Christine Kilgore

WASHINGTON – Several years after the U.S. Preventive Services Task Force recommended screening adolescents for depression in primary care, only half of pediatricians and other primary care providers are routinely using standardized instruments, according to a statewide survey of pediatricians, family physicians and nurse practitioners in Minnesota.

"In general, clinicians most frequently used clinical observation or overall impressions to identify adolescents experiencing depression [rather] than other methods," Lindsay Taliaferro, Ph.D., reported at the annual meeting of the Pediatric Academic Societies.

The estimated overall prevalence of major depressive disorder among adolescents is 5.6%, and the point prevalence in primary care settings is reported as ranging from 9% to 21%, according to the U.S. Preventive Services Task Force (USPSTF) recommendations.

Dr. Taliaferro and her colleagues at the University of Minnesota, Minneapolis, administered an online survey to a statewide sample of physicians and nurse practitioners (NPs) who provide direct ambulatory primary care services to adolescents aged 12-18 years. The clinicians were identified from lists obtained from the state’s boards of nursing and medical practice; there was a 20% response rate, which Dr. Taliaferro said is low but typical of such surveys.

The analytical sample included 127 pediatricians and 54 pediatric NPs, as well as 260 family physicians and 96 family medicine NPs.

Asked to report which depression identification practices they "usually/almost always" employ, 80% said they use clinical observation/overall impression, while 50% said they use a standardized written depression screening instrument, 40% use a "depression screening item within a comprehensive behavioral screening instrument," and 20% use a psychosocial interview (such as the HEADSS assessment, which stands for home, education and employment, activities, drugs, sexuality, suicide/depression).

There were no significant differences between physicians and nurse practitioners in the methods used to identify depression. There were differences, however, between pediatrics and family medicine in both the use of a psychosocial interview and the use of clinical observation/overall impression, with pediatric clinicians (both physicians and NPs) significantly more likely to report use of these methods, Dr. Taliaferro noted.

In another survey item, 75% of the pediatric providers reported routinely "asking about" depressive symptoms when providing health supervision. For family physicians and family nurse practitioners, this rate was 66%, she reported.

Asked if they had "ever" administered a standardized written depression instrument, 76% of providers indicated they had.

All told, Dr. Taliaferro said, it appears from the survey that "most [clinicians] don’t screen everyone, but instead are screening only high-risk patients after they identify some warning signs or in response to specific complaints."

The USPSTF issued its recommendation for adolescent screening in 2009, saying that clinicians should screen for major depressive disorder in adolescents (12- to 18-year-olds) when systems are in place to ensure accurate diagnosis, treatment, and follow-up.

"We all know that many adolescents in distress present with medical problems rather than psychological symptoms, and that adolescents may not verbalize their feelings or disclose their psychological issues without prompting from clinicians," said Dr. Taliaferro, who is now with the University of Missouri School of Health Professions, Columbia.

According to the task force, two screening instruments – the PHQ-A (the Patient Health Questionnaire–9 modified for adolescents) and the BDI-PC (Beck Depression Inventory for Primary Care) – have demonstrated good sensitivity and specificity for adolescents seen in primary care settings.

Dr. Taliaferro said after the meeting that "an overwhelming majority" of survey participants who use standardized instruments indicated that they use the PHQ-9, presumably the adolescent version. The PHQ-9 is integrated into the electronic medical record of many of the systems being utilized in primary care, she noted.

The investigators analyzed survey data to determine what factors were associated with use of a standardized written depression screening instrument and with inquiries about depression symptoms. Factors that increased the likelihood of administering a screening instrument included being female, being a family medicine clinician, having clear protocols for follow-up after depression, and feeling better prepared to address depression among adolescents.

Factors that increased the likelihood of asking about depression symptoms included believing more strongly that providers should be responsible for addressing depression among adolescents and being more familiar with recommendations regarding screening, Dr. Taliaferro reported.

Approximately 40% of participants reported having on-site mental health services that are available to their adolescent patients, she noted.

Dr. Taliaferro reported that she had no relevant financial disclosures. The investigators received funding for the survey from the Minnesota Department of Human Services.

WASHINGTON – Several years after the U.S. Preventive Services Task Force recommended screening adolescents for depression in primary care, only half of pediatricians and other primary care providers are routinely using standardized instruments, according to a statewide survey of pediatricians, family physicians and nurse practitioners in Minnesota.

"In general, clinicians most frequently used clinical observation or overall impressions to identify adolescents experiencing depression [rather] than other methods," Lindsay Taliaferro, Ph.D., reported at the annual meeting of the Pediatric Academic Societies.

The estimated overall prevalence of major depressive disorder among adolescents is 5.6%, and the point prevalence in primary care settings is reported as ranging from 9% to 21%, according to the U.S. Preventive Services Task Force (USPSTF) recommendations.

Dr. Taliaferro and her colleagues at the University of Minnesota, Minneapolis, administered an online survey to a statewide sample of physicians and nurse practitioners (NPs) who provide direct ambulatory primary care services to adolescents aged 12-18 years. The clinicians were identified from lists obtained from the state’s boards of nursing and medical practice; there was a 20% response rate, which Dr. Taliaferro said is low but typical of such surveys.

The analytical sample included 127 pediatricians and 54 pediatric NPs, as well as 260 family physicians and 96 family medicine NPs.

Asked to report which depression identification practices they "usually/almost always" employ, 80% said they use clinical observation/overall impression, while 50% said they use a standardized written depression screening instrument, 40% use a "depression screening item within a comprehensive behavioral screening instrument," and 20% use a psychosocial interview (such as the HEADSS assessment, which stands for home, education and employment, activities, drugs, sexuality, suicide/depression).

There were no significant differences between physicians and nurse practitioners in the methods used to identify depression. There were differences, however, between pediatrics and family medicine in both the use of a psychosocial interview and the use of clinical observation/overall impression, with pediatric clinicians (both physicians and NPs) significantly more likely to report use of these methods, Dr. Taliaferro noted.

In another survey item, 75% of the pediatric providers reported routinely "asking about" depressive symptoms when providing health supervision. For family physicians and family nurse practitioners, this rate was 66%, she reported.

Asked if they had "ever" administered a standardized written depression instrument, 76% of providers indicated they had.

All told, Dr. Taliaferro said, it appears from the survey that "most [clinicians] don’t screen everyone, but instead are screening only high-risk patients after they identify some warning signs or in response to specific complaints."

The USPSTF issued its recommendation for adolescent screening in 2009, saying that clinicians should screen for major depressive disorder in adolescents (12- to 18-year-olds) when systems are in place to ensure accurate diagnosis, treatment, and follow-up.

"We all know that many adolescents in distress present with medical problems rather than psychological symptoms, and that adolescents may not verbalize their feelings or disclose their psychological issues without prompting from clinicians," said Dr. Taliaferro, who is now with the University of Missouri School of Health Professions, Columbia.

According to the task force, two screening instruments – the PHQ-A (the Patient Health Questionnaire–9 modified for adolescents) and the BDI-PC (Beck Depression Inventory for Primary Care) – have demonstrated good sensitivity and specificity for adolescents seen in primary care settings.

Dr. Taliaferro said after the meeting that "an overwhelming majority" of survey participants who use standardized instruments indicated that they use the PHQ-9, presumably the adolescent version. The PHQ-9 is integrated into the electronic medical record of many of the systems being utilized in primary care, she noted.

The investigators analyzed survey data to determine what factors were associated with use of a standardized written depression screening instrument and with inquiries about depression symptoms. Factors that increased the likelihood of administering a screening instrument included being female, being a family medicine clinician, having clear protocols for follow-up after depression, and feeling better prepared to address depression among adolescents.

Factors that increased the likelihood of asking about depression symptoms included believing more strongly that providers should be responsible for addressing depression among adolescents and being more familiar with recommendations regarding screening, Dr. Taliaferro reported.

Approximately 40% of participants reported having on-site mental health services that are available to their adolescent patients, she noted.

Dr. Taliaferro reported that she had no relevant financial disclosures. The investigators received funding for the survey from the Minnesota Department of Human Services.

WASHINGTON – Several years after the U.S. Preventive Services Task Force recommended screening adolescents for depression in primary care, only half of pediatricians and other primary care providers are routinely using standardized instruments, according to a statewide survey of pediatricians, family physicians and nurse practitioners in Minnesota.

"In general, clinicians most frequently used clinical observation or overall impressions to identify adolescents experiencing depression [rather] than other methods," Lindsay Taliaferro, Ph.D., reported at the annual meeting of the Pediatric Academic Societies.

The estimated overall prevalence of major depressive disorder among adolescents is 5.6%, and the point prevalence in primary care settings is reported as ranging from 9% to 21%, according to the U.S. Preventive Services Task Force (USPSTF) recommendations.

Dr. Taliaferro and her colleagues at the University of Minnesota, Minneapolis, administered an online survey to a statewide sample of physicians and nurse practitioners (NPs) who provide direct ambulatory primary care services to adolescents aged 12-18 years. The clinicians were identified from lists obtained from the state’s boards of nursing and medical practice; there was a 20% response rate, which Dr. Taliaferro said is low but typical of such surveys.

The analytical sample included 127 pediatricians and 54 pediatric NPs, as well as 260 family physicians and 96 family medicine NPs.

Asked to report which depression identification practices they "usually/almost always" employ, 80% said they use clinical observation/overall impression, while 50% said they use a standardized written depression screening instrument, 40% use a "depression screening item within a comprehensive behavioral screening instrument," and 20% use a psychosocial interview (such as the HEADSS assessment, which stands for home, education and employment, activities, drugs, sexuality, suicide/depression).

There were no significant differences between physicians and nurse practitioners in the methods used to identify depression. There were differences, however, between pediatrics and family medicine in both the use of a psychosocial interview and the use of clinical observation/overall impression, with pediatric clinicians (both physicians and NPs) significantly more likely to report use of these methods, Dr. Taliaferro noted.

In another survey item, 75% of the pediatric providers reported routinely "asking about" depressive symptoms when providing health supervision. For family physicians and family nurse practitioners, this rate was 66%, she reported.

Asked if they had "ever" administered a standardized written depression instrument, 76% of providers indicated they had.

All told, Dr. Taliaferro said, it appears from the survey that "most [clinicians] don’t screen everyone, but instead are screening only high-risk patients after they identify some warning signs or in response to specific complaints."

The USPSTF issued its recommendation for adolescent screening in 2009, saying that clinicians should screen for major depressive disorder in adolescents (12- to 18-year-olds) when systems are in place to ensure accurate diagnosis, treatment, and follow-up.

"We all know that many adolescents in distress present with medical problems rather than psychological symptoms, and that adolescents may not verbalize their feelings or disclose their psychological issues without prompting from clinicians," said Dr. Taliaferro, who is now with the University of Missouri School of Health Professions, Columbia.

According to the task force, two screening instruments – the PHQ-A (the Patient Health Questionnaire–9 modified for adolescents) and the BDI-PC (Beck Depression Inventory for Primary Care) – have demonstrated good sensitivity and specificity for adolescents seen in primary care settings.

Dr. Taliaferro said after the meeting that "an overwhelming majority" of survey participants who use standardized instruments indicated that they use the PHQ-9, presumably the adolescent version. The PHQ-9 is integrated into the electronic medical record of many of the systems being utilized in primary care, she noted.

The investigators analyzed survey data to determine what factors were associated with use of a standardized written depression screening instrument and with inquiries about depression symptoms. Factors that increased the likelihood of administering a screening instrument included being female, being a family medicine clinician, having clear protocols for follow-up after depression, and feeling better prepared to address depression among adolescents.

Factors that increased the likelihood of asking about depression symptoms included believing more strongly that providers should be responsible for addressing depression among adolescents and being more familiar with recommendations regarding screening, Dr. Taliaferro reported.

Approximately 40% of participants reported having on-site mental health services that are available to their adolescent patients, she noted.

Dr. Taliaferro reported that she had no relevant financial disclosures. The investigators received funding for the survey from the Minnesota Department of Human Services.

WASHINGTON – Driving after marijuana use was common among college students at two large public universities who were randomly selected for phone interviews.

