Brian F. Mandell, MD, PhD

The medical aspects of globalization are myriad. The investigation of an index case of North American HIV infection 30 years ago and the tracking of the H1N1 virus through the pig farms of Mexico were like detective stories and showed us how infectious disease can spread across borders and across oceans. The threat of such spread can affect national policy as well as personal travel, as I was reminded of on a recent trip to Asia, when I encountered devices in airports to detect fever in disembarking travelers.

Closer to home, general internists and other primary care providers can use the awareness of global health concerns to the health advantage of our patients, including the young and healthy, who generally eschew preventive health visits to their physicians, and busy traveling executives, who only see a doctor for (hopefully) quick resolution to intermittent problems.

In this issue of the Journal, Powell and Ford offer a general primer on travel medicine, highlighting specific concerns that should be addressed to facilitate our patients’ safe and uninterrupted travels. But often, a pretravel visit is also a good time to introduce concepts of preventive health to patients who might not otherwise be accessible or amenable.

Just as the preoperative medical consultation can provide a “teaching moment” to address smoking cessation or reversible cardiac risks to a captive audience, the visit regarding “What shots do I need to go to Thailand?” can open the door for talk about general vaccinations (see the article by Campos-Outcalt of this issue), venereal disease, air-travel-associated thrombosis, excessive alcohol use, and perhaps other wellness issues. Creating a travel advisory service within most practices will not supplant the benefits of having travelers review the CDC travel Web site or the need to refer some patients to travel medicine experts regarding specific diseases and vaccinations. But it may create the opportunity for interaction, dialogue, and even a blood pressure check with patients who might not otherwise have the time or see the need to schedule a visit with a physician in the absence of an acute medical concern.

The medical aspects of globalization are myriad. The investigation of an index case of North American HIV infection 30 years ago and the tracking of the H1N1 virus through the pig farms of Mexico were like detective stories and showed us how infectious disease can spread across borders and across oceans. The threat of such spread can affect national policy as well as personal travel, as I was reminded of on a recent trip to Asia, when I encountered devices in airports to detect fever in disembarking travelers.

Closer to home, general internists and other primary care providers can use the awareness of global health concerns to the health advantage of our patients, including the young and healthy, who generally eschew preventive health visits to their physicians, and busy traveling executives, who only see a doctor for (hopefully) quick resolution to intermittent problems.

In this issue of the Journal, Powell and Ford offer a general primer on travel medicine, highlighting specific concerns that should be addressed to facilitate our patients’ safe and uninterrupted travels. But often, a pretravel visit is also a good time to introduce concepts of preventive health to patients who might not otherwise be accessible or amenable.

Just as the preoperative medical consultation can provide a “teaching moment” to address smoking cessation or reversible cardiac risks to a captive audience, the visit regarding “What shots do I need to go to Thailand?” can open the door for talk about general vaccinations (see the article by Campos-Outcalt of this issue), venereal disease, air-travel-associated thrombosis, excessive alcohol use, and perhaps other wellness issues. Creating a travel advisory service within most practices will not supplant the benefits of having travelers review the CDC travel Web site or the need to refer some patients to travel medicine experts regarding specific diseases and vaccinations. But it may create the opportunity for interaction, dialogue, and even a blood pressure check with patients who might not otherwise have the time or see the need to schedule a visit with a physician in the absence of an acute medical concern.

The medical aspects of globalization are myriad. The investigation of an index case of North American HIV infection 30 years ago and the tracking of the H1N1 virus through the pig farms of Mexico were like detective stories and showed us how infectious disease can spread across borders and across oceans. The threat of such spread can affect national policy as well as personal travel, as I was reminded of on a recent trip to Asia, when I encountered devices in airports to detect fever in disembarking travelers.

Closer to home, general internists and other primary care providers can use the awareness of global health concerns to the health advantage of our patients, including the young and healthy, who generally eschew preventive health visits to their physicians, and busy traveling executives, who only see a doctor for (hopefully) quick resolution to intermittent problems.

In this issue of the Journal, Powell and Ford offer a general primer on travel medicine, highlighting specific concerns that should be addressed to facilitate our patients’ safe and uninterrupted travels. But often, a pretravel visit is also a good time to introduce concepts of preventive health to patients who might not otherwise be accessible or amenable.

Just as the preoperative medical consultation can provide a “teaching moment” to address smoking cessation or reversible cardiac risks to a captive audience, the visit regarding “What shots do I need to go to Thailand?” can open the door for talk about general vaccinations (see the article by Campos-Outcalt of this issue), venereal disease, air-travel-associated thrombosis, excessive alcohol use, and perhaps other wellness issues. Creating a travel advisory service within most practices will not supplant the benefits of having travelers review the CDC travel Web site or the need to refer some patients to travel medicine experts regarding specific diseases and vaccinations. But it may create the opportunity for interaction, dialogue, and even a blood pressure check with patients who might not otherwise have the time or see the need to schedule a visit with a physician in the absence of an acute medical concern.

“Emerging” viral infections such as Ebola, Hantavirus, JC virus, and anthrax tend to attract attention. But reemerging infections once considered limited to children or virtually eradicated by vaccination programs also merit attention.

