Commentary

Following Dr. Sarmiento’s commentary, “Orthopedic Registries: Second Thoughts,” we agree that it is important and appropriate to question the value of any new additions to the orthopedic field, and registries are no exception. We thank Dr. Sarmiento for his comments on the viability of registries and the need for continued critical evaluation. Before joint registries, however, we had to rely on small-cohort analyses to assess outcomes and complications. Now, national and hospital registries, specifically joint registries, may be an invaluable source of information for orthopedic surgeons, patients, health care administrators, regulators, and implant suppliers.^1,2

Contrary to Dr. Sarmiento’s belief that registry data results are likely to have been reported in the literature, it is difficult to refute the value of recent years’ registry data in helping surgeons shape their practice. For example, according to Lewallen and Etkin,³ the National Joint Registry of England and Wales information has provided orthopedic surgeons with crucial findings regarding the outcomes of metal-on-metal hip arthroplasties. Using the England and Wales registry data from more than 400,000 primary total hip arthroplasties, Smith and colleagues⁴ noted that metal-on-metal stemmed articulations led to poor implant survival, particularly in young women with large-diameter heads, and indicated these articulations should not be used. Australian registry data on metal-on-metal devices and reports of failure rates up to 11%⁵ led one manufacturer to recall its implants.⁶ In addition, the Norwegian Arthroplasty Register evaluated survival rates and reasons for revision for 7 types of cemented primary total knee arthroplasty (TKA) between 1994 and 2009.⁷ Data on more than 17,000 primary TKAs allowed Plate and colleagues⁸ to confidently determine that aseptic loosening was related to certain TKA designs. Using registry information, they identified patients at risk for dislocation in total hip arthroplasty and concluded that large-diameter femoral head articulations could reduce dislocation rates.

Obtaining such large cohorts of patients in individual studies is not only difficult but highly unlikely. Unlike registry data, these studies are often impractical in evaluating factors of low incidence, such as revision rates, as it is often difficult to find significant differences in small populations.⁹ Furthermore, these controlled trials homogenize patients—using exclusion and inclusion criteria to eliminate potential confounders—and thus poorly represent the heterogeneity of a typical hospital’s patient population.¹⁰ Although the literature may indeed have alluded to such complications, only a database as extensive as a registry can allow us to fully comprehend the outcomes of particular implants and devices.

Dr. Sarmiento points to the AO Swiss Fracture Registry as being of little benefit and raises the concern that the American Joint Replacement Registry (AJRR) may follow with the same results. However, realizing a registry’s benefits may take time and the gradual accumulation of data. Supporting this, Hübschle and colleagues¹¹ recently used AO Swiss Fracture Registry data to validate use of balloon kyphoplasty for vertebral compression fractures and concluded that the technique is safe and effective in reducing pain—thus possibly providing the federal office with the evidence needed for reimbursement for this intervention. Therefore, this registry is now providing useful information.

We can never truly know the veracity of participating surgeons, but it is naïve to assume that this issue arises only vis-à-vis registries. If we were to debate the ethical and professional standards of colleagues in our field, such questions could extend to all studies performed, even peer-reviewed studies. Therefore, we do not think this is reason to exclude the patient data and outcomes found in registries. We must emphasize that ultimately registry data are often most useful in highlighting trends and determining triggers for further study rather than in arriving at conclusions.¹ In particular, registry data may be used in cohort studies that evaluate the risk factors for and incidence of certain outcomes. Focused higher-level interventional studies can then follow the trends observed.¹ However, registry data are also valuable on their own, when higher-level, randomized controlled trials may be impractical or unethical.¹²

Dr. Sarmiento refers to corrupt relationships between companies and orthopedists as “representing a widespread loss of professionalism in our ranks.” Despite a US Justice Department investigation into these relationships, only a few doctors were found to have had inappropriate relationships.¹³ In addition, the investigation and prosecution of companies led to an agreement requiring federal monitoring and new corporate compliance procedures, which should ensure stricter adherence to regulations.¹⁴ We do not believe this should undermine the value of registries and the work that has been contributed by thousands of surgeons hoping to improve the field of orthopedics. In addition, concerns about the influence of well-known individuals may be better directed at individual institution–based research, particularly as these specific authors also often have conflicts of interest that may skew the presentation of results. The strength of registry data is in providing collective data and large samples from a multitude of surgeons rather than from just high-volume surgeons, and therefore registry data provide a better overall picture of patients and their procedures.¹⁵ Furthermore, trends observed in national registries in countries such as New Zealand¹⁶ may aid in effectively reducing the revision rate, possibly up to 10%.¹⁷ If a US national joint registry is marginally as effective, then we may see considerable savings for our health care services.^17,18

We wholeheartedly agree that a yearly review of registries may be constructive. Dr. Sarmiento suggests an annual publication summarizing peer-reviewed articles and the opportunity for orthopedists to decide for themselves what treatments to choose based on reports from independent investigators. Although this sounds feasible, it would be difficult to decide which articles should be selected as pertinent for this type of publication. Any selection would be biased, and not all studies with high-level evidence are necessarily important or relevant. Therefore, selecting what is most appropriate to cite is not without its difficulties. We appreciate that there are problems in standardizing data reporting among registries. However, to improve interregistry collaboration, the US Food and Drug Administration is sponsoring the International Consortium of Orthopaedic Registries (ICOR) to facilitate data presentation.¹⁹ ICOR aims to increase cooperation, standardize analyses, and improve reporting, which will only strengthen the data available to us. Such efforts will ultimately enhance coordination and international collaboration among registries.¹⁵ In addition, incorporating patient-reported outcomes into our national registry will aid in quantifying arthroplasty outcomes from the patient’s perspective and will continue to improve total joint arthroplasties.²⁰

Overall, this debate is useful and highly relevant in highlighting potential issues with registries. Although registries are not without their flaws, like all aspects of orthopedics they are ever evolving, and they must be continually modified and improved. However, disregard for the potential value of AJRR, which has benefits for orthopedists and patients alike, is premature. Once again, we thank Dr. Sarmiento for starting this discussion, which will allow us to continue to evaluate and improve our registries.

Following Dr. Sarmiento’s commentary, “Orthopedic Registries: Second Thoughts,” we agree that it is important and appropriate to question the value of any new additions to the orthopedic field, and registries are no exception. We thank Dr. Sarmiento for his comments on the viability of registries and the need for continued critical evaluation. Before joint registries, however, we had to rely on small-cohort analyses to assess outcomes and complications. Now, national and hospital registries, specifically joint registries, may be an invaluable source of information for orthopedic surgeons, patients, health care administrators, regulators, and implant suppliers.^1,2

Contrary to Dr. Sarmiento’s belief that registry data results are likely to have been reported in the literature, it is difficult to refute the value of recent years’ registry data in helping surgeons shape their practice. For example, according to Lewallen and Etkin,³ the National Joint Registry of England and Wales information has provided orthopedic surgeons with crucial findings regarding the outcomes of metal-on-metal hip arthroplasties. Using the England and Wales registry data from more than 400,000 primary total hip arthroplasties, Smith and colleagues⁴ noted that metal-on-metal stemmed articulations led to poor implant survival, particularly in young women with large-diameter heads, and indicated these articulations should not be used. Australian registry data on metal-on-metal devices and reports of failure rates up to 11%⁵ led one manufacturer to recall its implants.⁶ In addition, the Norwegian Arthroplasty Register evaluated survival rates and reasons for revision for 7 types of cemented primary total knee arthroplasty (TKA) between 1994 and 2009.⁷ Data on more than 17,000 primary TKAs allowed Plate and colleagues⁸ to confidently determine that aseptic loosening was related to certain TKA designs. Using registry information, they identified patients at risk for dislocation in total hip arthroplasty and concluded that large-diameter femoral head articulations could reduce dislocation rates.

Obtaining such large cohorts of patients in individual studies is not only difficult but highly unlikely. Unlike registry data, these studies are often impractical in evaluating factors of low incidence, such as revision rates, as it is often difficult to find significant differences in small populations.⁹ Furthermore, these controlled trials homogenize patients—using exclusion and inclusion criteria to eliminate potential confounders—and thus poorly represent the heterogeneity of a typical hospital’s patient population.¹⁰ Although the literature may indeed have alluded to such complications, only a database as extensive as a registry can allow us to fully comprehend the outcomes of particular implants and devices.

Dr. Sarmiento points to the AO Swiss Fracture Registry as being of little benefit and raises the concern that the American Joint Replacement Registry (AJRR) may follow with the same results. However, realizing a registry’s benefits may take time and the gradual accumulation of data. Supporting this, Hübschle and colleagues¹¹ recently used AO Swiss Fracture Registry data to validate use of balloon kyphoplasty for vertebral compression fractures and concluded that the technique is safe and effective in reducing pain—thus possibly providing the federal office with the evidence needed for reimbursement for this intervention. Therefore, this registry is now providing useful information.

We can never truly know the veracity of participating surgeons, but it is naïve to assume that this issue arises only vis-à-vis registries. If we were to debate the ethical and professional standards of colleagues in our field, such questions could extend to all studies performed, even peer-reviewed studies. Therefore, we do not think this is reason to exclude the patient data and outcomes found in registries. We must emphasize that ultimately registry data are often most useful in highlighting trends and determining triggers for further study rather than in arriving at conclusions.¹ In particular, registry data may be used in cohort studies that evaluate the risk factors for and incidence of certain outcomes. Focused higher-level interventional studies can then follow the trends observed.¹ However, registry data are also valuable on their own, when higher-level, randomized controlled trials may be impractical or unethical.¹²

Dr. Sarmiento refers to corrupt relationships between companies and orthopedists as “representing a widespread loss of professionalism in our ranks.” Despite a US Justice Department investigation into these relationships, only a few doctors were found to have had inappropriate relationships.¹³ In addition, the investigation and prosecution of companies led to an agreement requiring federal monitoring and new corporate compliance procedures, which should ensure stricter adherence to regulations.¹⁴ We do not believe this should undermine the value of registries and the work that has been contributed by thousands of surgeons hoping to improve the field of orthopedics. In addition, concerns about the influence of well-known individuals may be better directed at individual institution–based research, particularly as these specific authors also often have conflicts of interest that may skew the presentation of results. The strength of registry data is in providing collective data and large samples from a multitude of surgeons rather than from just high-volume surgeons, and therefore registry data provide a better overall picture of patients and their procedures.¹⁵ Furthermore, trends observed in national registries in countries such as New Zealand¹⁶ may aid in effectively reducing the revision rate, possibly up to 10%.¹⁷ If a US national joint registry is marginally as effective, then we may see considerable savings for our health care services.^17,18

We wholeheartedly agree that a yearly review of registries may be constructive. Dr. Sarmiento suggests an annual publication summarizing peer-reviewed articles and the opportunity for orthopedists to decide for themselves what treatments to choose based on reports from independent investigators. Although this sounds feasible, it would be difficult to decide which articles should be selected as pertinent for this type of publication. Any selection would be biased, and not all studies with high-level evidence are necessarily important or relevant. Therefore, selecting what is most appropriate to cite is not without its difficulties. We appreciate that there are problems in standardizing data reporting among registries. However, to improve interregistry collaboration, the US Food and Drug Administration is sponsoring the International Consortium of Orthopaedic Registries (ICOR) to facilitate data presentation.¹⁹ ICOR aims to increase cooperation, standardize analyses, and improve reporting, which will only strengthen the data available to us. Such efforts will ultimately enhance coordination and international collaboration among registries.¹⁵ In addition, incorporating patient-reported outcomes into our national registry will aid in quantifying arthroplasty outcomes from the patient’s perspective and will continue to improve total joint arthroplasties.²⁰

Overall, this debate is useful and highly relevant in highlighting potential issues with registries. Although registries are not without their flaws, like all aspects of orthopedics they are ever evolving, and they must be continually modified and improved. However, disregard for the potential value of AJRR, which has benefits for orthopedists and patients alike, is premature. Once again, we thank Dr. Sarmiento for starting this discussion, which will allow us to continue to evaluate and improve our registries.

Following Dr. Sarmiento’s commentary, “Orthopedic Registries: Second Thoughts,” we agree that it is important and appropriate to question the value of any new additions to the orthopedic field, and registries are no exception. We thank Dr. Sarmiento for his comments on the viability of registries and the need for continued critical evaluation. Before joint registries, however, we had to rely on small-cohort analyses to assess outcomes and complications. Now, national and hospital registries, specifically joint registries, may be an invaluable source of information for orthopedic surgeons, patients, health care administrators, regulators, and implant suppliers.^1,2

Contrary to Dr. Sarmiento’s belief that registry data results are likely to have been reported in the literature, it is difficult to refute the value of recent years’ registry data in helping surgeons shape their practice. For example, according to Lewallen and Etkin,³ the National Joint Registry of England and Wales information has provided orthopedic surgeons with crucial findings regarding the outcomes of metal-on-metal hip arthroplasties. Using the England and Wales registry data from more than 400,000 primary total hip arthroplasties, Smith and colleagues⁴ noted that metal-on-metal stemmed articulations led to poor implant survival, particularly in young women with large-diameter heads, and indicated these articulations should not be used. Australian registry data on metal-on-metal devices and reports of failure rates up to 11%⁵ led one manufacturer to recall its implants.⁶ In addition, the Norwegian Arthroplasty Register evaluated survival rates and reasons for revision for 7 types of cemented primary total knee arthroplasty (TKA) between 1994 and 2009.⁷ Data on more than 17,000 primary TKAs allowed Plate and colleagues⁸ to confidently determine that aseptic loosening was related to certain TKA designs. Using registry information, they identified patients at risk for dislocation in total hip arthroplasty and concluded that large-diameter femoral head articulations could reduce dislocation rates.

Obtaining such large cohorts of patients in individual studies is not only difficult but highly unlikely. Unlike registry data, these studies are often impractical in evaluating factors of low incidence, such as revision rates, as it is often difficult to find significant differences in small populations.⁹ Furthermore, these controlled trials homogenize patients—using exclusion and inclusion criteria to eliminate potential confounders—and thus poorly represent the heterogeneity of a typical hospital’s patient population.¹⁰ Although the literature may indeed have alluded to such complications, only a database as extensive as a registry can allow us to fully comprehend the outcomes of particular implants and devices.

Dr. Sarmiento points to the AO Swiss Fracture Registry as being of little benefit and raises the concern that the American Joint Replacement Registry (AJRR) may follow with the same results. However, realizing a registry’s benefits may take time and the gradual accumulation of data. Supporting this, Hübschle and colleagues¹¹ recently used AO Swiss Fracture Registry data to validate use of balloon kyphoplasty for vertebral compression fractures and concluded that the technique is safe and effective in reducing pain—thus possibly providing the federal office with the evidence needed for reimbursement for this intervention. Therefore, this registry is now providing useful information.

We can never truly know the veracity of participating surgeons, but it is naïve to assume that this issue arises only vis-à-vis registries. If we were to debate the ethical and professional standards of colleagues in our field, such questions could extend to all studies performed, even peer-reviewed studies. Therefore, we do not think this is reason to exclude the patient data and outcomes found in registries. We must emphasize that ultimately registry data are often most useful in highlighting trends and determining triggers for further study rather than in arriving at conclusions.¹ In particular, registry data may be used in cohort studies that evaluate the risk factors for and incidence of certain outcomes. Focused higher-level interventional studies can then follow the trends observed.¹ However, registry data are also valuable on their own, when higher-level, randomized controlled trials may be impractical or unethical.¹²

Dr. Sarmiento refers to corrupt relationships between companies and orthopedists as “representing a widespread loss of professionalism in our ranks.” Despite a US Justice Department investigation into these relationships, only a few doctors were found to have had inappropriate relationships.¹³ In addition, the investigation and prosecution of companies led to an agreement requiring federal monitoring and new corporate compliance procedures, which should ensure stricter adherence to regulations.¹⁴ We do not believe this should undermine the value of registries and the work that has been contributed by thousands of surgeons hoping to improve the field of orthopedics. In addition, concerns about the influence of well-known individuals may be better directed at individual institution–based research, particularly as these specific authors also often have conflicts of interest that may skew the presentation of results. The strength of registry data is in providing collective data and large samples from a multitude of surgeons rather than from just high-volume surgeons, and therefore registry data provide a better overall picture of patients and their procedures.¹⁵ Furthermore, trends observed in national registries in countries such as New Zealand¹⁶ may aid in effectively reducing the revision rate, possibly up to 10%.¹⁷ If a US national joint registry is marginally as effective, then we may see considerable savings for our health care services.^17,18

We wholeheartedly agree that a yearly review of registries may be constructive. Dr. Sarmiento suggests an annual publication summarizing peer-reviewed articles and the opportunity for orthopedists to decide for themselves what treatments to choose based on reports from independent investigators. Although this sounds feasible, it would be difficult to decide which articles should be selected as pertinent for this type of publication. Any selection would be biased, and not all studies with high-level evidence are necessarily important or relevant. Therefore, selecting what is most appropriate to cite is not without its difficulties. We appreciate that there are problems in standardizing data reporting among registries. However, to improve interregistry collaboration, the US Food and Drug Administration is sponsoring the International Consortium of Orthopaedic Registries (ICOR) to facilitate data presentation.¹⁹ ICOR aims to increase cooperation, standardize analyses, and improve reporting, which will only strengthen the data available to us. Such efforts will ultimately enhance coordination and international collaboration among registries.¹⁵ In addition, incorporating patient-reported outcomes into our national registry will aid in quantifying arthroplasty outcomes from the patient’s perspective and will continue to improve total joint arthroplasties.²⁰

Overall, this debate is useful and highly relevant in highlighting potential issues with registries. Although registries are not without their flaws, like all aspects of orthopedics they are ever evolving, and they must be continually modified and improved. However, disregard for the potential value of AJRR, which has benefits for orthopedists and patients alike, is premature. Once again, we thank Dr. Sarmiento for starting this discussion, which will allow us to continue to evaluate and improve our registries.

