicine but pressed for time and functioning as an admitologist in deference to the subspecialists (it's called co-management) was as much in the dark as they concerning the patient’s idiosyncratic reaction to thiazides and blood pressure medications. I think, anyway, that that’s how this all too typical story plays out in many hospitals.

If you attended SHM 2008 you might think the hospitalist movement, like Walmart, is out to take over the world. But I don’t think most hospitalists in the trenches have that agenda. Some traditional practitioners have good reason to quit the hospital. Others can still juggle hospital and office duties and do it well. They should keep doing what they’re doing.

DB over at MedRants has blogged about this story a couple of times and posted a response in the journal. I may comment further after I read his take.

A point-counterpoint on commerce in medicine

In an earlier post about the CME Thought Police I briefly mentioned Tom Stossel’s piece on the proposed ban on commercial support of CME and larger issues regarding the interface between commerce and medicine. Stossel cites an inquisition against commercial influence in medicine. He appeals to a nuanced and careful analysis of risks and benefits of commerce and believes that guidelines for ethics and policy should be based on careful examination of evidence rather than extreme philosophical bent. To conclude that commercial interests are invariably conflicted with medicine’s professional ideals is simplistic, he said.

Read Stossel’s commentary, then go read a rebuttal by Howard Brody and an accompanying comment thread. I’ll have a thing or two to say about those in a future post.

Activated protein C from bench to bedside

Early this year the Surviving Sepsis Campaign downgraded its recommendation for activated protein C based on new evidence. I blogged it here. At about that time the journal Critical Care published a supplement containing a series of basic science and clinical topics on the use of apC and how it fits in with the overall management of sepsis.

Toxicology for the hospitalist

This review from Chest belongs in your list of references. You’ll find out how the latest evidence applies to questions such as these:

What tests are indicated when?

What is the role of the gaps (osmolar, anion and oxygen saturation) in establishing a diagnosis?

What is the role of GI decontamination?

When does the Rumack-Matthew nomogram fail to identify patients with acetaminophen toxicity in need of treatment with N-acetylcysteine?

What are the indications for hemodialysis?

Pacemaker ECG interpretation

A guide from the November 2001 issue of the American Journal of Emergency Medicine.

Medical management after acute coronary syndrome

----with a focus on post discharge antiplatelet agents.

Eli Lilly and the Surviving Sepsis Guidelines

Recent blistering attacks on the Surviving Sepsis Guidelines have made a large appeal to public distrust of the pharmaceutical industry (specifically Eli Lilly) with little regard for the actual evidence. I originally made that point here and here. Critics implied that the guidelines were little more than marketing for Lilly’s activated protein C (Xigris). They were proven wrong when the guideline authors remained true to the evidence by downgrading their recommendation for Xigris in the 2008 update.

A commentary just out in the journal Critical Care made those same points:

Some have argued that the campaign is simply advanced marketing for activated protein C. That Eli Lilly are interested in promoting education in the field of sepsis because they have a product to treat sepsis is unquestionably true. But the multiple checks and balances outlined above prevent any direct influence in the guidelines content. While the consensus process included a number of proponents of activated protein C, it also included some of activated protein C's more vocal critics. If Eli Lilly's primary objective is to cast their drug in a favourable commercial light, they have shown questionable judgment in supporting the SSC, as the current recommendation for activated protein C use in sepsis is a weak one.

You mean those free gifts don’t work after all?

Critics of pharmaceutical industry detailing like to accuse doctors of taking "bribes" in the form of small gifts in return for prescribing non-evidence based medications. Their premise: "The drug companies wouldn’t spend all that money on small gifts if it didn’t work." Well, if you believe the converse of that statement, as #1 Dinosaur does, it doesn’t work:

I have no doubt in the world that the recent withdrawal of pens and mugs from the drug reps' goodie bags is nothing more than the result of a consultant's report that the return on that investment is not worth it.

Maybe. The lobby opposing all forms of interaction between industry and the medical profession has focused on the giving of small gifts because it’s the easiest target for ridicule. What the Dinosaur refers to, the latest move by the industry trade organization (Pharma) to stop the gifts, may just take some of the wind out of their sails.

And that tired canard that accepting gifts is taking money out of our patients’ pockets because it drives up drug prices can now be put to the test, right?

You can access the new Pharma code here.

Bill Maher’s prescription for health care reform

One hundred cc of get up off your ass STAT!

Best hospitals?

U.S. News and World Report’s best hospitals list is out. Ironically, all but 4 of the 19 hospitals (Cedars-Sinai, Hopkins, Wash U. and University of Pittsburgh) also made the Academic Woo Aggregator.