We have previously discussed in the Journal the recrudescence of pertussis in adults and the challenges to its diagnosis, which include the misperception that it is a rare disease. ¹ Adult pertussis infection is usually due to the waning effect of childhood vaccination, and in adults it is more often an extreme annoyance than a life-threatening illness.

In this issue, Dr. Camille Sabella² discusses measles, an infection thought to be all but eradicated in the United States by vaccination, predominantly using the live-attenuated measles virus contained in the measles-mumps-rubella (MMR) vaccine.

But measles outbreaks are seemingly on the rise, and because measles is extremely contagious, it poses a real risk to closed communities such as college dormitories, churches, and health care facilities. Measles infection can have significant adverse outcomes, particularly in immunosuppressed patients.

Although outbreaks have been attributed to virus imported from locations outside the United States, the spread of infection has been blamed on an increased number of unvaccinated children and adults. The reasons for decreased vaccination rates are many, and include parental fears that the vaccine will cause problems such as autism.

This autism link is a goblin that refuses to go away, despite strongly worded debunking by the US Centers for Disease Control and Prevention, the Institute of Medicine,¹ and many peer-reviewed publications. The very recent retraction by the Lancet⁴—based on ethical and nondisclosure concerns—of the 1998 paper by Wakefield et al⁵ (which suggested a link in 12 children between MMR vaccine and chronic gastrointestinal problems and autism spectrum disorders) may further diffuse this concern. But I fear it will not.

So at present, we should reeducate ourselves on the clinical features, natural history, and potential complications of this eradicable disease, particularly if we treat patients who work in closed communities or have defects in cellular immunity.

“Emerging” viral infections such as Ebola, Hantavirus, JC virus, and anthrax tend to attract attention. But reemerging infections once considered limited to children or virtually eradicated by vaccination programs also merit attention.

We have previously discussed in the Journal the recrudescence of pertussis in adults and the challenges to its diagnosis, which include the misperception that it is a rare disease. ¹ Adult pertussis infection is usually due to the waning effect of childhood vaccination, and in adults it is more often an extreme annoyance than a life-threatening illness.

In this issue, Dr. Camille Sabella² discusses measles, an infection thought to be all but eradicated in the United States by vaccination, predominantly using the live-attenuated measles virus contained in the measles-mumps-rubella (MMR) vaccine.

But measles outbreaks are seemingly on the rise, and because measles is extremely contagious, it poses a real risk to closed communities such as college dormitories, churches, and health care facilities. Measles infection can have significant adverse outcomes, particularly in immunosuppressed patients.

Although outbreaks have been attributed to virus imported from locations outside the United States, the spread of infection has been blamed on an increased number of unvaccinated children and adults. The reasons for decreased vaccination rates are many, and include parental fears that the vaccine will cause problems such as autism.

This autism link is a goblin that refuses to go away, despite strongly worded debunking by the US Centers for Disease Control and Prevention, the Institute of Medicine,¹ and many peer-reviewed publications. The very recent retraction by the Lancet⁴—based on ethical and nondisclosure concerns—of the 1998 paper by Wakefield et al⁵ (which suggested a link in 12 children between MMR vaccine and chronic gastrointestinal problems and autism spectrum disorders) may further diffuse this concern. But I fear it will not.

So at present, we should reeducate ourselves on the clinical features, natural history, and potential complications of this eradicable disease, particularly if we treat patients who work in closed communities or have defects in cellular immunity.

“Emerging” viral infections such as Ebola, Hantavirus, JC virus, and anthrax tend to attract attention. But reemerging infections once considered limited to children or virtually eradicated by vaccination programs also merit attention.

We have previously discussed in the Journal the recrudescence of pertussis in adults and the challenges to its diagnosis, which include the misperception that it is a rare disease. ¹ Adult pertussis infection is usually due to the waning effect of childhood vaccination, and in adults it is more often an extreme annoyance than a life-threatening illness.

In this issue, Dr. Camille Sabella² discusses measles, an infection thought to be all but eradicated in the United States by vaccination, predominantly using the live-attenuated measles virus contained in the measles-mumps-rubella (MMR) vaccine.

But measles outbreaks are seemingly on the rise, and because measles is extremely contagious, it poses a real risk to closed communities such as college dormitories, churches, and health care facilities. Measles infection can have significant adverse outcomes, particularly in immunosuppressed patients.

Although outbreaks have been attributed to virus imported from locations outside the United States, the spread of infection has been blamed on an increased number of unvaccinated children and adults. The reasons for decreased vaccination rates are many, and include parental fears that the vaccine will cause problems such as autism.

This autism link is a goblin that refuses to go away, despite strongly worded debunking by the US Centers for Disease Control and Prevention, the Institute of Medicine,¹ and many peer-reviewed publications. The very recent retraction by the Lancet⁴—based on ethical and nondisclosure concerns—of the 1998 paper by Wakefield et al⁵ (which suggested a link in 12 children between MMR vaccine and chronic gastrointestinal problems and autism spectrum disorders) may further diffuse this concern. But I fear it will not.