Many assume that the American Joint Replacement Registry (AJRR) is moving forward as originally planned. No one has reported any obstacles that may cast doubt on its continued progress.

Despite the enthusiasm for AJRR, we must be realistic and admit that the project may not in the final analysis bring about its anticipated results. Therefore, periodic sober assessments of its course should be carried out, as they might result in identifying possible flaws and strengths. It is imperative to continue to express doubts regarding the true long-term value of this registry.

Much of the original support for an ongoing registry came from the example provided by the Swedish national registry. The Scandinavian registry had been said to dramatically reduce the number of complications and halve the revision rate for total hip arthroplasties. We need to question the claim that this reduction was solely the result of information produced by the registry. It is hard to believe that the literature had failed to report on those complications long before the registry publicized its findings.

As we take a fresh look at AJRR, it is perhaps wise to keep in mind the history of the AO Swiss Fracture Registry, founded by Maurice Müller and heavily subsidized by industry. Apparently, after gathering millions of pieces of information, primarily about equipment used for fracture fixation, the Swiss registry has failed to produce the greater benefits it had expected. Given the similarities between the Swiss Fracture Registry and AJRR, it is logical to assume that the latter may suffer the same fate.

I base my concerns on factors that, carefully analyzed, might be important in determining the future of AJRR. One major consideration is the difficulty in guaranteeing the veracity of data submitted—a factor shared by all registries.¹ To assume that all participating surgeons adhere to high ethical and professional standards is naïve. Some surgeons who stand to make large profits from their ownership of implants or equipment are submitting false and erroneous information. Other unscrupulous orthopedists are receiving large kickbacks for helping the industry market its implants. These people will be tempted to embellish and falsify information about successes and failures and submit it to the registry.^1-3

Militating against the “guaranteed success” of AJRR is this tainted relationship between the implant manufacturing industry and some members of the orthopedics community. A 2002–2006 investigation by the US Justice Department found egregious unethical transgressions and corrupt relationships between 5 companies and hundreds of orthopedists—representing a widespread loss of professionalism in our ranks.⁴ More recently, the Centers for Medicare & Medicaid Services⁵ disclosed that, in the last 5 months of 2013, $3.5 billion were paid by medical device companies to doctors and leading hospitals. As stated in a newspaper article, “‘Open Payments does not identify which financial relationships … could cause conflicts of interest,’ said Shantanu Agrawal, the agency official overseeing the project. ‘It simply makes the data available to the public.’”⁶ Further, “an initial Associated Press analysis found that orthopedists, cardiologists and adult medicine specialists were among the likeliest to receive payments from drug and device companies. Most of the contributions came in the form of cash payments, followed by in-kind gifts and services, and stock options.”⁶

This official government revelation is disturbing. Although the number of people who are deliberately committing clear infractions may be small, some of these people are likely well-known, and their influence should not be underestimated, particularly with regard to AJRR publications. Some in the orthopedic community do not question the accuracy of these publications but accept their conclusions as fact, and such may be the case with orthopedic guidelines.⁷

Given these concerns and the facts of the situation, can AJRR solve real problems that traditional systems have so far failed to solve? We have enough journals and scientific meetings informing us of the failures and successes of implants. I suspect it is wrong to believe that the AJRR data on 1 million patients’ arthroplasties are necessarily superior to the data from a 20,000-patient registry. Such an erroneous conclusion ignores the fact that, with clinical issues such as the one currently being addressed by AJRR, having a larger registry and more patients does not necessarily imply more meaningful information. In addition, follow-ups longer than those used with traditional methods are not possible—death will continue to intervene. No matter how many patients are included in the system, the maximum follow-up will forever remain the same.

Financing of AJRR is expensive, time-consuming, and likely to be terminated if clear evidence of the true value of the registry is not provided within the next few years. In light of such an outcome, we should replace the current system with a more effective mechanism. For example, we could produce an annual publication that summarizes the peer-reviewed articles published on joint replacement, with an emphasis on controversial topics. Orthopedic fellows, rather than readily accepting AJRR findings and recommendations, will instead be able to decide for themselves what treatment to use for each particular patient and situation, based on information provided by a number of independent investigators.

Meaningful progress in managing clinical conditions, such as the ones we are discussing, is achieved not by expanding the size of a registry but by being committed as individuals to making improvements. A cursory glance at the history of hip arthroplasty easily proves the point. Registries, guidelines, and other popular systems sometimes inadvertently create an environment that inhibits independent thinking. When powerful nonmedical economic and political bodies become involved in medical issues in order to ensure their continued profit, our autonomy is lost or compromised in major ways. Such scenarios must be avoided as forcefully as possible.⁸

Questioning the future of AJRR does not derive from rigid thinking or from a lack of awareness or understanding of the registry’s nature, procedures, benefits, goals, or highly altruistic and noble origins. However, pointing out a lack of evidence of success is not a crime. It is incumbent on us to look at this area and others with open minds while recognizing that honest and sincere scrutiny often helps make a better future a reality. The United States is working to achieve major goals for health care—access for all, lower costs, and fewer abuses of the system. Our involvement is a mandate to be followed enthusiastically.

Many assume that the American Joint Replacement Registry (AJRR) is moving forward as originally planned. No one has reported any obstacles that may cast doubt on its continued progress.

Despite the enthusiasm for AJRR, we must be realistic and admit that the project may not in the final analysis bring about its anticipated results. Therefore, periodic sober assessments of its course should be carried out, as they might result in identifying possible flaws and strengths. It is imperative to continue to express doubts regarding the true long-term value of this registry.

Much of the original support for an ongoing registry came from the example provided by the Swedish national registry. The Scandinavian registry had been said to dramatically reduce the number of complications and halve the revision rate for total hip arthroplasties. We need to question the claim that this reduction was solely the result of information produced by the registry. It is hard to believe that the literature had failed to report on those complications long before the registry publicized its findings.

As we take a fresh look at AJRR, it is perhaps wise to keep in mind the history of the AO Swiss Fracture Registry, founded by Maurice Müller and heavily subsidized by industry. Apparently, after gathering millions of pieces of information, primarily about equipment used for fracture fixation, the Swiss registry has failed to produce the greater benefits it had expected. Given the similarities between the Swiss Fracture Registry and AJRR, it is logical to assume that the latter may suffer the same fate.

I base my concerns on factors that, carefully analyzed, might be important in determining the future of AJRR. One major consideration is the difficulty in guaranteeing the veracity of data submitted—a factor shared by all registries.¹ To assume that all participating surgeons adhere to high ethical and professional standards is naïve. Some surgeons who stand to make large profits from their ownership of implants or equipment are submitting false and erroneous information. Other unscrupulous orthopedists are receiving large kickbacks for helping the industry market its implants. These people will be tempted to embellish and falsify information about successes and failures and submit it to the registry.^1-3

Militating against the “guaranteed success” of AJRR is this tainted relationship between the implant manufacturing industry and some members of the orthopedics community. A 2002–2006 investigation by the US Justice Department found egregious unethical transgressions and corrupt relationships between 5 companies and hundreds of orthopedists—representing a widespread loss of professionalism in our ranks.⁴ More recently, the Centers for Medicare & Medicaid Services⁵ disclosed that, in the last 5 months of 2013, $3.5 billion were paid by medical device companies to doctors and leading hospitals. As stated in a newspaper article, “‘Open Payments does not identify which financial relationships … could cause conflicts of interest,’ said Shantanu Agrawal, the agency official overseeing the project. ‘It simply makes the data available to the public.’”⁶ Further, “an initial Associated Press analysis found that orthopedists, cardiologists and adult medicine specialists were among the likeliest to receive payments from drug and device companies. Most of the contributions came in the form of cash payments, followed by in-kind gifts and services, and stock options.”⁶

This official government revelation is disturbing. Although the number of people who are deliberately committing clear infractions may be small, some of these people are likely well-known, and their influence should not be underestimated, particularly with regard to AJRR publications. Some in the orthopedic community do not question the accuracy of these publications but accept their conclusions as fact, and such may be the case with orthopedic guidelines.⁷

Given these concerns and the facts of the situation, can AJRR solve real problems that traditional systems have so far failed to solve? We have enough journals and scientific meetings informing us of the failures and successes of implants. I suspect it is wrong to believe that the AJRR data on 1 million patients’ arthroplasties are necessarily superior to the data from a 20,000-patient registry. Such an erroneous conclusion ignores the fact that, with clinical issues such as the one currently being addressed by AJRR, having a larger registry and more patients does not necessarily imply more meaningful information. In addition, follow-ups longer than those used with traditional methods are not possible—death will continue to intervene. No matter how many patients are included in the system, the maximum follow-up will forever remain the same.

Financing of AJRR is expensive, time-consuming, and likely to be terminated if clear evidence of the true value of the registry is not provided within the next few years. In light of such an outcome, we should replace the current system with a more effective mechanism. For example, we could produce an annual publication that summarizes the peer-reviewed articles published on joint replacement, with an emphasis on controversial topics. Orthopedic fellows, rather than readily accepting AJRR findings and recommendations, will instead be able to decide for themselves what treatment to use for each particular patient and situation, based on information provided by a number of independent investigators.

Meaningful progress in managing clinical conditions, such as the ones we are discussing, is achieved not by expanding the size of a registry but by being committed as individuals to making improvements. A cursory glance at the history of hip arthroplasty easily proves the point. Registries, guidelines, and other popular systems sometimes inadvertently create an environment that inhibits independent thinking. When powerful nonmedical economic and political bodies become involved in medical issues in order to ensure their continued profit, our autonomy is lost or compromised in major ways. Such scenarios must be avoided as forcefully as possible.⁸

Questioning the future of AJRR does not derive from rigid thinking or from a lack of awareness or understanding of the registry’s nature, procedures, benefits, goals, or highly altruistic and noble origins. However, pointing out a lack of evidence of success is not a crime. It is incumbent on us to look at this area and others with open minds while recognizing that honest and sincere scrutiny often helps make a better future a reality. The United States is working to achieve major goals for health care—access for all, lower costs, and fewer abuses of the system. Our involvement is a mandate to be followed enthusiastically.

Many assume that the American Joint Replacement Registry (AJRR) is moving forward as originally planned. No one has reported any obstacles that may cast doubt on its continued progress.

Despite the enthusiasm for AJRR, we must be realistic and admit that the project may not in the final analysis bring about its anticipated results. Therefore, periodic sober assessments of its course should be carried out, as they might result in identifying possible flaws and strengths. It is imperative to continue to express doubts regarding the true long-term value of this registry.

Much of the original support for an ongoing registry came from the example provided by the Swedish national registry. The Scandinavian registry had been said to dramatically reduce the number of complications and halve the revision rate for total hip arthroplasties. We need to question the claim that this reduction was solely the result of information produced by the registry. It is hard to believe that the literature had failed to report on those complications long before the registry publicized its findings.

As we take a fresh look at AJRR, it is perhaps wise to keep in mind the history of the AO Swiss Fracture Registry, founded by Maurice Müller and heavily subsidized by industry. Apparently, after gathering millions of pieces of information, primarily about equipment used for fracture fixation, the Swiss registry has failed to produce the greater benefits it had expected. Given the similarities between the Swiss Fracture Registry and AJRR, it is logical to assume that the latter may suffer the same fate.

I base my concerns on factors that, carefully analyzed, might be important in determining the future of AJRR. One major consideration is the difficulty in guaranteeing the veracity of data submitted—a factor shared by all registries.¹ To assume that all participating surgeons adhere to high ethical and professional standards is naïve. Some surgeons who stand to make large profits from their ownership of implants or equipment are submitting false and erroneous information. Other unscrupulous orthopedists are receiving large kickbacks for helping the industry market its implants. These people will be tempted to embellish and falsify information about successes and failures and submit it to the registry.^1-3

Militating against the “guaranteed success” of AJRR is this tainted relationship between the implant manufacturing industry and some members of the orthopedics community. A 2002–2006 investigation by the US Justice Department found egregious unethical transgressions and corrupt relationships between 5 companies and hundreds of orthopedists—representing a widespread loss of professionalism in our ranks.⁴ More recently, the Centers for Medicare & Medicaid Services⁵ disclosed that, in the last 5 months of 2013, $3.5 billion were paid by medical device companies to doctors and leading hospitals. As stated in a newspaper article, “‘Open Payments does not identify which financial relationships … could cause conflicts of interest,’ said Shantanu Agrawal, the agency official overseeing the project. ‘It simply makes the data available to the public.’”⁶ Further, “an initial Associated Press analysis found that orthopedists, cardiologists and adult medicine specialists were among the likeliest to receive payments from drug and device companies. Most of the contributions came in the form of cash payments, followed by in-kind gifts and services, and stock options.”⁶

This official government revelation is disturbing. Although the number of people who are deliberately committing clear infractions may be small, some of these people are likely well-known, and their influence should not be underestimated, particularly with regard to AJRR publications. Some in the orthopedic community do not question the accuracy of these publications but accept their conclusions as fact, and such may be the case with orthopedic guidelines.⁷

Given these concerns and the facts of the situation, can AJRR solve real problems that traditional systems have so far failed to solve? We have enough journals and scientific meetings informing us of the failures and successes of implants. I suspect it is wrong to believe that the AJRR data on 1 million patients’ arthroplasties are necessarily superior to the data from a 20,000-patient registry. Such an erroneous conclusion ignores the fact that, with clinical issues such as the one currently being addressed by AJRR, having a larger registry and more patients does not necessarily imply more meaningful information. In addition, follow-ups longer than those used with traditional methods are not possible—death will continue to intervene. No matter how many patients are included in the system, the maximum follow-up will forever remain the same.

Financing of AJRR is expensive, time-consuming, and likely to be terminated if clear evidence of the true value of the registry is not provided within the next few years. In light of such an outcome, we should replace the current system with a more effective mechanism. For example, we could produce an annual publication that summarizes the peer-reviewed articles published on joint replacement, with an emphasis on controversial topics. Orthopedic fellows, rather than readily accepting AJRR findings and recommendations, will instead be able to decide for themselves what treatment to use for each particular patient and situation, based on information provided by a number of independent investigators.

Meaningful progress in managing clinical conditions, such as the ones we are discussing, is achieved not by expanding the size of a registry but by being committed as individuals to making improvements. A cursory glance at the history of hip arthroplasty easily proves the point. Registries, guidelines, and other popular systems sometimes inadvertently create an environment that inhibits independent thinking. When powerful nonmedical economic and political bodies become involved in medical issues in order to ensure their continued profit, our autonomy is lost or compromised in major ways. Such scenarios must be avoided as forcefully as possible.⁸

Questioning the future of AJRR does not derive from rigid thinking or from a lack of awareness or understanding of the registry’s nature, procedures, benefits, goals, or highly altruistic and noble origins. However, pointing out a lack of evidence of success is not a crime. It is incumbent on us to look at this area and others with open minds while recognizing that honest and sincere scrutiny often helps make a better future a reality. The United States is working to achieve major goals for health care—access for all, lower costs, and fewer abuses of the system. Our involvement is a mandate to be followed enthusiastically.

The mission statement of the US Department of Veterans Affairs (VA) reiterates Abraham Lincoln’s promise, “to care for him who shall have borne the battle, and for his widow, and his orphan,” by serving the men and women who are American veterans.¹ Robert A. McDonald is the current Secretary of Veterans Affairs. He was recently appointed after the scheduling scandal at the VA. He was the previous Chairman and Chief Executive Officer of Procter & Gamble and is a graduate of West Point. Mr. McDonald has recently been criticized for some public misstatements after only being on the job for a few months.^2,3 His staff includes a wide variety of numerous secretaries, deputies, councils, and assistant associates. The budget for 2016 that was recently submitted was $169 billion.⁴ The scandalous scheduling fiasco in the entire VA system blatantly shows the neglect of our servicemen and servicewomen and is a permanent blemish on a government-run system. Despite claims of numerous firings, only 8 people have been dismissed out of an employee pool of over 300,000.³

I have been a volunteer physician for just under 40 years at the VA Hospital in La Jolla, California, which is also an associated teaching hospital for the University of California, San Diego. Many of my reflections are from personal experience. I am also a veteran. I have a deep affection for our veterans and their families, and write this column in the hope of some possible change in their care. The physicians and health care providers in this system are dedicated and professional individuals caught up in a tangled bureaucratic web that, in most cases, handcuffs the delivery of the health care that our veterans deserve.