"Driving after marijuana use was significantly more common than driving under the influence of alcohol in college-age students, and males were much more likely ... which is consistent with a lot of the data on injury risk," reported Jennifer Whitehill, Ph.D., a postdoctoral fellow at the Harborview Injury Prevention and Research Center at the University of Washington, Seattle.

Among current marijuana users – defined as those who had used marijuana in the past 28 days – 31% said they drove after using it and 45% rode with a driver who had used it. The prevalence rates were 44% and 51%, respectively, among males and 9% and 35% among females, she reported at the annual meeting of the Pediatric Academic Societies.

The findings are especially important given new legislation that is likely to increase marijuana availability and further influence teens’ perception of risk.

The University of Washington, one of the two universities where the study took place, resides in one of two states that legalized the recreational use of marijuana in 2012. The study was conducted prior to passage of the law; continued research will provide "a good, natural longitudinal look" at attitudes and practices in light of the legislation, Dr. Whitehill said.

The literature thus far suggests a two- to threefold increase in crash risk for driving under the influence of marijuana, Dr. Whitehill said after the meeting.

One recent meta-analysis of information from nine prior studies showed that the risk of a crash was almost 2.7 times higher among marijuana users than nonusers (Epidemiol. Rev. 2012;34:65-72). Another review found an overall twofold increased risk, with risk estimates higher in studies of fatal collisions (BMJ 2012;344:e536).

However, the contribution of marijuana to the risk of crashes "can be a tricky thing to study and to isolate," she said, and research is attempting to determine the degree to which marijuana intoxication deteriorates driving performance.

Of 315 students who had just completed their freshman year, alcohol use was much more prevalent than marijuana use, as was expected – 65% said they had used alcohol in the past 28 days, compared with 21% who reported having used marijuana. Alcohol users were less likely to drive under the influence, however: 12% of males and 3% of females said they drove after drinking. More of the students – 21% of males and 12% of females – reported riding with a driver who had just consumed alcohol.

Researchers attempted to identify possible predictors and risk factors for impaired driving. They found that students who drove after marijuana use were 5.2 times as likely to have also been a passenger of a marijuana-using driver, and 2.5 times as likely to have also driven after alcohol use, as students who did not drive after using marijuana.

A younger age at the first use of marijuana was associated with a lower risk of driving under the influence of marijuana.

Students also were asked about their nonmedical use of stimulants and other prescription drugs. Four percent –a "relatively rare" prevalence – reported recent nonmedical prescription drug use, of which 11% said they drove after use, Dr. Whitehill reported.

The study did not measure the time between substance use and driving, she noted.

Dr. Whitehill reported that she had no relevant financial disclosures.

WASHINGTON – Driving after marijuana use was common among college students at two large public universities who were randomly selected for phone interviews.

"Driving after marijuana use was significantly more common than driving under the influence of alcohol in college-age students, and males were much more likely ... which is consistent with a lot of the data on injury risk," reported Jennifer Whitehill, Ph.D., a postdoctoral fellow at the Harborview Injury Prevention and Research Center at the University of Washington, Seattle.

Among current marijuana users – defined as those who had used marijuana in the past 28 days – 31% said they drove after using it and 45% rode with a driver who had used it. The prevalence rates were 44% and 51%, respectively, among males and 9% and 35% among females, she reported at the annual meeting of the Pediatric Academic Societies.

The findings are especially important given new legislation that is likely to increase marijuana availability and further influence teens’ perception of risk.

The University of Washington, one of the two universities where the study took place, resides in one of two states that legalized the recreational use of marijuana in 2012. The study was conducted prior to passage of the law; continued research will provide "a good, natural longitudinal look" at attitudes and practices in light of the legislation, Dr. Whitehill said.

The literature thus far suggests a two- to threefold increase in crash risk for driving under the influence of marijuana, Dr. Whitehill said after the meeting.

One recent meta-analysis of information from nine prior studies showed that the risk of a crash was almost 2.7 times higher among marijuana users than nonusers (Epidemiol. Rev. 2012;34:65-72). Another review found an overall twofold increased risk, with risk estimates higher in studies of fatal collisions (BMJ 2012;344:e536).

However, the contribution of marijuana to the risk of crashes "can be a tricky thing to study and to isolate," she said, and research is attempting to determine the degree to which marijuana intoxication deteriorates driving performance.

Of 315 students who had just completed their freshman year, alcohol use was much more prevalent than marijuana use, as was expected – 65% said they had used alcohol in the past 28 days, compared with 21% who reported having used marijuana. Alcohol users were less likely to drive under the influence, however: 12% of males and 3% of females said they drove after drinking. More of the students – 21% of males and 12% of females – reported riding with a driver who had just consumed alcohol.

Researchers attempted to identify possible predictors and risk factors for impaired driving. They found that students who drove after marijuana use were 5.2 times as likely to have also been a passenger of a marijuana-using driver, and 2.5 times as likely to have also driven after alcohol use, as students who did not drive after using marijuana.

A younger age at the first use of marijuana was associated with a lower risk of driving under the influence of marijuana.

Students also were asked about their nonmedical use of stimulants and other prescription drugs. Four percent –a "relatively rare" prevalence – reported recent nonmedical prescription drug use, of which 11% said they drove after use, Dr. Whitehill reported.

The study did not measure the time between substance use and driving, she noted.

Dr. Whitehill reported that she had no relevant financial disclosures.

WASHINGTON – Driving after marijuana use was common among college students at two large public universities who were randomly selected for phone interviews.

"Driving after marijuana use was significantly more common than driving under the influence of alcohol in college-age students, and males were much more likely ... which is consistent with a lot of the data on injury risk," reported Jennifer Whitehill, Ph.D., a postdoctoral fellow at the Harborview Injury Prevention and Research Center at the University of Washington, Seattle.

Among current marijuana users – defined as those who had used marijuana in the past 28 days – 31% said they drove after using it and 45% rode with a driver who had used it. The prevalence rates were 44% and 51%, respectively, among males and 9% and 35% among females, she reported at the annual meeting of the Pediatric Academic Societies.

The findings are especially important given new legislation that is likely to increase marijuana availability and further influence teens’ perception of risk.

The University of Washington, one of the two universities where the study took place, resides in one of two states that legalized the recreational use of marijuana in 2012. The study was conducted prior to passage of the law; continued research will provide "a good, natural longitudinal look" at attitudes and practices in light of the legislation, Dr. Whitehill said.

The literature thus far suggests a two- to threefold increase in crash risk for driving under the influence of marijuana, Dr. Whitehill said after the meeting.

One recent meta-analysis of information from nine prior studies showed that the risk of a crash was almost 2.7 times higher among marijuana users than nonusers (Epidemiol. Rev. 2012;34:65-72). Another review found an overall twofold increased risk, with risk estimates higher in studies of fatal collisions (BMJ 2012;344:e536).

However, the contribution of marijuana to the risk of crashes "can be a tricky thing to study and to isolate," she said, and research is attempting to determine the degree to which marijuana intoxication deteriorates driving performance.

Of 315 students who had just completed their freshman year, alcohol use was much more prevalent than marijuana use, as was expected – 65% said they had used alcohol in the past 28 days, compared with 21% who reported having used marijuana. Alcohol users were less likely to drive under the influence, however: 12% of males and 3% of females said they drove after drinking. More of the students – 21% of males and 12% of females – reported riding with a driver who had just consumed alcohol.

Researchers attempted to identify possible predictors and risk factors for impaired driving. They found that students who drove after marijuana use were 5.2 times as likely to have also been a passenger of a marijuana-using driver, and 2.5 times as likely to have also driven after alcohol use, as students who did not drive after using marijuana.

A younger age at the first use of marijuana was associated with a lower risk of driving under the influence of marijuana.

Students also were asked about their nonmedical use of stimulants and other prescription drugs. Four percent –a "relatively rare" prevalence – reported recent nonmedical prescription drug use, of which 11% said they drove after use, Dr. Whitehill reported.

The study did not measure the time between substance use and driving, she noted.

Dr. Whitehill reported that she had no relevant financial disclosures.

WASHINGTON – The new Diagnostic and Statistical Manual of Mental Disorders criteria for autism spectrum disorder might significantly affect the diagnosis of ASD in very young children, a retrospective analysis has shown.

Only 35% of a sample of children diagnosed with ASD before age 3 based on DSM-IV criteria retained the diagnosis when DSM-5 criteria were applied.

"The strict nature of the criteria in a population whose symptomatology may be emerging is at odds with an early diagnosis model," said Dr. Lisa H. Shulman, director of the Rehabilitation, Evaluation and Learning for Autistic Infants and Toddlers program at the Albert Einstein College of Medicine, New York.

"Clearly, prospective studies on the impact of DSM-5 on early diagnosis are needed," she said at the annual meeting of the Pediatric Academic Societies (PAS).

Studies of the impact of the new criteria on diagnosis of ASD have focused on school-age children. Dr. Shulman and her coinvestigators looked at younger children, examining all the children who had been diagnosed with ASD by 3 years of age based on a multidisciplinary evaluation at their center during 2003-2010. Diagnoses were based on DSM-IV criteria. Childhood Autism Rating Scale (CARS) scores also were examined, however, and cognitive testing was completed in some of the children.

To determine how many of the children would retain the diagnosis using DSM-5 criteria, an algorithm was used to map data from the DSM-IV and the CARS scores onto the DSM-5 criteria. Of 237 children who had been diagnosed with ASD by age 3 at the inner-city early intervention program, only 84 children (35%) met the criteria for ASD using the DSM-5 criteria.

The children whose diagnosis was retained using DSM-5 criteria were significantly more likely to have had higher CARS scores (38.3 vs. 33.5), which are indicative of more severe social impairment. They also had a trend toward lower cognition, with 34% of those with an IQ of less than 70 diagnosed under DSM-5 criteria, compared with 12% with IQ greater than 70, Dr. Shulman reported.

The potential of the DSM-5 criteria to diagnose the more impaired children preferentially might present an obstacle to diagnosis for the children most likely to benefit from early intervention – those with the mildest symptomatology, she said.

To be classified as having ASD using the DSM-5 criteria, a child has to meet each of three categories of social-communication criteria: deficits in social-emotional reciprocity; deficits in nonverbal communicative behaviors used for social interaction; and deficits in developing and maintaining relationships and adjusting behavior to social contexts appropriate to developmental level.

In addition, a child also must have at least two out of four types of restrictive/repetitive patterns of behavior, interests, or activities: stereotyped or repetitive speech, motor movements, or use of objects; excessive adherence to routines or ritualized patterns of verbal or nonverbal behavior; highly restricted fixated interests that are abnormal in intensity or focus; and hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment.

The group of social-communication criteria least commonly met by the children in the study was "deficits in developing relationships." The specific criteria included in this group – difficulty sharing imaginative play, difficulty in making friends, and absence of interest in people – are especially challenging to apply to and evaluate in young children, said Dr. Shulman, associate professor of pediatrics at Albert Einstein.

Only 61% of the children met at least one of the criteria in this category. "For very young children, where we’re not in the situation to have information or parental concerns regarding making friends, we’re left with ‘absence of interest in people’ – a pretty extreme criteria," she said.

Three of the four "restrictive/repetitive" interests were reported in less than half of the children. While repetitive use of objects or motor movements was present in 89%, excessive adherence to routines was reported in 28%, restricted interests in 41%, and hyper-hypo sensitivity in 25%.

The low rate of hyper-hypo sensitivity was "interesting," Dr. Shulman noted, as inclusion of these sensitivities is new to the manual and "thought to be a nod to young children, who often have more of these symptoms." Consideration of CARS scores in the analysis provided some degree of a measure for these sensitivities, she noted.

The DSM-IV described five different disorders under the general category of "pervasive developmental disorders," for which diagnoses could be made based on 12 criteria; this allowed for any of 2,688 combinations of criteria to arrive at a diagnosis. Under the new version, which describes 1 disorder based on 5 out of 7 criteria being met, "only 12 combinations of criteria can arrive at a diagnosis," Dr. Shulman noted.

The children in the analysis had a mean age of 26.7 months and were 76% male, 19% white, 43% Hispanic, and 25% black.

"From our experience in New York City, a diagnosis made early is largely a valid one," Dr. Shulman said. "The kids who do best [with intervention] have the milder social impairment and the higher cognitive functioning."