So at present, we should reeducate ourselves on the clinical features, natural history, and potential complications of this eradicable disease, particularly if we treat patients who work in closed communities or have defects in cellular immunity.

We are enhancing the way the Cleveland Clinic Journal of Medicine offers continuing medical education for its articles, providing more options for our print and online readers.

For 16 years, we have offered CME based on a collection of articles in each issue (usually four). Many of you have complained that the maximum 1.5 credits for reading the articles and taking the test did not reflect the time you put into the activity.

Starting with this issue, all CME activities are based on individual articles, and you can receive up to 1 credit for each article read and test completed. The change gives you the flexibility to take a CME test for a specific article that interests you. If you want to receive credits for all CME-certified articles in one issue, it will mean extra effort to take separate tests, but you will be able to claim considerably more credit than in the past.

By offering CME for individual articles, we will also be able to offer it to those of you who read CCJM online rather than in print. Because the rules governing CME differ for print activities vs online-only activities, there will be two similar but separate pathways.

Print readers can identify CME-certified articles by the CME logo on the print issue table of contents or on the title page of each article. Those who wish to take the test for a CME-certified article can continue to our home page and click on the CME link. One more click on the appropriate link for print readers will take the reader directly to the test.

Online-only readers will find a link to the CME activity on the online table of contents or in the links next to the full-text version of the online article. They will be required to read the article online before taking the test.

We have tried to make this system as straightforward as possible, while still conforming to all the regulations governing CME.

We are also adding two innovations to our Web site. First, for those into social networking, there is now a social bookmarking feature. You can easily post a link to a CCJM article to a scholarly networking site such as CiteULike, or to a general social networking site such as Facebook, Twitter, or Digg. And second, we will soon add the ability for you to download some of our figures as PowerPoint slides.

Let us know what you think of our latest changes.

We are enhancing the way the Cleveland Clinic Journal of Medicine offers continuing medical education for its articles, providing more options for our print and online readers.

For 16 years, we have offered CME based on a collection of articles in each issue (usually four). Many of you have complained that the maximum 1.5 credits for reading the articles and taking the test did not reflect the time you put into the activity.

Starting with this issue, all CME activities are based on individual articles, and you can receive up to 1 credit for each article read and test completed. The change gives you the flexibility to take a CME test for a specific article that interests you. If you want to receive credits for all CME-certified articles in one issue, it will mean extra effort to take separate tests, but you will be able to claim considerably more credit than in the past.

By offering CME for individual articles, we will also be able to offer it to those of you who read CCJM online rather than in print. Because the rules governing CME differ for print activities vs online-only activities, there will be two similar but separate pathways.

Print readers can identify CME-certified articles by the CME logo on the print issue table of contents or on the title page of each article. Those who wish to take the test for a CME-certified article can continue to our home page and click on the CME link. One more click on the appropriate link for print readers will take the reader directly to the test.

Online-only readers will find a link to the CME activity on the online table of contents or in the links next to the full-text version of the online article. They will be required to read the article online before taking the test.

We have tried to make this system as straightforward as possible, while still conforming to all the regulations governing CME.

We are also adding two innovations to our Web site. First, for those into social networking, there is now a social bookmarking feature. You can easily post a link to a CCJM article to a scholarly networking site such as CiteULike, or to a general social networking site such as Facebook, Twitter, or Digg. And second, we will soon add the ability for you to download some of our figures as PowerPoint slides.

Let us know what you think of our latest changes.

We are enhancing the way the Cleveland Clinic Journal of Medicine offers continuing medical education for its articles, providing more options for our print and online readers.

For 16 years, we have offered CME based on a collection of articles in each issue (usually four). Many of you have complained that the maximum 1.5 credits for reading the articles and taking the test did not reflect the time you put into the activity.

Starting with this issue, all CME activities are based on individual articles, and you can receive up to 1 credit for each article read and test completed. The change gives you the flexibility to take a CME test for a specific article that interests you. If you want to receive credits for all CME-certified articles in one issue, it will mean extra effort to take separate tests, but you will be able to claim considerably more credit than in the past.

By offering CME for individual articles, we will also be able to offer it to those of you who read CCJM online rather than in print. Because the rules governing CME differ for print activities vs online-only activities, there will be two similar but separate pathways.

Print readers can identify CME-certified articles by the CME logo on the print issue table of contents or on the title page of each article. Those who wish to take the test for a CME-certified article can continue to our home page and click on the CME link. One more click on the appropriate link for print readers will take the reader directly to the test.

Online-only readers will find a link to the CME activity on the online table of contents or in the links next to the full-text version of the online article. They will be required to read the article online before taking the test.

We have tried to make this system as straightforward as possible, while still conforming to all the regulations governing CME.

We are also adding two innovations to our Web site. First, for those into social networking, there is now a social bookmarking feature. You can easily post a link to a CCJM article to a scholarly networking site such as CiteULike, or to a general social networking site such as Facebook, Twitter, or Digg. And second, we will soon add the ability for you to download some of our figures as PowerPoint slides.

Let us know what you think of our latest changes.