When one goes to the VA website, it appears that there are a myriad of services available, but, as with all government agencies, more time is spent in the creation of the website and structure of the agency than is spent in servicing the patient. Picture trying to get your health care through the local Department of Motor Vehicles office. The VA system is a huge bureaucratic overregulated agency currently out of control and lacking efficiency. From the clinic to the operating room, the process is frustrating to all involved. There are clinics staffed with medical doctors, nurse practitioners, physician assistants, medical students, residents, and fellows. Generally, they can only process 10 to 12 patients per half-day clinic because of the endless paperwork and regulatory requirements.

The operating rooms have been a formidable frustration to the surgeon. It is routine for a 7:30 am case to start at 9 am and then be followed by a 2½-hour turnover time until the second case could be scheduled. Cases cannot be scheduled that could potentially start after 3 pm. Most data would probably suggest that the operating room efficiency in terms of numbers of cases is approximately 50% to 60% of what can be done in the private environment. Staffing for all facets of the hospital operation is about double what is necessary in the outside world. Physicians must take tests on a very frequent basis on subjects that are totally unrelated to health care. Examinations on American history, electrical safety, and sexual harassment in the workplace are commonplace topics. These tests must be taken and passed in order to maintain one’s privileges at the hospital.

Is there an answer to this government-run system? Perhaps. Here is a potential solution. Over a 5-year period, divest all VA facilities, sell or rent them, and sell or rent the land. Use the proceeds, in combination with the normal budget for the VA, to create a private health care system. Veterans and their families would then receive a veteran-based private policy that would have no deductibles or copays and would allow them to seek medical care from any provider. For more complex situations such as quadriplegia, posttraumatic stress disorder (PTSD), or complex amputations, private entities would bid on a local basis, assuming they pass a strict credentialing process. These private entities would be required to pay strict attention to protocol, deliver prompt service, and produce outcomes that are acceptable in the medical workplace. The newly created system would be run by a private board composed of retired military, business executives, and entrepreneurs with no political affiliations. The trust fund would not be susceptible to any other allocation other than the medical care of veterans.    

I have seen far too many spouses and families of deployed servicemen and servicewomen whose care has been neglected while their spouses are serving in a foreign land. There are far too many homeless veterans that are in need of psychiatric care and suffering from PTSD. It is estimated that 11% of the current homeless population are veterans.⁵ Their housing needs have been completely neglected. These are not acceptable statistics. The government now provides some burial services and headstones for our deceased veterans instead of delivering the health care for them and their families while they are still alive.

The mission statement of the US Department of Veterans Affairs (VA) reiterates Abraham Lincoln’s promise, “to care for him who shall have borne the battle, and for his widow, and his orphan,” by serving the men and women who are American veterans.¹ Robert A. McDonald is the current Secretary of Veterans Affairs. He was recently appointed after the scheduling scandal at the VA. He was the previous Chairman and Chief Executive Officer of Procter & Gamble and is a graduate of West Point. Mr. McDonald has recently been criticized for some public misstatements after only being on the job for a few months.^2,3 His staff includes a wide variety of numerous secretaries, deputies, councils, and assistant associates. The budget for 2016 that was recently submitted was $169 billion.⁴ The scandalous scheduling fiasco in the entire VA system blatantly shows the neglect of our servicemen and servicewomen and is a permanent blemish on a government-run system. Despite claims of numerous firings, only 8 people have been dismissed out of an employee pool of over 300,000.³

I have been a volunteer physician for just under 40 years at the VA Hospital in La Jolla, California, which is also an associated teaching hospital for the University of California, San Diego. Many of my reflections are from personal experience. I am also a veteran. I have a deep affection for our veterans and their families, and write this column in the hope of some possible change in their care. The physicians and health care providers in this system are dedicated and professional individuals caught up in a tangled bureaucratic web that, in most cases, handcuffs the delivery of the health care that our veterans deserve.

When one goes to the VA website, it appears that there are a myriad of services available, but, as with all government agencies, more time is spent in the creation of the website and structure of the agency than is spent in servicing the patient. Picture trying to get your health care through the local Department of Motor Vehicles office. The VA system is a huge bureaucratic overregulated agency currently out of control and lacking efficiency. From the clinic to the operating room, the process is frustrating to all involved. There are clinics staffed with medical doctors, nurse practitioners, physician assistants, medical students, residents, and fellows. Generally, they can only process 10 to 12 patients per half-day clinic because of the endless paperwork and regulatory requirements.

The operating rooms have been a formidable frustration to the surgeon. It is routine for a 7:30 am case to start at 9 am and then be followed by a 2½-hour turnover time until the second case could be scheduled. Cases cannot be scheduled that could potentially start after 3 pm. Most data would probably suggest that the operating room efficiency in terms of numbers of cases is approximately 50% to 60% of what can be done in the private environment. Staffing for all facets of the hospital operation is about double what is necessary in the outside world. Physicians must take tests on a very frequent basis on subjects that are totally unrelated to health care. Examinations on American history, electrical safety, and sexual harassment in the workplace are commonplace topics. These tests must be taken and passed in order to maintain one’s privileges at the hospital.

Is there an answer to this government-run system? Perhaps. Here is a potential solution. Over a 5-year period, divest all VA facilities, sell or rent them, and sell or rent the land. Use the proceeds, in combination with the normal budget for the VA, to create a private health care system. Veterans and their families would then receive a veteran-based private policy that would have no deductibles or copays and would allow them to seek medical care from any provider. For more complex situations such as quadriplegia, posttraumatic stress disorder (PTSD), or complex amputations, private entities would bid on a local basis, assuming they pass a strict credentialing process. These private entities would be required to pay strict attention to protocol, deliver prompt service, and produce outcomes that are acceptable in the medical workplace. The newly created system would be run by a private board composed of retired military, business executives, and entrepreneurs with no political affiliations. The trust fund would not be susceptible to any other allocation other than the medical care of veterans.    

I have seen far too many spouses and families of deployed servicemen and servicewomen whose care has been neglected while their spouses are serving in a foreign land. There are far too many homeless veterans that are in need of psychiatric care and suffering from PTSD. It is estimated that 11% of the current homeless population are veterans.⁵ Their housing needs have been completely neglected. These are not acceptable statistics. The government now provides some burial services and headstones for our deceased veterans instead of delivering the health care for them and their families while they are still alive.

The mission statement of the US Department of Veterans Affairs (VA) reiterates Abraham Lincoln’s promise, “to care for him who shall have borne the battle, and for his widow, and his orphan,” by serving the men and women who are American veterans.¹ Robert A. McDonald is the current Secretary of Veterans Affairs. He was recently appointed after the scheduling scandal at the VA. He was the previous Chairman and Chief Executive Officer of Procter & Gamble and is a graduate of West Point. Mr. McDonald has recently been criticized for some public misstatements after only being on the job for a few months.^2,3 His staff includes a wide variety of numerous secretaries, deputies, councils, and assistant associates. The budget for 2016 that was recently submitted was $169 billion.⁴ The scandalous scheduling fiasco in the entire VA system blatantly shows the neglect of our servicemen and servicewomen and is a permanent blemish on a government-run system. Despite claims of numerous firings, only 8 people have been dismissed out of an employee pool of over 300,000.³

I have been a volunteer physician for just under 40 years at the VA Hospital in La Jolla, California, which is also an associated teaching hospital for the University of California, San Diego. Many of my reflections are from personal experience. I am also a veteran. I have a deep affection for our veterans and their families, and write this column in the hope of some possible change in their care. The physicians and health care providers in this system are dedicated and professional individuals caught up in a tangled bureaucratic web that, in most cases, handcuffs the delivery of the health care that our veterans deserve.

When one goes to the VA website, it appears that there are a myriad of services available, but, as with all government agencies, more time is spent in the creation of the website and structure of the agency than is spent in servicing the patient. Picture trying to get your health care through the local Department of Motor Vehicles office. The VA system is a huge bureaucratic overregulated agency currently out of control and lacking efficiency. From the clinic to the operating room, the process is frustrating to all involved. There are clinics staffed with medical doctors, nurse practitioners, physician assistants, medical students, residents, and fellows. Generally, they can only process 10 to 12 patients per half-day clinic because of the endless paperwork and regulatory requirements.

The operating rooms have been a formidable frustration to the surgeon. It is routine for a 7:30 am case to start at 9 am and then be followed by a 2½-hour turnover time until the second case could be scheduled. Cases cannot be scheduled that could potentially start after 3 pm. Most data would probably suggest that the operating room efficiency in terms of numbers of cases is approximately 50% to 60% of what can be done in the private environment. Staffing for all facets of the hospital operation is about double what is necessary in the outside world. Physicians must take tests on a very frequent basis on subjects that are totally unrelated to health care. Examinations on American history, electrical safety, and sexual harassment in the workplace are commonplace topics. These tests must be taken and passed in order to maintain one’s privileges at the hospital.

Is there an answer to this government-run system? Perhaps. Here is a potential solution. Over a 5-year period, divest all VA facilities, sell or rent them, and sell or rent the land. Use the proceeds, in combination with the normal budget for the VA, to create a private health care system. Veterans and their families would then receive a veteran-based private policy that would have no deductibles or copays and would allow them to seek medical care from any provider. For more complex situations such as quadriplegia, posttraumatic stress disorder (PTSD), or complex amputations, private entities would bid on a local basis, assuming they pass a strict credentialing process. These private entities would be required to pay strict attention to protocol, deliver prompt service, and produce outcomes that are acceptable in the medical workplace. The newly created system would be run by a private board composed of retired military, business executives, and entrepreneurs with no political affiliations. The trust fund would not be susceptible to any other allocation other than the medical care of veterans.    

I have seen far too many spouses and families of deployed servicemen and servicewomen whose care has been neglected while their spouses are serving in a foreign land. There are far too many homeless veterans that are in need of psychiatric care and suffering from PTSD. It is estimated that 11% of the current homeless population are veterans.⁵ Their housing needs have been completely neglected. These are not acceptable statistics. The government now provides some burial services and headstones for our deceased veterans instead of delivering the health care for them and their families while they are still alive.

Editor’s Note: The associate editors of Vascular Specialist were asked to provide their perspectives on the stenting controversy. Here is a selection.

Dr. Frank J. Veith: The recent lead article in the New York Times on excessive implantation of lower extremity stents highlights one key point. Vascular surgeons and all vascular specialists who treat lower extremity occlusive disease should always clearly inform patients with intermittent claudication that one acceptable treatment option is medical and lipid-lowering therapy without any invasive treatment of their arterial blockage. They should be informed that the condition almost never leads to limb loss and that invasive treatment can safely be delayed until such progression occurs.

Given such honest reassurance and the option to choose their treatment, most patients with claudication will choose a conservative rather than an invasive approach, and unnecessary stent/angioplasty and other lower extremity interventional procedures, as described in the Times article, will be minimized. 

Dr. John F. Eidt: The truth is we all bear responsibility. The treatment of lower extremity peripheral artery disease (PAD) has largely defied prior efforts to define appropriate care. Even the SVS document recommending risk factor modification in the initial management of intermittent claudication leaves substantial room for individualized judgment.

The appropriateness of intervention is largely in the eye of the beholder. “Lifestyle-limiting” claudication can be invoked as justification for intervention in virtually anyone. But I do believe that vascular surgeons are more wary of the adverse consequences of vascular intervention for one important reason – we do amputations. We are unique among vascular specialists in that we deal with the tragedies of unwarranted vascular procedures. For vascular surgeons, failure of intervention means more than binary restenosis or increased target lesion revascularization. Performing an amputation after failed intervention in a claudicant leaves an indelible mark on each of us and may underlie our inherently conservative approach to PAD. But we need to be fearless in speaking the truth and serving as advocates for exemplary patient care. Continuing a relationship with a source of carotid and aortic referrals while turning a blind eye to meddlesome lower extremity intervention sends the wrong message. Our silence constitutes tacit approval. Too frequently I hear a patient say “my cardiologist says there is nothing else he can do, go see a vascular surgeon.” Despite years of branding efforts by the SVS, surveys of primary care providers and the public alike confirm that many remain uncertain of our skills. We need to do a better job of spreading the word that vascular surgeons are “leaders in the minimally invasive treatment of PAD.” Not the last resort.

Dr. Frank Pomposelli: I could not agree more with Dr. Eidt. It’s easy to indict the outpatient labs for obvious reasons but I personally agree that the root of the problem lies in the overly aggressive posture being taken toward treatment of claudication.

It just so happens that outpatient labs are filled with claudicants since they are most likely to have the least complex disease – match made in heaven or hell, depending on your perspective.

One cardiologist quoted in the N.Y. Times piece said patients with claudication have been “grossly under treated” – a convenient posture to take when billing Medicare $4.5 million a year. The other cardiologist who was the focus of the investigation called the charges “baseless and fiction” and stated his center had the lowest rate of amputation in the country.

It gets back to Dr. Eidt’s point how it’s easy for the nonsurgeon to dismiss amputation as an occasional unfortunate byproduct of a busy practice when you never have had to tell a patient they need one and suffer with them through the emotional and physical trauma that always follows. I was taught like many of you, I suspect, that any amputation after treatment for claudication should be considered not only an unacceptable complication but also a failure of the trust the patient placed in me. My mentor was a militant nihilist when it came to surgery for claudication but that concept is always in my mind whenever I treat a patient and has always tempered my decision making.

I like to think our recently published practice guidelines will help but am skeptical that it will make a positive impact where it is most needed; on those who are primarily driven by financial gain. I’d also point out that Dr. Darren B. Schneider was quoted as a member of the Society for Vascular Medicine. I guess we need to work harder on our branding.

Dr. Mark Morasch: Remember, all politics are local, and any meaningful change needs to come from the grass roots.

Experts can write guidelines, specialty societies can make statements, and newspapers can print articles but the most influential transaction occurs in the exam room when we are face to face with our patients.

Remember, even though we are a small group, we can have great influence when we always, always, always do what we know is right.

Dr. Alan M. Dietzek: Dear Patient, Let me introduce myself. I am a Board-Certified Vascular Surgeon. My specialty is unique in that I am well versed and formally trained in both the medical and surgical management of peripheral vascular disease. No other specialist can make this claim.

Most often, vascular problems can be managed conservatively with a combination of risk factor and lifestyle modification, and occasionally prescription medications, all of which I can outline and or prescribe for you. When necessary, however, I am prepared to treat your vascular problem with either a minimally invasive procedure or open surgery depending on which treatment will provide you with the best outcomes. Again, only a vascular surgeon is capable of offering you these treatment options. I am dedicated to your well-being. I am a Board-Certified Vascular Surgeon

Dr. Murray L. Shames: The recent New York Times article, “Medicare payments surge for stents to unblock blood vessels in limbs,” brings up a critical issue in how we train our residents to think and practice in the future.

Our current generation of residents is faced with a tremendous financial burden of medical school debt, and they are being offered highly competitive salaries after graduation.

The motivation to join groups with outpatient vascular centers is certainly attractive: Why not have autonomy from the hospital, control your work environment, and increase efficiency. As educators we must continue to use clinical evidence and societal guidelines 
(J. Vasc. Surg. 2015:1-40) to guide our clinical practice.

As vascular surgeons we have been trained to manage asymptomatic PAD and intermittent claudication nonoperatively due to it’s relatively benign natural history; endovascular interventions have dramatically increased the treatment of claudication, even in our own hands. We must continue to teach our residents restraint and to consider the impact of the interventions we perform. That way we can maintain our status as the leaders in vascular disease management and not just “interventionalists” that treat lesions.

Dr. Joann Lohr: The presence of a stenotic lesion does not mandate treatment either with a stent or surgical intervention but needs critical assessment of the impact on the patient’s quality of life. Risk factor modification needs to be undertaken before any intervention and will improve outcomes and durability of repairs. The only outcome that matters is the patient’s.

“How does treatment of this lesion change my lifestyle?” is a question that needs to be answered for each patient. Treating physicians need to establish long-term relationships.

Never be afraid to tell patients a procedure is not the first line of treatment. Thoughtful application of new technology is needed in all areas of medicine. Just because we can, should we? Appropriate individualized treatment plans and goals need to be established for each patient we treat.

Dr. Larry Kraiss: Vascular surgeons provide the full spectrum of care for PAD from medical management through intervention to the unfortunate situations when amputation is necessary.

The more sobering of these experiences have imbued most of us with a healthy respect for how an intervention can go wrong. If you haven’t had to explain to a patient or family why an amputation is necessary, you probably don’t have the same concern.

Thus, many of us have a very conservative approach to PAD intervention; primum non nocere is the governing principle. This principle is supposed to guide the actions of all physicians but I can’t help but wonder if something happened to primum non nocere on the way to the outpatient endovascular center.

When physicians become financial stakeholders in these enterprises, a pernicious incentive is introduced that is almost impossible to exclude from daily clinical decision making. Hospital-based physicians are also subject to temptation to perform unnecessary yet lucrative procedures but at least these are being done more in the open.

I suspect that the development of these centers has allowed much activity to occur that would rightly be condemned under the scrutiny of one’s hospital peers.

