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U.S. flu activity continues to decline
The 2016-2017 U.S. influenza season appears to have peaked, as activity measures dropped for the third consecutive week, the Centers for Disease Control and Prevention reported.
For the week ending March 4, there were 11 states at level 10 on the CDC’s 1-10 scale of influenza-like illness (ILI) activity, with another three in the “high” range at levels 8 and 9. The previous week (Feb. 25), there were 22 states at level 10, with a total of 27 in the high range of ILI activity. At the peak of activity during the week of Feb. 11, there were 25 states at level 10, data from the CDC’s Outpatient ILI Surveillance Network show.
There were eight ILI-related pediatric deaths reported during the week ending March 4, although all occurred in earlier weeks. For the 2016-2017 season so far, 48 ILI-related pediatric deaths have been reported, the CDC said.
For the 70 counties in 13 states that report to the Influenza Hospitalization Surveillance Network, the flu-related hospitalization rate for the season is 43.5 per 100,000 population. The highest rate by age group is for those 65 years and over at 198.8 per 100,000, followed by 50- to 64-year-olds at 42.2 per 100,000 and children aged 0-4 years at 28.8 per 100,000, according to the CDC.
The 2016-2017 U.S. influenza season appears to have peaked, as activity measures dropped for the third consecutive week, the Centers for Disease Control and Prevention reported.
For the week ending March 4, there were 11 states at level 10 on the CDC’s 1-10 scale of influenza-like illness (ILI) activity, with another three in the “high” range at levels 8 and 9. The previous week (Feb. 25), there were 22 states at level 10, with a total of 27 in the high range of ILI activity. At the peak of activity during the week of Feb. 11, there were 25 states at level 10, data from the CDC’s Outpatient ILI Surveillance Network show.
There were eight ILI-related pediatric deaths reported during the week ending March 4, although all occurred in earlier weeks. For the 2016-2017 season so far, 48 ILI-related pediatric deaths have been reported, the CDC said.
For the 70 counties in 13 states that report to the Influenza Hospitalization Surveillance Network, the flu-related hospitalization rate for the season is 43.5 per 100,000 population. The highest rate by age group is for those 65 years and over at 198.8 per 100,000, followed by 50- to 64-year-olds at 42.2 per 100,000 and children aged 0-4 years at 28.8 per 100,000, according to the CDC.
The 2016-2017 U.S. influenza season appears to have peaked, as activity measures dropped for the third consecutive week, the Centers for Disease Control and Prevention reported.
For the week ending March 4, there were 11 states at level 10 on the CDC’s 1-10 scale of influenza-like illness (ILI) activity, with another three in the “high” range at levels 8 and 9. The previous week (Feb. 25), there were 22 states at level 10, with a total of 27 in the high range of ILI activity. At the peak of activity during the week of Feb. 11, there were 25 states at level 10, data from the CDC’s Outpatient ILI Surveillance Network show.
There were eight ILI-related pediatric deaths reported during the week ending March 4, although all occurred in earlier weeks. For the 2016-2017 season so far, 48 ILI-related pediatric deaths have been reported, the CDC said.
For the 70 counties in 13 states that report to the Influenza Hospitalization Surveillance Network, the flu-related hospitalization rate for the season is 43.5 per 100,000 population. The highest rate by age group is for those 65 years and over at 198.8 per 100,000, followed by 50- to 64-year-olds at 42.2 per 100,000 and children aged 0-4 years at 28.8 per 100,000, according to the CDC.
No benefit found for routine inpatient rehab after knee replacement
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
FROM JAMA
Key clinical point:
Major finding: There were no significant differences in the primary outcome of a 6-minute walk test at 26 weeks or in pain, function, and quality of life measures between patients randomized to inpatient or at-home rehab protocols.
Data source: A parallel, randomized controlled trial of 165 uncomplicated knee arthroplasty patients assigned to undergo either inpatient rehab for 10 days then in-home monitored rehab for 6 weeks or to a monitored 6-week home rehab 2 weeks after surgery. The study also included a third observational group of 112 patients (87 included in analysis) who underwent at-home rehab.
Disclosures: The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
Send children who had anaphylaxis home after 4 hours
ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.
The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.
In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.
The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.
Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.
“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.
The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.
Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.
Dr. Lee didn’t have any disclosures. There was no outside funding.
ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.
The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.
In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.
The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.
Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.
“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.
The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.
Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.