In the 1990s, Sackett et al¹ popularized the term evidence-based medicine, ie, the evaluation and use of clinical research in decision-making for individual patients. Some have not embraced evidence-based medicine as the be-all and end-all of clinical decision-making, and we should not expect clinical studies to tell us what to do in every decision that we make at the bedside. Nonetheless, almost everyone accepts the well-done randomized, placebo-controlled study as the most powerful tool in the evidence-based medicine toolbox.

In 1753, Lind² described how he gave fresh fruit vs cider, vinegar, sulfuric acid, seawater, or barley water to 12 sailors aboard the HMS Salisbury in an effort to find a cure for scurvy. This landmark clinical trial has been hailed as an example of how clinical research can dramatically alter clinical practice. Yet practice did not change aboard British naval ships until almost 50 years after Lind’s treatise was published.³

For many reasons, randomized clinical trials may not immediately affect what physicians do. Sometimes, physicians believe that the trials were not well designed or well conducted, or that the results do not apply to their patients. I briefly discussed some limitations of evidence-based clinical decision-making in our September 2009 issue.⁴

Another reason is that the conclusions from some trials do not jibe with the experience of seasoned clinicians. That is why, this month, I have asked two physicians, a rheumatologist⁵ and a spine surgeon,⁶ to comment on how two studies^7,8 have influenced their clinical practice. Both studies concluded that vertebroplasty (injecting cement to shore up osteoporotic vertebrae) was no more beneficial than a sham procedure in patients with vertebral compression fractures. Neither physician is ready to completely abandon vertebroplasty on the basis of these two studies. Thus, it seems that published evidence may provide us guidance and fruit for discussion, but does not give us certainty.

In the 1990s, Sackett et al¹ popularized the term evidence-based medicine, ie, the evaluation and use of clinical research in decision-making for individual patients. Some have not embraced evidence-based medicine as the be-all and end-all of clinical decision-making, and we should not expect clinical studies to tell us what to do in every decision that we make at the bedside. Nonetheless, almost everyone accepts the well-done randomized, placebo-controlled study as the most powerful tool in the evidence-based medicine toolbox.

In 1753, Lind² described how he gave fresh fruit vs cider, vinegar, sulfuric acid, seawater, or barley water to 12 sailors aboard the HMS Salisbury in an effort to find a cure for scurvy. This landmark clinical trial has been hailed as an example of how clinical research can dramatically alter clinical practice. Yet practice did not change aboard British naval ships until almost 50 years after Lind’s treatise was published.³

For many reasons, randomized clinical trials may not immediately affect what physicians do. Sometimes, physicians believe that the trials were not well designed or well conducted, or that the results do not apply to their patients. I briefly discussed some limitations of evidence-based clinical decision-making in our September 2009 issue.⁴

Another reason is that the conclusions from some trials do not jibe with the experience of seasoned clinicians. That is why, this month, I have asked two physicians, a rheumatologist⁵ and a spine surgeon,⁶ to comment on how two studies^7,8 have influenced their clinical practice. Both studies concluded that vertebroplasty (injecting cement to shore up osteoporotic vertebrae) was no more beneficial than a sham procedure in patients with vertebral compression fractures. Neither physician is ready to completely abandon vertebroplasty on the basis of these two studies. Thus, it seems that published evidence may provide us guidance and fruit for discussion, but does not give us certainty.

In the 1990s, Sackett et al¹ popularized the term evidence-based medicine, ie, the evaluation and use of clinical research in decision-making for individual patients. Some have not embraced evidence-based medicine as the be-all and end-all of clinical decision-making, and we should not expect clinical studies to tell us what to do in every decision that we make at the bedside. Nonetheless, almost everyone accepts the well-done randomized, placebo-controlled study as the most powerful tool in the evidence-based medicine toolbox.

In 1753, Lind² described how he gave fresh fruit vs cider, vinegar, sulfuric acid, seawater, or barley water to 12 sailors aboard the HMS Salisbury in an effort to find a cure for scurvy. This landmark clinical trial has been hailed as an example of how clinical research can dramatically alter clinical practice. Yet practice did not change aboard British naval ships until almost 50 years after Lind’s treatise was published.³

For many reasons, randomized clinical trials may not immediately affect what physicians do. Sometimes, physicians believe that the trials were not well designed or well conducted, or that the results do not apply to their patients. I briefly discussed some limitations of evidence-based clinical decision-making in our September 2009 issue.⁴

Another reason is that the conclusions from some trials do not jibe with the experience of seasoned clinicians. That is why, this month, I have asked two physicians, a rheumatologist⁵ and a spine surgeon,⁶ to comment on how two studies^7,8 have influenced their clinical practice. Both studies concluded that vertebroplasty (injecting cement to shore up osteoporotic vertebrae) was no more beneficial than a sham procedure in patients with vertebral compression fractures. Neither physician is ready to completely abandon vertebroplasty on the basis of these two studies. Thus, it seems that published evidence may provide us guidance and fruit for discussion, but does not give us certainty.

