ACS Surgery News

Hardly a day goes by anymore without an announcement of a new mobile health app, but there are precious few data to show which apps are useful in clinical or financial terms. Lots of people would like to change that, but how?

Three experts offered ideas in a recent opinion article in the Journal of the American Medical Association, and some partnerships between academia and industry may be laying the groundwork for greater validation of new mobile health (mHealth) tools.

Courtesy of UCSF

Of the more than 40,000 health, fitness, and medical apps on the market, reviews "have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security," Adam C. Powell, Ph.D., Dr. Adam B. Landman, and Dr. David W. Bates wrote in their article, "In Search of a Few Good Apps" (JAMA 2014;311:1851-2).

The Office of the National Coordinator for Health Information Technology (ONC) could play a greater role supporting development of mHealth app guidelines and, eventually, commission non-profit or for-profit entities to certify apps, as it does now for electronic health records, they suggested.

Dr. Powell is a Boston-based consultant. Dr. Landman, an emergency medicine specialist, is chief medical information officer for health information innovation and integration at Brigham and Women’s Hospital, Boston. Dr. Bates is chief of general internal medicine and the chief quality officer at Brigham and Women’s. Dr. Landman and Dr. Bates are both at Harvard Medical School in Boston.

The National Institutes of Health mHealth Training Institute is educating an interdisciplinary group of researchers about the potential of mHealth and the need to evaluate these new tools. "If this effort is coupled with increased funding for mHealth research, it may help galvanize a larger body of evidence to inform mHealth app development and certification," the authors wrote.

Meanwhile, a new partnership between the University of California, San Francisco (UCSF), and Samsung Electronics aims to validate and commercialize promising digital tools for health care, including apps, in a Digital Health Innovation Lab. A few other universities recently entered into similar partnerships with industry.

Both UCSF and Samsung are making a "significant investment" to fund the lab but are not ready to release financial details, Dr. Michael Blum said in an interview.

The partnership initially will focus on preventive health, said Dr. Blum, who will direct the lab to be located at UCSF’s Mission Bay campus. "There is no better way to treat disease than by avoiding it in the first place. [Moe than] 70% of our health care dollars are spent on avoidable disease," said Dr. Blum, a cardiologist who has been leading UCSF’s relatively new Center for Digital Health Innovation.

UCSF already has begun testing medical apps in clinical trials, such as a smoking cessation app, and will pursue clinical testing of tools including health sensors, wearable computing, and cloud-based analytics.

"There are many sites designing medical apps but very few are rigorously validated," Dr. Blum said. "We believe that validation is critical to the success of these apps and products. It is important for health care providers to know that they can trust the data and information which will lead to more consistent use and, hopefully, better outcomes for the users."

In Michigan, the William Davidson Foundation in January 2014 awarded $3 million to the Henry Ford Health System to create the William Davidson Center for Entrepreneurs in Digital Health. The center hopes to attract corporate partners and others to create, clinically validate, and commercialize digital health tools and to create a curriculum integrating health care, digital technologies, and entrepreneurship, according to a statement released by the Henry Ford Innovation Institute.

At the University of Colorado, Denver, the Center for Information Technology Innovation recently launched a Digital Health Consortium to bring its business school faculty together with entrepreneurs, health care providers, researchers, educators, and others to develop and clinically validate the next generation of digital health tools. The Center is funded by its members, which include the university and more than 30 Colorado information technology business leaders.

As each of these initiatives and others like them report results from their validation efforts, we’ll bring you the latest news on medical apps. Watch this space.

[email protected]

On Twitter @sherryboschert

Hardly a day goes by anymore without an announcement of a new mobile health app, but there are precious few data to show which apps are useful in clinical or financial terms. Lots of people would like to change that, but how?

Three experts offered ideas in a recent opinion article in the Journal of the American Medical Association, and some partnerships between academia and industry may be laying the groundwork for greater validation of new mobile health (mHealth) tools.

Courtesy of UCSF

Of the more than 40,000 health, fitness, and medical apps on the market, reviews "have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security," Adam C. Powell, Ph.D., Dr. Adam B. Landman, and Dr. David W. Bates wrote in their article, "In Search of a Few Good Apps" (JAMA 2014;311:1851-2).

The Office of the National Coordinator for Health Information Technology (ONC) could play a greater role supporting development of mHealth app guidelines and, eventually, commission non-profit or for-profit entities to certify apps, as it does now for electronic health records, they suggested.

Dr. Powell is a Boston-based consultant. Dr. Landman, an emergency medicine specialist, is chief medical information officer for health information innovation and integration at Brigham and Women’s Hospital, Boston. Dr. Bates is chief of general internal medicine and the chief quality officer at Brigham and Women’s. Dr. Landman and Dr. Bates are both at Harvard Medical School in Boston.

The National Institutes of Health mHealth Training Institute is educating an interdisciplinary group of researchers about the potential of mHealth and the need to evaluate these new tools. "If this effort is coupled with increased funding for mHealth research, it may help galvanize a larger body of evidence to inform mHealth app development and certification," the authors wrote.

Meanwhile, a new partnership between the University of California, San Francisco (UCSF), and Samsung Electronics aims to validate and commercialize promising digital tools for health care, including apps, in a Digital Health Innovation Lab. A few other universities recently entered into similar partnerships with industry.

Both UCSF and Samsung are making a "significant investment" to fund the lab but are not ready to release financial details, Dr. Michael Blum said in an interview.

The partnership initially will focus on preventive health, said Dr. Blum, who will direct the lab to be located at UCSF’s Mission Bay campus. "There is no better way to treat disease than by avoiding it in the first place. [Moe than] 70% of our health care dollars are spent on avoidable disease," said Dr. Blum, a cardiologist who has been leading UCSF’s relatively new Center for Digital Health Innovation.

UCSF already has begun testing medical apps in clinical trials, such as a smoking cessation app, and will pursue clinical testing of tools including health sensors, wearable computing, and cloud-based analytics.

"There are many sites designing medical apps but very few are rigorously validated," Dr. Blum said. "We believe that validation is critical to the success of these apps and products. It is important for health care providers to know that they can trust the data and information which will lead to more consistent use and, hopefully, better outcomes for the users."

In Michigan, the William Davidson Foundation in January 2014 awarded $3 million to the Henry Ford Health System to create the William Davidson Center for Entrepreneurs in Digital Health. The center hopes to attract corporate partners and others to create, clinically validate, and commercialize digital health tools and to create a curriculum integrating health care, digital technologies, and entrepreneurship, according to a statement released by the Henry Ford Innovation Institute.

At the University of Colorado, Denver, the Center for Information Technology Innovation recently launched a Digital Health Consortium to bring its business school faculty together with entrepreneurs, health care providers, researchers, educators, and others to develop and clinically validate the next generation of digital health tools. The Center is funded by its members, which include the university and more than 30 Colorado information technology business leaders.

As each of these initiatives and others like them report results from their validation efforts, we’ll bring you the latest news on medical apps. Watch this space.

[email protected]

On Twitter @sherryboschert

Hardly a day goes by anymore without an announcement of a new mobile health app, but there are precious few data to show which apps are useful in clinical or financial terms. Lots of people would like to change that, but how?

Three experts offered ideas in a recent opinion article in the Journal of the American Medical Association, and some partnerships between academia and industry may be laying the groundwork for greater validation of new mobile health (mHealth) tools.

Courtesy of UCSF

Of the more than 40,000 health, fitness, and medical apps on the market, reviews "have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security," Adam C. Powell, Ph.D., Dr. Adam B. Landman, and Dr. David W. Bates wrote in their article, "In Search of a Few Good Apps" (JAMA 2014;311:1851-2).

The Office of the National Coordinator for Health Information Technology (ONC) could play a greater role supporting development of mHealth app guidelines and, eventually, commission non-profit or for-profit entities to certify apps, as it does now for electronic health records, they suggested.