To all Wal-Mart haters

DB’s recent posts on these topics give me an excuse to write about Wal-Mart. Disclosure (aside from the fact that I have a little Wal-Mart stock): I live about 5 miles from Wal-Mart corporate headquarters. The quality of life and the professional opportunities in my community are attributable in no small part to Wal-Mart. Wal-Mart and Mr. Sam (as the locals called him) helped transform a few sleepy towns into a small metropolitan area with an ever-expanding list of amenities. Yes, I’m conflicted.

Last Monday DB quoted Sam Walton:

Outstanding leaders go out of their way to boost the self-esteem of their personnel. If people believe in themselves, it’s amazing what they can accomplish. - Sam Walton

There are many Mr. Sam stories circulating around which attest to the fact that he believed in people. Here’s one:

Back in the late 80s, when I was a teenager, I worked at a restaurant on the MO-AR stateline called the Stephenson's Cider Mill. At the time, this was one of very few restaurants in the area. Mr. Sam and his family visited many times.

On a busy Friday night, I was elected to be the "bun girl", which meant I would have a basket of hot rolls and would hand them out to customers that wanted one. In a hurry to get hot rolls to our customers, I left one of the dining rooms and started running quickly to the other dining room. (I knew I wasn't supposed to be running in the hall, do teenagers ever listen?) Mr. Sam was coming around the corner at the same time and I ran right into him, almost knocking myself down. Hot rolls flew everywhere! He helped me pick them up, shook my hand and said keep up the good work! He was a wonderful person!

On Wednesday DB praised the Wal-Mart $4 generic drug program and quoted from a Wal-Mart hating web site:

Rep. Pennartz, for her part, expressed concerns for independent pharmacists across the country, who would face serious difficulties matching Wal-Mart’s low price. Independent businesses are certainly struggling to keep up with Wal-Mart’s pricing, but Pennartz’s concerns reveal a larger point: Wal-Mart’s $4 generics are aren’t an answer to America’s health care problems, they’re a way for Wal-Mart to make more money. Whether that means luring in Medicaid recipients who need cheaper drugs, getting employees to use the company pharmacies for their prescriptions or driving out competing pharmacies, Wal-Mart is only looking out for one thing: itself.

Catch the logic: The company benefits from the program, so it doesn’t matter that it helps patients.

So, Wal-Mart haters of the world, lighten up and watch this vid. It’s pretty funny.

Wrong side surgery

Reading CEO Paul Levy’s post about the recent episode of wrong side surgery at his institution and Bob Wachter’s reaction I’m left wondering. This evokes all kinds of questions and reactions, a few of which I want to share here. Lest I come across as insensitive or cynical I first want to say that judging from Levy’s post and the comments of some of the people who work with him, it’s clear the folks at Beth Israel Deaconess Medical Center (BIDMC) take safety very seriously. I can only imagine what they and the patient must be going through.

Wachter deals with two dimensions of safety, starting with the notion that our obsession with “throughput” (Wachter also refers to it as “production pressure”) may threaten patient safety. The OR crew at BIDMC was having a hectic day, full of distractions. But today’s culture of production pressure makes every day hectic. Some see throughput itself as a safety goal because of its ultimate impact on ER crowding. That goal may come into conflict with other safety and quality concerns as I observed in Wednesday’s post on early goal directed therapy in which I quoted a rant from an academic leader in emergency medicine (italics mine):

The crowded ED is a blatant patient safety issue, much more so than medication reviews by pharmacists, medication reconciliation, time-outs, or two patient
IDs.

A time out, omitted in this case, would have averted the error. Wachter goes on to address the issue of blame surrounding the failure to observe the time out. While boosters of today’s patient safety movement purport to deemphasize blame their efforts have had the opposite effect as I noted here, here and here. Wachter asks whether this is a situation where we should go beyond our systems approach and actually assign blame. Not if it’s a case of human error, he concludes, but perhaps so if individuals are found to have flouted established safety measures. We don’t have enough information about this case to make the call.

What surgical procedure was actually done? We aren’t told, but given that it was characterized as wrong side we know it involved a structure of bilateral symmetry. And, from White Coat Notes (linked from Levy’s post) we learn that it was not an organ removal and did not result in permanent harm. Was it a biopsy, an arthroscopic procedure or carpal tunnel release?

Whatever it was the hospital is apparently not threatened with huge financial loss. Levy’s candor, laudable as it is, must be viewed in that context. After the OR staff disclosed the error to the patient Levy emailed the entire hospital staff, the Boston Globe and other media about the incident! But what if the patient had renal cell carcinoma and had the wrong kidney removed, sentencing him/her to long term hemodialysis? Would Levy have responded in the same way? I doubt it. If he shared such an incident with the media Beth Israel’s attorneys would have concerns and the malpractice carrier would arguably be within its rights to refuse coverage. One of Levy's commenters said:

Because the team of doctors are working so hard for everything to be perfect, they need assistance from a protocol ambassador that will check final review before any procedure starts. The ambassador will then give the green light to go ahead with the procedure. This would eliminate a number of errors.