Dr. Laura Drudi: It really comes down to adequately informing the patient. I always find it astounding how many patients I encounter asking me in a timid tone, “What exactly did I have done on my leg?” I question what patients actually understand and retain after being overwhelmed by the informed consent we have prior to an intervention.

I see first hand the catastrophic failures of intervening on severe claudication leading to limb loss and worsening of quality of life. It’s disheartening to see adverse outcomes following vascular interventions either by vascular surgeons or other interventionalists, but I believe that if you are performing an intervention you should have the expertise and technical skills to deal with the complications.

The best interventionalists know when not to intervene and that should be the mantra we live by. We should be advocates for our patients at a local institutional level as well as a public level. I believe that following the New York Times article the public will be more aware of the potential for inappropriate or unnecessary interventions, many of which are being performed by specialists other than vascular surgeons.

The Society and individual vascular surgeons should capitalize on this opportunity to educate patients as to the benefits of consulting with a vascular surgeon before undertaking any endovascular procedure.

Dr. Elliot L. Chaikof: Both government and private payers have a vested interest in ensuring that patients receive the highest quality care, while reducing the unsustainable rate of increase in health care costs. In Massachusetts and elsewhere in the United States, this has led to the introduction of new risk contracting models that features a global payment with incentives linked to efficiency and quality.

At our institution, approximately 60% of patients are now in such risk contracts. Primary care physicians are most directly incentivized and, along with government and private payors, are highly motivated to ensure that our population of patients receives the right care, at the right time, from the right physician. The U.S. health care system continues to be in a state of flux with substantial regional variations in the delivery of care and how that care is financed.

Despite these challenges, the Society for Vascular Surgery can best serve our patients through advocacy and education, including promoting the need for full transparency of costs to our patients and their physicians. This would be most effective in active partnership with primary care providers, along with regional and national payors.

Dr. Erica L. Mitchell: The line separating a business from a profession is not entirely clear when professionals engage in business practices that serve to benefit the individual financially.

One crucial difference distinguishing the profession of medicine from other professions is that physicians have a fiduciary duty toward those whom they serve. This means that we have a legal duty to provide services to our patients that place the patient’s interest above our own financial interest.

This article highlights how legal and ethical issues arise if health care professionals forgo their fiduciary duties for personal gain. Unethical physicians should be held accountable for unethical practices.

Dr. Larry Scher: The recent article by Julie Creswell and Reed Abelson in the Jan. 29, 2015, New York Times highlights a recent problem in the care of patients with peripheral vascular disease. Vascular surgeons have been treating peripheral arterial disease for over 50 years and have generally adopted a conservative approach toward patients with claudication, emphasizing risk factor modification and exercise.

This is based on an understanding that the disease is benign, rarely progressive, and only occasionally disabling to the point that intervention is indicated for symptom relief.

With new minimally invasive techniques available and specialists other than vascular surgeons performing peripheral catheter based procedures we seem to have forgotten all that vascular surgeons have learned over the past 5 decades.

Most patients with claudication do not benefit from and may be harmed by interventions when long-term rather than short-term outcomes are analyzed. Although practitioners such as those identified in this article may believe they are pioneers in the treatment of peripheral arterial disease and specifically claudication, I would consider them cowboys who have forgotten the lessons of the past.

Editor’s Note: The associate editors of Vascular Specialist were asked to provide their perspectives on the stenting controversy. Here is a selection.

Dr. Frank J. Veith: The recent lead article in the New York Times on excessive implantation of lower extremity stents highlights one key point. Vascular surgeons and all vascular specialists who treat lower extremity occlusive disease should always clearly inform patients with intermittent claudication that one acceptable treatment option is medical and lipid-lowering therapy without any invasive treatment of their arterial blockage. They should be informed that the condition almost never leads to limb loss and that invasive treatment can safely be delayed until such progression occurs.

Given such honest reassurance and the option to choose their treatment, most patients with claudication will choose a conservative rather than an invasive approach, and unnecessary stent/angioplasty and other lower extremity interventional procedures, as described in the Times article, will be minimized. 

Dr. John F. Eidt: The truth is we all bear responsibility. The treatment of lower extremity peripheral artery disease (PAD) has largely defied prior efforts to define appropriate care. Even the SVS document recommending risk factor modification in the initial management of intermittent claudication leaves substantial room for individualized judgment.

The appropriateness of intervention is largely in the eye of the beholder. “Lifestyle-limiting” claudication can be invoked as justification for intervention in virtually anyone. But I do believe that vascular surgeons are more wary of the adverse consequences of vascular intervention for one important reason – we do amputations. We are unique among vascular specialists in that we deal with the tragedies of unwarranted vascular procedures. For vascular surgeons, failure of intervention means more than binary restenosis or increased target lesion revascularization. Performing an amputation after failed intervention in a claudicant leaves an indelible mark on each of us and may underlie our inherently conservative approach to PAD. But we need to be fearless in speaking the truth and serving as advocates for exemplary patient care. Continuing a relationship with a source of carotid and aortic referrals while turning a blind eye to meddlesome lower extremity intervention sends the wrong message. Our silence constitutes tacit approval. Too frequently I hear a patient say “my cardiologist says there is nothing else he can do, go see a vascular surgeon.” Despite years of branding efforts by the SVS, surveys of primary care providers and the public alike confirm that many remain uncertain of our skills. We need to do a better job of spreading the word that vascular surgeons are “leaders in the minimally invasive treatment of PAD.” Not the last resort.

Dr. Frank Pomposelli: I could not agree more with Dr. Eidt. It’s easy to indict the outpatient labs for obvious reasons but I personally agree that the root of the problem lies in the overly aggressive posture being taken toward treatment of claudication.

It just so happens that outpatient labs are filled with claudicants since they are most likely to have the least complex disease – match made in heaven or hell, depending on your perspective.

One cardiologist quoted in the N.Y. Times piece said patients with claudication have been “grossly under treated” – a convenient posture to take when billing Medicare $4.5 million a year. The other cardiologist who was the focus of the investigation called the charges “baseless and fiction” and stated his center had the lowest rate of amputation in the country.

It gets back to Dr. Eidt’s point how it’s easy for the nonsurgeon to dismiss amputation as an occasional unfortunate byproduct of a busy practice when you never have had to tell a patient they need one and suffer with them through the emotional and physical trauma that always follows. I was taught like many of you, I suspect, that any amputation after treatment for claudication should be considered not only an unacceptable complication but also a failure of the trust the patient placed in me. My mentor was a militant nihilist when it came to surgery for claudication but that concept is always in my mind whenever I treat a patient and has always tempered my decision making.

I like to think our recently published practice guidelines will help but am skeptical that it will make a positive impact where it is most needed; on those who are primarily driven by financial gain. I’d also point out that Dr. Darren B. Schneider was quoted as a member of the Society for Vascular Medicine. I guess we need to work harder on our branding.

Dr. Mark Morasch: Remember, all politics are local, and any meaningful change needs to come from the grass roots.

Experts can write guidelines, specialty societies can make statements, and newspapers can print articles but the most influential transaction occurs in the exam room when we are face to face with our patients.

Remember, even though we are a small group, we can have great influence when we always, always, always do what we know is right.

Dr. Alan M. Dietzek: Dear Patient, Let me introduce myself. I am a Board-Certified Vascular Surgeon. My specialty is unique in that I am well versed and formally trained in both the medical and surgical management of peripheral vascular disease. No other specialist can make this claim.

Most often, vascular problems can be managed conservatively with a combination of risk factor and lifestyle modification, and occasionally prescription medications, all of which I can outline and or prescribe for you. When necessary, however, I am prepared to treat your vascular problem with either a minimally invasive procedure or open surgery depending on which treatment will provide you with the best outcomes. Again, only a vascular surgeon is capable of offering you these treatment options. I am dedicated to your well-being. I am a Board-Certified Vascular Surgeon

Dr. Murray L. Shames: The recent New York Times article, “Medicare payments surge for stents to unblock blood vessels in limbs,” brings up a critical issue in how we train our residents to think and practice in the future.

Our current generation of residents is faced with a tremendous financial burden of medical school debt, and they are being offered highly competitive salaries after graduation.

The motivation to join groups with outpatient vascular centers is certainly attractive: Why not have autonomy from the hospital, control your work environment, and increase efficiency. As educators we must continue to use clinical evidence and societal guidelines 
(J. Vasc. Surg. 2015:1-40) to guide our clinical practice.

As vascular surgeons we have been trained to manage asymptomatic PAD and intermittent claudication nonoperatively due to it’s relatively benign natural history; endovascular interventions have dramatically increased the treatment of claudication, even in our own hands. We must continue to teach our residents restraint and to consider the impact of the interventions we perform. That way we can maintain our status as the leaders in vascular disease management and not just “interventionalists” that treat lesions.

Dr. Joann Lohr: The presence of a stenotic lesion does not mandate treatment either with a stent or surgical intervention but needs critical assessment of the impact on the patient’s quality of life. Risk factor modification needs to be undertaken before any intervention and will improve outcomes and durability of repairs. The only outcome that matters is the patient’s.

“How does treatment of this lesion change my lifestyle?” is a question that needs to be answered for each patient. Treating physicians need to establish long-term relationships.

Never be afraid to tell patients a procedure is not the first line of treatment. Thoughtful application of new technology is needed in all areas of medicine. Just because we can, should we? Appropriate individualized treatment plans and goals need to be established for each patient we treat.

Dr. Larry Kraiss: Vascular surgeons provide the full spectrum of care for PAD from medical management through intervention to the unfortunate situations when amputation is necessary.

The more sobering of these experiences have imbued most of us with a healthy respect for how an intervention can go wrong. If you haven’t had to explain to a patient or family why an amputation is necessary, you probably don’t have the same concern.

Thus, many of us have a very conservative approach to PAD intervention; primum non nocere is the governing principle. This principle is supposed to guide the actions of all physicians but I can’t help but wonder if something happened to primum non nocere on the way to the outpatient endovascular center.

When physicians become financial stakeholders in these enterprises, a pernicious incentive is introduced that is almost impossible to exclude from daily clinical decision making. Hospital-based physicians are also subject to temptation to perform unnecessary yet lucrative procedures but at least these are being done more in the open.

I suspect that the development of these centers has allowed much activity to occur that would rightly be condemned under the scrutiny of one’s hospital peers.

Dr. Laura Drudi: It really comes down to adequately informing the patient. I always find it astounding how many patients I encounter asking me in a timid tone, “What exactly did I have done on my leg?” I question what patients actually understand and retain after being overwhelmed by the informed consent we have prior to an intervention.

I see first hand the catastrophic failures of intervening on severe claudication leading to limb loss and worsening of quality of life. It’s disheartening to see adverse outcomes following vascular interventions either by vascular surgeons or other interventionalists, but I believe that if you are performing an intervention you should have the expertise and technical skills to deal with the complications.

The best interventionalists know when not to intervene and that should be the mantra we live by. We should be advocates for our patients at a local institutional level as well as a public level. I believe that following the New York Times article the public will be more aware of the potential for inappropriate or unnecessary interventions, many of which are being performed by specialists other than vascular surgeons.

The Society and individual vascular surgeons should capitalize on this opportunity to educate patients as to the benefits of consulting with a vascular surgeon before undertaking any endovascular procedure.

Dr. Elliot L. Chaikof: Both government and private payers have a vested interest in ensuring that patients receive the highest quality care, while reducing the unsustainable rate of increase in health care costs. In Massachusetts and elsewhere in the United States, this has led to the introduction of new risk contracting models that features a global payment with incentives linked to efficiency and quality.

At our institution, approximately 60% of patients are now in such risk contracts. Primary care physicians are most directly incentivized and, along with government and private payors, are highly motivated to ensure that our population of patients receives the right care, at the right time, from the right physician. The U.S. health care system continues to be in a state of flux with substantial regional variations in the delivery of care and how that care is financed.

Despite these challenges, the Society for Vascular Surgery can best serve our patients through advocacy and education, including promoting the need for full transparency of costs to our patients and their physicians. This would be most effective in active partnership with primary care providers, along with regional and national payors.

Dr. Erica L. Mitchell: The line separating a business from a profession is not entirely clear when professionals engage in business practices that serve to benefit the individual financially.

One crucial difference distinguishing the profession of medicine from other professions is that physicians have a fiduciary duty toward those whom they serve. This means that we have a legal duty to provide services to our patients that place the patient’s interest above our own financial interest.

This article highlights how legal and ethical issues arise if health care professionals forgo their fiduciary duties for personal gain. Unethical physicians should be held accountable for unethical practices.

Dr. Larry Scher: The recent article by Julie Creswell and Reed Abelson in the Jan. 29, 2015, New York Times highlights a recent problem in the care of patients with peripheral vascular disease. Vascular surgeons have been treating peripheral arterial disease for over 50 years and have generally adopted a conservative approach toward patients with claudication, emphasizing risk factor modification and exercise.

This is based on an understanding that the disease is benign, rarely progressive, and only occasionally disabling to the point that intervention is indicated for symptom relief.

With new minimally invasive techniques available and specialists other than vascular surgeons performing peripheral catheter based procedures we seem to have forgotten all that vascular surgeons have learned over the past 5 decades.

Most patients with claudication do not benefit from and may be harmed by interventions when long-term rather than short-term outcomes are analyzed. Although practitioners such as those identified in this article may believe they are pioneers in the treatment of peripheral arterial disease and specifically claudication, I would consider them cowboys who have forgotten the lessons of the past.

Editor’s Note: The associate editors of Vascular Specialist were asked to provide their perspectives on the stenting controversy. Here is a selection.

Dr. Frank J. Veith: The recent lead article in the New York Times on excessive implantation of lower extremity stents highlights one key point. Vascular surgeons and all vascular specialists who treat lower extremity occlusive disease should always clearly inform patients with intermittent claudication that one acceptable treatment option is medical and lipid-lowering therapy without any invasive treatment of their arterial blockage. They should be informed that the condition almost never leads to limb loss and that invasive treatment can safely be delayed until such progression occurs.

Given such honest reassurance and the option to choose their treatment, most patients with claudication will choose a conservative rather than an invasive approach, and unnecessary stent/angioplasty and other lower extremity interventional procedures, as described in the Times article, will be minimized. 

Dr. John F. Eidt: The truth is we all bear responsibility. The treatment of lower extremity peripheral artery disease (PAD) has largely defied prior efforts to define appropriate care. Even the SVS document recommending risk factor modification in the initial management of intermittent claudication leaves substantial room for individualized judgment.

The appropriateness of intervention is largely in the eye of the beholder. “Lifestyle-limiting” claudication can be invoked as justification for intervention in virtually anyone. But I do believe that vascular surgeons are more wary of the adverse consequences of vascular intervention for one important reason – we do amputations. We are unique among vascular specialists in that we deal with the tragedies of unwarranted vascular procedures. For vascular surgeons, failure of intervention means more than binary restenosis or increased target lesion revascularization. Performing an amputation after failed intervention in a claudicant leaves an indelible mark on each of us and may underlie our inherently conservative approach to PAD. But we need to be fearless in speaking the truth and serving as advocates for exemplary patient care. Continuing a relationship with a source of carotid and aortic referrals while turning a blind eye to meddlesome lower extremity intervention sends the wrong message. Our silence constitutes tacit approval. Too frequently I hear a patient say “my cardiologist says there is nothing else he can do, go see a vascular surgeon.” Despite years of branding efforts by the SVS, surveys of primary care providers and the public alike confirm that many remain uncertain of our skills. We need to do a better job of spreading the word that vascular surgeons are “leaders in the minimally invasive treatment of PAD.” Not the last resort.

Dr. Frank Pomposelli: I could not agree more with Dr. Eidt. It’s easy to indict the outpatient labs for obvious reasons but I personally agree that the root of the problem lies in the overly aggressive posture being taken toward treatment of claudication.

It just so happens that outpatient labs are filled with claudicants since they are most likely to have the least complex disease – match made in heaven or hell, depending on your perspective.

One cardiologist quoted in the N.Y. Times piece said patients with claudication have been “grossly under treated” – a convenient posture to take when billing Medicare $4.5 million a year. The other cardiologist who was the focus of the investigation called the charges “baseless and fiction” and stated his center had the lowest rate of amputation in the country.

It gets back to Dr. Eidt’s point how it’s easy for the nonsurgeon to dismiss amputation as an occasional unfortunate byproduct of a busy practice when you never have had to tell a patient they need one and suffer with them through the emotional and physical trauma that always follows. I was taught like many of you, I suspect, that any amputation after treatment for claudication should be considered not only an unacceptable complication but also a failure of the trust the patient placed in me. My mentor was a militant nihilist when it came to surgery for claudication but that concept is always in my mind whenever I treat a patient and has always tempered my decision making.

I like to think our recently published practice guidelines will help but am skeptical that it will make a positive impact where it is most needed; on those who are primarily driven by financial gain. I’d also point out that Dr. Darren B. Schneider was quoted as a member of the Society for Vascular Medicine. I guess we need to work harder on our branding.

Dr. Mark Morasch: Remember, all politics are local, and any meaningful change needs to come from the grass roots.