Dr. Powell is a Boston-based consultant. Dr. Landman, an emergency medicine specialist, is chief medical information officer for health information innovation and integration at Brigham and Women’s Hospital, Boston. Dr. Bates is chief of general internal medicine and the chief quality officer at Brigham and Women’s. Dr. Landman and Dr. Bates are both at Harvard Medical School in Boston.

The National Institutes of Health mHealth Training Institute is educating an interdisciplinary group of researchers about the potential of mHealth and the need to evaluate these new tools. "If this effort is coupled with increased funding for mHealth research, it may help galvanize a larger body of evidence to inform mHealth app development and certification," the authors wrote.

Meanwhile, a new partnership between the University of California, San Francisco (UCSF), and Samsung Electronics aims to validate and commercialize promising digital tools for health care, including apps, in a Digital Health Innovation Lab. A few other universities recently entered into similar partnerships with industry.

Both UCSF and Samsung are making a "significant investment" to fund the lab but are not ready to release financial details, Dr. Michael Blum said in an interview.

The partnership initially will focus on preventive health, said Dr. Blum, who will direct the lab to be located at UCSF’s Mission Bay campus. "There is no better way to treat disease than by avoiding it in the first place. [Moe than] 70% of our health care dollars are spent on avoidable disease," said Dr. Blum, a cardiologist who has been leading UCSF’s relatively new Center for Digital Health Innovation.

UCSF already has begun testing medical apps in clinical trials, such as a smoking cessation app, and will pursue clinical testing of tools including health sensors, wearable computing, and cloud-based analytics.

"There are many sites designing medical apps but very few are rigorously validated," Dr. Blum said. "We believe that validation is critical to the success of these apps and products. It is important for health care providers to know that they can trust the data and information which will lead to more consistent use and, hopefully, better outcomes for the users."

In Michigan, the William Davidson Foundation in January 2014 awarded $3 million to the Henry Ford Health System to create the William Davidson Center for Entrepreneurs in Digital Health. The center hopes to attract corporate partners and others to create, clinically validate, and commercialize digital health tools and to create a curriculum integrating health care, digital technologies, and entrepreneurship, according to a statement released by the Henry Ford Innovation Institute.

At the University of Colorado, Denver, the Center for Information Technology Innovation recently launched a Digital Health Consortium to bring its business school faculty together with entrepreneurs, health care providers, researchers, educators, and others to develop and clinically validate the next generation of digital health tools. The Center is funded by its members, which include the university and more than 30 Colorado information technology business leaders.

As each of these initiatives and others like them report results from their validation efforts, we’ll bring you the latest news on medical apps. Watch this space.

[email protected]

On Twitter @sherryboschert

Doctors will continue to drop out of the federal government’s Electronic Health Records Incentive Programs unless officials ease some program requirements, the American Medical Association warned in a May 8 letter to government officials.

The AMA offered a laundry list of needed changes from abandoning the "all-or-nothing" approach for meeting meaningful use standards to removing requirements that are outside the control of physicians.

"In any other grading system a 99% is an A+, but it’s a fail in the meaningful use program, which just seems entirely inconsistent with what Congress intended, which was to foster the adoption of these tools," Dr. Steven J. Stack, an emergency physician and immediate past chairman of the AMA’s board of trustees, said in an interview.

In the letter to officials at the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), the AMA advocated for ending the "all-or-nothing" approach, which requires physicians to successfully meet all meaningful use requirements to earn incentives. The AMA instead recommended a 75% threshold for qualifying for incentives and a 50% threshold to avoid penalties.

The AMA also urged the government not to measure activities outside of the physician’s control, such as whether a patient views or downloads information from a portal.

While the government has been touting widespread participation in the Electronic Health Records Incentive Programs, the AMA said that physicians are beginning to abandon the program. The AMA said that partial data from 2013 showed that there was already a 20% drop out rate in the meaningful use program. It will only grow if the program continues as is, Dr. Stack said.

But there’s time to make changes both to Stage 2 and Stage 3 of the program, Dr. Stack added.

"We don’t see this as a done deal. We see this as a live program that requires ongoing adjustment and tailoring," he said. "The federal government, in order to advance the policy objective of fostering electronic health record adoption and health information exchange, should have a mid-course correction immediately for Stage 2 to make it more possible to have flexibility and a better opportunity for success for the clinicians and the hospitals."

[email protected]

On Twitter @maryellenny

Doctors will continue to drop out of the federal government’s Electronic Health Records Incentive Programs unless officials ease some program requirements, the American Medical Association warned in a May 8 letter to government officials.

The AMA offered a laundry list of needed changes from abandoning the "all-or-nothing" approach for meeting meaningful use standards to removing requirements that are outside the control of physicians.

"In any other grading system a 99% is an A+, but it’s a fail in the meaningful use program, which just seems entirely inconsistent with what Congress intended, which was to foster the adoption of these tools," Dr. Steven J. Stack, an emergency physician and immediate past chairman of the AMA’s board of trustees, said in an interview.

In the letter to officials at the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), the AMA advocated for ending the "all-or-nothing" approach, which requires physicians to successfully meet all meaningful use requirements to earn incentives. The AMA instead recommended a 75% threshold for qualifying for incentives and a 50% threshold to avoid penalties.

The AMA also urged the government not to measure activities outside of the physician’s control, such as whether a patient views or downloads information from a portal.

While the government has been touting widespread participation in the Electronic Health Records Incentive Programs, the AMA said that physicians are beginning to abandon the program. The AMA said that partial data from 2013 showed that there was already a 20% drop out rate in the meaningful use program. It will only grow if the program continues as is, Dr. Stack said.

But there’s time to make changes both to Stage 2 and Stage 3 of the program, Dr. Stack added.

"We don’t see this as a done deal. We see this as a live program that requires ongoing adjustment and tailoring," he said. "The federal government, in order to advance the policy objective of fostering electronic health record adoption and health information exchange, should have a mid-course correction immediately for Stage 2 to make it more possible to have flexibility and a better opportunity for success for the clinicians and the hospitals."

[email protected]

On Twitter @maryellenny

Doctors will continue to drop out of the federal government’s Electronic Health Records Incentive Programs unless officials ease some program requirements, the American Medical Association warned in a May 8 letter to government officials.

The AMA offered a laundry list of needed changes from abandoning the "all-or-nothing" approach for meeting meaningful use standards to removing requirements that are outside the control of physicians.

"In any other grading system a 99% is an A+, but it’s a fail in the meaningful use program, which just seems entirely inconsistent with what Congress intended, which was to foster the adoption of these tools," Dr. Steven J. Stack, an emergency physician and immediate past chairman of the AMA’s board of trustees, said in an interview.

In the letter to officials at the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), the AMA advocated for ending the "all-or-nothing" approach, which requires physicians to successfully meet all meaningful use requirements to earn incentives. The AMA instead recommended a 75% threshold for qualifying for incentives and a 50% threshold to avoid penalties.

The AMA also urged the government not to measure activities outside of the physician’s control, such as whether a patient views or downloads information from a portal.

While the government has been touting widespread participation in the Electronic Health Records Incentive Programs, the AMA said that physicians are beginning to abandon the program. The AMA said that partial data from 2013 showed that there was already a 20% drop out rate in the meaningful use program. It will only grow if the program continues as is, Dr. Stack said.

But there’s time to make changes both to Stage 2 and Stage 3 of the program, Dr. Stack added.

"We don’t see this as a done deal. We see this as a live program that requires ongoing adjustment and tailoring," he said. "The federal government, in order to advance the policy objective of fostering electronic health record adoption and health information exchange, should have a mid-course correction immediately for Stage 2 to make it more possible to have flexibility and a better opportunity for success for the clinicians and the hospitals."