Not a bad idea. The ambassador, an outsider not in a hurry and not distracted by other details of the case, would have added a layer of safety and likely have averted the error. So I was a little disappointed in Levy’s response:

I have to respectfully disagree.In my view, you have the right sentiment, but the wrong cure. Nobody should need to be appointed to go in to the OR to make sure a time out is done. That is the responsibility of the surgeon, first, and everybody else, too. That happens in the overwhelming majority of cases. It did not here. The goal is to make sure it does. But, if you take away the responsibility from those who should own it, you don't ever get to the result that is needed.

The exchange highlights a fundamental question. In response to an incident such as this should we look for someone to blame or should we look to improve system design? Design is the first principle of today’s patient safety movement. Adding a final check point in the form of a protocol ambassador is a design enhancement. It adds a safety net; it doesn’t remove responsibility from anyone.

Some might ask how many more safety nets we need in a system already designed with redundancies. A review of wrong site surgery in the Annals of Surgery (reproduced in Medscape) suggests that the time outs and check points now in place are not enough; wrong site surgery still occurs at an alarming rate. Suggestions for design improvement were made in the discussion at the end of the article: Withhold instruments from the surgeon until the time out is done; hold a briefing among OR personnel before entering the OR (in addition to the last minute time out in the OR); require documentation of the time out in the op note.

Donald Berwick, safety expert and leader of the Institute for Healthcare Improvement (IHI) addressed this issue in his talk at SMH 2008. Berwick is a big advocate for system design. He believes asking individual doctors to be more vigilant and take more “ownership” of patient safety is 180 degrees wrong. Doctors in general are conscientious and work at top speed, he said. If the surgeon at BIDMC is an exception to this rule it will be revealed in the root cause analysis and can be addressed appropriately.

Why haven’t we done a better job of implementing early goal directed therapy?

Last December the journal Critical Care ran a supplement on the treatment of sepsis focusing on activated protein C. One article I found useful was a general overview of sepsis management. It gave an insightful analysis on putting best evidence into practice. That seems to be a particularly difficult task when it comes to early goal directed therapy (EGDT).

With the exception of timely and appropriate antibiotic therapy EGDT is the most robust of the measures advocated in the Surviving Sepsis Campaign. Despite that fact, as well as the fact that it’s been several years since publication of Rivers’s classic paper validating EGDT, implementation is not as widespread as it should be. Even after all these years we seem to be in the talking stage of implementation. Why?

Barriers to implementation are both institutional and cultural. I mentioned the institutional barriers before. Briefly, when it’s not a “core measure” that will show up on public report cards it’s difficult to convince a hospital to commit resources. (Unfortunately, hospital administrators probably don’t realize that EGDT shortens ICU stay and can save money). Should EGDT become a publicly reported core measure? I doubt it. Think of the unintended consequences---hasty and ill advised central lines, transfusions and inotropes come to mind.

A significant cultural barrier may exist in the emergency department, where EGDT, or at least its initial phase, is supposed to be carried out. But with the current concerns over ED crowding the big push nowadays is “throughput.” Just read emergency medicine professor Richard Bukata’s rant on ED crowding in a recent piece from Emergency Medicine News:

The philosophy is to sacrifice the ED and its patients for the sake of the rest of the hospital. Until recently, the perceived consequence of this decision was to reinforce the general beliefs of the community that EDs are associated with long waits and a litany of other indignities.

ED staff become frustrated and exasperated because it seems they are powerless to change the situation. The concept that excess patients are, in reality, a hospital challenge rather than simply an ED challenge has been a tough sell when you look at the typically impotent actions taken to address the problem.

and…

…why aren't regulatory agencies interested in the problem? It is obviously dangerous to be working in an environment that is substantially over capacity. It is obviously a problem when ED patients wait hours to see a doctor. It is obviously a problem when the rate of patients leaving the ED without being seen is five percent to 10 percent. With the mantra of patient safety on everyone's lips, how can these obvious problems be overlooked? It would be one thing if there were truly nothing that could be done, but this is fundamentally untrue. There are myriad solutions that have been demonstrated to facilitate turnaround times in the ED. It requires the hospital leadership (both medical staff and administration) to have the stomach to make some hard and not-so-hard
choices.

Why not offer incentives? If the CEO's annual bonus were linked to ED patient throughput, it is guaranteed that most hospitals would see their problem solved. This may sound like an inflammatory statement, but truly, the only one who can fix the ED problem is the CEO. It is a top-down initiative. Driven by money or fear, it can be fixed. Money has already been suggested; make it a criterion for the bonus, and watch what happens. But what about fear? For all practical purposes, the most feared entity in the hospital world is the Joint Commission, and its ability to shut down a hospital gives it unprecedented clout. So why hasn't the Joint Commission taken on the hospitals, given its passion for patient safety and multiple initiatives in this matter? The crowded ED is a blatant patient safety issue, much more so than medication reviews by pharmacists, medication reconciliation, time-outs, or two patient IDs.