Experts can write guidelines, specialty societies can make statements, and newspapers can print articles but the most influential transaction occurs in the exam room when we are face to face with our patients.

Remember, even though we are a small group, we can have great influence when we always, always, always do what we know is right.

Dr. Alan M. Dietzek: Dear Patient, Let me introduce myself. I am a Board-Certified Vascular Surgeon. My specialty is unique in that I am well versed and formally trained in both the medical and surgical management of peripheral vascular disease. No other specialist can make this claim.

Most often, vascular problems can be managed conservatively with a combination of risk factor and lifestyle modification, and occasionally prescription medications, all of which I can outline and or prescribe for you. When necessary, however, I am prepared to treat your vascular problem with either a minimally invasive procedure or open surgery depending on which treatment will provide you with the best outcomes. Again, only a vascular surgeon is capable of offering you these treatment options. I am dedicated to your well-being. I am a Board-Certified Vascular Surgeon

Dr. Murray L. Shames: The recent New York Times article, “Medicare payments surge for stents to unblock blood vessels in limbs,” brings up a critical issue in how we train our residents to think and practice in the future.

Our current generation of residents is faced with a tremendous financial burden of medical school debt, and they are being offered highly competitive salaries after graduation.

The motivation to join groups with outpatient vascular centers is certainly attractive: Why not have autonomy from the hospital, control your work environment, and increase efficiency. As educators we must continue to use clinical evidence and societal guidelines 
(J. Vasc. Surg. 2015:1-40) to guide our clinical practice.

As vascular surgeons we have been trained to manage asymptomatic PAD and intermittent claudication nonoperatively due to it’s relatively benign natural history; endovascular interventions have dramatically increased the treatment of claudication, even in our own hands. We must continue to teach our residents restraint and to consider the impact of the interventions we perform. That way we can maintain our status as the leaders in vascular disease management and not just “interventionalists” that treat lesions.

Dr. Joann Lohr: The presence of a stenotic lesion does not mandate treatment either with a stent or surgical intervention but needs critical assessment of the impact on the patient’s quality of life. Risk factor modification needs to be undertaken before any intervention and will improve outcomes and durability of repairs. The only outcome that matters is the patient’s.

“How does treatment of this lesion change my lifestyle?” is a question that needs to be answered for each patient. Treating physicians need to establish long-term relationships.

Never be afraid to tell patients a procedure is not the first line of treatment. Thoughtful application of new technology is needed in all areas of medicine. Just because we can, should we? Appropriate individualized treatment plans and goals need to be established for each patient we treat.

Dr. Larry Kraiss: Vascular surgeons provide the full spectrum of care for PAD from medical management through intervention to the unfortunate situations when amputation is necessary.

The more sobering of these experiences have imbued most of us with a healthy respect for how an intervention can go wrong. If you haven’t had to explain to a patient or family why an amputation is necessary, you probably don’t have the same concern.

Thus, many of us have a very conservative approach to PAD intervention; primum non nocere is the governing principle. This principle is supposed to guide the actions of all physicians but I can’t help but wonder if something happened to primum non nocere on the way to the outpatient endovascular center.

When physicians become financial stakeholders in these enterprises, a pernicious incentive is introduced that is almost impossible to exclude from daily clinical decision making. Hospital-based physicians are also subject to temptation to perform unnecessary yet lucrative procedures but at least these are being done more in the open.

I suspect that the development of these centers has allowed much activity to occur that would rightly be condemned under the scrutiny of one’s hospital peers.

Dr. Laura Drudi: It really comes down to adequately informing the patient. I always find it astounding how many patients I encounter asking me in a timid tone, “What exactly did I have done on my leg?” I question what patients actually understand and retain after being overwhelmed by the informed consent we have prior to an intervention.

I see first hand the catastrophic failures of intervening on severe claudication leading to limb loss and worsening of quality of life. It’s disheartening to see adverse outcomes following vascular interventions either by vascular surgeons or other interventionalists, but I believe that if you are performing an intervention you should have the expertise and technical skills to deal with the complications.

The best interventionalists know when not to intervene and that should be the mantra we live by. We should be advocates for our patients at a local institutional level as well as a public level. I believe that following the New York Times article the public will be more aware of the potential for inappropriate or unnecessary interventions, many of which are being performed by specialists other than vascular surgeons.

The Society and individual vascular surgeons should capitalize on this opportunity to educate patients as to the benefits of consulting with a vascular surgeon before undertaking any endovascular procedure.

Dr. Elliot L. Chaikof: Both government and private payers have a vested interest in ensuring that patients receive the highest quality care, while reducing the unsustainable rate of increase in health care costs. In Massachusetts and elsewhere in the United States, this has led to the introduction of new risk contracting models that features a global payment with incentives linked to efficiency and quality.

At our institution, approximately 60% of patients are now in such risk contracts. Primary care physicians are most directly incentivized and, along with government and private payors, are highly motivated to ensure that our population of patients receives the right care, at the right time, from the right physician. The U.S. health care system continues to be in a state of flux with substantial regional variations in the delivery of care and how that care is financed.

Despite these challenges, the Society for Vascular Surgery can best serve our patients through advocacy and education, including promoting the need for full transparency of costs to our patients and their physicians. This would be most effective in active partnership with primary care providers, along with regional and national payors.

Dr. Erica L. Mitchell: The line separating a business from a profession is not entirely clear when professionals engage in business practices that serve to benefit the individual financially.

One crucial difference distinguishing the profession of medicine from other professions is that physicians have a fiduciary duty toward those whom they serve. This means that we have a legal duty to provide services to our patients that place the patient’s interest above our own financial interest.

This article highlights how legal and ethical issues arise if health care professionals forgo their fiduciary duties for personal gain. Unethical physicians should be held accountable for unethical practices.

Dr. Larry Scher: The recent article by Julie Creswell and Reed Abelson in the Jan. 29, 2015, New York Times highlights a recent problem in the care of patients with peripheral vascular disease. Vascular surgeons have been treating peripheral arterial disease for over 50 years and have generally adopted a conservative approach toward patients with claudication, emphasizing risk factor modification and exercise.

This is based on an understanding that the disease is benign, rarely progressive, and only occasionally disabling to the point that intervention is indicated for symptom relief.

With new minimally invasive techniques available and specialists other than vascular surgeons performing peripheral catheter based procedures we seem to have forgotten all that vascular surgeons have learned over the past 5 decades.

Most patients with claudication do not benefit from and may be harmed by interventions when long-term rather than short-term outcomes are analyzed. Although practitioners such as those identified in this article may believe they are pioneers in the treatment of peripheral arterial disease and specifically claudication, I would consider them cowboys who have forgotten the lessons of the past.

I suspect that most members of the SVS are aware of the recent New York Times article entitled “Medicare payments surge for stents to unblock blood vessels in limbs” and which was the subject of our front page news article last month (http://vswebn.org/NYTstents). In that article Dr. Peter Lawrence, the President of the SVS, described steps that the SVS has taken to address the appropriateness of vascular interventions. It was his inspired leadership that led to his devoting the Stanley Crawford symposium at last year’s Vascular Annual Meeting specifically to the problem of unnecessary procedures. Those of you who have read my editorials over the last year will recognize that I also have been on a campaign against the indiscriminate use of both venous and endovascular procedures, especially by non–vascular physicians. However, we must acknowledge that even some of our own are abusing the system for financial gain.

One of the major points made by the New York Times article is that many of these unnecessary procedures are being performed by cardiologists in outpatient centers with little or no oversight. In full disclosure I must admit that my group does lease space in an outpatient center. I have also published on the benefits of such a center and the mechanism for its installation (J. Vasc. Surg. 2009; 49:1073-6).

The reimbursement for a procedure performed in a physician-owned or -leased outpatient facility is far greater than can be achieved in a hospital-owned facility. However, since the physician is responsible for the expenses incurred in such outpatient facilities, there is a financial incentive to do more with inexpensive devices that may be less effective. However, most vascular surgeons who utilize such centers will nevertheless do what is best for the patient in spite of higher costs. Further, patients may benefit from these centers because of convenience and for the provision of a more personable environment than can be found in a hospital inpatient or outpatient facility. Additionally, since the risk of complications from complex interventions, which can be difficult to manage in an outpatient facility, most ethical physicians will ensure that only the safest procedures are undertaken. Personally, I have performed more than 500 procedures in our facility over the last 7 years and have never encountered a pseudoaneurysm, retroperitoneal hematoma, or other complication needing hospitalization.

It is my belief that the excessive procedures delineated in the New York Times article are probably not representative of the majority of such centers. It is, however, quite true that there is no oversight or ombudsman to protect the patient in these outpatient facilities. Hospital-employed or university vascular surgeons may correctly imply that there is more oversight of procedures performed in hospital facilities and that this should limit unnecessary procedures. Needless to say, that is not the case in all institutions.

In our 600-bed municipal hospital, there is limited peer review and the few times when it has been applied it has, on occasion, resulted in legal suits against the reviewing medical staff. Additionally, institutions that reward practitioners based on relative value units may also induce a perverse incentive to overuse procedures.

As Dr. Lawrence describes in his article, site of service may not be the only driving force behind unnecessary interventions. In fact the Clinical Council of the SVS has seized upon appropriate care in office-based centers and is working on constructive suggestions to ensure not only that site of service is convenient for patients, but also that it provides appropriate high quality care. For the time being the SVS recognizes that we need improved oversight and peer review in these physician-owned centers, and that we should not simply abandon them because of the abusive behavior of a few unethical practitioners.

The New York Times article and Dr. Lawrence’s article and letter to the New York Times struck a chord with our membership. It has provoked an outpouring of comments and suggestions from our membership. Some of these are to be found in this edition as letters to the editor. It is apparent that many of us are horrified by what we are seeing, not only in outpatient facilities but also in hospitals.

I believe this is such an important issue that I have requested our associate editors to write a brief comment on their views on the matter and to specifically identify methods of rectifying the current overuse of vascular procedures (see the following 2 pages).

I am hopeful that the NY Times article and the responses we publish will instigate vascular surgeons to stand up for our profession and the well-being of our patients. For if we do not, we will continue to be marginalized by newspaper reporters and government agencies. They will continue to lump us together with interventionalists who may not follow the same ethical road that most of us travel.

I suspect that most members of the SVS are aware of the recent New York Times article entitled “Medicare payments surge for stents to unblock blood vessels in limbs” and which was the subject of our front page news article last month (http://vswebn.org/NYTstents). In that article Dr. Peter Lawrence, the President of the SVS, described steps that the SVS has taken to address the appropriateness of vascular interventions. It was his inspired leadership that led to his devoting the Stanley Crawford symposium at last year’s Vascular Annual Meeting specifically to the problem of unnecessary procedures. Those of you who have read my editorials over the last year will recognize that I also have been on a campaign against the indiscriminate use of both venous and endovascular procedures, especially by non–vascular physicians. However, we must acknowledge that even some of our own are abusing the system for financial gain.

One of the major points made by the New York Times article is that many of these unnecessary procedures are being performed by cardiologists in outpatient centers with little or no oversight. In full disclosure I must admit that my group does lease space in an outpatient center. I have also published on the benefits of such a center and the mechanism for its installation (J. Vasc. Surg. 2009; 49:1073-6).

The reimbursement for a procedure performed in a physician-owned or -leased outpatient facility is far greater than can be achieved in a hospital-owned facility. However, since the physician is responsible for the expenses incurred in such outpatient facilities, there is a financial incentive to do more with inexpensive devices that may be less effective. However, most vascular surgeons who utilize such centers will nevertheless do what is best for the patient in spite of higher costs. Further, patients may benefit from these centers because of convenience and for the provision of a more personable environment than can be found in a hospital inpatient or outpatient facility. Additionally, since the risk of complications from complex interventions, which can be difficult to manage in an outpatient facility, most ethical physicians will ensure that only the safest procedures are undertaken. Personally, I have performed more than 500 procedures in our facility over the last 7 years and have never encountered a pseudoaneurysm, retroperitoneal hematoma, or other complication needing hospitalization.

It is my belief that the excessive procedures delineated in the New York Times article are probably not representative of the majority of such centers. It is, however, quite true that there is no oversight or ombudsman to protect the patient in these outpatient facilities. Hospital-employed or university vascular surgeons may correctly imply that there is more oversight of procedures performed in hospital facilities and that this should limit unnecessary procedures. Needless to say, that is not the case in all institutions.

In our 600-bed municipal hospital, there is limited peer review and the few times when it has been applied it has, on occasion, resulted in legal suits against the reviewing medical staff. Additionally, institutions that reward practitioners based on relative value units may also induce a perverse incentive to overuse procedures.

As Dr. Lawrence describes in his article, site of service may not be the only driving force behind unnecessary interventions. In fact the Clinical Council of the SVS has seized upon appropriate care in office-based centers and is working on constructive suggestions to ensure not only that site of service is convenient for patients, but also that it provides appropriate high quality care. For the time being the SVS recognizes that we need improved oversight and peer review in these physician-owned centers, and that we should not simply abandon them because of the abusive behavior of a few unethical practitioners.

The New York Times article and Dr. Lawrence’s article and letter to the New York Times struck a chord with our membership. It has provoked an outpouring of comments and suggestions from our membership. Some of these are to be found in this edition as letters to the editor. It is apparent that many of us are horrified by what we are seeing, not only in outpatient facilities but also in hospitals.

I believe this is such an important issue that I have requested our associate editors to write a brief comment on their views on the matter and to specifically identify methods of rectifying the current overuse of vascular procedures (see the following 2 pages).

I am hopeful that the NY Times article and the responses we publish will instigate vascular surgeons to stand up for our profession and the well-being of our patients. For if we do not, we will continue to be marginalized by newspaper reporters and government agencies. They will continue to lump us together with interventionalists who may not follow the same ethical road that most of us travel.

I suspect that most members of the SVS are aware of the recent New York Times article entitled “Medicare payments surge for stents to unblock blood vessels in limbs” and which was the subject of our front page news article last month (http://vswebn.org/NYTstents). In that article Dr. Peter Lawrence, the President of the SVS, described steps that the SVS has taken to address the appropriateness of vascular interventions. It was his inspired leadership that led to his devoting the Stanley Crawford symposium at last year’s Vascular Annual Meeting specifically to the problem of unnecessary procedures. Those of you who have read my editorials over the last year will recognize that I also have been on a campaign against the indiscriminate use of both venous and endovascular procedures, especially by non–vascular physicians. However, we must acknowledge that even some of our own are abusing the system for financial gain.

One of the major points made by the New York Times article is that many of these unnecessary procedures are being performed by cardiologists in outpatient centers with little or no oversight. In full disclosure I must admit that my group does lease space in an outpatient center. I have also published on the benefits of such a center and the mechanism for its installation (J. Vasc. Surg. 2009; 49:1073-6).

The reimbursement for a procedure performed in a physician-owned or -leased outpatient facility is far greater than can be achieved in a hospital-owned facility. However, since the physician is responsible for the expenses incurred in such outpatient facilities, there is a financial incentive to do more with inexpensive devices that may be less effective. However, most vascular surgeons who utilize such centers will nevertheless do what is best for the patient in spite of higher costs. Further, patients may benefit from these centers because of convenience and for the provision of a more personable environment than can be found in a hospital inpatient or outpatient facility. Additionally, since the risk of complications from complex interventions, which can be difficult to manage in an outpatient facility, most ethical physicians will ensure that only the safest procedures are undertaken. Personally, I have performed more than 500 procedures in our facility over the last 7 years and have never encountered a pseudoaneurysm, retroperitoneal hematoma, or other complication needing hospitalization.

It is my belief that the excessive procedures delineated in the New York Times article are probably not representative of the majority of such centers. It is, however, quite true that there is no oversight or ombudsman to protect the patient in these outpatient facilities. Hospital-employed or university vascular surgeons may correctly imply that there is more oversight of procedures performed in hospital facilities and that this should limit unnecessary procedures. Needless to say, that is not the case in all institutions.

In our 600-bed municipal hospital, there is limited peer review and the few times when it has been applied it has, on occasion, resulted in legal suits against the reviewing medical staff. Additionally, institutions that reward practitioners based on relative value units may also induce a perverse incentive to overuse procedures.

As Dr. Lawrence describes in his article, site of service may not be the only driving force behind unnecessary interventions. In fact the Clinical Council of the SVS has seized upon appropriate care in office-based centers and is working on constructive suggestions to ensure not only that site of service is convenient for patients, but also that it provides appropriate high quality care. For the time being the SVS recognizes that we need improved oversight and peer review in these physician-owned centers, and that we should not simply abandon them because of the abusive behavior of a few unethical practitioners.

The New York Times article and Dr. Lawrence’s article and letter to the New York Times struck a chord with our membership. It has provoked an outpouring of comments and suggestions from our membership. Some of these are to be found in this edition as letters to the editor. It is apparent that many of us are horrified by what we are seeing, not only in outpatient facilities but also in hospitals.

I believe this is such an important issue that I have requested our associate editors to write a brief comment on their views on the matter and to specifically identify methods of rectifying the current overuse of vascular procedures (see the following 2 pages).