[email protected]

On Twitter @maryellenny

Question: On antitrust, the U.S. courts have made the following statements, except:

A. To agree to prices is to fix them.

B. There is no learned profession exception to the antitrust laws.

C. To fix maximum price may amount to a fix of minimum price.

D. A group boycott of chiropractors violates the Sherman Act.

E. Tying arrangement in the health care industry is per se illegal.

Answer: E (see Jefferson Parish Hospital below). In the second part of the 20th century, the U.S. Supreme Court and other appellate courts began issuing a number of landmark opinions regarding health care economics and antitrust. Group boycotts were a major target, as was price fixing. This article briefly reviews a few of these decisions to impart a sense of how the judicial system views free market competition in health care.

In AMA v. United States (317 U.S. 519 [1943]), the issue was whether the medical profession’s leading organization, the American Medical Association, could be allowed to expel its salaried doctors or those who associated professionally with salaried doctors. Those who were denied AMA membership were naturally less able to compete (hospital privileges, consultations, etc.).

The U.S. Supreme Court held that such a group boycott of all salaried doctors was illegal because of its anticompetitive purpose, even if it allegedly promoted professional competence and public welfare.

Wilk v. AMA (895 F.2d 352 [1990]) was the culmination of a number of lawsuits surrounding the AMA and chiropractic. In 1963, the AMA had formed a Committee on Quackery aimed at eliminating chiropractic as a profession. The AMA Code of Ethics, Principle 3, opined that it was unethical for a physician to associate professionally with chiropractors. In 1976, Dr. Wilk and four other licensed chiropractors filed suit against the AMA, and a jury trial found that the purpose of the boycott was to eliminate substantial competition without corresponding procompetitive benefits.

The U.S. Court of Appeals for the Seventh Circuit subsequently affirmed the lower court’s finding that the AMA violated Section 1 of the Sherman Act in its illegal boycott of chiropractors, although the court did not answer the question as to whether chiropractic theory was in fact scientific. The court inquired into whether there was a genuine reasonable concern for the use of the scientific method in the doctor-patient relationship, and whether that concern was the dominating, motivating factor in the boycott, and if so, whether it could have been satisfied without restraining competition.

The court found that the AMA’s motive for the boycott was anticompetitive, believing that concern for patient care could be expressed, for example, through public-education campaigns. Although the AMA had formally removed Principle 3 in 1980, it nonetheless appealed this adverse decision to the U.S. Supreme Court on three separate occasions, but the latter declined to hear the case.

In Goldfarb v. Virginia State Bar (421 U.S. 773 [1975]), the Virginia State Bar enforced an "advisory" minimum fee schedule for legal services. The U.S. Supreme Court found that this was an agreement to fix prices, holding, "This is not merely a case of an agreement that may be inferred from an exchange of price information ... for here a naked agreement was clearly shown, and the effect on prices is plain."

The court rejected the defendant’s argument that the practice of law was not a trade or commerce intended to be under Sherman Act scrutiny, declaring there was to be no "learned profession" exemption.

However, it noted that special considerations might apply, holding that "It would be unrealistic to view the practice of professions as interchangeable with other business activities, and automatically to apply to the professions antitrust concepts, which originated in other areas. The public service aspect, and other features of the professions, may require that a particular practice, which could properly be viewed as a violation of the Sherman Act in another context, be treated differently."

Following Goldfarb, there remains no doubt that professional services – legal, medical, and other services – are all to be governed by the antitrust laws.

A flurry of health care–related antitrust cases, including Patrick v. Burget (to be discussed in part 3), reached the courts in the 1980s. In Arizona v. Maricopa County Medical Society (457 U.S. 332 [1982]), the county medical society set maximum allowable fees that member physicians could charge their patients, presumably to guard against price gouging. However, the U.S. Supreme Court, using the tough illegal per se standard, characterized the agreement as price fixing, despite it being for maximum rather than minimum fees.

The court ruled, "Maximum and minimum price fixing may have different consequences in many situations. But schemes to fix maximum prices, by substituting perhaps the erroneous judgment of a seller for the forces of the competitive market, may severely intrude upon the ability of buyers to compete and survive in that market. ... Maximum prices may be fixed too low ... may channel distribution through a few large or specifically advantaged dealers. ... Moreover, if the actual price charged under a maximum price scheme is nearly always the fixed maximum price, which is increasingly likely as the maximum price approaches the actual cost of the dealer, the scheme tends to acquire all the attributes of an arrangement fixing minimum prices."

At issue in Jefferson Parish Hospital District No. 2 v. Hyde (466 U.S. 2 [1984]) was an exclusive contract between a group of four anesthesiologists and Jefferson Parish Hospital in the New Orleans area. Dr. Hyde was an independent board-certified anesthesiologist who was denied medical staff privileges at the hospital because of this exclusive contract. The exclusive arrangement in effect required patients at the hospital to use the services of the four anesthesiologists and none others, raising the issue of unlawful "tying," where a seller requires a customer to purchase one product or service as a condition of being allowed to purchase another.

In a rare unanimous decision, the U.S. Supreme Court, while agreeing that the contract was a tying arrangement, nonetheless rejected the argument that it was per se illegal or that it unreasonably restrained competition among anesthesiologists. The court reasoned that the hospital’s 30% share of the market did not amount to sufficient market power in the provision of hospital services in the Jefferson Parish area. Pointing out that every patient undergoing surgery needed anesthesia, the court found no evidence that any patient received unnecessary services, and it noted that the tying arrangement that was generally employed in the health care industry improved patient care and promoted hospital efficiency.

Tying arrangements in health care are frequently analyzed under a rule of reason standard instead of the strict per se standard, and the favorable decision in this specific case depended heavily on the hospitals’ relatively small market power.

Finally, consider a case on insurance reimbursement and a group boycott against a third-party payer. In Federal Trade Commission v. Indiana Federation of Dentists (476 U.S. 447 [1986]), dental health insurers in Indiana attempted to contain the cost of dental treatment by limiting payments to the least expensive yet adequate treatment suitable to the needs of the patient. The insurers required the submission of x-rays by treating dentists for review of their insurance claims.

Viewing such review of diagnostic and treatment decisions as a threat to their professional independence and economic well-being, members of the Indiana Dental Association and later the Indiana Federation of Dentists agreed collectively to refuse to submit the requested x-rays. These concerted activities resulted in the denial of information that dental customers had requested and had a right to know, and forced them to choose between acquiring the information in a more costly manner or forgoing it altogether.

The lower court had ruled in favor of the dentists, but the U.S. Supreme Court reversed. It agreed that in the absence of concerted behavior, an individual dentist would have been subject to market forces of competition, creating incentives for him or her to comply with the requests of patients’ third-party insurers. But the conduct of the federation was tantamount to a group boycott, which unreasonably restrained trade. The court noted that while this was not price fixing as such, no elaborate industry analysis was required to demonstrate the anticompetitive character of such an agreement.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk", and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: On antitrust, the U.S. courts have made the following statements, except:

A. To agree to prices is to fix them.

B. There is no learned profession exception to the antitrust laws.

C. To fix maximum price may amount to a fix of minimum price.

D. A group boycott of chiropractors violates the Sherman Act.

E. Tying arrangement in the health care industry is per se illegal.

Answer: E (see Jefferson Parish Hospital below). In the second part of the 20th century, the U.S. Supreme Court and other appellate courts began issuing a number of landmark opinions regarding health care economics and antitrust. Group boycotts were a major target, as was price fixing. This article briefly reviews a few of these decisions to impart a sense of how the judicial system views free market competition in health care.

In AMA v. United States (317 U.S. 519 [1943]), the issue was whether the medical profession’s leading organization, the American Medical Association, could be allowed to expel its salaried doctors or those who associated professionally with salaried doctors. Those who were denied AMA membership were naturally less able to compete (hospital privileges, consultations, etc.).

The U.S. Supreme Court held that such a group boycott of all salaried doctors was illegal because of its anticompetitive purpose, even if it allegedly promoted professional competence and public welfare.