Thus far, New York has had a "very generous" approach to intervention for ASD, with early intervention programs making their own diagnoses. "I’m more concerned about places that require [an outside] diagnosis in order to get ASD-specific services in early intervention programs," she noted.

The fifth edition of psychiatry’s diagnostic guide was officially released in May at the American Psychiatric Association’s annual meeting, shortly after Dr. Shulman presented the findings at the PAS meeting. The update is the first in nearly 20 years.

Dr. Shulman reported that she and her coinvestigators have no relevant disclosures.

WASHINGTON – The new Diagnostic and Statistical Manual of Mental Disorders criteria for autism spectrum disorder might significantly affect the diagnosis of ASD in very young children, a retrospective analysis has shown.

Only 35% of a sample of children diagnosed with ASD before age 3 based on DSM-IV criteria retained the diagnosis when DSM-5 criteria were applied.

"The strict nature of the criteria in a population whose symptomatology may be emerging is at odds with an early diagnosis model," said Dr. Lisa H. Shulman, director of the Rehabilitation, Evaluation and Learning for Autistic Infants and Toddlers program at the Albert Einstein College of Medicine, New York.

"Clearly, prospective studies on the impact of DSM-5 on early diagnosis are needed," she said at the annual meeting of the Pediatric Academic Societies (PAS).

Studies of the impact of the new criteria on diagnosis of ASD have focused on school-age children. Dr. Shulman and her coinvestigators looked at younger children, examining all the children who had been diagnosed with ASD by 3 years of age based on a multidisciplinary evaluation at their center during 2003-2010. Diagnoses were based on DSM-IV criteria. Childhood Autism Rating Scale (CARS) scores also were examined, however, and cognitive testing was completed in some of the children.

To determine how many of the children would retain the diagnosis using DSM-5 criteria, an algorithm was used to map data from the DSM-IV and the CARS scores onto the DSM-5 criteria. Of 237 children who had been diagnosed with ASD by age 3 at the inner-city early intervention program, only 84 children (35%) met the criteria for ASD using the DSM-5 criteria.

The children whose diagnosis was retained using DSM-5 criteria were significantly more likely to have had higher CARS scores (38.3 vs. 33.5), which are indicative of more severe social impairment. They also had a trend toward lower cognition, with 34% of those with an IQ of less than 70 diagnosed under DSM-5 criteria, compared with 12% with IQ greater than 70, Dr. Shulman reported.

The potential of the DSM-5 criteria to diagnose the more impaired children preferentially might present an obstacle to diagnosis for the children most likely to benefit from early intervention – those with the mildest symptomatology, she said.

To be classified as having ASD using the DSM-5 criteria, a child has to meet each of three categories of social-communication criteria: deficits in social-emotional reciprocity; deficits in nonverbal communicative behaviors used for social interaction; and deficits in developing and maintaining relationships and adjusting behavior to social contexts appropriate to developmental level.

In addition, a child also must have at least two out of four types of restrictive/repetitive patterns of behavior, interests, or activities: stereotyped or repetitive speech, motor movements, or use of objects; excessive adherence to routines or ritualized patterns of verbal or nonverbal behavior; highly restricted fixated interests that are abnormal in intensity or focus; and hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment.

The group of social-communication criteria least commonly met by the children in the study was "deficits in developing relationships." The specific criteria included in this group – difficulty sharing imaginative play, difficulty in making friends, and absence of interest in people – are especially challenging to apply to and evaluate in young children, said Dr. Shulman, associate professor of pediatrics at Albert Einstein.

Only 61% of the children met at least one of the criteria in this category. "For very young children, where we’re not in the situation to have information or parental concerns regarding making friends, we’re left with ‘absence of interest in people’ – a pretty extreme criteria," she said.

Three of the four "restrictive/repetitive" interests were reported in less than half of the children. While repetitive use of objects or motor movements was present in 89%, excessive adherence to routines was reported in 28%, restricted interests in 41%, and hyper-hypo sensitivity in 25%.

The low rate of hyper-hypo sensitivity was "interesting," Dr. Shulman noted, as inclusion of these sensitivities is new to the manual and "thought to be a nod to young children, who often have more of these symptoms." Consideration of CARS scores in the analysis provided some degree of a measure for these sensitivities, she noted.

The DSM-IV described five different disorders under the general category of "pervasive developmental disorders," for which diagnoses could be made based on 12 criteria; this allowed for any of 2,688 combinations of criteria to arrive at a diagnosis. Under the new version, which describes 1 disorder based on 5 out of 7 criteria being met, "only 12 combinations of criteria can arrive at a diagnosis," Dr. Shulman noted.

The children in the analysis had a mean age of 26.7 months and were 76% male, 19% white, 43% Hispanic, and 25% black.

"From our experience in New York City, a diagnosis made early is largely a valid one," Dr. Shulman said. "The kids who do best [with intervention] have the milder social impairment and the higher cognitive functioning."

Thus far, New York has had a "very generous" approach to intervention for ASD, with early intervention programs making their own diagnoses. "I’m more concerned about places that require [an outside] diagnosis in order to get ASD-specific services in early intervention programs," she noted.

The fifth edition of psychiatry’s diagnostic guide was officially released in May at the American Psychiatric Association’s annual meeting, shortly after Dr. Shulman presented the findings at the PAS meeting. The update is the first in nearly 20 years.

Dr. Shulman reported that she and her coinvestigators have no relevant disclosures.

WASHINGTON – The new Diagnostic and Statistical Manual of Mental Disorders criteria for autism spectrum disorder might significantly affect the diagnosis of ASD in very young children, a retrospective analysis has shown.

Only 35% of a sample of children diagnosed with ASD before age 3 based on DSM-IV criteria retained the diagnosis when DSM-5 criteria were applied.

"The strict nature of the criteria in a population whose symptomatology may be emerging is at odds with an early diagnosis model," said Dr. Lisa H. Shulman, director of the Rehabilitation, Evaluation and Learning for Autistic Infants and Toddlers program at the Albert Einstein College of Medicine, New York.

"Clearly, prospective studies on the impact of DSM-5 on early diagnosis are needed," she said at the annual meeting of the Pediatric Academic Societies (PAS).

Studies of the impact of the new criteria on diagnosis of ASD have focused on school-age children. Dr. Shulman and her coinvestigators looked at younger children, examining all the children who had been diagnosed with ASD by 3 years of age based on a multidisciplinary evaluation at their center during 2003-2010. Diagnoses were based on DSM-IV criteria. Childhood Autism Rating Scale (CARS) scores also were examined, however, and cognitive testing was completed in some of the children.

To determine how many of the children would retain the diagnosis using DSM-5 criteria, an algorithm was used to map data from the DSM-IV and the CARS scores onto the DSM-5 criteria. Of 237 children who had been diagnosed with ASD by age 3 at the inner-city early intervention program, only 84 children (35%) met the criteria for ASD using the DSM-5 criteria.

The children whose diagnosis was retained using DSM-5 criteria were significantly more likely to have had higher CARS scores (38.3 vs. 33.5), which are indicative of more severe social impairment. They also had a trend toward lower cognition, with 34% of those with an IQ of less than 70 diagnosed under DSM-5 criteria, compared with 12% with IQ greater than 70, Dr. Shulman reported.

The potential of the DSM-5 criteria to diagnose the more impaired children preferentially might present an obstacle to diagnosis for the children most likely to benefit from early intervention – those with the mildest symptomatology, she said.

To be classified as having ASD using the DSM-5 criteria, a child has to meet each of three categories of social-communication criteria: deficits in social-emotional reciprocity; deficits in nonverbal communicative behaviors used for social interaction; and deficits in developing and maintaining relationships and adjusting behavior to social contexts appropriate to developmental level.

In addition, a child also must have at least two out of four types of restrictive/repetitive patterns of behavior, interests, or activities: stereotyped or repetitive speech, motor movements, or use of objects; excessive adherence to routines or ritualized patterns of verbal or nonverbal behavior; highly restricted fixated interests that are abnormal in intensity or focus; and hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment.

The group of social-communication criteria least commonly met by the children in the study was "deficits in developing relationships." The specific criteria included in this group – difficulty sharing imaginative play, difficulty in making friends, and absence of interest in people – are especially challenging to apply to and evaluate in young children, said Dr. Shulman, associate professor of pediatrics at Albert Einstein.

Only 61% of the children met at least one of the criteria in this category. "For very young children, where we’re not in the situation to have information or parental concerns regarding making friends, we’re left with ‘absence of interest in people’ – a pretty extreme criteria," she said.

Three of the four "restrictive/repetitive" interests were reported in less than half of the children. While repetitive use of objects or motor movements was present in 89%, excessive adherence to routines was reported in 28%, restricted interests in 41%, and hyper-hypo sensitivity in 25%.

The low rate of hyper-hypo sensitivity was "interesting," Dr. Shulman noted, as inclusion of these sensitivities is new to the manual and "thought to be a nod to young children, who often have more of these symptoms." Consideration of CARS scores in the analysis provided some degree of a measure for these sensitivities, she noted.

The DSM-IV described five different disorders under the general category of "pervasive developmental disorders," for which diagnoses could be made based on 12 criteria; this allowed for any of 2,688 combinations of criteria to arrive at a diagnosis. Under the new version, which describes 1 disorder based on 5 out of 7 criteria being met, "only 12 combinations of criteria can arrive at a diagnosis," Dr. Shulman noted.

The children in the analysis had a mean age of 26.7 months and were 76% male, 19% white, 43% Hispanic, and 25% black.

"From our experience in New York City, a diagnosis made early is largely a valid one," Dr. Shulman said. "The kids who do best [with intervention] have the milder social impairment and the higher cognitive functioning."

Thus far, New York has had a "very generous" approach to intervention for ASD, with early intervention programs making their own diagnoses. "I’m more concerned about places that require [an outside] diagnosis in order to get ASD-specific services in early intervention programs," she noted.

The fifth edition of psychiatry’s diagnostic guide was officially released in May at the American Psychiatric Association’s annual meeting, shortly after Dr. Shulman presented the findings at the PAS meeting. The update is the first in nearly 20 years.

Dr. Shulman reported that she and her coinvestigators have no relevant disclosures.

A recent explosion of interest in robotic surgery for routine hysterectomies and treatment of other nononcologic gynecologic conditions is raising concern about the cost and comparative value of the robot over conventional laparoscopy, as well as the future of vaginal hysterectomy and current and future training needs.

In 2010, for the first time, more hysterectomies were performed with the da Vinci Surgical System than any other procedure, including prostatectomy. The number of robotic-assisted hysterectomies performed worldwide grew to 110,000 in 2010, from approximately 69,000 the year before.

Approximately 32,000 of these hysterectomies were for treatment of cancer, and the remaining 78,000 were related to benign conditions, according to Chris Simmonds, senior director of marketing for Intuitive Surgical, which makes the da Vinci, the only such system currently on the market.

Gynecologic oncologists swiftly embraced the robotic surgical system after it was approved in 2005 for gynecologic surgical procedures because it enabled them to perform minimally invasive endometrial cancer staging – something most surgeons found too technically challenging with pure laparoscopy.

While issues of cost and training have been part of an ongoing debate in gynecologic oncology, such issues have taken on new meaning – and more urgency – with the more recent rise in robotically assisted routine hysterectomy. It can be argued, some experts explain, that an advantage exists for robotics in gynecologic oncology that, overall, does not exist for benign disease.

“Robotics will probably be the future of surgery,” said Dr. Resad P. Pasic, professor of obstetrics and gynecology and director of operative gynecologic endoscopy at the University of Louisville (Ky.). “We need to [better understand] what the real advantages are, however, especially for routine laparoscopic hysterectomies, because the cost is higher than traditional laparoscopy and vaginal surgery.”

Robotic assistance “is great for some procedures, like myomectomies, where there is more suturing. But I really don't see a huge benefit overall for less complex, benign cases,” he said in an interview. “We're even seeing supracervical hysterectomies being done [robotically] – that doesn't make any sense.”

A study published last year, which Dr. Pasic coauthored, found higher per-case hospital costs with robotic-assisted hysterectomies, compared with conventional laparoscopic hysterectomies, without any significant differences in complications, postsurgical infections, or frequency of hemorrhage.