Dr. Lee didn’t have any disclosures. There was no outside funding.
ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.
The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.
In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.
The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.
Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.
“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.
The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.
Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.
Dr. Lee didn’t have any disclosures. There was no outside funding.
Key clinical point:
Major finding: The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED doctors opted for 4-hour observation in 2014, a near 60% reduction.
Data source: A study of 182 children who underwent 8-hour observation and 257 children who underwent 4-hour observation at the Children’s Hospital of Philadelphia ED.
Disclosures: The lead investigator didn’t have any disclosures. There was no outside funding.
Universal preterm birth screening not ready for prime time
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
FROM JAMA
Key clinical point:
Major finding: With a threshold of transvaginal cervical length of 25 mm or less at 16-22 weeks’ gestation, 247 women would need to be screened to identify one case of spontaneous preterm birth before 37 weeks’ gestation.
Data source: A prospective multicenter observational cohort study involving 9,410 nulliparous women across the United States.
Disclosures: The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. An associate reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
Managing family differences
What is it about families that makes our patients so upset? Why can our patients not just walk away from conflict? Why do they get so bent out of shape when family members do not say or do what they expect them to do? We all have families that are less than ideal and struggle with how to manage difference.
This column gives psychiatrists a framework for thinking with families about the universal dilemma of managing difference. This dilemma can be viewed from the perspectives of the individual, the family, and society: Identity is formed in the crucible of the family, where parental introjects become a model for the child’s development and can be rejected as an adolescent or adult as individuals shape their own identity. Processes within the family shape family members’ relationships and, therefore, their expectations of one another. Strong boundaries provide safety for those inside the family versus those outside the family.
Individual perspective
Family members’ perspective and expectations of others depend on their family position. Children or young adults want to please the parent, and to be accepted and recognized for who they are. They want their unique qualities to be valued, they want to be loved, and they want to feel that they belong.
Parents want their young adult to reach what they consider a successful life, and to be fulfilled and healthy. When their child strikes out on his or her own, the parent may not understand, and may feel let down or angry. The parent may say: “She married him to get back at me.” “Why is my son so rejecting of the business our family spent generations to build?” “How can my child reject our family values that we brought from the old country?” “How did it happen that my son is gay?”
Siblings have an idea of who their sibling should be, and this idea often is fixed and immutable. They may ask, “Why won’t my sister help me out?” “Why can’t she be a good sister?” “Why is my brother so jealous of me?”
Family elders may wonder why their adult children do not want to return home to care for them or why they want their parents to go into a nursing home.
These dilemmas are easy to understand as conscious expectations. More difficult to understand are the unconscious projections that tangle up families.
Unconscious psychological processes
The two main unconscious psychological processes that tangle up families are projection and projective identification. Projective identification is an unconscious process in which aspects of the self are split off and projected onto another person. In 1946, Melanie Klein introduced the term “projective identification” as follows: “Much of the hatred against parts of the self is now directed toward the mother. This leads to a particular form of identification which establishes the prototype of an aggressive object-relation. I suggest for these processes the term ‘projective identification’ ” (Int J Psychoanal. 1946;27[pt 3-4]:99-110).
Mutual projective processes can occur in committed relationships. The following scenario helps illustrate this: Ms. A. projects onto her husband her own feared and unwanted aggressive, dominating aspects of herself. The result is that she fears and respects him. He, in turn, comes to feel aggressive and dominating toward her, not only because of his own resources but because of her projections, which she forces onto him. He may, in turn, despise and disown timid and fearful aspects of his own personality and by a similar mechanism of projective identification force these unwanted aspects of himself onto his wife. Ms. A. is then composed of timid unaggressive parts of herself as well as his projections, and she carries these feelings as her part in the relationship. Some couples, like Mr. and Ms. A., live in such locked systems, dominated by mutual projections, with each not truly married to the other person but to the unwanted, split-off, and projected parts of themselves.
In this scenario, the husband becomes dominant and cruel, and the wife becomes stupidly timid and respectful. These marriages are stable, because each partner needs the other for narcissistic pathologic purposes (see “Some Psychodynamics of Large Groups” in “The Large Group: Dynamics and Therapy” [London: Karnac Books, 1975] and “The Ailment and Other Psychoanalytic Essays” [London: Free Association Books, 2015]).
Marriage offers an opportunity for individuals to work out these types of issues, or, in the case of Mr. and Ms. A, not work through them. Instead, they exist in tight mutual projections.