I am hopeful that the NY Times article and the responses we publish will instigate vascular surgeons to stand up for our profession and the well-being of our patients. For if we do not, we will continue to be marginalized by newspaper reporters and government agencies. They will continue to lump us together with interventionalists who may not follow the same ethical road that most of us travel.

Is it possible to give the best critical care while spending less money and resources doing it? Can we reduce waste while improving quality in a so-called lean approach to critical care? I believe that we have too many critical care beds, and we fill some of those beds with patients who can be taken care of at less intense levels of care—which are also less expensive.

Most work that is done to improve critical care looks at the quality of care. This is an area where a lot of data are accumulating. Take septic shock, for example. In the recently published ProCESS trial (The ProCESS Investigators. N Engl J Med. 2014. 370[18]:1683), the 60-day in-hospital mortality for septic shock was 18.2% to 21.0%. A lot of institutions (including mine) are struggling to get their septic shock mortality rate under 30%. Although some people critique the ProCESS trial mortality rate on patient selection, most of us try to figure out how to duplicate that lower rate. We do this in areas other than septic shock. If we are comparable in whatever quality statistic, we applaud our success. If we aren’t comparable, we look at ways to improve, often based on what was done in that particular study.

How big of a financial burden is our critical care spending? According to an analysis of critical care beds by Halpern and colleagues (Crit Care Med. 2004;32[6]:1254), the number of hospital beds decreased 26.4% between 1985 and 2000, and the absolute number of critical care beds increased 26.2% (quantitated at 67,357 adult beds in 2007 per SCCM.org, www.sccm.org/Communications/Pages/CriticalCareStats.aspx). Critical care beds cost $2,674 per day in 2000, up from $1,185 (our CFOs tell us it is more like $3,500 to $4,000 per day now). They represented 13.3% of hospital costs, 4.2% of national health expenditures (NHE), and 0.56% of gross domestic product (GDP). There are 55,000 critically ill patients cared for each day in the United States, representing 5 million ICU patients per year. This is an enormous expenditure of money and it is growing.

Another interesting observation by Halpern and colleagues (Crit Care Med. 2004;32:1254) was that critical care beds were only at 65% occupancy. This reflects my own experience where we operate at a 70% average ICU bed occupancy. We have created a larger financial burden with the fixed costs of one-third more ICU beds than we actually use. Some bed availability is desirable, but how much is too much? Are we doing the best job to give quality care and spend money wisely? Can we be more efficient in the throughput of patients and in their care? Admission criteria should be part of any unit, designed to place all patients who need ICU care appropriately in the ICU and exclude those whose care can be managed at a lesser level of intensity and cost. Discharge criteria, care protocols (e.g., wake up and wean), checklists, and daily attention to the usual parameters (e.g., DVT prophylaxis) are essential for high-quality but efficient care. Done 24/7, we can maximize efficiency and quality with a minimum of ICU readmissions. Throughput is part of every physician’s job description. The physician who wants one more day for his or her patient in the ICU simply because the nurse has fewer patients misses a number of points. Why would anyone want more exposure to resistant organisms, more noise, more awakenings, and less sleep, just to name a few? Keeping that non-ICU patient in the ICU bed might even delay the transfer of another patient coming from the ED, where we know they often don’t get good ICU care.

Are the beds filled only with what we intensivists would consider legitimate ICU patients, defined by both generally accepted (endotracheal tube in place) and individually specified criteria (unit specific related to other unit capabilities)? That would impact cost. An interesting article by Gooch and Kahn (JAMA. 2014; 311[6]:567) discussed the demand elasticity of the ICU. They considered the changes in case mix of patients between days of high and low bed availability. They contended that when ICU beds were available, there was an increase in patients who were unlikely to benefit from ICU admission. This group included a population of patients likely to survive and whose illness severity was low and a population of patients who were unlikely to survive and had a high illness severity. In other words, admissions expand to fill the staff-able beds. If this is true, it is another area where better management could lower costs without reducing the quality of care.

What if bed availability truly is reduced, often by a lack of critical care nursing staff if not physical beds? Here the answer is unclear. Town (Crit Care Med. 2014;42[9]:2037) looked at ICU readmission rates and the odds of having a cardiac arrest on the ward related to bed availability. Five ICUs with 63 beds total were examined. As ICU bed availability decreased, the odds of patients who were discharged from the ICU being readmitted to the ICU went up. Also, the odds of patients having a cardiac arrest on the ward increased when medical (not total) ICU beds were less available. In 2013, Wagner and colleagues (Ann Intern Med. 2013;159[7]:447) looked at 155 ICUs with 200,730 patients discharged from ICUs to hospital floors from 2001 to 2008. They examined what they call the strain metrics. These included the standardized ICU census, the proportion of new admissions, and the average predicted probability of death of the other patients in the ICU on the days of ICU discharge. When the strain metrics increased, ICU patients had shorter ICU length of stay and ICU readmission odds went up. They didn’t, however, see an increased odds of death, a reduced odds of being discharged home, or a longer total hospital LOS. In a third study reported in 2008 in the Annals of Internal Medicine by Howell and colleagues (Ann Intern Med. 2008;149[11]:804), an innovative method of bed management was described. Because of an overcrowded ED and a high ambulance diversion rate, hospitalists implemented a system of bed control that was based on knowledge of ICU beds and ED congestion and flow. Bed assignments were better controlled by twice-daily ICU rounds and regular visits to the ED: throughput for admitted patients decreased by 98 minutes and time on diversion decreased significantly.

Mery and Kahn reported in 2013 (Crit Care. 2013;17[3]:315) that when ICU bed availability was reduced, there was a reduction in the likelihood of ICU admission within 2 hours of a medical emergency team (MET) activation. What is interesting about this study done in three hospitals in Calgary, Alberta, Canada, is that there was an increased likelihood that the patient goals of care changed to comfort care when there was no bed availability, compared with two ICU beds being available. Even more interesting is that hospital mortality did not vary significantly by ICU bed availability: More patients were moved to palliative care yet no more people died. Perhaps a lack of ICU beds expedited appropriateness of care.

To summarize, we have more patients in critical care beds where we spend ever-increasing amounts of our health-care dollars, but we seem to have more critical care beds than we need. We still have patients in our ICUs who would be better cared for elsewhere in our institutions. We can perform more cost-effective throughput when we are pressed to do so and usually we can do it safely.

I contend that the next improvement in lean ICU medicine will be better management tools. Comprehensive checklists have helped me where computer solutions have yet to be developed. I am working to create hardware/software management solutions that will make my job more cost-effective and provide a sustainable process for what comes after me.

Dr. Waxman is associate professor of medicine, KU School of Medicine, Kansas City, Kan.; medical director, Medical Surgical ICU/PCU, Research Medical Center; and adjunct professor, Rockhurst University, Helzberg School of Management, Kansas City, Mo.

Is it possible to give the best critical care while spending less money and resources doing it? Can we reduce waste while improving quality in a so-called lean approach to critical care? I believe that we have too many critical care beds, and we fill some of those beds with patients who can be taken care of at less intense levels of care—which are also less expensive.

Most work that is done to improve critical care looks at the quality of care. This is an area where a lot of data are accumulating. Take septic shock, for example. In the recently published ProCESS trial (The ProCESS Investigators. N Engl J Med. 2014. 370[18]:1683), the 60-day in-hospital mortality for septic shock was 18.2% to 21.0%. A lot of institutions (including mine) are struggling to get their septic shock mortality rate under 30%. Although some people critique the ProCESS trial mortality rate on patient selection, most of us try to figure out how to duplicate that lower rate. We do this in areas other than septic shock. If we are comparable in whatever quality statistic, we applaud our success. If we aren’t comparable, we look at ways to improve, often based on what was done in that particular study.

How big of a financial burden is our critical care spending? According to an analysis of critical care beds by Halpern and colleagues (Crit Care Med. 2004;32[6]:1254), the number of hospital beds decreased 26.4% between 1985 and 2000, and the absolute number of critical care beds increased 26.2% (quantitated at 67,357 adult beds in 2007 per SCCM.org, www.sccm.org/Communications/Pages/CriticalCareStats.aspx). Critical care beds cost $2,674 per day in 2000, up from $1,185 (our CFOs tell us it is more like $3,500 to $4,000 per day now). They represented 13.3% of hospital costs, 4.2% of national health expenditures (NHE), and 0.56% of gross domestic product (GDP). There are 55,000 critically ill patients cared for each day in the United States, representing 5 million ICU patients per year. This is an enormous expenditure of money and it is growing.

Another interesting observation by Halpern and colleagues (Crit Care Med. 2004;32:1254) was that critical care beds were only at 65% occupancy. This reflects my own experience where we operate at a 70% average ICU bed occupancy. We have created a larger financial burden with the fixed costs of one-third more ICU beds than we actually use. Some bed availability is desirable, but how much is too much? Are we doing the best job to give quality care and spend money wisely? Can we be more efficient in the throughput of patients and in their care? Admission criteria should be part of any unit, designed to place all patients who need ICU care appropriately in the ICU and exclude those whose care can be managed at a lesser level of intensity and cost. Discharge criteria, care protocols (e.g., wake up and wean), checklists, and daily attention to the usual parameters (e.g., DVT prophylaxis) are essential for high-quality but efficient care. Done 24/7, we can maximize efficiency and quality with a minimum of ICU readmissions. Throughput is part of every physician’s job description. The physician who wants one more day for his or her patient in the ICU simply because the nurse has fewer patients misses a number of points. Why would anyone want more exposure to resistant organisms, more noise, more awakenings, and less sleep, just to name a few? Keeping that non-ICU patient in the ICU bed might even delay the transfer of another patient coming from the ED, where we know they often don’t get good ICU care.

Are the beds filled only with what we intensivists would consider legitimate ICU patients, defined by both generally accepted (endotracheal tube in place) and individually specified criteria (unit specific related to other unit capabilities)? That would impact cost. An interesting article by Gooch and Kahn (JAMA. 2014; 311[6]:567) discussed the demand elasticity of the ICU. They considered the changes in case mix of patients between days of high and low bed availability. They contended that when ICU beds were available, there was an increase in patients who were unlikely to benefit from ICU admission. This group included a population of patients likely to survive and whose illness severity was low and a population of patients who were unlikely to survive and had a high illness severity. In other words, admissions expand to fill the staff-able beds. If this is true, it is another area where better management could lower costs without reducing the quality of care.

What if bed availability truly is reduced, often by a lack of critical care nursing staff if not physical beds? Here the answer is unclear. Town (Crit Care Med. 2014;42[9]:2037) looked at ICU readmission rates and the odds of having a cardiac arrest on the ward related to bed availability. Five ICUs with 63 beds total were examined. As ICU bed availability decreased, the odds of patients who were discharged from the ICU being readmitted to the ICU went up. Also, the odds of patients having a cardiac arrest on the ward increased when medical (not total) ICU beds were less available. In 2013, Wagner and colleagues (Ann Intern Med. 2013;159[7]:447) looked at 155 ICUs with 200,730 patients discharged from ICUs to hospital floors from 2001 to 2008. They examined what they call the strain metrics. These included the standardized ICU census, the proportion of new admissions, and the average predicted probability of death of the other patients in the ICU on the days of ICU discharge. When the strain metrics increased, ICU patients had shorter ICU length of stay and ICU readmission odds went up. They didn’t, however, see an increased odds of death, a reduced odds of being discharged home, or a longer total hospital LOS. In a third study reported in 2008 in the Annals of Internal Medicine by Howell and colleagues (Ann Intern Med. 2008;149[11]:804), an innovative method of bed management was described. Because of an overcrowded ED and a high ambulance diversion rate, hospitalists implemented a system of bed control that was based on knowledge of ICU beds and ED congestion and flow. Bed assignments were better controlled by twice-daily ICU rounds and regular visits to the ED: throughput for admitted patients decreased by 98 minutes and time on diversion decreased significantly.

Mery and Kahn reported in 2013 (Crit Care. 2013;17[3]:315) that when ICU bed availability was reduced, there was a reduction in the likelihood of ICU admission within 2 hours of a medical emergency team (MET) activation. What is interesting about this study done in three hospitals in Calgary, Alberta, Canada, is that there was an increased likelihood that the patient goals of care changed to comfort care when there was no bed availability, compared with two ICU beds being available. Even more interesting is that hospital mortality did not vary significantly by ICU bed availability: More patients were moved to palliative care yet no more people died. Perhaps a lack of ICU beds expedited appropriateness of care.

To summarize, we have more patients in critical care beds where we spend ever-increasing amounts of our health-care dollars, but we seem to have more critical care beds than we need. We still have patients in our ICUs who would be better cared for elsewhere in our institutions. We can perform more cost-effective throughput when we are pressed to do so and usually we can do it safely.

I contend that the next improvement in lean ICU medicine will be better management tools. Comprehensive checklists have helped me where computer solutions have yet to be developed. I am working to create hardware/software management solutions that will make my job more cost-effective and provide a sustainable process for what comes after me.

Dr. Waxman is associate professor of medicine, KU School of Medicine, Kansas City, Kan.; medical director, Medical Surgical ICU/PCU, Research Medical Center; and adjunct professor, Rockhurst University, Helzberg School of Management, Kansas City, Mo.

Is it possible to give the best critical care while spending less money and resources doing it? Can we reduce waste while improving quality in a so-called lean approach to critical care? I believe that we have too many critical care beds, and we fill some of those beds with patients who can be taken care of at less intense levels of care—which are also less expensive.

Most work that is done to improve critical care looks at the quality of care. This is an area where a lot of data are accumulating. Take septic shock, for example. In the recently published ProCESS trial (The ProCESS Investigators. N Engl J Med. 2014. 370[18]:1683), the 60-day in-hospital mortality for septic shock was 18.2% to 21.0%. A lot of institutions (including mine) are struggling to get their septic shock mortality rate under 30%. Although some people critique the ProCESS trial mortality rate on patient selection, most of us try to figure out how to duplicate that lower rate. We do this in areas other than septic shock. If we are comparable in whatever quality statistic, we applaud our success. If we aren’t comparable, we look at ways to improve, often based on what was done in that particular study.

How big of a financial burden is our critical care spending? According to an analysis of critical care beds by Halpern and colleagues (Crit Care Med. 2004;32[6]:1254), the number of hospital beds decreased 26.4% between 1985 and 2000, and the absolute number of critical care beds increased 26.2% (quantitated at 67,357 adult beds in 2007 per SCCM.org, www.sccm.org/Communications/Pages/CriticalCareStats.aspx). Critical care beds cost $2,674 per day in 2000, up from $1,185 (our CFOs tell us it is more like $3,500 to $4,000 per day now). They represented 13.3% of hospital costs, 4.2% of national health expenditures (NHE), and 0.56% of gross domestic product (GDP). There are 55,000 critically ill patients cared for each day in the United States, representing 5 million ICU patients per year. This is an enormous expenditure of money and it is growing.

Another interesting observation by Halpern and colleagues (Crit Care Med. 2004;32:1254) was that critical care beds were only at 65% occupancy. This reflects my own experience where we operate at a 70% average ICU bed occupancy. We have created a larger financial burden with the fixed costs of one-third more ICU beds than we actually use. Some bed availability is desirable, but how much is too much? Are we doing the best job to give quality care and spend money wisely? Can we be more efficient in the throughput of patients and in their care? Admission criteria should be part of any unit, designed to place all patients who need ICU care appropriately in the ICU and exclude those whose care can be managed at a lesser level of intensity and cost. Discharge criteria, care protocols (e.g., wake up and wean), checklists, and daily attention to the usual parameters (e.g., DVT prophylaxis) are essential for high-quality but efficient care. Done 24/7, we can maximize efficiency and quality with a minimum of ICU readmissions. Throughput is part of every physician’s job description. The physician who wants one more day for his or her patient in the ICU simply because the nurse has fewer patients misses a number of points. Why would anyone want more exposure to resistant organisms, more noise, more awakenings, and less sleep, just to name a few? Keeping that non-ICU patient in the ICU bed might even delay the transfer of another patient coming from the ED, where we know they often don’t get good ICU care.

Are the beds filled only with what we intensivists would consider legitimate ICU patients, defined by both generally accepted (endotracheal tube in place) and individually specified criteria (unit specific related to other unit capabilities)? That would impact cost. An interesting article by Gooch and Kahn (JAMA. 2014; 311[6]:567) discussed the demand elasticity of the ICU. They considered the changes in case mix of patients between days of high and low bed availability. They contended that when ICU beds were available, there was an increase in patients who were unlikely to benefit from ICU admission. This group included a population of patients likely to survive and whose illness severity was low and a population of patients who were unlikely to survive and had a high illness severity. In other words, admissions expand to fill the staff-able beds. If this is true, it is another area where better management could lower costs without reducing the quality of care.