Robot-assisted hysterectomies were associated with longer surgical times and cost an average of $2,600 more, the investigators reported (J. Minim. Invasive Gynecol. 2010;17:730-8).

Using the Premier hospital database, they analyzed patient records and billing and insurance data for more than 36,000 women who received minimally invasive hysterectomy during 2007-2008 in more than 350 hospitals. Their cost analysis reflected the cost of the robotic procedure to the hospital but did not include the acquisition or maintenance costs of the robotic device over time.

The robotic unit costs between $1 million and $2.3 million and is associated with annual maintenance costs of $100,000-$170,000 a year, and instrumentation/accessories costs of $1,300-$2,200 per procedure, according to Intuitive Surgical.

“Further decisions regarding the diffusion of robot technology in routine laparoscopic hysterectomy,” they concluded, must be informed by randomized controlled studies of comparative effectiveness.

At the annual meeting of the American Association of Gynecologic Laparoscopists last month, the paper won the organization's Robert Hunt Award for the “best article” published in the Journal of Minimally Invasive Gynecology in the past year. The study may cause some to pause, however, in that it was funded by Ethicon Endo-Surgery, and because three of the six coauthors have notable ties with Ethicon – one is employed by the company, one is a consultant, and Dr. Pasic is a speaker for the company.

Dr. Pasic, who said he uses the da Vinci for about 10% of his procedures, dismissed any suggestions of bias. “We're not the only paper concluding there is a high cost to robotics, and we made every effort to be as impartial as possible,” he said.

Authors of a broader recently published analysis of robotic-assisted surgery and health care costs drew similar conclusions about comparative value. The investigators examined all the cost studies of robot-assisted procedures published since 2005 and reported that, on average, “across the full range of 20 types of surgery for which studies exist,” the additional cost of using a robot-assisted procedure was about $1,600, or about 6% of the cost of the procedure in 2007 (N. Eng. J. Med. 2010;363:701-4).

There have not been any large-scale randomized trials of robot-assisted surgery, and the “limited observational evidence fails to show that the long-term outcomes of robot-assisted surgery are superior to those of conventional procedures,” said Dr. Gabriel I. Barbash of the medical school at Tel Aviv University and Sherry A. Glied, Ph.D., of the school of public health at Columbia University, New York.

With hysterectomy, a pure vaginal approach has long been viewed by many experts as the preferable approach whenever possible – the most cost-effective minimally invasive method – and some experts are concerned that the growing popularity of robotics may chip away at its use.

“Vaginal hysterectomy is an art, so the question is, are we killing the art with the new technology we're using for laparoscopy and now robotics? Maybe … there are some studies suggesting [this], but we have no definitive data,” Dr. Pasic said.

Dr. Javier Magrina, a professor of obstetrics and gynecology and director of gynecologic oncology at the Mayo Clinic in Scottsdale, Ariz., who has written and lectured extensively on robotic surgery from the standpoint of both benign and malignant disease, said that so far, vaginal hysterectomy rates appear to be “stable in spite of robotics,” comprising about 20%-25% of all hysterectomies. “The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good,” he said in an interview.

Dr. Jed Delmore and his colleagues at the University of Kansas in Wichita found just this when they compared the types of hysterectomy performed at their teaching hospital and two outpatient surgery centers during two periods of time: before robotic surgery became locally available (2006-2007) and 2 years after it arrived (2009-2010).

Using electronic medical record and billing data to identify hysterectomies, they found that the number of abdominal hysterectomies decreased significantly, while the number of vaginal hysterectomies remained relatively constant. The unpublished findings were presented at the American Congress of Obstetricians and Gynecologists District VII meeting in Kansas City in September.

“At least in our community of 400,000 women, there was a positive shift,” Dr. Delmore said in an interview.

Still, he said, the potential longer-term impact of robotics on vaginal hysterectomy is a concern. “If there's a big shift from abdominal surgery to robotic surgery, that will be cost effective. … But if it turns out that over time fewer women end up having vaginal hysterectomies, and have robotic hysterectomies instead, there will be greater expense to individuals and society,” said Dr. Delmore, professor of obstetrics and gynecology and director of gynecologic oncology at the university.

An even larger concern, he noted, is “whether robotic surgery, as it becomes more and more available, will increase the total volume of hysterectomies – in women who would have previously been treated with hormone therapy or [other modalities].”

Such a trend may be occurring with prostatectomy, note the authors of the New England Journal of Medicine cost analysis, with robotic technology possibly contributing to the substitution of surgical for nonsurgical treatments for prostate cancer.

This does not appear to be happening with hysterectomy in the Kansas City area thus far, Dr. Delmore said.

The undercurrents may already exist, however. Gynecology is one of Intuitive Surgical's five main “target markets,” according to a company investor presentation, and hysterectomy is one of four “target” gynecologic procedures, along with sacral colpopexy, myomectomy, and endometrial resection.

With an estimated 600,000 hysterectomies being performed each year in the United States, Intuitive sees potential for growth. As of this fall, the 2011 surgical volume with the da Vinci had increased 30% over 2010 volume across all types of procedures, said Intuitive Surgical's Mr. Simmonds.

Having a surgical robot has become a status symbol of sorts for hospitals in many urban areas – as of September, Intuitive had installed 1,478 da Vinci surgical systems in the United States – and ob.gyns. may feel compelled to keep up with market demands.

“General ob.gyns. don't want to be the only physicians in the community not offering it,” said Dr. Delmore, who teaches robotic surgery as a proctor for Intuitive Surgical.

Many ob.gyns., moreover, find robotic-assisted laparoscopy much easier than conventional laparoscopy to learn and adopt. Suturing is easier, and Dr. Magrina and other proponents of robotics maintain that the advantages of instrument articulation and steady three-dimensional vision have proven even higher than expected – for hysterectomies as well as more complex gynecologic procedures.

While the learning curve for robotics is said to be relatively short, Dr. Pasic and his coauthors caution that robotic assistance should not be used by physicians who are unwilling to invest time and effort into laparoscopic training. Exuberance for the da Vinci could have an “unintended negative effect on resident and fellow training as it relates to overall laparoscopic competencies,” they said.

Institutions, in the meantime, are individually attempting to determine how best to train residents in robotic-assisted surgery. The University of Kansas is implementing a training model for ob.gyn. residents that includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies.

Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. utilize this training. “What if residents go somewhere afterward where there isn't a robot, for instance? Will [they have learned enough] to safely operate?” he said.

Dr. Magrina said he had no relevant financial disclosures. Dr. Delmore teaches robotic surgery as a proctor for Intuitive Surgical. Dr. Pasic is a speaker for Ethicon Endo-Surgery.

'Are we killing the art with the new technology we're using for laparoscopy and now robotics?'

Source DR. PASIC

'The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good.'

Source DR. MAGRINA

'General ob.gyns. don't want to be the only physicians in the community not offering [robotic surgery].'

Source DR. DELMORE

Source Elsevier Global Medical News

A recent explosion of interest in robotic surgery for routine hysterectomies and treatment of other nononcologic gynecologic conditions is raising concern about the cost and comparative value of the robot over conventional laparoscopy, as well as the future of vaginal hysterectomy and current and future training needs.

In 2010, for the first time, more hysterectomies were performed with the da Vinci Surgical System than any other procedure, including prostatectomy. The number of robotic-assisted hysterectomies performed worldwide grew to 110,000 in 2010, from approximately 69,000 the year before.

Approximately 32,000 of these hysterectomies were for treatment of cancer, and the remaining 78,000 were related to benign conditions, according to Chris Simmonds, senior director of marketing for Intuitive Surgical, which makes the da Vinci, the only such system currently on the market.

Gynecologic oncologists swiftly embraced the robotic surgical system after it was approved in 2005 for gynecologic surgical procedures because it enabled them to perform minimally invasive endometrial cancer staging – something most surgeons found too technically challenging with pure laparoscopy.

While issues of cost and training have been part of an ongoing debate in gynecologic oncology, such issues have taken on new meaning – and more urgency – with the more recent rise in robotically assisted routine hysterectomy. It can be argued, some experts explain, that an advantage exists for robotics in gynecologic oncology that, overall, does not exist for benign disease.

“Robotics will probably be the future of surgery,” said Dr. Resad P. Pasic, professor of obstetrics and gynecology and director of operative gynecologic endoscopy at the University of Louisville (Ky.). “We need to [better understand] what the real advantages are, however, especially for routine laparoscopic hysterectomies, because the cost is higher than traditional laparoscopy and vaginal surgery.”

Robotic assistance “is great for some procedures, like myomectomies, where there is more suturing. But I really don't see a huge benefit overall for less complex, benign cases,” he said in an interview. “We're even seeing supracervical hysterectomies being done [robotically] – that doesn't make any sense.”

A study published last year, which Dr. Pasic coauthored, found higher per-case hospital costs with robotic-assisted hysterectomies, compared with conventional laparoscopic hysterectomies, without any significant differences in complications, postsurgical infections, or frequency of hemorrhage.

Robot-assisted hysterectomies were associated with longer surgical times and cost an average of $2,600 more, the investigators reported (J. Minim. Invasive Gynecol. 2010;17:730-8).

Using the Premier hospital database, they analyzed patient records and billing and insurance data for more than 36,000 women who received minimally invasive hysterectomy during 2007-2008 in more than 350 hospitals. Their cost analysis reflected the cost of the robotic procedure to the hospital but did not include the acquisition or maintenance costs of the robotic device over time.

The robotic unit costs between $1 million and $2.3 million and is associated with annual maintenance costs of $100,000-$170,000 a year, and instrumentation/accessories costs of $1,300-$2,200 per procedure, according to Intuitive Surgical.

“Further decisions regarding the diffusion of robot technology in routine laparoscopic hysterectomy,” they concluded, must be informed by randomized controlled studies of comparative effectiveness.

At the annual meeting of the American Association of Gynecologic Laparoscopists last month, the paper won the organization's Robert Hunt Award for the “best article” published in the Journal of Minimally Invasive Gynecology in the past year. The study may cause some to pause, however, in that it was funded by Ethicon Endo-Surgery, and because three of the six coauthors have notable ties with Ethicon – one is employed by the company, one is a consultant, and Dr. Pasic is a speaker for the company.

Dr. Pasic, who said he uses the da Vinci for about 10% of his procedures, dismissed any suggestions of bias. “We're not the only paper concluding there is a high cost to robotics, and we made every effort to be as impartial as possible,” he said.

Authors of a broader recently published analysis of robotic-assisted surgery and health care costs drew similar conclusions about comparative value. The investigators examined all the cost studies of robot-assisted procedures published since 2005 and reported that, on average, “across the full range of 20 types of surgery for which studies exist,” the additional cost of using a robot-assisted procedure was about $1,600, or about 6% of the cost of the procedure in 2007 (N. Eng. J. Med. 2010;363:701-4).

There have not been any large-scale randomized trials of robot-assisted surgery, and the “limited observational evidence fails to show that the long-term outcomes of robot-assisted surgery are superior to those of conventional procedures,” said Dr. Gabriel I. Barbash of the medical school at Tel Aviv University and Sherry A. Glied, Ph.D., of the school of public health at Columbia University, New York.

With hysterectomy, a pure vaginal approach has long been viewed by many experts as the preferable approach whenever possible – the most cost-effective minimally invasive method – and some experts are concerned that the growing popularity of robotics may chip away at its use.

“Vaginal hysterectomy is an art, so the question is, are we killing the art with the new technology we're using for laparoscopy and now robotics? Maybe … there are some studies suggesting [this], but we have no definitive data,” Dr. Pasic said.

Dr. Javier Magrina, a professor of obstetrics and gynecology and director of gynecologic oncology at the Mayo Clinic in Scottsdale, Ariz., who has written and lectured extensively on robotic surgery from the standpoint of both benign and malignant disease, said that so far, vaginal hysterectomy rates appear to be “stable in spite of robotics,” comprising about 20%-25% of all hysterectomies. “The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good,” he said in an interview.

Dr. Jed Delmore and his colleagues at the University of Kansas in Wichita found just this when they compared the types of hysterectomy performed at their teaching hospital and two outpatient surgery centers during two periods of time: before robotic surgery became locally available (2006-2007) and 2 years after it arrived (2009-2010).