Family process perspective
Families function as a system or unit, and each person in the family has a role or function. When change occurs, basic rules of systems theory apply. For example, if the mother functions as the emotional barometer, no one else needs to pay attention to emotions, as that is the mother’s job. If she leaves or becomes ill, someone else will take on that role or the family will fall apart. If the father becomes depressed and unable to function in his role as a parent, the oldest child may have to step up to become the parent. When he gets better and his depression resolves, there may be tension – as the older child may not want to give up that role. There may be a disagreement in the family vision.
When the children grow and develop their own identities and lifestyles, the family has to adjust to include the adult children or cut them off. Individuals also may cut themselves off from the family if there are significant disagreements. There are variations, such as “semi-cutoffs,” where there is little contact except at ritualized holidays and significant family events. Therefore, tensions arise most clearly at these times when family members come together.
Boundaries protect the family
A family functions like a pack. As with most species, families and parents protect the young until they are able to care for themselves. The marriage contract specifies that spouses care for each other but additionally that they join extended families together. Family cares for family before caring for strangers. It is the elder’s role and responsibility to keep the family together, or the family members may drift apart or be subsumed into other family groups.
A clan is made up of related families that form a larger extended family unit. Historically, strong alliances, as in clans or family dynasties, become dominant socially. In recent history, the idea of clans has become less attractive as the idea of individualism has become the American ideal.
Modern families tend to be individually oriented and do not need their families for protection as much as primitive tribes did. Modern families have fairly loose boundaries, and problems can arise when the family tries to define boundaries and values.
Families also change composition with the impact of sociocultural influences, such as migration. However, the primitive social drive still forces us to form families and clans. This drive can explain much of the need for identifying people as “in or out” of the family. The Amish intentionally address this dilemma. At adolescence, the ritual of Rumspringa allows the young person to experience 1 year out of Amish life in Western life. The adolescent can then decide to be in or out. If the adolescent decides to be in, conformity to Amish lifestyle is required (“Serving the Amish,” Baltimore: Johns Hopkins University Press, 2014).
Lastly, our families provide memories of where we have come from and where we are going, both as individuals and as a clan. Powerful stories serve the next generation with a sense of belonging and a specific orientation to the world. The studies of third-generation Holocaust survivors attest to the power of family narratives. Individuals can choose to embrace the family narrative or alter it to allow individual growth.
Explaining families to families
When helping patients work through issues with their families, it is helpful to provide them with context. Among the important points we can make are:
● Families came into existence as a way to protect our young; this is true across the animal kingdom. Humans congregated into clans or tribes that demanded conformity and obedience to the chief. There was a clear sense of who was in and who was out. Many of the difficulties that we experience are tied to the primitive tension of needing to decide who is in and who is out. This is a normal function of families.
● These days, families have much looser boundaries, and individuals have the freedom to strike out on their own. Families have to grapple with their collective identity only when they get together at holiday times or transitional events like marriages, births, and deaths. So, is it worth getting upset about this? If so, ask patients what they would like to change – and why.
● With this background, the family can dive deeper. Ask your patients, “Is the issue a problem with roles within the family? Has there been a role transition? Has there been a death, serious illness, or birth? Has someone left, retired, or joined the family? How would you as a family like to proceed?”
● Lastly, is there a complicated tangled web or relationship that might be explained by mutual projective identifications? If so, refer to a colleague with family therapy skills.
Key points to keep in mind
1. Families should be placed in the context of clans and tribes.
2. Transitions and family events cause families to question their family identity, boundaries, and values.
3. Patients should explore their individual expectations about what families should do. This conversation can be extensive, and include cultural and generational flash points.
4. If there is a tangled web that makes no sense to you, refer to a colleague with family therapy skills.
Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.
What is it about families that makes our patients so upset? Why can our patients not just walk away from conflict? Why do they get so bent out of shape when family members do not say or do what they expect them to do? We all have families that are less than ideal and struggle with how to manage difference.
This column gives psychiatrists a framework for thinking with families about the universal dilemma of managing difference. This dilemma can be viewed from the perspectives of the individual, the family, and society: Identity is formed in the crucible of the family, where parental introjects become a model for the child’s development and can be rejected as an adolescent or adult as individuals shape their own identity. Processes within the family shape family members’ relationships and, therefore, their expectations of one another. Strong boundaries provide safety for those inside the family versus those outside the family.