Recently, two clinical trials^1,2 reported that, compared with a sham intervention, vertebroplasty had little if any efficacy at reducing the short- and long-term pain of patients with vertebral compression fractures. Previously this common procedure had scant rigorous evidence of efficacy, but many clinicians and some of my patients felt it to be effective at reducing pain. I wondered what effect the new reports would or should have on how often vertebroplasty (injection of polymethylmethacrylate into a fractured vertebral body) is performed, and on its reimbursement. The more I thought about it, the more issues I realized need to be considered.

Should only evidence-based medicine be reimbursed?

In this time of intense discussion about ways to reduce health costs, and of President Obama’s desire to include efficacy and safety outcome data in the dialogue of how to deliver health services to everyone (although perhaps not every possible health service to everyone), the practical and philosophical implications of studies like these are worth pondering. Like it or not, the concept that all health care services will be paid for on demand by third-party payers is not a sustainable model of health care.

Randomized placebo-controlled trials are the cornerstone of evidence-based medicine. But at their best they provide only an approximation of the truth. Sample size is always a limitation. Patients and physicians in the office or operating suite do not always behave exactly like those in clinical trials. Yet, well-designed clinical trials are often considered to be the best we can do. Practice guidelines and US Food and Drug Administration approvals are based more on the results of randomized clinical trials and less on information from clinical registries and real-world observational outcome studies (which have technical foibles of their own). Approval for devices and procedures does not historically get the same type of regulatory scrutiny, but health care payers in the future may be less likely to cover the cost of procedures that lack proof of efficacy from rigorously conducted outcome studies. The development of quality care measures also depends on appropriate conduct and application of these trials.

The deadly sins and decision-making

We physicians generally take umbrage with external oversight of our decision-making. It is our job and our responsibility to balance the science (evidence-based medicine) and the art (experience and gestalt) of clinical care for the benefit of our patients. But as I thought about the impact these new studies may exert on vertebroplasty utilization, I also wondered about the factors that influence our decision-making process. For example, we have long had solid data on the value of treating systolic hypertension (we undertreat), and of treating uncomplicated urinary tract infections with only 3 days of antibiotics (we overtreat). Performance indicators suggest that this solid evidence has only a modest influence on practice patterns. Why?

I recently heard Dr. Louis B. Rice, Professor of Medicine at Case Western Reserve University and Chief of the Medical Service at the Louis Stokes Cleveland VA Medical Center, discuss the possible impact of some of the seven deadly sins on clinical decision-making. A similar analysis applies when thinking about why some treatments continue to be offered despite good evidence of only limited efficacy.

Pride plays a role. We believe that our own clinical skills will permit us to select the ideal patient to undergo a procedure or therapy, whereas such cherry-picking of patients does not generally occur in large clinical trials. This argument (and others of “external validity,” in the lingo of evidence-based medicine) has been put forth to defend the continued use of some procedures that may not have fared well against sham controls in clinical trials, and these procedures continue to flourish.

Pride may also apply to the feeling we physicians have for doing something right for our patients. This feeling may push us to believe we can succeed where an impersonal clinical trial failed. I suspect this is most keenly felt when the therapy is a procedure that depends on our own individual skills. I suspect that internists and subspecialists with special interest in osteoporosis will interpret these trials differently than surgeons and interventional radiologists who are routinely performing these procedures.

Avarice must be considered, and regulatory controls in the future may limit financial gain from these therapies. But I am not convinced that monetary greed drives all clinical decisions that go against the grain of evidence-based medicine.

And then there is gluttony: we and our patients want it all. We do not want to hear that our patient cannot be provided the most recent therapeutic advance—it might work.

Placebo effect, other issues in ‘negative’ studies

A number of factors in these trials of vertebroplasty need to be dissected and discussed. Not the least is the apparent salubrious effect of the sham procedure. This was documented previously with intra-articular injections of saline (placebo) in studies of hyaluronate joint injections for the pain of knee osteoarthritis,³ in which either type of injection provided significant pain relief. Are these truly markedly positive effects of the sham but invasive maneuvers in the vertebroplasty studies, or are we witnessing the natural history of pain resolution in these disorders (in the absence of a true nonintervention control group that could help make this distinction)?

Crossover issues in one of the vertebroplasty papers will certainly generate letters to the editor. Were patients really blinded to their procedure throughout? Which subsets of patients might have responded better or worse? What about balloon kyphoplasty?

We plan to publish commentaries from proceduralists and medical experts in osteoporosis to critique these key clinical trials for us and to put these issues into clinical perspective.

What role for evidence-based medicine?

In the meantime, I urge you to peruse these papers along with the op-ed pieces in your local newspapers as catalysts to reconsider the role evidence-based medicine should play in our daily one-on-one routine with patients, as well as in the redesign of our health care delivery and reimbursement systems. I don’t think that clinical conundrums can be resolved with a simple look at P values and confidence intervals; clinical trials are not the total story. As physicians, we always need to put the trial results into a clinical perspective. Nonetheless, our personal belief of efficacy (or lack of efficacy) also should not be the total story as we make decisions with individual patients and allocate resources within the health care system.

In the end, it should be all about giving high-quality care to the patient sitting in front of us. A question to be addressed is how well we can assess the quality of a given treatment prior to its administration.