Wilk v. AMA (895 F.2d 352 [1990]) was the culmination of a number of lawsuits surrounding the AMA and chiropractic. In 1963, the AMA had formed a Committee on Quackery aimed at eliminating chiropractic as a profession. The AMA Code of Ethics, Principle 3, opined that it was unethical for a physician to associate professionally with chiropractors. In 1976, Dr. Wilk and four other licensed chiropractors filed suit against the AMA, and a jury trial found that the purpose of the boycott was to eliminate substantial competition without corresponding procompetitive benefits.

The U.S. Court of Appeals for the Seventh Circuit subsequently affirmed the lower court’s finding that the AMA violated Section 1 of the Sherman Act in its illegal boycott of chiropractors, although the court did not answer the question as to whether chiropractic theory was in fact scientific. The court inquired into whether there was a genuine reasonable concern for the use of the scientific method in the doctor-patient relationship, and whether that concern was the dominating, motivating factor in the boycott, and if so, whether it could have been satisfied without restraining competition.

The court found that the AMA’s motive for the boycott was anticompetitive, believing that concern for patient care could be expressed, for example, through public-education campaigns. Although the AMA had formally removed Principle 3 in 1980, it nonetheless appealed this adverse decision to the U.S. Supreme Court on three separate occasions, but the latter declined to hear the case.

In Goldfarb v. Virginia State Bar (421 U.S. 773 [1975]), the Virginia State Bar enforced an "advisory" minimum fee schedule for legal services. The U.S. Supreme Court found that this was an agreement to fix prices, holding, "This is not merely a case of an agreement that may be inferred from an exchange of price information ... for here a naked agreement was clearly shown, and the effect on prices is plain."

The court rejected the defendant’s argument that the practice of law was not a trade or commerce intended to be under Sherman Act scrutiny, declaring there was to be no "learned profession" exemption.

However, it noted that special considerations might apply, holding that "It would be unrealistic to view the practice of professions as interchangeable with other business activities, and automatically to apply to the professions antitrust concepts, which originated in other areas. The public service aspect, and other features of the professions, may require that a particular practice, which could properly be viewed as a violation of the Sherman Act in another context, be treated differently."

Following Goldfarb, there remains no doubt that professional services – legal, medical, and other services – are all to be governed by the antitrust laws.

A flurry of health care–related antitrust cases, including Patrick v. Burget (to be discussed in part 3), reached the courts in the 1980s. In Arizona v. Maricopa County Medical Society (457 U.S. 332 [1982]), the county medical society set maximum allowable fees that member physicians could charge their patients, presumably to guard against price gouging. However, the U.S. Supreme Court, using the tough illegal per se standard, characterized the agreement as price fixing, despite it being for maximum rather than minimum fees.

The court ruled, "Maximum and minimum price fixing may have different consequences in many situations. But schemes to fix maximum prices, by substituting perhaps the erroneous judgment of a seller for the forces of the competitive market, may severely intrude upon the ability of buyers to compete and survive in that market. ... Maximum prices may be fixed too low ... may channel distribution through a few large or specifically advantaged dealers. ... Moreover, if the actual price charged under a maximum price scheme is nearly always the fixed maximum price, which is increasingly likely as the maximum price approaches the actual cost of the dealer, the scheme tends to acquire all the attributes of an arrangement fixing minimum prices."

At issue in Jefferson Parish Hospital District No. 2 v. Hyde (466 U.S. 2 [1984]) was an exclusive contract between a group of four anesthesiologists and Jefferson Parish Hospital in the New Orleans area. Dr. Hyde was an independent board-certified anesthesiologist who was denied medical staff privileges at the hospital because of this exclusive contract. The exclusive arrangement in effect required patients at the hospital to use the services of the four anesthesiologists and none others, raising the issue of unlawful "tying," where a seller requires a customer to purchase one product or service as a condition of being allowed to purchase another.

In a rare unanimous decision, the U.S. Supreme Court, while agreeing that the contract was a tying arrangement, nonetheless rejected the argument that it was per se illegal or that it unreasonably restrained competition among anesthesiologists. The court reasoned that the hospital’s 30% share of the market did not amount to sufficient market power in the provision of hospital services in the Jefferson Parish area. Pointing out that every patient undergoing surgery needed anesthesia, the court found no evidence that any patient received unnecessary services, and it noted that the tying arrangement that was generally employed in the health care industry improved patient care and promoted hospital efficiency.

Tying arrangements in health care are frequently analyzed under a rule of reason standard instead of the strict per se standard, and the favorable decision in this specific case depended heavily on the hospitals’ relatively small market power.

Finally, consider a case on insurance reimbursement and a group boycott against a third-party payer. In Federal Trade Commission v. Indiana Federation of Dentists (476 U.S. 447 [1986]), dental health insurers in Indiana attempted to contain the cost of dental treatment by limiting payments to the least expensive yet adequate treatment suitable to the needs of the patient. The insurers required the submission of x-rays by treating dentists for review of their insurance claims.

Viewing such review of diagnostic and treatment decisions as a threat to their professional independence and economic well-being, members of the Indiana Dental Association and later the Indiana Federation of Dentists agreed collectively to refuse to submit the requested x-rays. These concerted activities resulted in the denial of information that dental customers had requested and had a right to know, and forced them to choose between acquiring the information in a more costly manner or forgoing it altogether.

The lower court had ruled in favor of the dentists, but the U.S. Supreme Court reversed. It agreed that in the absence of concerted behavior, an individual dentist would have been subject to market forces of competition, creating incentives for him or her to comply with the requests of patients’ third-party insurers. But the conduct of the federation was tantamount to a group boycott, which unreasonably restrained trade. The court noted that while this was not price fixing as such, no elaborate industry analysis was required to demonstrate the anticompetitive character of such an agreement.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk", and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: On antitrust, the U.S. courts have made the following statements, except:

A. To agree to prices is to fix them.

B. There is no learned profession exception to the antitrust laws.

C. To fix maximum price may amount to a fix of minimum price.

D. A group boycott of chiropractors violates the Sherman Act.

E. Tying arrangement in the health care industry is per se illegal.

Answer: E (see Jefferson Parish Hospital below). In the second part of the 20th century, the U.S. Supreme Court and other appellate courts began issuing a number of landmark opinions regarding health care economics and antitrust. Group boycotts were a major target, as was price fixing. This article briefly reviews a few of these decisions to impart a sense of how the judicial system views free market competition in health care.

In AMA v. United States (317 U.S. 519 [1943]), the issue was whether the medical profession’s leading organization, the American Medical Association, could be allowed to expel its salaried doctors or those who associated professionally with salaried doctors. Those who were denied AMA membership were naturally less able to compete (hospital privileges, consultations, etc.).

The U.S. Supreme Court held that such a group boycott of all salaried doctors was illegal because of its anticompetitive purpose, even if it allegedly promoted professional competence and public welfare.

Wilk v. AMA (895 F.2d 352 [1990]) was the culmination of a number of lawsuits surrounding the AMA and chiropractic. In 1963, the AMA had formed a Committee on Quackery aimed at eliminating chiropractic as a profession. The AMA Code of Ethics, Principle 3, opined that it was unethical for a physician to associate professionally with chiropractors. In 1976, Dr. Wilk and four other licensed chiropractors filed suit against the AMA, and a jury trial found that the purpose of the boycott was to eliminate substantial competition without corresponding procompetitive benefits.

The U.S. Court of Appeals for the Seventh Circuit subsequently affirmed the lower court’s finding that the AMA violated Section 1 of the Sherman Act in its illegal boycott of chiropractors, although the court did not answer the question as to whether chiropractic theory was in fact scientific. The court inquired into whether there was a genuine reasonable concern for the use of the scientific method in the doctor-patient relationship, and whether that concern was the dominating, motivating factor in the boycott, and if so, whether it could have been satisfied without restraining competition.

The court found that the AMA’s motive for the boycott was anticompetitive, believing that concern for patient care could be expressed, for example, through public-education campaigns. Although the AMA had formally removed Principle 3 in 1980, it nonetheless appealed this adverse decision to the U.S. Supreme Court on three separate occasions, but the latter declined to hear the case.