What if bed availability truly is reduced, often by a lack of critical care nursing staff if not physical beds? Here the answer is unclear. Town (Crit Care Med. 2014;42[9]:2037) looked at ICU readmission rates and the odds of having a cardiac arrest on the ward related to bed availability. Five ICUs with 63 beds total were examined. As ICU bed availability decreased, the odds of patients who were discharged from the ICU being readmitted to the ICU went up. Also, the odds of patients having a cardiac arrest on the ward increased when medical (not total) ICU beds were less available. In 2013, Wagner and colleagues (Ann Intern Med. 2013;159[7]:447) looked at 155 ICUs with 200,730 patients discharged from ICUs to hospital floors from 2001 to 2008. They examined what they call the strain metrics. These included the standardized ICU census, the proportion of new admissions, and the average predicted probability of death of the other patients in the ICU on the days of ICU discharge. When the strain metrics increased, ICU patients had shorter ICU length of stay and ICU readmission odds went up. They didn’t, however, see an increased odds of death, a reduced odds of being discharged home, or a longer total hospital LOS. In a third study reported in 2008 in the Annals of Internal Medicine by Howell and colleagues (Ann Intern Med. 2008;149[11]:804), an innovative method of bed management was described. Because of an overcrowded ED and a high ambulance diversion rate, hospitalists implemented a system of bed control that was based on knowledge of ICU beds and ED congestion and flow. Bed assignments were better controlled by twice-daily ICU rounds and regular visits to the ED: throughput for admitted patients decreased by 98 minutes and time on diversion decreased significantly.

Mery and Kahn reported in 2013 (Crit Care. 2013;17[3]:315) that when ICU bed availability was reduced, there was a reduction in the likelihood of ICU admission within 2 hours of a medical emergency team (MET) activation. What is interesting about this study done in three hospitals in Calgary, Alberta, Canada, is that there was an increased likelihood that the patient goals of care changed to comfort care when there was no bed availability, compared with two ICU beds being available. Even more interesting is that hospital mortality did not vary significantly by ICU bed availability: More patients were moved to palliative care yet no more people died. Perhaps a lack of ICU beds expedited appropriateness of care.

To summarize, we have more patients in critical care beds where we spend ever-increasing amounts of our health-care dollars, but we seem to have more critical care beds than we need. We still have patients in our ICUs who would be better cared for elsewhere in our institutions. We can perform more cost-effective throughput when we are pressed to do so and usually we can do it safely.

I contend that the next improvement in lean ICU medicine will be better management tools. Comprehensive checklists have helped me where computer solutions have yet to be developed. I am working to create hardware/software management solutions that will make my job more cost-effective and provide a sustainable process for what comes after me.

Dr. Waxman is associate professor of medicine, KU School of Medicine, Kansas City, Kan.; medical director, Medical Surgical ICU/PCU, Research Medical Center; and adjunct professor, Rockhurst University, Helzberg School of Management, Kansas City, Mo.

The Centers for Disease Control and Prevention’s recent report updating the estimated number of neural tube defects prevented by folic acid fortification of enriched cereal grain products clearly shows the huge impact of fortification: From 1999 through 2011, fortification prevented neural tube defects in about 1,300 births a year in the United States (MMWR 2015;64:1-5).

This is a dramatic example of how a relatively simple public health intervention – in this case, the mandatory addition of an inexpensive B vitamin to a portion of the food supply – is having a dramatic impact on a major birth defect.

Unfortunately, though, people may develop similar expectations that other micronutrients during pregnancy may prevent other birth defects or improve developmental outcomes, without adequate supportive evidence. For example, experimental animal studies have suggested that supplements of polyunsaturated fatty acids (PUFAs) during pregnancy improve brain development in the offspring (J. Perinat. Med. 2008;36;5-14). While there is no evidence that this is true in humans, there are prenatal vitamins that include PUFAs on the market.

Based on a review of nine randomized controlled studies that compared long chain PUFA supplementation to a placebo or no supplement in pregnant women, my colleagues and I concluded that the available research “regarding the maternal supplementation of PUFAs in retinal and neurocognitive development of the infant is not consistent in showing a benefit to supplementation” (Obstet.Gynecol. Int. 2012 [doi:10.1155/2012/591531]).

In a somewhat similar manner, an increasing number of women are taking megavitamins as part of their lifestyle, with the belief that “more is better.”

©Juanmonino/iStockphoto

Megavitamins may not necessarily be harmless. There is evidence from randomized trials that evaluated vitamin E or vitamin C for preeclampsia that vitamin E supplementation during pregnancy may cause intrauterine growth restriction (IUGR). This was confirmed by a study of 82 women who had been exposed to high doses of vitamin E supplements ranging from 400 IU to 1,200 IU a day during the first trimester. At Motherisk, we found that the mean birth weight among the babies of the women who had been exposed to high doses of vitamin E was significantly lower than the mean birth weight of the babies of the controls. But we did not find a significant difference in the rates of live births, preterm delivery, miscarriages, or stillbirths (Reprod. Toxicol. 2005;20:85-8). These women were on vitamin E as part of their lifestyle and not for any particular medical reason.

The medical community needs to keep in mind that while the folic acid fortification of flour and other products has shown dramatic effects in the overall population, as the CDC report shows, it may not meet the needs of specific populations of women who are at a greater risk of having a baby with a neural tube defect. As pointed out in the Morbidity and Mortality Weekly Report, these groups include Hispanic women, who may not consume as much folic acid or are at a greater risk of having a genetic polymorphism that makes them more susceptible to a folate insufficiency.

Flour fortification provides relatively small amounts of folic acid, possibly 200 mcg more a day, at best. But it has been shown that a woman who has had a previous child with a neural tube defect, a high-risk group, needs 5 mg per day to have an impact on prevention (Lancet 1991;338:131-7).

It is therefore important to keep in mind that there are high-risk groups who may need more than the amount provided by flour fortification. These groups include women on antiepileptic drugs or drugs that have antifolate activity, such as sulfonamide and methotrexate; as well as those with some genetic polymorphisms in the folate cycle.

Courtesy of the National Cancer Institute (NCI)

Women who smoke also tend to have lower folate levels, as do women with diabetes or who are obese. Women with celiac disease may have lower folate levels because they do not eat bread or flour-based products. Low-income women who may not eat sufficient green leafy vegetables, which are expensive and contain high levels of folic acid, may also be at greater risk.

A question that is still not resolved is whether folic acid can prevent other malformations, not just neural tube defects. There is some evidence that folic acid supplementation may also reduce the risk of cardiovascular defects and oral clefts. A randomized trial comparing folic acid to no folic acid to address these questions would be unethical. Instead, observational studies could evaluate the rate of these malformations after the fortification program began. Despite this major public health advance, we should always try to do even better and prevent more cases of neural tube defects and other malformations.

Dr. Koren is professor of pediatrics, pharmacology, pharmacy, and medical genetics at the University of Toronto. He is director of the Motherisk Program. He received grant support to conduct studies on folic acid from Duchesnay Inc., Canada. E-mail him at [email protected].

The Centers for Disease Control and Prevention’s recent report updating the estimated number of neural tube defects prevented by folic acid fortification of enriched cereal grain products clearly shows the huge impact of fortification: From 1999 through 2011, fortification prevented neural tube defects in about 1,300 births a year in the United States (MMWR 2015;64:1-5).

This is a dramatic example of how a relatively simple public health intervention – in this case, the mandatory addition of an inexpensive B vitamin to a portion of the food supply – is having a dramatic impact on a major birth defect.

Unfortunately, though, people may develop similar expectations that other micronutrients during pregnancy may prevent other birth defects or improve developmental outcomes, without adequate supportive evidence. For example, experimental animal studies have suggested that supplements of polyunsaturated fatty acids (PUFAs) during pregnancy improve brain development in the offspring (J. Perinat. Med. 2008;36;5-14). While there is no evidence that this is true in humans, there are prenatal vitamins that include PUFAs on the market.

Based on a review of nine randomized controlled studies that compared long chain PUFA supplementation to a placebo or no supplement in pregnant women, my colleagues and I concluded that the available research “regarding the maternal supplementation of PUFAs in retinal and neurocognitive development of the infant is not consistent in showing a benefit to supplementation” (Obstet.Gynecol. Int. 2012 [doi:10.1155/2012/591531]).

In a somewhat similar manner, an increasing number of women are taking megavitamins as part of their lifestyle, with the belief that “more is better.”

©Juanmonino/iStockphoto

Megavitamins may not necessarily be harmless. There is evidence from randomized trials that evaluated vitamin E or vitamin C for preeclampsia that vitamin E supplementation during pregnancy may cause intrauterine growth restriction (IUGR). This was confirmed by a study of 82 women who had been exposed to high doses of vitamin E supplements ranging from 400 IU to 1,200 IU a day during the first trimester. At Motherisk, we found that the mean birth weight among the babies of the women who had been exposed to high doses of vitamin E was significantly lower than the mean birth weight of the babies of the controls. But we did not find a significant difference in the rates of live births, preterm delivery, miscarriages, or stillbirths (Reprod. Toxicol. 2005;20:85-8). These women were on vitamin E as part of their lifestyle and not for any particular medical reason.

The medical community needs to keep in mind that while the folic acid fortification of flour and other products has shown dramatic effects in the overall population, as the CDC report shows, it may not meet the needs of specific populations of women who are at a greater risk of having a baby with a neural tube defect. As pointed out in the Morbidity and Mortality Weekly Report, these groups include Hispanic women, who may not consume as much folic acid or are at a greater risk of having a genetic polymorphism that makes them more susceptible to a folate insufficiency.

Flour fortification provides relatively small amounts of folic acid, possibly 200 mcg more a day, at best. But it has been shown that a woman who has had a previous child with a neural tube defect, a high-risk group, needs 5 mg per day to have an impact on prevention (Lancet 1991;338:131-7).

It is therefore important to keep in mind that there are high-risk groups who may need more than the amount provided by flour fortification. These groups include women on antiepileptic drugs or drugs that have antifolate activity, such as sulfonamide and methotrexate; as well as those with some genetic polymorphisms in the folate cycle.

Courtesy of the National Cancer Institute (NCI)

Women who smoke also tend to have lower folate levels, as do women with diabetes or who are obese. Women with celiac disease may have lower folate levels because they do not eat bread or flour-based products. Low-income women who may not eat sufficient green leafy vegetables, which are expensive and contain high levels of folic acid, may also be at greater risk.

A question that is still not resolved is whether folic acid can prevent other malformations, not just neural tube defects. There is some evidence that folic acid supplementation may also reduce the risk of cardiovascular defects and oral clefts. A randomized trial comparing folic acid to no folic acid to address these questions would be unethical. Instead, observational studies could evaluate the rate of these malformations after the fortification program began. Despite this major public health advance, we should always try to do even better and prevent more cases of neural tube defects and other malformations.

Dr. Koren is professor of pediatrics, pharmacology, pharmacy, and medical genetics at the University of Toronto. He is director of the Motherisk Program. He received grant support to conduct studies on folic acid from Duchesnay Inc., Canada. E-mail him at [email protected].

The Centers for Disease Control and Prevention’s recent report updating the estimated number of neural tube defects prevented by folic acid fortification of enriched cereal grain products clearly shows the huge impact of fortification: From 1999 through 2011, fortification prevented neural tube defects in about 1,300 births a year in the United States (MMWR 2015;64:1-5).

This is a dramatic example of how a relatively simple public health intervention – in this case, the mandatory addition of an inexpensive B vitamin to a portion of the food supply – is having a dramatic impact on a major birth defect.

Unfortunately, though, people may develop similar expectations that other micronutrients during pregnancy may prevent other birth defects or improve developmental outcomes, without adequate supportive evidence. For example, experimental animal studies have suggested that supplements of polyunsaturated fatty acids (PUFAs) during pregnancy improve brain development in the offspring (J. Perinat. Med. 2008;36;5-14). While there is no evidence that this is true in humans, there are prenatal vitamins that include PUFAs on the market.

Based on a review of nine randomized controlled studies that compared long chain PUFA supplementation to a placebo or no supplement in pregnant women, my colleagues and I concluded that the available research “regarding the maternal supplementation of PUFAs in retinal and neurocognitive development of the infant is not consistent in showing a benefit to supplementation” (Obstet.Gynecol. Int. 2012 [doi:10.1155/2012/591531]).

In a somewhat similar manner, an increasing number of women are taking megavitamins as part of their lifestyle, with the belief that “more is better.”

©Juanmonino/iStockphoto

Megavitamins may not necessarily be harmless. There is evidence from randomized trials that evaluated vitamin E or vitamin C for preeclampsia that vitamin E supplementation during pregnancy may cause intrauterine growth restriction (IUGR). This was confirmed by a study of 82 women who had been exposed to high doses of vitamin E supplements ranging from 400 IU to 1,200 IU a day during the first trimester. At Motherisk, we found that the mean birth weight among the babies of the women who had been exposed to high doses of vitamin E was significantly lower than the mean birth weight of the babies of the controls. But we did not find a significant difference in the rates of live births, preterm delivery, miscarriages, or stillbirths (Reprod. Toxicol. 2005;20:85-8). These women were on vitamin E as part of their lifestyle and not for any particular medical reason.

The medical community needs to keep in mind that while the folic acid fortification of flour and other products has shown dramatic effects in the overall population, as the CDC report shows, it may not meet the needs of specific populations of women who are at a greater risk of having a baby with a neural tube defect. As pointed out in the Morbidity and Mortality Weekly Report, these groups include Hispanic women, who may not consume as much folic acid or are at a greater risk of having a genetic polymorphism that makes them more susceptible to a folate insufficiency.

Flour fortification provides relatively small amounts of folic acid, possibly 200 mcg more a day, at best. But it has been shown that a woman who has had a previous child with a neural tube defect, a high-risk group, needs 5 mg per day to have an impact on prevention (Lancet 1991;338:131-7).

It is therefore important to keep in mind that there are high-risk groups who may need more than the amount provided by flour fortification. These groups include women on antiepileptic drugs or drugs that have antifolate activity, such as sulfonamide and methotrexate; as well as those with some genetic polymorphisms in the folate cycle.

Courtesy of the National Cancer Institute (NCI)

Women who smoke also tend to have lower folate levels, as do women with diabetes or who are obese. Women with celiac disease may have lower folate levels because they do not eat bread or flour-based products. Low-income women who may not eat sufficient green leafy vegetables, which are expensive and contain high levels of folic acid, may also be at greater risk.

A question that is still not resolved is whether folic acid can prevent other malformations, not just neural tube defects. There is some evidence that folic acid supplementation may also reduce the risk of cardiovascular defects and oral clefts. A randomized trial comparing folic acid to no folic acid to address these questions would be unethical. Instead, observational studies could evaluate the rate of these malformations after the fortification program began. Despite this major public health advance, we should always try to do even better and prevent more cases of neural tube defects and other malformations.

Dr. Koren is professor of pediatrics, pharmacology, pharmacy, and medical genetics at the University of Toronto. He is director of the Motherisk Program. He received grant support to conduct studies on folic acid from Duchesnay Inc., Canada. E-mail him at [email protected].

In these days of struggles over obesity, it may be hard to remember that being too thin may be a bigger health threat than being too fat. Anorexia nervosa is a very serious but hidden disorder in which the person has a relentless pursuit of thinness, is unwilling to maintain a healthy weight, has distorted body image and intense fear of gaining weight, disturbed eating behavior, and, in girls, amenorrhea.

Anorexia nervosa is actually the third-leading chronic illness in adolescent females and has a mortality rate as high as 20% – one-third by suicide. Boys are not only not immune, but also are even more difficult to suspect and detect. While most affected children improve with behavioral treatment, anorexia nervosa severe enough to warrant hospitalization can result in permanent damage to bones, heart, and brain.

I refer to these patients as “children” here, but you may rightly associate anorexia with adolescents: 43% of those affected had onset at 16-20 years and 86% by 20 years. But listen to this disturbing statistic: 42% of 1st-3rd grade girls report that they want to be thinner and 81% of 10-year-olds are “afraid” of being fat. Over half of teen girls and one-third of boys skip meals, fast, smoke cigarettes, vomit, or take laxatives to control weight – ineffective practices that can lead to eating disorders. Healthy foods and exercise may seem too slow or difficult ways to control weight.

Even with a prevalence of 0.5% you may be wondering, “Gee, I haven’t seen anyone with that for years!” But you probably have been seeing children with the most common presentations of anorexia, which are concerns over complications rather than a request for help with excess weight loss. These are usually complaints about abdominal pain, bloating, or constipation, but may be about headaches, amenorrhea, or feeling faint. You may see them for the first time after an intercurrent illness such as viral gastroenteritis or mononucleosis that sends their emaciated bodies over the edge. Do those patients sound more familiar?

Anorexia nervosa works its damage from starvation and purging behaviors. Any system of the body can be affected from starvation, ranging from suppression of bone marrow with anemia, low white count, and low platelets; endocrine suppression with low TSH and T4 and amenorrhea; cardiomyopathy with resulting mitral valve prolapse, arrhythmias, and syncope; or even seizures and brain atrophy. Depression and anxiety are pretty inevitable when one is starving but, while comorbid, their primacy or severity really can’t be assessed until the starvation state is resolved.