Using electronic medical record and billing data to identify hysterectomies, they found that the number of abdominal hysterectomies decreased significantly, while the number of vaginal hysterectomies remained relatively constant. The unpublished findings were presented at the American Congress of Obstetricians and Gynecologists District VII meeting in Kansas City in September.

“At least in our community of 400,000 women, there was a positive shift,” Dr. Delmore said in an interview.

Still, he said, the potential longer-term impact of robotics on vaginal hysterectomy is a concern. “If there's a big shift from abdominal surgery to robotic surgery, that will be cost effective. … But if it turns out that over time fewer women end up having vaginal hysterectomies, and have robotic hysterectomies instead, there will be greater expense to individuals and society,” said Dr. Delmore, professor of obstetrics and gynecology and director of gynecologic oncology at the university.

An even larger concern, he noted, is “whether robotic surgery, as it becomes more and more available, will increase the total volume of hysterectomies – in women who would have previously been treated with hormone therapy or [other modalities].”

Such a trend may be occurring with prostatectomy, note the authors of the New England Journal of Medicine cost analysis, with robotic technology possibly contributing to the substitution of surgical for nonsurgical treatments for prostate cancer.

This does not appear to be happening with hysterectomy in the Kansas City area thus far, Dr. Delmore said.

The undercurrents may already exist, however. Gynecology is one of Intuitive Surgical's five main “target markets,” according to a company investor presentation, and hysterectomy is one of four “target” gynecologic procedures, along with sacral colpopexy, myomectomy, and endometrial resection.

With an estimated 600,000 hysterectomies being performed each year in the United States, Intuitive sees potential for growth. As of this fall, the 2011 surgical volume with the da Vinci had increased 30% over 2010 volume across all types of procedures, said Intuitive Surgical's Mr. Simmonds.

Having a surgical robot has become a status symbol of sorts for hospitals in many urban areas – as of September, Intuitive had installed 1,478 da Vinci surgical systems in the United States – and ob.gyns. may feel compelled to keep up with market demands.

“General ob.gyns. don't want to be the only physicians in the community not offering it,” said Dr. Delmore, who teaches robotic surgery as a proctor for Intuitive Surgical.

Many ob.gyns., moreover, find robotic-assisted laparoscopy much easier than conventional laparoscopy to learn and adopt. Suturing is easier, and Dr. Magrina and other proponents of robotics maintain that the advantages of instrument articulation and steady three-dimensional vision have proven even higher than expected – for hysterectomies as well as more complex gynecologic procedures.

While the learning curve for robotics is said to be relatively short, Dr. Pasic and his coauthors caution that robotic assistance should not be used by physicians who are unwilling to invest time and effort into laparoscopic training. Exuberance for the da Vinci could have an “unintended negative effect on resident and fellow training as it relates to overall laparoscopic competencies,” they said.

Institutions, in the meantime, are individually attempting to determine how best to train residents in robotic-assisted surgery. The University of Kansas is implementing a training model for ob.gyn. residents that includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies.

Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. utilize this training. “What if residents go somewhere afterward where there isn't a robot, for instance? Will [they have learned enough] to safely operate?” he said.

Dr. Magrina said he had no relevant financial disclosures. Dr. Delmore teaches robotic surgery as a proctor for Intuitive Surgical. Dr. Pasic is a speaker for Ethicon Endo-Surgery.

'Are we killing the art with the new technology we're using for laparoscopy and now robotics?'

Source DR. PASIC

'The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good.'

Source DR. MAGRINA

'General ob.gyns. don't want to be the only physicians in the community not offering [robotic surgery].'

Source DR. DELMORE

Source Elsevier Global Medical News

A recent explosion of interest in robotic surgery for routine hysterectomies and treatment of other nononcologic gynecologic conditions is raising concern about the cost and comparative value of the robot over conventional laparoscopy, as well as the future of vaginal hysterectomy and current and future training needs.

In 2010, for the first time, more hysterectomies were performed with the da Vinci Surgical System than any other procedure, including prostatectomy. The number of robotic-assisted hysterectomies performed worldwide grew to 110,000 in 2010, from approximately 69,000 the year before.

Approximately 32,000 of these hysterectomies were for treatment of cancer, and the remaining 78,000 were related to benign conditions, according to Chris Simmonds, senior director of marketing for Intuitive Surgical, which makes the da Vinci, the only such system currently on the market.

Gynecologic oncologists swiftly embraced the robotic surgical system after it was approved in 2005 for gynecologic surgical procedures because it enabled them to perform minimally invasive endometrial cancer staging – something most surgeons found too technically challenging with pure laparoscopy.

While issues of cost and training have been part of an ongoing debate in gynecologic oncology, such issues have taken on new meaning – and more urgency – with the more recent rise in robotically assisted routine hysterectomy. It can be argued, some experts explain, that an advantage exists for robotics in gynecologic oncology that, overall, does not exist for benign disease.

“Robotics will probably be the future of surgery,” said Dr. Resad P. Pasic, professor of obstetrics and gynecology and director of operative gynecologic endoscopy at the University of Louisville (Ky.). “We need to [better understand] what the real advantages are, however, especially for routine laparoscopic hysterectomies, because the cost is higher than traditional laparoscopy and vaginal surgery.”

Robotic assistance “is great for some procedures, like myomectomies, where there is more suturing. But I really don't see a huge benefit overall for less complex, benign cases,” he said in an interview. “We're even seeing supracervical hysterectomies being done [robotically] – that doesn't make any sense.”

A study published last year, which Dr. Pasic coauthored, found higher per-case hospital costs with robotic-assisted hysterectomies, compared with conventional laparoscopic hysterectomies, without any significant differences in complications, postsurgical infections, or frequency of hemorrhage.

Robot-assisted hysterectomies were associated with longer surgical times and cost an average of $2,600 more, the investigators reported (J. Minim. Invasive Gynecol. 2010;17:730-8).

Using the Premier hospital database, they analyzed patient records and billing and insurance data for more than 36,000 women who received minimally invasive hysterectomy during 2007-2008 in more than 350 hospitals. Their cost analysis reflected the cost of the robotic procedure to the hospital but did not include the acquisition or maintenance costs of the robotic device over time.

The robotic unit costs between $1 million and $2.3 million and is associated with annual maintenance costs of $100,000-$170,000 a year, and instrumentation/accessories costs of $1,300-$2,200 per procedure, according to Intuitive Surgical.

“Further decisions regarding the diffusion of robot technology in routine laparoscopic hysterectomy,” they concluded, must be informed by randomized controlled studies of comparative effectiveness.

At the annual meeting of the American Association of Gynecologic Laparoscopists last month, the paper won the organization's Robert Hunt Award for the “best article” published in the Journal of Minimally Invasive Gynecology in the past year. The study may cause some to pause, however, in that it was funded by Ethicon Endo-Surgery, and because three of the six coauthors have notable ties with Ethicon – one is employed by the company, one is a consultant, and Dr. Pasic is a speaker for the company.

Dr. Pasic, who said he uses the da Vinci for about 10% of his procedures, dismissed any suggestions of bias. “We're not the only paper concluding there is a high cost to robotics, and we made every effort to be as impartial as possible,” he said.

Authors of a broader recently published analysis of robotic-assisted surgery and health care costs drew similar conclusions about comparative value. The investigators examined all the cost studies of robot-assisted procedures published since 2005 and reported that, on average, “across the full range of 20 types of surgery for which studies exist,” the additional cost of using a robot-assisted procedure was about $1,600, or about 6% of the cost of the procedure in 2007 (N. Eng. J. Med. 2010;363:701-4).

There have not been any large-scale randomized trials of robot-assisted surgery, and the “limited observational evidence fails to show that the long-term outcomes of robot-assisted surgery are superior to those of conventional procedures,” said Dr. Gabriel I. Barbash of the medical school at Tel Aviv University and Sherry A. Glied, Ph.D., of the school of public health at Columbia University, New York.

With hysterectomy, a pure vaginal approach has long been viewed by many experts as the preferable approach whenever possible – the most cost-effective minimally invasive method – and some experts are concerned that the growing popularity of robotics may chip away at its use.

“Vaginal hysterectomy is an art, so the question is, are we killing the art with the new technology we're using for laparoscopy and now robotics? Maybe … there are some studies suggesting [this], but we have no definitive data,” Dr. Pasic said.

Dr. Javier Magrina, a professor of obstetrics and gynecology and director of gynecologic oncology at the Mayo Clinic in Scottsdale, Ariz., who has written and lectured extensively on robotic surgery from the standpoint of both benign and malignant disease, said that so far, vaginal hysterectomy rates appear to be “stable in spite of robotics,” comprising about 20%-25% of all hysterectomies. “The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good,” he said in an interview.

Dr. Jed Delmore and his colleagues at the University of Kansas in Wichita found just this when they compared the types of hysterectomy performed at their teaching hospital and two outpatient surgery centers during two periods of time: before robotic surgery became locally available (2006-2007) and 2 years after it arrived (2009-2010).

Using electronic medical record and billing data to identify hysterectomies, they found that the number of abdominal hysterectomies decreased significantly, while the number of vaginal hysterectomies remained relatively constant. The unpublished findings were presented at the American Congress of Obstetricians and Gynecologists District VII meeting in Kansas City in September.

“At least in our community of 400,000 women, there was a positive shift,” Dr. Delmore said in an interview.

Still, he said, the potential longer-term impact of robotics on vaginal hysterectomy is a concern. “If there's a big shift from abdominal surgery to robotic surgery, that will be cost effective. … But if it turns out that over time fewer women end up having vaginal hysterectomies, and have robotic hysterectomies instead, there will be greater expense to individuals and society,” said Dr. Delmore, professor of obstetrics and gynecology and director of gynecologic oncology at the university.

An even larger concern, he noted, is “whether robotic surgery, as it becomes more and more available, will increase the total volume of hysterectomies – in women who would have previously been treated with hormone therapy or [other modalities].”

Such a trend may be occurring with prostatectomy, note the authors of the New England Journal of Medicine cost analysis, with robotic technology possibly contributing to the substitution of surgical for nonsurgical treatments for prostate cancer.

This does not appear to be happening with hysterectomy in the Kansas City area thus far, Dr. Delmore said.

The undercurrents may already exist, however. Gynecology is one of Intuitive Surgical's five main “target markets,” according to a company investor presentation, and hysterectomy is one of four “target” gynecologic procedures, along with sacral colpopexy, myomectomy, and endometrial resection.

With an estimated 600,000 hysterectomies being performed each year in the United States, Intuitive sees potential for growth. As of this fall, the 2011 surgical volume with the da Vinci had increased 30% over 2010 volume across all types of procedures, said Intuitive Surgical's Mr. Simmonds.

Having a surgical robot has become a status symbol of sorts for hospitals in many urban areas – as of September, Intuitive had installed 1,478 da Vinci surgical systems in the United States – and ob.gyns. may feel compelled to keep up with market demands.

“General ob.gyns. don't want to be the only physicians in the community not offering it,” said Dr. Delmore, who teaches robotic surgery as a proctor for Intuitive Surgical.

Many ob.gyns., moreover, find robotic-assisted laparoscopy much easier than conventional laparoscopy to learn and adopt. Suturing is easier, and Dr. Magrina and other proponents of robotics maintain that the advantages of instrument articulation and steady three-dimensional vision have proven even higher than expected – for hysterectomies as well as more complex gynecologic procedures.

While the learning curve for robotics is said to be relatively short, Dr. Pasic and his coauthors caution that robotic assistance should not be used by physicians who are unwilling to invest time and effort into laparoscopic training. Exuberance for the da Vinci could have an “unintended negative effect on resident and fellow training as it relates to overall laparoscopic competencies,” they said.

Institutions, in the meantime, are individually attempting to determine how best to train residents in robotic-assisted surgery. The University of Kansas is implementing a training model for ob.gyn. residents that includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies.

Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. utilize this training. “What if residents go somewhere afterward where there isn't a robot, for instance? Will [they have learned enough] to safely operate?” he said.