In Goldfarb v. Virginia State Bar (421 U.S. 773 [1975]), the Virginia State Bar enforced an "advisory" minimum fee schedule for legal services. The U.S. Supreme Court found that this was an agreement to fix prices, holding, "This is not merely a case of an agreement that may be inferred from an exchange of price information ... for here a naked agreement was clearly shown, and the effect on prices is plain."

The court rejected the defendant’s argument that the practice of law was not a trade or commerce intended to be under Sherman Act scrutiny, declaring there was to be no "learned profession" exemption.

However, it noted that special considerations might apply, holding that "It would be unrealistic to view the practice of professions as interchangeable with other business activities, and automatically to apply to the professions antitrust concepts, which originated in other areas. The public service aspect, and other features of the professions, may require that a particular practice, which could properly be viewed as a violation of the Sherman Act in another context, be treated differently."

Following Goldfarb, there remains no doubt that professional services – legal, medical, and other services – are all to be governed by the antitrust laws.

A flurry of health care–related antitrust cases, including Patrick v. Burget (to be discussed in part 3), reached the courts in the 1980s. In Arizona v. Maricopa County Medical Society (457 U.S. 332 [1982]), the county medical society set maximum allowable fees that member physicians could charge their patients, presumably to guard against price gouging. However, the U.S. Supreme Court, using the tough illegal per se standard, characterized the agreement as price fixing, despite it being for maximum rather than minimum fees.

The court ruled, "Maximum and minimum price fixing may have different consequences in many situations. But schemes to fix maximum prices, by substituting perhaps the erroneous judgment of a seller for the forces of the competitive market, may severely intrude upon the ability of buyers to compete and survive in that market. ... Maximum prices may be fixed too low ... may channel distribution through a few large or specifically advantaged dealers. ... Moreover, if the actual price charged under a maximum price scheme is nearly always the fixed maximum price, which is increasingly likely as the maximum price approaches the actual cost of the dealer, the scheme tends to acquire all the attributes of an arrangement fixing minimum prices."

At issue in Jefferson Parish Hospital District No. 2 v. Hyde (466 U.S. 2 [1984]) was an exclusive contract between a group of four anesthesiologists and Jefferson Parish Hospital in the New Orleans area. Dr. Hyde was an independent board-certified anesthesiologist who was denied medical staff privileges at the hospital because of this exclusive contract. The exclusive arrangement in effect required patients at the hospital to use the services of the four anesthesiologists and none others, raising the issue of unlawful "tying," where a seller requires a customer to purchase one product or service as a condition of being allowed to purchase another.

In a rare unanimous decision, the U.S. Supreme Court, while agreeing that the contract was a tying arrangement, nonetheless rejected the argument that it was per se illegal or that it unreasonably restrained competition among anesthesiologists. The court reasoned that the hospital’s 30% share of the market did not amount to sufficient market power in the provision of hospital services in the Jefferson Parish area. Pointing out that every patient undergoing surgery needed anesthesia, the court found no evidence that any patient received unnecessary services, and it noted that the tying arrangement that was generally employed in the health care industry improved patient care and promoted hospital efficiency.

Tying arrangements in health care are frequently analyzed under a rule of reason standard instead of the strict per se standard, and the favorable decision in this specific case depended heavily on the hospitals’ relatively small market power.

Finally, consider a case on insurance reimbursement and a group boycott against a third-party payer. In Federal Trade Commission v. Indiana Federation of Dentists (476 U.S. 447 [1986]), dental health insurers in Indiana attempted to contain the cost of dental treatment by limiting payments to the least expensive yet adequate treatment suitable to the needs of the patient. The insurers required the submission of x-rays by treating dentists for review of their insurance claims.

Viewing such review of diagnostic and treatment decisions as a threat to their professional independence and economic well-being, members of the Indiana Dental Association and later the Indiana Federation of Dentists agreed collectively to refuse to submit the requested x-rays. These concerted activities resulted in the denial of information that dental customers had requested and had a right to know, and forced them to choose between acquiring the information in a more costly manner or forgoing it altogether.

The lower court had ruled in favor of the dentists, but the U.S. Supreme Court reversed. It agreed that in the absence of concerted behavior, an individual dentist would have been subject to market forces of competition, creating incentives for him or her to comply with the requests of patients’ third-party insurers. But the conduct of the federation was tantamount to a group boycott, which unreasonably restrained trade. The court noted that while this was not price fixing as such, no elaborate industry analysis was required to demonstrate the anticompetitive character of such an agreement.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk", and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

In 2007-2010, 10% of Americans reported taking five or more prescription drugs in the past 30 days, up from 4% in 1988-1994, the National Center for Health Statistics said in its "Health, United States, 2013" report released May 14.

By 2007-2010, close to half of all Americans (47%) reported that they had taken at least one prescription drug in the past month, compared with 40% in 1988-1994, according to the NCHS.

Drug use was greater among older age groups, with 40% of those aged 65 years and over and 17% of those aged 45-64 years taking five or more drugs in the past 30 days, compared with 3% of those aged 18-44 years and 1% of those under age 18, the report said.

The analysis of prescription drug use is based on data from the National Health and Nutrition Examination Survey.

[email protected]

In 2007-2010, 10% of Americans reported taking five or more prescription drugs in the past 30 days, up from 4% in 1988-1994, the National Center for Health Statistics said in its "Health, United States, 2013" report released May 14.

By 2007-2010, close to half of all Americans (47%) reported that they had taken at least one prescription drug in the past month, compared with 40% in 1988-1994, according to the NCHS.

Drug use was greater among older age groups, with 40% of those aged 65 years and over and 17% of those aged 45-64 years taking five or more drugs in the past 30 days, compared with 3% of those aged 18-44 years and 1% of those under age 18, the report said.

The analysis of prescription drug use is based on data from the National Health and Nutrition Examination Survey.

[email protected]

In 2007-2010, 10% of Americans reported taking five or more prescription drugs in the past 30 days, up from 4% in 1988-1994, the National Center for Health Statistics said in its "Health, United States, 2013" report released May 14.

By 2007-2010, close to half of all Americans (47%) reported that they had taken at least one prescription drug in the past month, compared with 40% in 1988-1994, according to the NCHS.

Drug use was greater among older age groups, with 40% of those aged 65 years and over and 17% of those aged 45-64 years taking five or more drugs in the past 30 days, compared with 3% of those aged 18-44 years and 1% of those under age 18, the report said.

The analysis of prescription drug use is based on data from the National Health and Nutrition Examination Survey.

[email protected]

SCOTTSDALE, ARIZ. – Rates of perioperative complications among women undergoing hysterectomy for benign indications vary according to the route, an ancillary analysis of a retrospective cohort study found.

Analyses were based on 1,440 women who underwent hysterectomy at four teaching hospitals, with procedures about evenly split between the eras before and after introduction of robotic surgery, lead author Dr. Salma Rahimi of Mount Sinai Hospital, New York, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

In the prerobot era, the rate of intraoperative complications – injury of the ureter, bladder, or bowel, or transfusion – was lowest at 3.7% for laparoscopic hysterectomy, about half that for abdominal procedures, and roughly the same as that for vaginal ones. The rate of postoperative complications – infection requiring antibiotics, transfusion, small bowel obstruction, or ileus – was 1.8% with laparoscopic hysterectomy, roughly a third of that seen with the other approaches.

In the postrobot era, the rate of intraoperative complications was 2.8% with vaginal hysterectomy, the lowest value for any approach, including the robotic one. The rate of postoperative complications was 3.0% for robotic hysterectomy, about a quarter of that for abdominal procedures and roughly on a par with that for vaginal and laparoscopic ones.