Recently, two clinical trials^1,2 reported that, compared with a sham intervention, vertebroplasty had little if any efficacy at reducing the short- and long-term pain of patients with vertebral compression fractures. Previously this common procedure had scant rigorous evidence of efficacy, but many clinicians and some of my patients felt it to be effective at reducing pain. I wondered what effect the new reports would or should have on how often vertebroplasty (injection of polymethylmethacrylate into a fractured vertebral body) is performed, and on its reimbursement. The more I thought about it, the more issues I realized need to be considered.

Should only evidence-based medicine be reimbursed?

In this time of intense discussion about ways to reduce health costs, and of President Obama’s desire to include efficacy and safety outcome data in the dialogue of how to deliver health services to everyone (although perhaps not every possible health service to everyone), the practical and philosophical implications of studies like these are worth pondering. Like it or not, the concept that all health care services will be paid for on demand by third-party payers is not a sustainable model of health care.

Randomized placebo-controlled trials are the cornerstone of evidence-based medicine. But at their best they provide only an approximation of the truth. Sample size is always a limitation. Patients and physicians in the office or operating suite do not always behave exactly like those in clinical trials. Yet, well-designed clinical trials are often considered to be the best we can do. Practice guidelines and US Food and Drug Administration approvals are based more on the results of randomized clinical trials and less on information from clinical registries and real-world observational outcome studies (which have technical foibles of their own). Approval for devices and procedures does not historically get the same type of regulatory scrutiny, but health care payers in the future may be less likely to cover the cost of procedures that lack proof of efficacy from rigorously conducted outcome studies. The development of quality care measures also depends on appropriate conduct and application of these trials.

The deadly sins and decision-making

We physicians generally take umbrage with external oversight of our decision-making. It is our job and our responsibility to balance the science (evidence-based medicine) and the art (experience and gestalt) of clinical care for the benefit of our patients. But as I thought about the impact these new studies may exert on vertebroplasty utilization, I also wondered about the factors that influence our decision-making process. For example, we have long had solid data on the value of treating systolic hypertension (we undertreat), and of treating uncomplicated urinary tract infections with only 3 days of antibiotics (we overtreat). Performance indicators suggest that this solid evidence has only a modest influence on practice patterns. Why?

I recently heard Dr. Louis B. Rice, Professor of Medicine at Case Western Reserve University and Chief of the Medical Service at the Louis Stokes Cleveland VA Medical Center, discuss the possible impact of some of the seven deadly sins on clinical decision-making. A similar analysis applies when thinking about why some treatments continue to be offered despite good evidence of only limited efficacy.

Pride plays a role. We believe that our own clinical skills will permit us to select the ideal patient to undergo a procedure or therapy, whereas such cherry-picking of patients does not generally occur in large clinical trials. This argument (and others of “external validity,” in the lingo of evidence-based medicine) has been put forth to defend the continued use of some procedures that may not have fared well against sham controls in clinical trials, and these procedures continue to flourish.

Pride may also apply to the feeling we physicians have for doing something right for our patients. This feeling may push us to believe we can succeed where an impersonal clinical trial failed. I suspect this is most keenly felt when the therapy is a procedure that depends on our own individual skills. I suspect that internists and subspecialists with special interest in osteoporosis will interpret these trials differently than surgeons and interventional radiologists who are routinely performing these procedures.

Avarice must be considered, and regulatory controls in the future may limit financial gain from these therapies. But I am not convinced that monetary greed drives all clinical decisions that go against the grain of evidence-based medicine.

And then there is gluttony: we and our patients want it all. We do not want to hear that our patient cannot be provided the most recent therapeutic advance—it might work.

Placebo effect, other issues in ‘negative’ studies

A number of factors in these trials of vertebroplasty need to be dissected and discussed. Not the least is the apparent salubrious effect of the sham procedure. This was documented previously with intra-articular injections of saline (placebo) in studies of hyaluronate joint injections for the pain of knee osteoarthritis,³ in which either type of injection provided significant pain relief. Are these truly markedly positive effects of the sham but invasive maneuvers in the vertebroplasty studies, or are we witnessing the natural history of pain resolution in these disorders (in the absence of a true nonintervention control group that could help make this distinction)?

Crossover issues in one of the vertebroplasty papers will certainly generate letters to the editor. Were patients really blinded to their procedure throughout? Which subsets of patients might have responded better or worse? What about balloon kyphoplasty?

We plan to publish commentaries from proceduralists and medical experts in osteoporosis to critique these key clinical trials for us and to put these issues into clinical perspective.

What role for evidence-based medicine?

In the meantime, I urge you to peruse these papers along with the op-ed pieces in your local newspapers as catalysts to reconsider the role evidence-based medicine should play in our daily one-on-one routine with patients, as well as in the redesign of our health care delivery and reimbursement systems. I don’t think that clinical conundrums can be resolved with a simple look at P values and confidence intervals; clinical trials are not the total story. As physicians, we always need to put the trial results into a clinical perspective. Nonetheless, our personal belief of efficacy (or lack of efficacy) also should not be the total story as we make decisions with individual patients and allocate resources within the health care system.