Dr. Magrina said he had no relevant financial disclosures. Dr. Delmore teaches robotic surgery as a proctor for Intuitive Surgical. Dr. Pasic is a speaker for Ethicon Endo-Surgery.

'Are we killing the art with the new technology we're using for laparoscopy and now robotics?'

Source DR. PASIC

'The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good.'

Source DR. MAGRINA

'General ob.gyns. don't want to be the only physicians in the community not offering [robotic surgery].'

Source DR. DELMORE

Source Elsevier Global Medical News

A recent explosion of interest in robotic surgery for routine hysterectomies and treatment of other nononcologic gynecologic conditions is raising concern about the cost and comparative value of the robot over conventional laparoscopy, as well as the future of vaginal hysterectomy and current and future training needs.

In 2010, for the first time, more hysterectomies were performed with the da Vinci Surgical System than any other procedure, including prostatectomy. The number of robotic-assisted hysterectomies performed worldwide grew to 110,000 in 2010, from approximately 69,000 the year before.

Approximately 32,000 of these hysterectomies were for treatment of cancer, and the remaining 78,000 were related to benign conditions, according to Chris Simmonds, senior director of marketing for Intuitive Surgical, which makes the da Vinci, the only such system currently on the market.

Gynecologic oncologists swiftly embraced the robotic surgical system after it was approved in 2005 for gynecologic surgical procedures because it enabled them to perform minimally invasive endometrial cancer staging – something most surgeons found too technically challenging with pure laparoscopy.

While issues of cost and training have been part of an ongoing debate in gynecologic oncology, such issues have taken on new meaning – and more urgency – with the more recent rise in robotically-assisted routine hysterectomy. It can be argued, some experts explain, that an advantage exists for robotics in gynecologic oncology that, overall, does not exist for benign disease.

"Robotics will probably be the future of surgery," said Dr. Resad P. Pasic, professor of obstetrics and gynecology and director of operative gynecologic endoscopy at the University of Louisville (Ky.). "We need to [better understand] what the real advantages are, however, especially for routine laparoscopic hysterectomies, because the cost is higher than traditional laparoscopy and vaginal surgery."

Robotic assistance "is great for some procedures, like myomectomies, where there is more suturing. But I really don’t see a huge benefit overall for less complex, benign cases," he said in an interview. "We’re even seeing supracervical hysterectomies being done [robotically] – that doesn’t make any sense."

A study published last year, which Dr. Pasic coauthored, found higher per-case hospital costs with robotic-assisted hysterectomies, compared with conventional laparoscopic hysterectomies, without any significant differences in complications, postsurgical infections, or frequency of hemorrhage.

Robot-assisted hysterectomies were associated with longer surgical times and cost an average of $2,600 more, the investigators reported (J. Minim. Invasive Gynecol. 2010;17:730-8).

Using the Premier hospital database, they analyzed patient records and billing and insurance data for more than 36,000 women who received minimally invasive hysterectomy during 2007-2008 in more than 350 hospitals. Their cost analysis reflected the cost of the robotic procedure to the hospital but did not include the acquisition or maintenance costs of the robotic device over time.

The robotic unit costs between $1 million and $2.3 million and is associated with annual maintenance costs of $100,000-$170,000 a year, and instrumentation/accessories costs of $1,300-$2,200 per procedure, according to Intuitive Surgical.

"Further decisions regarding the diffusion of robot technology in routine laparoscopic hysterectomy," they concluded, must be informed by randomized controlled studies of comparative effectiveness.

At the annual meeting of the American Association of Gynecologic Laparoscopists last month, the paper won the organization’s Robert Hunt Award for the "best article" published in the Journal of Minimally Invasive Gynecology in the past year. The study may cause some to pause, however, in that it was funded by Ethicon Endo-Surgery, and because three of the six coauthors have notable ties with Ethicon – one is employed by the company, one is a consultant, and Dr. Pasic is a speaker for the company.

Dr. Pasic, who said he uses the da Vinci for about 10% of his procedures, dismissed any suggestions of bias. "We’re not the only paper concluding there is a high cost to robotics, and we made every effort to be as impartial as possible," he said.

Authors of a broader recently-published analysis of robotic-assisted surgery and health care costs drew similar conclusions about comparative value. The investigators examined all the cost studies of robot-assisted procedures published since 2005 and reported that, on average, "across the full range of 20 types of surgery for which studies exist," the additional cost of using a robot-assisted procedure was about $1,600, or about 6% of the cost of the procedure in 2007 (N. Eng. J. Med. 2010;363:701-4).

There have not been any large-scale randomized trials of robot-assisted surgery, and the "limited observational evidence fails to show that the long-term outcomes of robot-assisted surgery are superior to those of conventional procedures," said Dr. Gabriel I. Barbash of the medical school at Tel Aviv (Israel) University and Sherry A. Glied, Ph.D., of the school of public health at Columbia University, New York.

With hysterectomy, a pure vaginal approach has long been viewed by many experts as the preferable approach whenever possible – the most cost-effective minimally invasive method – and some experts are concerned that the growing popularity of robotics may chip away at its use.

"Vaginal hysterectomy is an art, so the question is, are we killing the art with the new technology we’re using for laparoscopy and now robotics? Maybe ... there are some studies suggesting [this], but we have no definitive data," Dr. Pasic said.

Dr. Javier Magrina, a professor of obstetrics and gynecology and director of gynecologic oncology at the Mayo Clinic in Scottsdale, Ariz., who has written and lectured extensively on robotic surgery from the standpoint of both benign and malignant disease, said that so far, vaginal hysterectomy rates appear to be "stable in spite of robotics," comprising about 20%-25% of all hysterectomies. "The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good," he said in an interview.

Dr. Jed Delmore and his colleagues at the University of Kansas in Wichita found just this when they compared the types of hysterectomy performed at their teaching hospital and two outpatient surgery centers during two periods of time: before robotic surgery became locally available (2006-2007) and 2 years after it arrived (2009-2010).

Using electronic medical record and billing data to identify hysterectomies, they found that the number of abdominal hysterectomies decreased significantly, while the number of vaginal hysterectomies remained relatively constant. The unpublished findings were presented at the American Congress of Obstetricians and Gynecologists District VII meeting in Kansas City in September.

"At least in our community of 400,000 women, there was a positive shift," Dr. Delmore said in an interview.

Still, he said, the potential longer-term impact of robotics on vaginal hysterectomy is a concern. "If there’s a big shift from abdominal surgery to robotic surgery, that will be cost-effective. ... But if it turns out that over time fewer women end up having vaginal hysterectomies, and have robotic hysterectomies instead, there will be greater expense to individuals and society," said Dr. Delmore, professor of obstetrics and gynecology and director of gynecologic oncology at the university.

An even larger concern, he noted, is "whether robotic surgery, as it becomes more and more available, will increase the total volume of hysterectomies – in women who would have previously been treated with hormone therapy or [other modalities]."

Such a trend may be occurring with prostatectomy, note the authors of the New England Journal of Medicine cost analysis, with robotic technology possibly contributing to the substitution of surgical for non-surgical treatments for prostate cancer.

This does not appear to be happening with hysterectomy in the Kansas City area thus far, Dr. Delmore said.

The undercurrents may already exist, however. Gynecology is one of Intuitive Surgical’s five main "target markets," according to a company investor presentation, and hysterectomy is one of four "target" gynecologic procedures, along with sacral colpopexy, myomectomy, and endometrial resection.

With an estimated 600,000 hysterectomies being performed each year in the United States, Intuitive sees potential for growth. As of this fall, the 2011 surgical volume with the da Vinci had increased 30% over 2010 volume across all types of procedures, said Intuitive Surgical’s Mr. Simmonds.

Having a surgical robot has become a status symbol of sorts for hospitals in many urban areas – as of September, Intuitive had installed 1,478 da Vinci surgical systems in the United States – and ob.gyns. may feel compelled to keep up with market demands.

"General ob.gyns. don’t want to be the only physicians in the community not offering it," said Dr. Delmore, who teaches robotic surgery as a proctor for Intuitive Surgical.

Many ob.gyns., moreover, find robotic-assisted laparoscopy much easier than conventional laparoscopy to learn and adopt. Suturing is easier, and Dr. Magrina and other proponents of robotics maintain that the advantages of instrument articulation and steady three-dimensional vision have proven even higher than expected – for hysterectomies as well as more complex gynecologic procedures.

While the learning curve for robotics is said to be relatively short, Dr. Pasic and his coauthors caution that robotic assistance should not be used by physicians who are unwilling to invest time and effort into laparoscopic training. Exuberance for the da Vinci could have an "unintended negative effect on resident and fellow training as it relates to overall laparoscopic competencies," they said.

Institutions, in the meantime, are individually attempting to determine how best to train residents in robotic-assisted surgery. The University of Kansas is implementing a training model for ob.gyn. residents that includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies.

Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. utilize this training. "What if residents go somewhere afterward where there isn’t a robot, for instance? Will [they have learned enough] to safely operate?" he said.

Dr. Magrina said he had no relevant financial disclosures. Dr. Delmore teaches robotic surgery as a proctor for Intuitive Surgical. Dr. Pasic is a speaker for Ethicon Endo-Surgery.

A recent explosion of interest in robotic surgery for routine hysterectomies and treatment of other nononcologic gynecologic conditions is raising concern about the cost and comparative value of the robot over conventional laparoscopy, as well as the future of vaginal hysterectomy and current and future training needs.

In 2010, for the first time, more hysterectomies were performed with the da Vinci Surgical System than any other procedure, including prostatectomy. The number of robotic-assisted hysterectomies performed worldwide grew to 110,000 in 2010, from approximately 69,000 the year before.

Approximately 32,000 of these hysterectomies were for treatment of cancer, and the remaining 78,000 were related to benign conditions, according to Chris Simmonds, senior director of marketing for Intuitive Surgical, which makes the da Vinci, the only such system currently on the market.

Gynecologic oncologists swiftly embraced the robotic surgical system after it was approved in 2005 for gynecologic surgical procedures because it enabled them to perform minimally invasive endometrial cancer staging – something most surgeons found too technically challenging with pure laparoscopy.

While issues of cost and training have been part of an ongoing debate in gynecologic oncology, such issues have taken on new meaning – and more urgency – with the more recent rise in robotically-assisted routine hysterectomy. It can be argued, some experts explain, that an advantage exists for robotics in gynecologic oncology that, overall, does not exist for benign disease.

"Robotics will probably be the future of surgery," said Dr. Resad P. Pasic, professor of obstetrics and gynecology and director of operative gynecologic endoscopy at the University of Louisville (Ky.). "We need to [better understand] what the real advantages are, however, especially for routine laparoscopic hysterectomies, because the cost is higher than traditional laparoscopy and vaginal surgery."

Robotic assistance "is great for some procedures, like myomectomies, where there is more suturing. But I really don’t see a huge benefit overall for less complex, benign cases," he said in an interview. "We’re even seeing supracervical hysterectomies being done [robotically] – that doesn’t make any sense."

A study published last year, which Dr. Pasic coauthored, found higher per-case hospital costs with robotic-assisted hysterectomies, compared with conventional laparoscopic hysterectomies, without any significant differences in complications, postsurgical infections, or frequency of hemorrhage.

Robot-assisted hysterectomies were associated with longer surgical times and cost an average of $2,600 more, the investigators reported (J. Minim. Invasive Gynecol. 2010;17:730-8).

Using the Premier hospital database, they analyzed patient records and billing and insurance data for more than 36,000 women who received minimally invasive hysterectomy during 2007-2008 in more than 350 hospitals. Their cost analysis reflected the cost of the robotic procedure to the hospital but did not include the acquisition or maintenance costs of the robotic device over time.

The robotic unit costs between $1 million and $2.3 million and is associated with annual maintenance costs of $100,000-$170,000 a year, and instrumentation/accessories costs of $1,300-$2,200 per procedure, according to Intuitive Surgical.

"Further decisions regarding the diffusion of robot technology in routine laparoscopic hysterectomy," they concluded, must be informed by randomized controlled studies of comparative effectiveness.