"Our data demonstrate that a vaginal hysterectomy is associated with fewer intraoperative complications in both the pre- and postrobot period," Dr. Rahimi commented. However, "vaginal hysterectomy was associated with more postoperative infections in the prerobot period."

"The highest complications were noted in the abdominal group, mostly due to transfusions, infections, small bowel obstructions, and ileus," she added.

Introducing the study, she noted that the American College of Obstetricians and Gynecologists recommends vaginal hysterectomy as a first choice over other routes given its relatively better outcomes and lower rates of complications (Obstet. Gynecol. 2009;114:1156-8). "Despite this, most are performed by laparotomy, and there is an increasing trend toward the use of minimally invasive abdominal approaches. Only about 20% are performed by the vaginal approach," she said.

The investigators studied women undergoing hysterectomy identified through the Fellows’ Pelvic Research Network. All of the operations were performed at hospitals with an obstetrics and gynecology residency and had a fellow belonging to the network. Women were excluded if their hysterectomy was performed by a gynecologic oncologist, was for a suspected malignancy, or was done emergently (including cesarean hysterectomies).

Analyses were based on 732 women in the prerobot era (the year before introduction of robotics at each hospital) and 708 in the postrobot era (2011). Characteristics of the women from the two eras were essentially the same, Dr. Rahimi reported at the meeting, jointly sponsored by the American College of Surgeons.

In the prerobot era, the rate of intraoperative complications was 3.9% for vaginal hysterectomy, compared with 7.4% for abdominal hysterectomy (P less than .05) and 3.7% for laparoscopic hysterectomy (P not significant).

The rate of postoperative complications was 8.3% for vaginal hysterectomy, compared with 7.4% for abdominal hysterectomy (P not significant) and 1.8% for laparoscopic hysterectomy (P = .001). These differences were mainly driven by higher rates of infection with the vaginal and abdominal approaches, and a higher rate of small bowel obstruction and ileus with the abdominal approach.

In the postrobot era, the rate of intraoperative complications was 2.8% for vaginal hysterectomy, compared with 10.8% for abdominal hysterectomy (P = .003), 4.6% for laparoscopic hysterectomy (P not significant), and 3.0% for robotic hysterectomy (P not significant). The differences were mainly due to a higher rate of transfusion with the abdominal approach.

The rate of postoperative complications was 5.1% for vaginal hysterectomy, compared with 13.9% for abdominal hysterectomy (P = .008), 3.6% for laparoscopic hysterectomy (P not significant), and 3.0% for robotic hysterectomy (P not significant). The differences again were mainly due to a higher rate of transfusion when surgery was done abdominally.

Dr. Rahimi disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Rates of perioperative complications among women undergoing hysterectomy for benign indications vary according to the route, an ancillary analysis of a retrospective cohort study found.

Analyses were based on 1,440 women who underwent hysterectomy at four teaching hospitals, with procedures about evenly split between the eras before and after introduction of robotic surgery, lead author Dr. Salma Rahimi of Mount Sinai Hospital, New York, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

In the prerobot era, the rate of intraoperative complications – injury of the ureter, bladder, or bowel, or transfusion – was lowest at 3.7% for laparoscopic hysterectomy, about half that for abdominal procedures, and roughly the same as that for vaginal ones. The rate of postoperative complications – infection requiring antibiotics, transfusion, small bowel obstruction, or ileus – was 1.8% with laparoscopic hysterectomy, roughly a third of that seen with the other approaches.

In the postrobot era, the rate of intraoperative complications was 2.8% with vaginal hysterectomy, the lowest value for any approach, including the robotic one. The rate of postoperative complications was 3.0% for robotic hysterectomy, about a quarter of that for abdominal procedures and roughly on a par with that for vaginal and laparoscopic ones.

"Our data demonstrate that a vaginal hysterectomy is associated with fewer intraoperative complications in both the pre- and postrobot period," Dr. Rahimi commented. However, "vaginal hysterectomy was associated with more postoperative infections in the prerobot period."

"The highest complications were noted in the abdominal group, mostly due to transfusions, infections, small bowel obstructions, and ileus," she added.

Introducing the study, she noted that the American College of Obstetricians and Gynecologists recommends vaginal hysterectomy as a first choice over other routes given its relatively better outcomes and lower rates of complications (Obstet. Gynecol. 2009;114:1156-8). "Despite this, most are performed by laparotomy, and there is an increasing trend toward the use of minimally invasive abdominal approaches. Only about 20% are performed by the vaginal approach," she said.

The investigators studied women undergoing hysterectomy identified through the Fellows’ Pelvic Research Network. All of the operations were performed at hospitals with an obstetrics and gynecology residency and had a fellow belonging to the network. Women were excluded if their hysterectomy was performed by a gynecologic oncologist, was for a suspected malignancy, or was done emergently (including cesarean hysterectomies).

Analyses were based on 732 women in the prerobot era (the year before introduction of robotics at each hospital) and 708 in the postrobot era (2011). Characteristics of the women from the two eras were essentially the same, Dr. Rahimi reported at the meeting, jointly sponsored by the American College of Surgeons.

In the prerobot era, the rate of intraoperative complications was 3.9% for vaginal hysterectomy, compared with 7.4% for abdominal hysterectomy (P less than .05) and 3.7% for laparoscopic hysterectomy (P not significant).

The rate of postoperative complications was 8.3% for vaginal hysterectomy, compared with 7.4% for abdominal hysterectomy (P not significant) and 1.8% for laparoscopic hysterectomy (P = .001). These differences were mainly driven by higher rates of infection with the vaginal and abdominal approaches, and a higher rate of small bowel obstruction and ileus with the abdominal approach.

In the postrobot era, the rate of intraoperative complications was 2.8% for vaginal hysterectomy, compared with 10.8% for abdominal hysterectomy (P = .003), 4.6% for laparoscopic hysterectomy (P not significant), and 3.0% for robotic hysterectomy (P not significant). The differences were mainly due to a higher rate of transfusion with the abdominal approach.

The rate of postoperative complications was 5.1% for vaginal hysterectomy, compared with 13.9% for abdominal hysterectomy (P = .008), 3.6% for laparoscopic hysterectomy (P not significant), and 3.0% for robotic hysterectomy (P not significant). The differences again were mainly due to a higher rate of transfusion when surgery was done abdominally.

Dr. Rahimi disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Rates of perioperative complications among women undergoing hysterectomy for benign indications vary according to the route, an ancillary analysis of a retrospective cohort study found.

Analyses were based on 1,440 women who underwent hysterectomy at four teaching hospitals, with procedures about evenly split between the eras before and after introduction of robotic surgery, lead author Dr. Salma Rahimi of Mount Sinai Hospital, New York, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

In the prerobot era, the rate of intraoperative complications – injury of the ureter, bladder, or bowel, or transfusion – was lowest at 3.7% for laparoscopic hysterectomy, about half that for abdominal procedures, and roughly the same as that for vaginal ones. The rate of postoperative complications – infection requiring antibiotics, transfusion, small bowel obstruction, or ileus – was 1.8% with laparoscopic hysterectomy, roughly a third of that seen with the other approaches.

In the postrobot era, the rate of intraoperative complications was 2.8% with vaginal hysterectomy, the lowest value for any approach, including the robotic one. The rate of postoperative complications was 3.0% for robotic hysterectomy, about a quarter of that for abdominal procedures and roughly on a par with that for vaginal and laparoscopic ones.

"Our data demonstrate that a vaginal hysterectomy is associated with fewer intraoperative complications in both the pre- and postrobot period," Dr. Rahimi commented. However, "vaginal hysterectomy was associated with more postoperative infections in the prerobot period."

"The highest complications were noted in the abdominal group, mostly due to transfusions, infections, small bowel obstructions, and ileus," she added.

Introducing the study, she noted that the American College of Obstetricians and Gynecologists recommends vaginal hysterectomy as a first choice over other routes given its relatively better outcomes and lower rates of complications (Obstet. Gynecol. 2009;114:1156-8). "Despite this, most are performed by laparotomy, and there is an increasing trend toward the use of minimally invasive abdominal approaches. Only about 20% are performed by the vaginal approach," she said.