In the end, it should be all about giving high-quality care to the patient sitting in front of us. A question to be addressed is how well we can assess the quality of a given treatment prior to its administration.

Recently, two clinical trials^1,2 reported that, compared with a sham intervention, vertebroplasty had little if any efficacy at reducing the short- and long-term pain of patients with vertebral compression fractures. Previously this common procedure had scant rigorous evidence of efficacy, but many clinicians and some of my patients felt it to be effective at reducing pain. I wondered what effect the new reports would or should have on how often vertebroplasty (injection of polymethylmethacrylate into a fractured vertebral body) is performed, and on its reimbursement. The more I thought about it, the more issues I realized need to be considered.

Should only evidence-based medicine be reimbursed?

In this time of intense discussion about ways to reduce health costs, and of President Obama’s desire to include efficacy and safety outcome data in the dialogue of how to deliver health services to everyone (although perhaps not every possible health service to everyone), the practical and philosophical implications of studies like these are worth pondering. Like it or not, the concept that all health care services will be paid for on demand by third-party payers is not a sustainable model of health care.

Randomized placebo-controlled trials are the cornerstone of evidence-based medicine. But at their best they provide only an approximation of the truth. Sample size is always a limitation. Patients and physicians in the office or operating suite do not always behave exactly like those in clinical trials. Yet, well-designed clinical trials are often considered to be the best we can do. Practice guidelines and US Food and Drug Administration approvals are based more on the results of randomized clinical trials and less on information from clinical registries and real-world observational outcome studies (which have technical foibles of their own). Approval for devices and procedures does not historically get the same type of regulatory scrutiny, but health care payers in the future may be less likely to cover the cost of procedures that lack proof of efficacy from rigorously conducted outcome studies. The development of quality care measures also depends on appropriate conduct and application of these trials.

The deadly sins and decision-making

We physicians generally take umbrage with external oversight of our decision-making. It is our job and our responsibility to balance the science (evidence-based medicine) and the art (experience and gestalt) of clinical care for the benefit of our patients. But as I thought about the impact these new studies may exert on vertebroplasty utilization, I also wondered about the factors that influence our decision-making process. For example, we have long had solid data on the value of treating systolic hypertension (we undertreat), and of treating uncomplicated urinary tract infections with only 3 days of antibiotics (we overtreat). Performance indicators suggest that this solid evidence has only a modest influence on practice patterns. Why?

I recently heard Dr. Louis B. Rice, Professor of Medicine at Case Western Reserve University and Chief of the Medical Service at the Louis Stokes Cleveland VA Medical Center, discuss the possible impact of some of the seven deadly sins on clinical decision-making. A similar analysis applies when thinking about why some treatments continue to be offered despite good evidence of only limited efficacy.

Pride plays a role. We believe that our own clinical skills will permit us to select the ideal patient to undergo a procedure or therapy, whereas such cherry-picking of patients does not generally occur in large clinical trials. This argument (and others of “external validity,” in the lingo of evidence-based medicine) has been put forth to defend the continued use of some procedures that may not have fared well against sham controls in clinical trials, and these procedures continue to flourish.

Pride may also apply to the feeling we physicians have for doing something right for our patients. This feeling may push us to believe we can succeed where an impersonal clinical trial failed. I suspect this is most keenly felt when the therapy is a procedure that depends on our own individual skills. I suspect that internists and subspecialists with special interest in osteoporosis will interpret these trials differently than surgeons and interventional radiologists who are routinely performing these procedures.

Avarice must be considered, and regulatory controls in the future may limit financial gain from these therapies. But I am not convinced that monetary greed drives all clinical decisions that go against the grain of evidence-based medicine.

And then there is gluttony: we and our patients want it all. We do not want to hear that our patient cannot be provided the most recent therapeutic advance—it might work.

Placebo effect, other issues in ‘negative’ studies

A number of factors in these trials of vertebroplasty need to be dissected and discussed. Not the least is the apparent salubrious effect of the sham procedure. This was documented previously with intra-articular injections of saline (placebo) in studies of hyaluronate joint injections for the pain of knee osteoarthritis,³ in which either type of injection provided significant pain relief. Are these truly markedly positive effects of the sham but invasive maneuvers in the vertebroplasty studies, or are we witnessing the natural history of pain resolution in these disorders (in the absence of a true nonintervention control group that could help make this distinction)?

Crossover issues in one of the vertebroplasty papers will certainly generate letters to the editor. Were patients really blinded to their procedure throughout? Which subsets of patients might have responded better or worse? What about balloon kyphoplasty?

We plan to publish commentaries from proceduralists and medical experts in osteoporosis to critique these key clinical trials for us and to put these issues into clinical perspective.

What role for evidence-based medicine?

In the meantime, I urge you to peruse these papers along with the op-ed pieces in your local newspapers as catalysts to reconsider the role evidence-based medicine should play in our daily one-on-one routine with patients, as well as in the redesign of our health care delivery and reimbursement systems. I don’t think that clinical conundrums can be resolved with a simple look at P values and confidence intervals; clinical trials are not the total story. As physicians, we always need to put the trial results into a clinical perspective. Nonetheless, our personal belief of efficacy (or lack of efficacy) also should not be the total story as we make decisions with individual patients and allocate resources within the health care system.