At the annual meeting of the American Association of Gynecologic Laparoscopists last month, the paper won the organization’s Robert Hunt Award for the "best article" published in the Journal of Minimally Invasive Gynecology in the past year. The study may cause some to pause, however, in that it was funded by Ethicon Endo-Surgery, and because three of the six coauthors have notable ties with Ethicon – one is employed by the company, one is a consultant, and Dr. Pasic is a speaker for the company.

Dr. Pasic, who said he uses the da Vinci for about 10% of his procedures, dismissed any suggestions of bias. "We’re not the only paper concluding there is a high cost to robotics, and we made every effort to be as impartial as possible," he said.

Authors of a broader recently-published analysis of robotic-assisted surgery and health care costs drew similar conclusions about comparative value. The investigators examined all the cost studies of robot-assisted procedures published since 2005 and reported that, on average, "across the full range of 20 types of surgery for which studies exist," the additional cost of using a robot-assisted procedure was about $1,600, or about 6% of the cost of the procedure in 2007 (N. Eng. J. Med. 2010;363:701-4).

There have not been any large-scale randomized trials of robot-assisted surgery, and the "limited observational evidence fails to show that the long-term outcomes of robot-assisted surgery are superior to those of conventional procedures," said Dr. Gabriel I. Barbash of the medical school at Tel Aviv (Israel) University and Sherry A. Glied, Ph.D., of the school of public health at Columbia University, New York.

With hysterectomy, a pure vaginal approach has long been viewed by many experts as the preferable approach whenever possible – the most cost-effective minimally invasive method – and some experts are concerned that the growing popularity of robotics may chip away at its use.

"Vaginal hysterectomy is an art, so the question is, are we killing the art with the new technology we’re using for laparoscopy and now robotics? Maybe ... there are some studies suggesting [this], but we have no definitive data," Dr. Pasic said.

Dr. Javier Magrina, a professor of obstetrics and gynecology and director of gynecologic oncology at the Mayo Clinic in Scottsdale, Ariz., who has written and lectured extensively on robotic surgery from the standpoint of both benign and malignant disease, said that so far, vaginal hysterectomy rates appear to be "stable in spite of robotics," comprising about 20%-25% of all hysterectomies. "The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good," he said in an interview.

Dr. Jed Delmore and his colleagues at the University of Kansas in Wichita found just this when they compared the types of hysterectomy performed at their teaching hospital and two outpatient surgery centers during two periods of time: before robotic surgery became locally available (2006-2007) and 2 years after it arrived (2009-2010).

Using electronic medical record and billing data to identify hysterectomies, they found that the number of abdominal hysterectomies decreased significantly, while the number of vaginal hysterectomies remained relatively constant. The unpublished findings were presented at the American Congress of Obstetricians and Gynecologists District VII meeting in Kansas City in September.

"At least in our community of 400,000 women, there was a positive shift," Dr. Delmore said in an interview.

Still, he said, the potential longer-term impact of robotics on vaginal hysterectomy is a concern. "If there’s a big shift from abdominal surgery to robotic surgery, that will be cost-effective. ... But if it turns out that over time fewer women end up having vaginal hysterectomies, and have robotic hysterectomies instead, there will be greater expense to individuals and society," said Dr. Delmore, professor of obstetrics and gynecology and director of gynecologic oncology at the university.

An even larger concern, he noted, is "whether robotic surgery, as it becomes more and more available, will increase the total volume of hysterectomies – in women who would have previously been treated with hormone therapy or [other modalities]."

Such a trend may be occurring with prostatectomy, note the authors of the New England Journal of Medicine cost analysis, with robotic technology possibly contributing to the substitution of surgical for non-surgical treatments for prostate cancer.

This does not appear to be happening with hysterectomy in the Kansas City area thus far, Dr. Delmore said.

The undercurrents may already exist, however. Gynecology is one of Intuitive Surgical’s five main "target markets," according to a company investor presentation, and hysterectomy is one of four "target" gynecologic procedures, along with sacral colpopexy, myomectomy, and endometrial resection.

With an estimated 600,000 hysterectomies being performed each year in the United States, Intuitive sees potential for growth. As of this fall, the 2011 surgical volume with the da Vinci had increased 30% over 2010 volume across all types of procedures, said Intuitive Surgical’s Mr. Simmonds.

Having a surgical robot has become a status symbol of sorts for hospitals in many urban areas – as of September, Intuitive had installed 1,478 da Vinci surgical systems in the United States – and ob.gyns. may feel compelled to keep up with market demands.

"General ob.gyns. don’t want to be the only physicians in the community not offering it," said Dr. Delmore, who teaches robotic surgery as a proctor for Intuitive Surgical.

Many ob.gyns., moreover, find robotic-assisted laparoscopy much easier than conventional laparoscopy to learn and adopt. Suturing is easier, and Dr. Magrina and other proponents of robotics maintain that the advantages of instrument articulation and steady three-dimensional vision have proven even higher than expected – for hysterectomies as well as more complex gynecologic procedures.

While the learning curve for robotics is said to be relatively short, Dr. Pasic and his coauthors caution that robotic assistance should not be used by physicians who are unwilling to invest time and effort into laparoscopic training. Exuberance for the da Vinci could have an "unintended negative effect on resident and fellow training as it relates to overall laparoscopic competencies," they said.

Institutions, in the meantime, are individually attempting to determine how best to train residents in robotic-assisted surgery. The University of Kansas is implementing a training model for ob.gyn. residents that includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies.

Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. utilize this training. "What if residents go somewhere afterward where there isn’t a robot, for instance? Will [they have learned enough] to safely operate?" he said.

Dr. Magrina said he had no relevant financial disclosures. Dr. Delmore teaches robotic surgery as a proctor for Intuitive Surgical. Dr. Pasic is a speaker for Ethicon Endo-Surgery.

A recent explosion of interest in robotic surgery for routine hysterectomies and treatment of other nononcologic gynecologic conditions is raising concern about the cost and comparative value of the robot over conventional laparoscopy, as well as the future of vaginal hysterectomy and current and future training needs.

In 2010, for the first time, more hysterectomies were performed with the da Vinci Surgical System than any other procedure, including prostatectomy. The number of robotic-assisted hysterectomies performed worldwide grew to 110,000 in 2010, from approximately 69,000 the year before.

Approximately 32,000 of these hysterectomies were for treatment of cancer, and the remaining 78,000 were related to benign conditions, according to Chris Simmonds, senior director of marketing for Intuitive Surgical, which makes the da Vinci, the only such system currently on the market.

Gynecologic oncologists swiftly embraced the robotic surgical system after it was approved in 2005 for gynecologic surgical procedures because it enabled them to perform minimally invasive endometrial cancer staging – something most surgeons found too technically challenging with pure laparoscopy.

While issues of cost and training have been part of an ongoing debate in gynecologic oncology, such issues have taken on new meaning – and more urgency – with the more recent rise in robotically-assisted routine hysterectomy. It can be argued, some experts explain, that an advantage exists for robotics in gynecologic oncology that, overall, does not exist for benign disease.

"Robotics will probably be the future of surgery," said Dr. Resad P. Pasic, professor of obstetrics and gynecology and director of operative gynecologic endoscopy at the University of Louisville (Ky.). "We need to [better understand] what the real advantages are, however, especially for routine laparoscopic hysterectomies, because the cost is higher than traditional laparoscopy and vaginal surgery."

Robotic assistance "is great for some procedures, like myomectomies, where there is more suturing. But I really don’t see a huge benefit overall for less complex, benign cases," he said in an interview. "We’re even seeing supracervical hysterectomies being done [robotically] – that doesn’t make any sense."

A study published last year, which Dr. Pasic coauthored, found higher per-case hospital costs with robotic-assisted hysterectomies, compared with conventional laparoscopic hysterectomies, without any significant differences in complications, postsurgical infections, or frequency of hemorrhage.

Robot-assisted hysterectomies were associated with longer surgical times and cost an average of $2,600 more, the investigators reported (J. Minim. Invasive Gynecol. 2010;17:730-8).

Using the Premier hospital database, they analyzed patient records and billing and insurance data for more than 36,000 women who received minimally invasive hysterectomy during 2007-2008 in more than 350 hospitals. Their cost analysis reflected the cost of the robotic procedure to the hospital but did not include the acquisition or maintenance costs of the robotic device over time.

The robotic unit costs between $1 million and $2.3 million and is associated with annual maintenance costs of $100,000-$170,000 a year, and instrumentation/accessories costs of $1,300-$2,200 per procedure, according to Intuitive Surgical.

"Further decisions regarding the diffusion of robot technology in routine laparoscopic hysterectomy," they concluded, must be informed by randomized controlled studies of comparative effectiveness.

At the annual meeting of the American Association of Gynecologic Laparoscopists last month, the paper won the organization’s Robert Hunt Award for the "best article" published in the Journal of Minimally Invasive Gynecology in the past year. The study may cause some to pause, however, in that it was funded by Ethicon Endo-Surgery, and because three of the six coauthors have notable ties with Ethicon – one is employed by the company, one is a consultant, and Dr. Pasic is a speaker for the company.

Dr. Pasic, who said he uses the da Vinci for about 10% of his procedures, dismissed any suggestions of bias. "We’re not the only paper concluding there is a high cost to robotics, and we made every effort to be as impartial as possible," he said.

Authors of a broader recently-published analysis of robotic-assisted surgery and health care costs drew similar conclusions about comparative value. The investigators examined all the cost studies of robot-assisted procedures published since 2005 and reported that, on average, "across the full range of 20 types of surgery for which studies exist," the additional cost of using a robot-assisted procedure was about $1,600, or about 6% of the cost of the procedure in 2007 (N. Eng. J. Med. 2010;363:701-4).

There have not been any large-scale randomized trials of robot-assisted surgery, and the "limited observational evidence fails to show that the long-term outcomes of robot-assisted surgery are superior to those of conventional procedures," said Dr. Gabriel I. Barbash of the medical school at Tel Aviv (Israel) University and Sherry A. Glied, Ph.D., of the school of public health at Columbia University, New York.

With hysterectomy, a pure vaginal approach has long been viewed by many experts as the preferable approach whenever possible – the most cost-effective minimally invasive method – and some experts are concerned that the growing popularity of robotics may chip away at its use.

"Vaginal hysterectomy is an art, so the question is, are we killing the art with the new technology we’re using for laparoscopy and now robotics? Maybe ... there are some studies suggesting [this], but we have no definitive data," Dr. Pasic said.

Dr. Javier Magrina, a professor of obstetrics and gynecology and director of gynecologic oncology at the Mayo Clinic in Scottsdale, Ariz., who has written and lectured extensively on robotic surgery from the standpoint of both benign and malignant disease, said that so far, vaginal hysterectomy rates appear to be "stable in spite of robotics," comprising about 20%-25% of all hysterectomies. "The increase of robotic hysterectomy so far has decreased the number of laparotomies, which is very good," he said in an interview.

Dr. Jed Delmore and his colleagues at the University of Kansas in Wichita found just this when they compared the types of hysterectomy performed at their teaching hospital and two outpatient surgery centers during two periods of time: before robotic surgery became locally available (2006-2007) and 2 years after it arrived (2009-2010).

Using electronic medical record and billing data to identify hysterectomies, they found that the number of abdominal hysterectomies decreased significantly, while the number of vaginal hysterectomies remained relatively constant. The unpublished findings were presented at the American Congress of Obstetricians and Gynecologists District VII meeting in Kansas City in September.

"At least in our community of 400,000 women, there was a positive shift," Dr. Delmore said in an interview.

Still, he said, the potential longer-term impact of robotics on vaginal hysterectomy is a concern. "If there’s a big shift from abdominal surgery to robotic surgery, that will be cost-effective. ... But if it turns out that over time fewer women end up having vaginal hysterectomies, and have robotic hysterectomies instead, there will be greater expense to individuals and society," said Dr. Delmore, professor of obstetrics and gynecology and director of gynecologic oncology at the university.

An even larger concern, he noted, is "whether robotic surgery, as it becomes more and more available, will increase the total volume of hysterectomies – in women who would have previously been treated with hormone therapy or [other modalities]."

Such a trend may be occurring with prostatectomy, note the authors of the New England Journal of Medicine cost analysis, with robotic technology possibly contributing to the substitution of surgical for non-surgical treatments for prostate cancer.

This does not appear to be happening with hysterectomy in the Kansas City area thus far, Dr. Delmore said.