The investigators studied women undergoing hysterectomy identified through the Fellows’ Pelvic Research Network. All of the operations were performed at hospitals with an obstetrics and gynecology residency and had a fellow belonging to the network. Women were excluded if their hysterectomy was performed by a gynecologic oncologist, was for a suspected malignancy, or was done emergently (including cesarean hysterectomies).

Analyses were based on 732 women in the prerobot era (the year before introduction of robotics at each hospital) and 708 in the postrobot era (2011). Characteristics of the women from the two eras were essentially the same, Dr. Rahimi reported at the meeting, jointly sponsored by the American College of Surgeons.

In the prerobot era, the rate of intraoperative complications was 3.9% for vaginal hysterectomy, compared with 7.4% for abdominal hysterectomy (P less than .05) and 3.7% for laparoscopic hysterectomy (P not significant).

The rate of postoperative complications was 8.3% for vaginal hysterectomy, compared with 7.4% for abdominal hysterectomy (P not significant) and 1.8% for laparoscopic hysterectomy (P = .001). These differences were mainly driven by higher rates of infection with the vaginal and abdominal approaches, and a higher rate of small bowel obstruction and ileus with the abdominal approach.

In the postrobot era, the rate of intraoperative complications was 2.8% for vaginal hysterectomy, compared with 10.8% for abdominal hysterectomy (P = .003), 4.6% for laparoscopic hysterectomy (P not significant), and 3.0% for robotic hysterectomy (P not significant). The differences were mainly due to a higher rate of transfusion with the abdominal approach.

The rate of postoperative complications was 5.1% for vaginal hysterectomy, compared with 13.9% for abdominal hysterectomy (P = .008), 3.6% for laparoscopic hysterectomy (P not significant), and 3.0% for robotic hysterectomy (P not significant). The differences again were mainly due to a higher rate of transfusion when surgery was done abdominally.

Dr. Rahimi disclosed no relevant conflicts of interest.

PARIS – Recent knee injuries are strongly associated with accelerated knee osteoarthritis, according to an analysis from the prospective, multicenter Osteoarthritis Initiative.

"Certain injuries may initiate or coincide with an accelerated cascade towards joint failure in as little as 12 months," Jeffrey Driban, Ph.D., said at the World Congress on Osteoarthritis. "In fact, 76% of individuals with an injury and accelerated knee osteoarthritis experienced their injury in the 12 months prior to the study outcome."

The study defined accelerated knee OA as progression from a Kellgren-Lawrence grade 0 or 1 on baseline bilateral radiographs to end-stage KL grade 3 or 4 within 48 months.

Although knee OA typically has been a slowly progressive disorder, 5%-17% of patients now experience accelerated forms of OA.

"If we can better characterize this phenomenon and its potential risk factors, we can provide more insights into the nature of progression in hopes of identifying an at-risk subset," said Dr. Driban of the division of rheumatology at Tufts Medical Center, Boston.

The study by Dr. Driban and his colleagues was published in Arthritis Care & Research (2014 April 29 [doi:10.1002/acr.22359]).

A total of 1,930 participants in the Osteoarthritis Initiative, all with a KL grade of 0 or 1 on baseline bilateral radiographs, were asked at baseline and at each annual visit whether they had ever been "injured enough to limit ability to walk for at least 2 days."

On follow-up, 1,325 had no knee OA, 54 had accelerated knee OA, and 187 had typical knee OA, defined as at least one knee increased in radiographic scoring within 48 months (excluding accelerated OA).

After exclusion of 12 patients with missing data, 30% of the accelerated OA group, 28% in the typical OA group, and 35% in the no OA group had a history of knee injury before baseline. A new knee injury was reported by 32%, 13%, and 11%, respectively, with data missing from 59 persons.

In univariate analyses, participants with accelerated knee OA were significantly older than were those with typical OA or no OA (61.8 years vs. 58 years vs. 59.2 years; P = .023) and had a greater body mass index (28.9 kg/m² vs. 27.9 kg/m² vs. 27.1 kg/m²; P = .002), Dr. Driban said.

In multinomial logistic regression analyses that adjusted for age, sex, BMI, presence of static knee malalignment, and systolic blood pressure, there was no association between prior knee injury and accelerated OA (odds ratio, 0.84) or typical OA (OR, 0.76).

However, when the investigators looked further, participants with accelerated OA were almost 3.5 times more likely to report a recent knee injury during the observation period (OR, 3.37; 95% confidence interval, 1.82-6.25) than were those with typical OA (OR, 0.99) or no OA (reference), he said.

Moreover, if a participant experienced a knee injury 1 year before the study outcome, the risk of accelerated OA increased ninefold (OR, 9.22; CI, 4.50-18.90) versus threefold for typical OA (OR, 3.04; CI, 1.66-5.58).

Despite the focus on injuries leading to accelerated OA, the analyses can’t rule out that accelerated OA may also cause an injury or that there could be a "vicious cycle," in which an injury can cause accelerated OA, associated with joint space loss, increased symptoms, and increased risk for subsequent injury, Dr. Driban said.

This line of thought helps explain why prior injury was not associated with accelerated knee OA, but recent injury was. As patients were free of radiographic OA at baseline, those with a history of a prior injury that could cause accelerated knee OA would already have been eliminated from the study, he explained in an interview.

Secondly, if accelerated knee OA can increase the risk of injury, knee injuries from years ago would not be related to accelerated knee OA because the disorder did not exist at the time of the injury.

Finally, there also could be a recall bias, as patients often have a hard time recalling injuries that may have happened years ago.

Despite the limitations of self-reported injuries and insufficient data regarding the type, severity, status of the meniscus, mechanism, or subsequent treatment of the knee injury, the findings represent an important "starting point" in understanding the association between injuries and accelerated osteoarthritis, Dr. Driban said.

"We need to monitor older adults who report an injury, as this may initiate accelerated OA or indicate an individual experiencing accelerated OA, and we need to determine which injuries may be related to accelerated osteoarthritis," he said at the meeting, sponsored by the Osteoarthritis Research Society International.

During the discussion following the formal presentation, Dr. David Felson, professor of medicine and epidemiology at Boston University, said, "I think what you are saying is exactly right," but suggested that the investigators exclude patients with spontaneous osteonecrosis of the knee and osteochondritis dissecans, as both conditions are more common than anticipated and can drive very rapid development of OA. Conversely, inclusion of patients with osteophyte-only knee OA would increase the number likely identified with accelerated OA, he said.

Dr. Driban reported no conflicting interests.

[email protected]

PARIS – Recent knee injuries are strongly associated with accelerated knee osteoarthritis, according to an analysis from the prospective, multicenter Osteoarthritis Initiative.

"Certain injuries may initiate or coincide with an accelerated cascade towards joint failure in as little as 12 months," Jeffrey Driban, Ph.D., said at the World Congress on Osteoarthritis. "In fact, 76% of individuals with an injury and accelerated knee osteoarthritis experienced their injury in the 12 months prior to the study outcome."

The study defined accelerated knee OA as progression from a Kellgren-Lawrence grade 0 or 1 on baseline bilateral radiographs to end-stage KL grade 3 or 4 within 48 months.

Although knee OA typically has been a slowly progressive disorder, 5%-17% of patients now experience accelerated forms of OA.

"If we can better characterize this phenomenon and its potential risk factors, we can provide more insights into the nature of progression in hopes of identifying an at-risk subset," said Dr. Driban of the division of rheumatology at Tufts Medical Center, Boston.

The study by Dr. Driban and his colleagues was published in Arthritis Care & Research (2014 April 29 [doi:10.1002/acr.22359]).

A total of 1,930 participants in the Osteoarthritis Initiative, all with a KL grade of 0 or 1 on baseline bilateral radiographs, were asked at baseline and at each annual visit whether they had ever been "injured enough to limit ability to walk for at least 2 days."