In the end, it should be all about giving high-quality care to the patient sitting in front of us. A question to be addressed is how well we can assess the quality of a given treatment prior to its administration.

We see our patients and their medical problems through lenses colored by our experiences. As internists, we pride ourselves on our reflective skills and our ability to draw on our understanding of pathophysiologic principles in therapeutic decision-making. But we, and our surgical colleagues, recognize our limitations as we deal with acute disease. We internists cogitate and temporize, and we are sometimes called “fleas” because of our attention to minuscule detail. Surgeons, on the other hand, get to act, working in the moment of acuity to bring resolution and, hopefully, prevent chronic disease from taking hold. The professional roles are cast, and we play our parts as expected—except in cases of ischemic colitis.

As Elder et al point out in this issue of the Journal, the management of ischemic colitis presents an interesting clinical paradox: the internist makes the diagnosis of potentially life-threatening impending tissue necrosis, while the surgeon, consulted to act, tends to be a cheerleader for temperate observation.

Ischemic colitis may account for 1 in 1,000 hospitalizations. Many patients present with a combination of focal lower abdominal pain and some bloody diarrhea. The examiner often localizes the tender colon either by anterior palpation or by rectal examination, unlike the scenario of life-threatening small bowel ischemia, in which severe pain may be accompanied by a fairly “benign” examination.

Some cases of ischemic colitis require resection of a gangrenous colon or become chronic and lead to the development of a stricture. But far more often the ischemic episode resolves after several days of watchful waiting. The typical but not specific endoscopic findings and the thumb-printing and thickening seen on radiographic imaging resolve.

Whatever the assumed cause (a specific one is often not found), ischemic colitis gives the internist and the surgeon a chance to commiserate on the power of informed watchful waiting.

We see our patients and their medical problems through lenses colored by our experiences. As internists, we pride ourselves on our reflective skills and our ability to draw on our understanding of pathophysiologic principles in therapeutic decision-making. But we, and our surgical colleagues, recognize our limitations as we deal with acute disease. We internists cogitate and temporize, and we are sometimes called “fleas” because of our attention to minuscule detail. Surgeons, on the other hand, get to act, working in the moment of acuity to bring resolution and, hopefully, prevent chronic disease from taking hold. The professional roles are cast, and we play our parts as expected—except in cases of ischemic colitis.

As Elder et al point out in this issue of the Journal, the management of ischemic colitis presents an interesting clinical paradox: the internist makes the diagnosis of potentially life-threatening impending tissue necrosis, while the surgeon, consulted to act, tends to be a cheerleader for temperate observation.

Ischemic colitis may account for 1 in 1,000 hospitalizations. Many patients present with a combination of focal lower abdominal pain and some bloody diarrhea. The examiner often localizes the tender colon either by anterior palpation or by rectal examination, unlike the scenario of life-threatening small bowel ischemia, in which severe pain may be accompanied by a fairly “benign” examination.

Some cases of ischemic colitis require resection of a gangrenous colon or become chronic and lead to the development of a stricture. But far more often the ischemic episode resolves after several days of watchful waiting. The typical but not specific endoscopic findings and the thumb-printing and thickening seen on radiographic imaging resolve.

Whatever the assumed cause (a specific one is often not found), ischemic colitis gives the internist and the surgeon a chance to commiserate on the power of informed watchful waiting.

We see our patients and their medical problems through lenses colored by our experiences. As internists, we pride ourselves on our reflective skills and our ability to draw on our understanding of pathophysiologic principles in therapeutic decision-making. But we, and our surgical colleagues, recognize our limitations as we deal with acute disease. We internists cogitate and temporize, and we are sometimes called “fleas” because of our attention to minuscule detail. Surgeons, on the other hand, get to act, working in the moment of acuity to bring resolution and, hopefully, prevent chronic disease from taking hold. The professional roles are cast, and we play our parts as expected—except in cases of ischemic colitis.

As Elder et al point out in this issue of the Journal, the management of ischemic colitis presents an interesting clinical paradox: the internist makes the diagnosis of potentially life-threatening impending tissue necrosis, while the surgeon, consulted to act, tends to be a cheerleader for temperate observation.

Ischemic colitis may account for 1 in 1,000 hospitalizations. Many patients present with a combination of focal lower abdominal pain and some bloody diarrhea. The examiner often localizes the tender colon either by anterior palpation or by rectal examination, unlike the scenario of life-threatening small bowel ischemia, in which severe pain may be accompanied by a fairly “benign” examination.

Some cases of ischemic colitis require resection of a gangrenous colon or become chronic and lead to the development of a stricture. But far more often the ischemic episode resolves after several days of watchful waiting. The typical but not specific endoscopic findings and the thumb-printing and thickening seen on radiographic imaging resolve.

Whatever the assumed cause (a specific one is often not found), ischemic colitis gives the internist and the surgeon a chance to commiserate on the power of informed watchful waiting.