Why aren’t the affected children worried about these serious complications? Actually, they may be worried when they find out about them, but their first fear is about getting fat. Characteristic of anorexia is a distorted body image that nags at them incessantly to lose weight. In U.S. culture, weight loss and fitness ads are all around us, making this concern seem quite normal or even more urgent. They may even panic and get angry if their excessive exercise routine is interrupted. The missing link is that they can’t see that they are not overweight, instead fearing being fat.

Many children with anorexia have tried to stop their dieting but failed. They may be ashamed, embarrassed, or worried about being stigmatized if they are found out. But they often feel that they are on the right path for themselves. At best they are ambivalent about being detected and pushed into treatment. So they get really good at hiding their condition, sometimes getting new ideas online. Common strategies to evade detection include eating apart from the family, saying they are “not hungry now” or even cooking for others but not eating themselves. They wear baggy clothes to hide their emaciation. They often exercise to an extreme, in any weather, whether sick or well. When it is time to be weighed they may drink quarts of water and fill pockets with stones so their true weight loss is not evident.

Actions children take for weight control or loss create much of the morbidity. Most common are use of laxatives and diuretics that can result in fatal electrolyte imbalances and arrhythmias. Purging in anorexia and also in bulimia nervosa can result in gastroesophageal reflux disease, esophageal tears, and bleeding. Self-induced vomiting also destroys tooth enamel, fosters cavities, and can cause scars of palate or knuckles from forcing their hand down their throat. Hypoglycemia from severe restriction can even result in seizures.

When your patients have those metabolic and physical signs, you are not likely to be tricked into thinking all is well. But those athletes in your practice, of whom you and the parents are so proud, can sneak up on you. Those participating in individual “aesthetic” sports such as dance, figure skating, and gymnastics are especially vulnerable to (and rewarded by) extreme thinness. They have been coached to be slim. But to make it worse, the most elite athletes also often have personalities that make extreme weight control possible including perfectionism, competitiveness, compulsiveness, drive, and high activity level.

Parents of children with anorexia may be ambivalent, also, as they see their child eating healthy foods and exercising as they have encouraged them to do. It is not so clear when they have gone too far. But 35% of “normal dieters” go on to pathological dieting and, of those, 20%-25% develop eating disorders of varying degree.

As with most disorders, earlier detection of anorexia symptoms can allow for an easier treatment course and fewer long-term complications. So, when should you be thinking and asking about abnormal eating? Certainly, it is time to ask questions when a child is not gaining weight appropriately, is losing weight to below 15% of appropriate weight for height, or has 3 or more months of amenorrhea. But also consider it when you hear complaints of abdominal pain, headache, or feeling faint that you can’t explain. Ask directly “What would you like to weigh?” A desired weight that would give a body mass index (BMI) of <19 kg/m² is nearly diagnostic. Also ask them to, “Tell me what you eat at each meal on a typical day,” looking for extremely low-calorie bizarre choices such as all lettuce, and “How much exercise do you do daily?” Be specific in collecting information about dieting, binging, self-induced vomiting, and use of laxatives, diuretics, or diet pills for weight control. Asking family members what they have observed about the child’s exercise, dieting, and statements about body image gives even more objective information that the child may try to obscure.

Specific screening self report tools such as the SCOFF questionnaire and Patient Health Questionnaire – Adolescents (PHQ-A) used for all teens or those with signs of weight loss are both a way to get more accurate information and a valuable point of conversation.

When you detect signs and symptoms, the initial work up should include complete blood count, electrolytes, liver function, thyroid-stimulating hormone, and urinalysis, but most importantly an accurate height, weight, and BMI measured in underwear in a gown. Amenorrhea may require endocrine tests as well. While malignancy, endocrine and gastrointestinal disorders are in the differential, characteristic history, physical exam, and lab results will point to the diagnosis. If there is bradycardia or low potassium, chloride, or sodium, an electrocardiogram and hospitalization are urgent as these are the harbingers of life-threatening arrhythmias that are the most common cause of death.

So when you suspect anorexia, you may be facing a difficult-to-detect, life-threatening condition with resistant patients and even reluctant parents. While you may be able to make a contract for biweekly weigh-ins and coaching for subclinical anorexia not otherwise specified, a team will be needed in most full-blown cases. Eating disorder programs are often part of departments of psychiatry, but adolescent specialists also may have assembled needed teams.

Dr. Howard is assistant professor of pediatrics at the Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She has no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline. E-mail her at [email protected].

In these days of struggles over obesity, it may be hard to remember that being too thin may be a bigger health threat than being too fat. Anorexia nervosa is a very serious but hidden disorder in which the person has a relentless pursuit of thinness, is unwilling to maintain a healthy weight, has distorted body image and intense fear of gaining weight, disturbed eating behavior, and, in girls, amenorrhea.

Anorexia nervosa is actually the third-leading chronic illness in adolescent females and has a mortality rate as high as 20% – one-third by suicide. Boys are not only not immune, but also are even more difficult to suspect and detect. While most affected children improve with behavioral treatment, anorexia nervosa severe enough to warrant hospitalization can result in permanent damage to bones, heart, and brain.

I refer to these patients as “children” here, but you may rightly associate anorexia with adolescents: 43% of those affected had onset at 16-20 years and 86% by 20 years. But listen to this disturbing statistic: 42% of 1st-3rd grade girls report that they want to be thinner and 81% of 10-year-olds are “afraid” of being fat. Over half of teen girls and one-third of boys skip meals, fast, smoke cigarettes, vomit, or take laxatives to control weight – ineffective practices that can lead to eating disorders. Healthy foods and exercise may seem too slow or difficult ways to control weight.

Even with a prevalence of 0.5% you may be wondering, “Gee, I haven’t seen anyone with that for years!” But you probably have been seeing children with the most common presentations of anorexia, which are concerns over complications rather than a request for help with excess weight loss. These are usually complaints about abdominal pain, bloating, or constipation, but may be about headaches, amenorrhea, or feeling faint. You may see them for the first time after an intercurrent illness such as viral gastroenteritis or mononucleosis that sends their emaciated bodies over the edge. Do those patients sound more familiar?

Anorexia nervosa works its damage from starvation and purging behaviors. Any system of the body can be affected from starvation, ranging from suppression of bone marrow with anemia, low white count, and low platelets; endocrine suppression with low TSH and T4 and amenorrhea; cardiomyopathy with resulting mitral valve prolapse, arrhythmias, and syncope; or even seizures and brain atrophy. Depression and anxiety are pretty inevitable when one is starving but, while comorbid, their primacy or severity really can’t be assessed until the starvation state is resolved.

Why aren’t the affected children worried about these serious complications? Actually, they may be worried when they find out about them, but their first fear is about getting fat. Characteristic of anorexia is a distorted body image that nags at them incessantly to lose weight. In U.S. culture, weight loss and fitness ads are all around us, making this concern seem quite normal or even more urgent. They may even panic and get angry if their excessive exercise routine is interrupted. The missing link is that they can’t see that they are not overweight, instead fearing being fat.

Many children with anorexia have tried to stop their dieting but failed. They may be ashamed, embarrassed, or worried about being stigmatized if they are found out. But they often feel that they are on the right path for themselves. At best they are ambivalent about being detected and pushed into treatment. So they get really good at hiding their condition, sometimes getting new ideas online. Common strategies to evade detection include eating apart from the family, saying they are “not hungry now” or even cooking for others but not eating themselves. They wear baggy clothes to hide their emaciation. They often exercise to an extreme, in any weather, whether sick or well. When it is time to be weighed they may drink quarts of water and fill pockets with stones so their true weight loss is not evident.

Actions children take for weight control or loss create much of the morbidity. Most common are use of laxatives and diuretics that can result in fatal electrolyte imbalances and arrhythmias. Purging in anorexia and also in bulimia nervosa can result in gastroesophageal reflux disease, esophageal tears, and bleeding. Self-induced vomiting also destroys tooth enamel, fosters cavities, and can cause scars of palate or knuckles from forcing their hand down their throat. Hypoglycemia from severe restriction can even result in seizures.

When your patients have those metabolic and physical signs, you are not likely to be tricked into thinking all is well. But those athletes in your practice, of whom you and the parents are so proud, can sneak up on you. Those participating in individual “aesthetic” sports such as dance, figure skating, and gymnastics are especially vulnerable to (and rewarded by) extreme thinness. They have been coached to be slim. But to make it worse, the most elite athletes also often have personalities that make extreme weight control possible including perfectionism, competitiveness, compulsiveness, drive, and high activity level.

Parents of children with anorexia may be ambivalent, also, as they see their child eating healthy foods and exercising as they have encouraged them to do. It is not so clear when they have gone too far. But 35% of “normal dieters” go on to pathological dieting and, of those, 20%-25% develop eating disorders of varying degree.

As with most disorders, earlier detection of anorexia symptoms can allow for an easier treatment course and fewer long-term complications. So, when should you be thinking and asking about abnormal eating? Certainly, it is time to ask questions when a child is not gaining weight appropriately, is losing weight to below 15% of appropriate weight for height, or has 3 or more months of amenorrhea. But also consider it when you hear complaints of abdominal pain, headache, or feeling faint that you can’t explain. Ask directly “What would you like to weigh?” A desired weight that would give a body mass index (BMI) of <19 kg/m² is nearly diagnostic. Also ask them to, “Tell me what you eat at each meal on a typical day,” looking for extremely low-calorie bizarre choices such as all lettuce, and “How much exercise do you do daily?” Be specific in collecting information about dieting, binging, self-induced vomiting, and use of laxatives, diuretics, or diet pills for weight control. Asking family members what they have observed about the child’s exercise, dieting, and statements about body image gives even more objective information that the child may try to obscure.

Specific screening self report tools such as the SCOFF questionnaire and Patient Health Questionnaire – Adolescents (PHQ-A) used for all teens or those with signs of weight loss are both a way to get more accurate information and a valuable point of conversation.

When you detect signs and symptoms, the initial work up should include complete blood count, electrolytes, liver function, thyroid-stimulating hormone, and urinalysis, but most importantly an accurate height, weight, and BMI measured in underwear in a gown. Amenorrhea may require endocrine tests as well. While malignancy, endocrine and gastrointestinal disorders are in the differential, characteristic history, physical exam, and lab results will point to the diagnosis. If there is bradycardia or low potassium, chloride, or sodium, an electrocardiogram and hospitalization are urgent as these are the harbingers of life-threatening arrhythmias that are the most common cause of death.

So when you suspect anorexia, you may be facing a difficult-to-detect, life-threatening condition with resistant patients and even reluctant parents. While you may be able to make a contract for biweekly weigh-ins and coaching for subclinical anorexia not otherwise specified, a team will be needed in most full-blown cases. Eating disorder programs are often part of departments of psychiatry, but adolescent specialists also may have assembled needed teams.

Dr. Howard is assistant professor of pediatrics at the Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She has no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline. E-mail her at [email protected].

In these days of struggles over obesity, it may be hard to remember that being too thin may be a bigger health threat than being too fat. Anorexia nervosa is a very serious but hidden disorder in which the person has a relentless pursuit of thinness, is unwilling to maintain a healthy weight, has distorted body image and intense fear of gaining weight, disturbed eating behavior, and, in girls, amenorrhea.

Anorexia nervosa is actually the third-leading chronic illness in adolescent females and has a mortality rate as high as 20% – one-third by suicide. Boys are not only not immune, but also are even more difficult to suspect and detect. While most affected children improve with behavioral treatment, anorexia nervosa severe enough to warrant hospitalization can result in permanent damage to bones, heart, and brain.

I refer to these patients as “children” here, but you may rightly associate anorexia with adolescents: 43% of those affected had onset at 16-20 years and 86% by 20 years. But listen to this disturbing statistic: 42% of 1st-3rd grade girls report that they want to be thinner and 81% of 10-year-olds are “afraid” of being fat. Over half of teen girls and one-third of boys skip meals, fast, smoke cigarettes, vomit, or take laxatives to control weight – ineffective practices that can lead to eating disorders. Healthy foods and exercise may seem too slow or difficult ways to control weight.

Even with a prevalence of 0.5% you may be wondering, “Gee, I haven’t seen anyone with that for years!” But you probably have been seeing children with the most common presentations of anorexia, which are concerns over complications rather than a request for help with excess weight loss. These are usually complaints about abdominal pain, bloating, or constipation, but may be about headaches, amenorrhea, or feeling faint. You may see them for the first time after an intercurrent illness such as viral gastroenteritis or mononucleosis that sends their emaciated bodies over the edge. Do those patients sound more familiar?

Anorexia nervosa works its damage from starvation and purging behaviors. Any system of the body can be affected from starvation, ranging from suppression of bone marrow with anemia, low white count, and low platelets; endocrine suppression with low TSH and T4 and amenorrhea; cardiomyopathy with resulting mitral valve prolapse, arrhythmias, and syncope; or even seizures and brain atrophy. Depression and anxiety are pretty inevitable when one is starving but, while comorbid, their primacy or severity really can’t be assessed until the starvation state is resolved.

Why aren’t the affected children worried about these serious complications? Actually, they may be worried when they find out about them, but their first fear is about getting fat. Characteristic of anorexia is a distorted body image that nags at them incessantly to lose weight. In U.S. culture, weight loss and fitness ads are all around us, making this concern seem quite normal or even more urgent. They may even panic and get angry if their excessive exercise routine is interrupted. The missing link is that they can’t see that they are not overweight, instead fearing being fat.

Many children with anorexia have tried to stop their dieting but failed. They may be ashamed, embarrassed, or worried about being stigmatized if they are found out. But they often feel that they are on the right path for themselves. At best they are ambivalent about being detected and pushed into treatment. So they get really good at hiding their condition, sometimes getting new ideas online. Common strategies to evade detection include eating apart from the family, saying they are “not hungry now” or even cooking for others but not eating themselves. They wear baggy clothes to hide their emaciation. They often exercise to an extreme, in any weather, whether sick or well. When it is time to be weighed they may drink quarts of water and fill pockets with stones so their true weight loss is not evident.

Actions children take for weight control or loss create much of the morbidity. Most common are use of laxatives and diuretics that can result in fatal electrolyte imbalances and arrhythmias. Purging in anorexia and also in bulimia nervosa can result in gastroesophageal reflux disease, esophageal tears, and bleeding. Self-induced vomiting also destroys tooth enamel, fosters cavities, and can cause scars of palate or knuckles from forcing their hand down their throat. Hypoglycemia from severe restriction can even result in seizures.

When your patients have those metabolic and physical signs, you are not likely to be tricked into thinking all is well. But those athletes in your practice, of whom you and the parents are so proud, can sneak up on you. Those participating in individual “aesthetic” sports such as dance, figure skating, and gymnastics are especially vulnerable to (and rewarded by) extreme thinness. They have been coached to be slim. But to make it worse, the most elite athletes also often have personalities that make extreme weight control possible including perfectionism, competitiveness, compulsiveness, drive, and high activity level.

Parents of children with anorexia may be ambivalent, also, as they see their child eating healthy foods and exercising as they have encouraged them to do. It is not so clear when they have gone too far. But 35% of “normal dieters” go on to pathological dieting and, of those, 20%-25% develop eating disorders of varying degree.

As with most disorders, earlier detection of anorexia symptoms can allow for an easier treatment course and fewer long-term complications. So, when should you be thinking and asking about abnormal eating? Certainly, it is time to ask questions when a child is not gaining weight appropriately, is losing weight to below 15% of appropriate weight for height, or has 3 or more months of amenorrhea. But also consider it when you hear complaints of abdominal pain, headache, or feeling faint that you can’t explain. Ask directly “What would you like to weigh?” A desired weight that would give a body mass index (BMI) of <19 kg/m² is nearly diagnostic. Also ask them to, “Tell me what you eat at each meal on a typical day,” looking for extremely low-calorie bizarre choices such as all lettuce, and “How much exercise do you do daily?” Be specific in collecting information about dieting, binging, self-induced vomiting, and use of laxatives, diuretics, or diet pills for weight control. Asking family members what they have observed about the child’s exercise, dieting, and statements about body image gives even more objective information that the child may try to obscure.

Specific screening self report tools such as the SCOFF questionnaire and Patient Health Questionnaire – Adolescents (PHQ-A) used for all teens or those with signs of weight loss are both a way to get more accurate information and a valuable point of conversation.

When you detect signs and symptoms, the initial work up should include complete blood count, electrolytes, liver function, thyroid-stimulating hormone, and urinalysis, but most importantly an accurate height, weight, and BMI measured in underwear in a gown. Amenorrhea may require endocrine tests as well. While malignancy, endocrine and gastrointestinal disorders are in the differential, characteristic history, physical exam, and lab results will point to the diagnosis. If there is bradycardia or low potassium, chloride, or sodium, an electrocardiogram and hospitalization are urgent as these are the harbingers of life-threatening arrhythmias that are the most common cause of death.

So when you suspect anorexia, you may be facing a difficult-to-detect, life-threatening condition with resistant patients and even reluctant parents. While you may be able to make a contract for biweekly weigh-ins and coaching for subclinical anorexia not otherwise specified, a team will be needed in most full-blown cases. Eating disorder programs are often part of departments of psychiatry, but adolescent specialists also may have assembled needed teams.

Dr. Howard is assistant professor of pediatrics at the Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She has no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline. E-mail her at [email protected].