On follow-up, 1,325 had no knee OA, 54 had accelerated knee OA, and 187 had typical knee OA, defined as at least one knee increased in radiographic scoring within 48 months (excluding accelerated OA).

After exclusion of 12 patients with missing data, 30% of the accelerated OA group, 28% in the typical OA group, and 35% in the no OA group had a history of knee injury before baseline. A new knee injury was reported by 32%, 13%, and 11%, respectively, with data missing from 59 persons.

In univariate analyses, participants with accelerated knee OA were significantly older than were those with typical OA or no OA (61.8 years vs. 58 years vs. 59.2 years; P = .023) and had a greater body mass index (28.9 kg/m² vs. 27.9 kg/m² vs. 27.1 kg/m²; P = .002), Dr. Driban said.

In multinomial logistic regression analyses that adjusted for age, sex, BMI, presence of static knee malalignment, and systolic blood pressure, there was no association between prior knee injury and accelerated OA (odds ratio, 0.84) or typical OA (OR, 0.76).

However, when the investigators looked further, participants with accelerated OA were almost 3.5 times more likely to report a recent knee injury during the observation period (OR, 3.37; 95% confidence interval, 1.82-6.25) than were those with typical OA (OR, 0.99) or no OA (reference), he said.

Moreover, if a participant experienced a knee injury 1 year before the study outcome, the risk of accelerated OA increased ninefold (OR, 9.22; CI, 4.50-18.90) versus threefold for typical OA (OR, 3.04; CI, 1.66-5.58).

Despite the focus on injuries leading to accelerated OA, the analyses can’t rule out that accelerated OA may also cause an injury or that there could be a "vicious cycle," in which an injury can cause accelerated OA, associated with joint space loss, increased symptoms, and increased risk for subsequent injury, Dr. Driban said.

This line of thought helps explain why prior injury was not associated with accelerated knee OA, but recent injury was. As patients were free of radiographic OA at baseline, those with a history of a prior injury that could cause accelerated knee OA would already have been eliminated from the study, he explained in an interview.

Secondly, if accelerated knee OA can increase the risk of injury, knee injuries from years ago would not be related to accelerated knee OA because the disorder did not exist at the time of the injury.

Finally, there also could be a recall bias, as patients often have a hard time recalling injuries that may have happened years ago.

Despite the limitations of self-reported injuries and insufficient data regarding the type, severity, status of the meniscus, mechanism, or subsequent treatment of the knee injury, the findings represent an important "starting point" in understanding the association between injuries and accelerated osteoarthritis, Dr. Driban said.

"We need to monitor older adults who report an injury, as this may initiate accelerated OA or indicate an individual experiencing accelerated OA, and we need to determine which injuries may be related to accelerated osteoarthritis," he said at the meeting, sponsored by the Osteoarthritis Research Society International.

During the discussion following the formal presentation, Dr. David Felson, professor of medicine and epidemiology at Boston University, said, "I think what you are saying is exactly right," but suggested that the investigators exclude patients with spontaneous osteonecrosis of the knee and osteochondritis dissecans, as both conditions are more common than anticipated and can drive very rapid development of OA. Conversely, inclusion of patients with osteophyte-only knee OA would increase the number likely identified with accelerated OA, he said.

Dr. Driban reported no conflicting interests.

[email protected]

PARIS – Recent knee injuries are strongly associated with accelerated knee osteoarthritis, according to an analysis from the prospective, multicenter Osteoarthritis Initiative.

"Certain injuries may initiate or coincide with an accelerated cascade towards joint failure in as little as 12 months," Jeffrey Driban, Ph.D., said at the World Congress on Osteoarthritis. "In fact, 76% of individuals with an injury and accelerated knee osteoarthritis experienced their injury in the 12 months prior to the study outcome."

The study defined accelerated knee OA as progression from a Kellgren-Lawrence grade 0 or 1 on baseline bilateral radiographs to end-stage KL grade 3 or 4 within 48 months.

Although knee OA typically has been a slowly progressive disorder, 5%-17% of patients now experience accelerated forms of OA.

"If we can better characterize this phenomenon and its potential risk factors, we can provide more insights into the nature of progression in hopes of identifying an at-risk subset," said Dr. Driban of the division of rheumatology at Tufts Medical Center, Boston.

The study by Dr. Driban and his colleagues was published in Arthritis Care & Research (2014 April 29 [doi:10.1002/acr.22359]).

A total of 1,930 participants in the Osteoarthritis Initiative, all with a KL grade of 0 or 1 on baseline bilateral radiographs, were asked at baseline and at each annual visit whether they had ever been "injured enough to limit ability to walk for at least 2 days."

On follow-up, 1,325 had no knee OA, 54 had accelerated knee OA, and 187 had typical knee OA, defined as at least one knee increased in radiographic scoring within 48 months (excluding accelerated OA).

After exclusion of 12 patients with missing data, 30% of the accelerated OA group, 28% in the typical OA group, and 35% in the no OA group had a history of knee injury before baseline. A new knee injury was reported by 32%, 13%, and 11%, respectively, with data missing from 59 persons.

In univariate analyses, participants with accelerated knee OA were significantly older than were those with typical OA or no OA (61.8 years vs. 58 years vs. 59.2 years; P = .023) and had a greater body mass index (28.9 kg/m² vs. 27.9 kg/m² vs. 27.1 kg/m²; P = .002), Dr. Driban said.

In multinomial logistic regression analyses that adjusted for age, sex, BMI, presence of static knee malalignment, and systolic blood pressure, there was no association between prior knee injury and accelerated OA (odds ratio, 0.84) or typical OA (OR, 0.76).

However, when the investigators looked further, participants with accelerated OA were almost 3.5 times more likely to report a recent knee injury during the observation period (OR, 3.37; 95% confidence interval, 1.82-6.25) than were those with typical OA (OR, 0.99) or no OA (reference), he said.

Moreover, if a participant experienced a knee injury 1 year before the study outcome, the risk of accelerated OA increased ninefold (OR, 9.22; CI, 4.50-18.90) versus threefold for typical OA (OR, 3.04; CI, 1.66-5.58).

Despite the focus on injuries leading to accelerated OA, the analyses can’t rule out that accelerated OA may also cause an injury or that there could be a "vicious cycle," in which an injury can cause accelerated OA, associated with joint space loss, increased symptoms, and increased risk for subsequent injury, Dr. Driban said.

This line of thought helps explain why prior injury was not associated with accelerated knee OA, but recent injury was. As patients were free of radiographic OA at baseline, those with a history of a prior injury that could cause accelerated knee OA would already have been eliminated from the study, he explained in an interview.

Secondly, if accelerated knee OA can increase the risk of injury, knee injuries from years ago would not be related to accelerated knee OA because the disorder did not exist at the time of the injury.

Finally, there also could be a recall bias, as patients often have a hard time recalling injuries that may have happened years ago.

Despite the limitations of self-reported injuries and insufficient data regarding the type, severity, status of the meniscus, mechanism, or subsequent treatment of the knee injury, the findings represent an important "starting point" in understanding the association between injuries and accelerated osteoarthritis, Dr. Driban said.

"We need to monitor older adults who report an injury, as this may initiate accelerated OA or indicate an individual experiencing accelerated OA, and we need to determine which injuries may be related to accelerated osteoarthritis," he said at the meeting, sponsored by the Osteoarthritis Research Society International.

During the discussion following the formal presentation, Dr. David Felson, professor of medicine and epidemiology at Boston University, said, "I think what you are saying is exactly right," but suggested that the investigators exclude patients with spontaneous osteonecrosis of the knee and osteochondritis dissecans, as both conditions are more common than anticipated and can drive very rapid development of OA. Conversely, inclusion of patients with osteophyte-only knee OA would increase the number likely identified with accelerated OA, he said.

Dr. Driban reported no conflicting interests.

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