Clearly safety concerns surrounding ED crowding may, in the minds of some, be in conflict with other quality and safety goals including the implementation of EGDT. The notion that some patients, even after being designated for admission, should remain in the department for an extended time to receive ongoing treatment may be foreign to some ED types. In Rivers’s original study the entire six hours of EGDT were delivered by the ED (the intensivists in the ICU were blinded to the type of ED treatment patients received). Such an arrangement would be impractical in many departments and undoubtedly evoke howls of protest from ED personnel.

Although the review cites evidence of poor ED adherence to sepsis guidelines (one example here) this paper reports successful ED implementation. In most institutions collaboration across hospital departments works best. Initial rapid screening can be done in the ED. If the patient is eligible for EGDT a sepsis page is sent. A sepsis team presents and initiates therapy. The protocol continues in the department until an ICU bed is available.

Lipid lowering drugs underutilized

This survey from the American Journal of Cardiology looked at factors associated with more evidence based prescribing.

TTP and related disorders

Reviewed in CCJM.

Background:

Thrombotic microangiopathies.

Platelets on the Web (from OUHSC).

Obesity can be costly

---to you or someone on your behalf, despite a shortened life span, according to a study of obesity related health care expenses.

Internet meltdown ahead?

Is this a real concern or just another Y2K scare?

Thoughts on the 4 hour rule and other core measures

Bob Wachter’s post on the 4 hour pneumonia rule lists these lessons to apply to future quality measure development:

First, results from studies of patients with known diagnoses should be extrapolated cautiously, if at all, to patients who lack a diagnosis.

Second, or some measures, “bands” of performance (i.e., 80-100% adherence) may make more sense than “all-or-nothing” expectations.

Third, representative end users of quality measures (in this case, ED docs and hospitalists) should participate in measure development.

Fourth, quality measurement and reporting programs should build in mechanisms to reassess measures over time. In this case, CMS and the Joint Commission are to be praised for listening to the chorus of criticism: in response, the measure has been revised from a 4-hour to a 6-hour standard. Even though a 6-hour TFAD rule is still not evidence-based, it should cause less harm.

Finally, biases, both financial and intellectual, that may influence quality measure development should be minimized. The TFAD measure was proposed and endorsed by many of the same people who conducted the foundational studies. None of us can be completely unbiased when evaluating our own research results.

These are important lessons for developers of quality measures. But I think there may be an even larger lesson for us “end users.” One of Wachter’s observations is telling:

As I’ve discussed previously, the biggest surprise of the last decade in the quality field has been this: public reporting alone (even without pay-for-performance) leads to huge changes in the behavior of providers and healthcare organizations… even though there is virtually no evidence that patients are reading or acting on the reports.In other words, shame and pride are powerful forces for change.

The lesson? Shame and pride are about me, us, our institutions. Shame and pride motivate us to play for the test. It’s called performance. I would submit that real quality is something different. Real quality is not about us or our public reports; it’s about the patient. Yes, shame and pride get results, but are they may not be the results we want.

The 4 hour pneumonia rule is just one example of the conflict between what performs well and what really works for patients. Last year I commented on the disappointing results for heart failure core measures:

The rush by hospitals to get a good report card may have diverted attention from other life saving therapies such as devices and aldosterone receptor antagonists.The first quality measure was the provision of discharge instructions on medications, diet and other aspects of heart failure care. In one study on which this recommendation was based the instructions included a full hour of one-on-one verbal counseling. The intervention was associated with improved outcomes. The “core quality” measure, in contrast, required only that written instructions be given to the patient. It’s one thing to hand patients a ream of paper as they are rushed out the door and quite another to provide detailed counseling. Nominal compliance may earn the hospital a perfect report card while doing little of substance to help patients.

DB weighed in here.

The four hour antibiotic rule for pneumonia is a sentinel event

---in patient safety policy. Bob Wachter, a leader in the field, said so and I agree. Like every sentinel event it deserves a root cause analysis, which Wachter and his colleagues provided in an article in the current issue of Annals of Internal Medicine.

Via Kevin MD

Neurotoxicity of cefepime

All beta lactam antibiotics can cause neurotoxicity, chief among them penicillin and imepenem. A paper showing increased mortality associated with cefepime use suggested neurotoxicity, including encephalopathy and non-convulsive status epilepticus, may be responsible for the increased mortality. Now comes this report suggesting severe neurotoxicity of cefepime in patients with renal failure. I have access only to the abstract, but a review citing this report suggested that cefepime was not renally adjusted and some patients were massively overdosed.

Neuro exam tips

---focusing on the cranial nerve and cerebellar exam. From Today’s Hospitalist.