The undercurrents may already exist, however. Gynecology is one of Intuitive Surgical’s five main "target markets," according to a company investor presentation, and hysterectomy is one of four "target" gynecologic procedures, along with sacral colpopexy, myomectomy, and endometrial resection.

With an estimated 600,000 hysterectomies being performed each year in the United States, Intuitive sees potential for growth. As of this fall, the 2011 surgical volume with the da Vinci had increased 30% over 2010 volume across all types of procedures, said Intuitive Surgical’s Mr. Simmonds.

Having a surgical robot has become a status symbol of sorts for hospitals in many urban areas – as of September, Intuitive had installed 1,478 da Vinci surgical systems in the United States – and ob.gyns. may feel compelled to keep up with market demands.

"General ob.gyns. don’t want to be the only physicians in the community not offering it," said Dr. Delmore, who teaches robotic surgery as a proctor for Intuitive Surgical.

Many ob.gyns., moreover, find robotic-assisted laparoscopy much easier than conventional laparoscopy to learn and adopt. Suturing is easier, and Dr. Magrina and other proponents of robotics maintain that the advantages of instrument articulation and steady three-dimensional vision have proven even higher than expected – for hysterectomies as well as more complex gynecologic procedures.

While the learning curve for robotics is said to be relatively short, Dr. Pasic and his coauthors caution that robotic assistance should not be used by physicians who are unwilling to invest time and effort into laparoscopic training. Exuberance for the da Vinci could have an "unintended negative effect on resident and fellow training as it relates to overall laparoscopic competencies," they said.

Institutions, in the meantime, are individually attempting to determine how best to train residents in robotic-assisted surgery. The University of Kansas is implementing a training model for ob.gyn. residents that includes an online tutorial, training with inanimate objects, animal lab training, and bedside assistance in real robotic-assisted hysterectomies.

Dr. Delmore and his colleagues have a study underway to look at how graduate ob.gyns. utilize this training. "What if residents go somewhere afterward where there isn’t a robot, for instance? Will [they have learned enough] to safely operate?" he said.

Dr. Magrina said he had no relevant financial disclosures. Dr. Delmore teaches robotic surgery as a proctor for Intuitive Surgical. Dr. Pasic is a speaker for Ethicon Endo-Surgery.

Repeated exposure to anesthesia and surgery before the age of 2 years was a significant independent risk factor for the later development of learning disabilities in a matched cohort study involving children in one school district, adjustment for comorbidity, and multiple outcome measures.

No association was seen after a single episode of anesthesia and surgery, according to Dr. Randall P. Flick and his colleagues at the Mayo Clinic in Rochester, Minn.

In the past decade, animal studies have firmly established a relationship between the use of general anesthetics during periods of rapid brain growth and widespread apoptotic neurodegeneration, with adverse effects of learning and behavior, according to the researchers.

Some clinical studies have provided insight, but with mixed findings and without controlling for comorbidity and without examining multiple types of outcomes, they wrote.

Even with the new study, which identified multiple anesthesia exposures as a significant risk factor for the development of learning disabilities (hazard ratio of 2.16), the clinical relevance remains uncertain. But "at this point, we cannot exclude the possibility that multiple exposures to anesthesia/surgery may adversely affect neurodevelopment," said Dr. Flick of the department of anesthesiology, and his associates (Pediatrics 2011 [doi:10.1542/peds.2011-0351]).

The investigators followed a cohort of children born between 1976 and 1982 to mothers who resided in the same community, attended the same schools, and received virtually all their health care at the Mayo Clinic or at Olmstead Medical Center in Rochester, Minn.

Children who were exposed to anesthesia before age 2 years (350 of the 5,357 children in the cohort) were matched with two unexposed children (700 of the children in the cohort) on the basis on factors known to influence the incidence of learning disabilities, including gender, mother’s education, birth weight, and gestational age.

Two methods were used to quantify health status at age 5 years, and school records were used to track when children developed learning disabilities.

In addition to learning disabilities (overall as well as the subtypes of reading, written language, and mathematics), the study’s outcomes included receipt of an individualized education program (IEP) and results of group-administered tests of cognition and achievement.

By age 19, the cumulative incidence of learning disabilities (with adjustments made for comorbidities and health status) was 21.3% for unexposed controls, 23.6% for those with a single exposure, and 36.6% for those with multiple exposures.

A similar pattern was observed for each subtype of learning disability and in group-administered tests of achievement and cognition. Multiple exposures were associated with lower scores in most of the standardized tests.

Multiple exposures to anesthesia also appeared to affect the rate of children receiving an IEP for difficulties with speech and language, but had no effect on the need for an IEP relating to emotional/behavioral disorders, the investigators reported.

Of the 350 children exposed to general anesthesia early on, 286 were exposed once and 64 were exposed more than once. The most frequent anesthesia was a combination of halothane (87.5%) and nitrous oxide (88.1%).

The findings suggest that any neurodevelopmental effects of multiple exposure may be limited to impairment of speech and language rather than to developmental disorders more generally, the researchers wrote. "However, this can only be a provisional conclusion," they wrote, because the IEP for emotional/behavioral disorders captures only more severely disruptive behaviors.

Overall, they cautioned, the study cannot distinguish between the effects of anesthesia per se, and surgery or the need for surgery. In addition, the measures used to control for health status may not have captured all potential confounders.

Children who were severely mentally retarded were excluded from the study; of these 19 children, all but 1 were known to have profound neurodevelopmental deficits before exposure to anesthesia and surgery.

The study was supported by a grant from the U.S. National Institute of Aging. Dr. Flick and his colleagues reported no relevant financial relationships.

Repeated exposure to anesthesia and surgery before the age of 2 years was a significant independent risk factor for the later development of learning disabilities in a matched cohort study involving children in one school district, adjustment for comorbidity, and multiple outcome measures.

No association was seen after a single episode of anesthesia and surgery, according to Dr. Randall P. Flick and his colleagues at the Mayo Clinic in Rochester, Minn.

In the past decade, animal studies have firmly established a relationship between the use of general anesthetics during periods of rapid brain growth and widespread apoptotic neurodegeneration, with adverse effects of learning and behavior, according to the researchers.

Some clinical studies have provided insight, but with mixed findings and without controlling for comorbidity and without examining multiple types of outcomes, they wrote.

Even with the new study, which identified multiple anesthesia exposures as a significant risk factor for the development of learning disabilities (hazard ratio of 2.16), the clinical relevance remains uncertain. But "at this point, we cannot exclude the possibility that multiple exposures to anesthesia/surgery may adversely affect neurodevelopment," said Dr. Flick of the department of anesthesiology, and his associates (Pediatrics 2011 [doi:10.1542/peds.2011-0351]).

The investigators followed a cohort of children born between 1976 and 1982 to mothers who resided in the same community, attended the same schools, and received virtually all their health care at the Mayo Clinic or at Olmstead Medical Center in Rochester, Minn.

Children who were exposed to anesthesia before age 2 years (350 of the 5,357 children in the cohort) were matched with two unexposed children (700 of the children in the cohort) on the basis on factors known to influence the incidence of learning disabilities, including gender, mother’s education, birth weight, and gestational age.

Two methods were used to quantify health status at age 5 years, and school records were used to track when children developed learning disabilities.

In addition to learning disabilities (overall as well as the subtypes of reading, written language, and mathematics), the study’s outcomes included receipt of an individualized education program (IEP) and results of group-administered tests of cognition and achievement.

By age 19, the cumulative incidence of learning disabilities (with adjustments made for comorbidities and health status) was 21.3% for unexposed controls, 23.6% for those with a single exposure, and 36.6% for those with multiple exposures.

A similar pattern was observed for each subtype of learning disability and in group-administered tests of achievement and cognition. Multiple exposures were associated with lower scores in most of the standardized tests.

Multiple exposures to anesthesia also appeared to affect the rate of children receiving an IEP for difficulties with speech and language, but had no effect on the need for an IEP relating to emotional/behavioral disorders, the investigators reported.

Of the 350 children exposed to general anesthesia early on, 286 were exposed once and 64 were exposed more than once. The most frequent anesthesia was a combination of halothane (87.5%) and nitrous oxide (88.1%).

The findings suggest that any neurodevelopmental effects of multiple exposure may be limited to impairment of speech and language rather than to developmental disorders more generally, the researchers wrote. "However, this can only be a provisional conclusion," they wrote, because the IEP for emotional/behavioral disorders captures only more severely disruptive behaviors.

Overall, they cautioned, the study cannot distinguish between the effects of anesthesia per se, and surgery or the need for surgery. In addition, the measures used to control for health status may not have captured all potential confounders.

Children who were severely mentally retarded were excluded from the study; of these 19 children, all but 1 were known to have profound neurodevelopmental deficits before exposure to anesthesia and surgery.

The study was supported by a grant from the U.S. National Institute of Aging. Dr. Flick and his colleagues reported no relevant financial relationships.

Repeated exposure to anesthesia and surgery before the age of 2 years was a significant independent risk factor for the later development of learning disabilities in a matched cohort study involving children in one school district, adjustment for comorbidity, and multiple outcome measures.

No association was seen after a single episode of anesthesia and surgery, according to Dr. Randall P. Flick and his colleagues at the Mayo Clinic in Rochester, Minn.

In the past decade, animal studies have firmly established a relationship between the use of general anesthetics during periods of rapid brain growth and widespread apoptotic neurodegeneration, with adverse effects of learning and behavior, according to the researchers.

Some clinical studies have provided insight, but with mixed findings and without controlling for comorbidity and without examining multiple types of outcomes, they wrote.

Even with the new study, which identified multiple anesthesia exposures as a significant risk factor for the development of learning disabilities (hazard ratio of 2.16), the clinical relevance remains uncertain. But "at this point, we cannot exclude the possibility that multiple exposures to anesthesia/surgery may adversely affect neurodevelopment," said Dr. Flick of the department of anesthesiology, and his associates (Pediatrics 2011 [doi:10.1542/peds.2011-0351]).

The investigators followed a cohort of children born between 1976 and 1982 to mothers who resided in the same community, attended the same schools, and received virtually all their health care at the Mayo Clinic or at Olmstead Medical Center in Rochester, Minn.

Children who were exposed to anesthesia before age 2 years (350 of the 5,357 children in the cohort) were matched with two unexposed children (700 of the children in the cohort) on the basis on factors known to influence the incidence of learning disabilities, including gender, mother’s education, birth weight, and gestational age.

Two methods were used to quantify health status at age 5 years, and school records were used to track when children developed learning disabilities.

In addition to learning disabilities (overall as well as the subtypes of reading, written language, and mathematics), the study’s outcomes included receipt of an individualized education program (IEP) and results of group-administered tests of cognition and achievement.

By age 19, the cumulative incidence of learning disabilities (with adjustments made for comorbidities and health status) was 21.3% for unexposed controls, 23.6% for those with a single exposure, and 36.6% for those with multiple exposures.

A similar pattern was observed for each subtype of learning disability and in group-administered tests of achievement and cognition. Multiple exposures were associated with lower scores in most of the standardized tests.

Multiple exposures to anesthesia also appeared to affect the rate of children receiving an IEP for difficulties with speech and language, but had no effect on the need for an IEP relating to emotional/behavioral disorders, the investigators reported.

Of the 350 children exposed to general anesthesia early on, 286 were exposed once and 64 were exposed more than once. The most frequent anesthesia was a combination of halothane (87.5%) and nitrous oxide (88.1%).

The findings suggest that any neurodevelopmental effects of multiple exposure may be limited to impairment of speech and language rather than to developmental disorders more generally, the researchers wrote. "However, this can only be a provisional conclusion," they wrote, because the IEP for emotional/behavioral disorders captures only more severely disruptive behaviors.

Overall, they cautioned, the study cannot distinguish between the effects of anesthesia per se, and surgery or the need for surgery. In addition, the measures used to control for health status may not have captured all potential confounders.

Children who were severely mentally retarded were excluded from the study; of these 19 children, all but 1 were known to have profound neurodevelopmental deficits before exposure to anesthesia and surgery.

The study was supported by a grant from the U.S. National Institute of Aging. Dr. Flick and his colleagues reported no relevant financial relationships.