Individual perspective
Family members’ perspective and expectations of others depend on their family position. Children or young adults want to please the parent, and to be accepted and recognized for who they are. They want their unique qualities to be valued, they want to be loved, and they want to feel that they belong.
Parents want their young adult to reach what they consider a successful life, and to be fulfilled and healthy. When their child strikes out on his or her own, the parent may not understand, and may feel let down or angry. The parent may say: “She married him to get back at me.” “Why is my son so rejecting of the business our family spent generations to build?” “How can my child reject our family values that we brought from the old country?” “How did it happen that my son is gay?”
Siblings have an idea of who their sibling should be, and this idea often is fixed and immutable. They may ask, “Why won’t my sister help me out?” “Why can’t she be a good sister?” “Why is my brother so jealous of me?”
Family elders may wonder why their adult children do not want to return home to care for them or why they want their parents to go into a nursing home.
These dilemmas are easy to understand as conscious expectations. More difficult to understand are the unconscious projections that tangle up families.
Unconscious psychological processes
The two main unconscious psychological processes that tangle up families are projection and projective identification. Projective identification is an unconscious process in which aspects of the self are split off and projected onto another person. In 1946, Melanie Klein introduced the term “projective identification” as follows: “Much of the hatred against parts of the self is now directed toward the mother. This leads to a particular form of identification which establishes the prototype of an aggressive object-relation. I suggest for these processes the term ‘projective identification’ ” (Int J Psychoanal. 1946;27[pt 3-4]:99-110).
Mutual projective processes can occur in committed relationships. The following scenario helps illustrate this: Ms. A. projects onto her husband her own feared and unwanted aggressive, dominating aspects of herself. The result is that she fears and respects him. He, in turn, comes to feel aggressive and dominating toward her, not only because of his own resources but because of her projections, which she forces onto him. He may, in turn, despise and disown timid and fearful aspects of his own personality and by a similar mechanism of projective identification force these unwanted aspects of himself onto his wife. Ms. A. is then composed of timid unaggressive parts of herself as well as his projections, and she carries these feelings as her part in the relationship. Some couples, like Mr. and Ms. A., live in such locked systems, dominated by mutual projections, with each not truly married to the other person but to the unwanted, split-off, and projected parts of themselves.
In this scenario, the husband becomes dominant and cruel, and the wife becomes stupidly timid and respectful. These marriages are stable, because each partner needs the other for narcissistic pathologic purposes (see “Some Psychodynamics of Large Groups” in “The Large Group: Dynamics and Therapy” [London: Karnac Books, 1975] and “The Ailment and Other Psychoanalytic Essays” [London: Free Association Books, 2015]).
Marriage offers an opportunity for individuals to work out these types of issues, or, in the case of Mr. and Ms. A, not work through them. Instead, they exist in tight mutual projections.
Family process perspective
Families function as a system or unit, and each person in the family has a role or function. When change occurs, basic rules of systems theory apply. For example, if the mother functions as the emotional barometer, no one else needs to pay attention to emotions, as that is the mother’s job. If she leaves or becomes ill, someone else will take on that role or the family will fall apart. If the father becomes depressed and unable to function in his role as a parent, the oldest child may have to step up to become the parent. When he gets better and his depression resolves, there may be tension – as the older child may not want to give up that role. There may be a disagreement in the family vision.
When the children grow and develop their own identities and lifestyles, the family has to adjust to include the adult children or cut them off. Individuals also may cut themselves off from the family if there are significant disagreements. There are variations, such as “semi-cutoffs,” where there is little contact except at ritualized holidays and significant family events. Therefore, tensions arise most clearly at these times when family members come together.
Boundaries protect the family
A family functions like a pack. As with most species, families and parents protect the young until they are able to care for themselves. The marriage contract specifies that spouses care for each other but additionally that they join extended families together. Family cares for family before caring for strangers. It is the elder’s role and responsibility to keep the family together, or the family members may drift apart or be subsumed into other family groups.
A clan is made up of related families that form a larger extended family unit. Historically, strong alliances, as in clans or family dynasties, become dominant socially. In recent history, the idea of clans has become less attractive as the idea of individualism has become the American ideal.
Modern families tend to be individually oriented and do not need their families for protection as much as primitive tribes did. Modern families have fairly loose boundaries, and problems can arise when the family tries to define boundaries and values.
Families also change composition with the impact of sociocultural influences, such as migration. However, the primitive social drive still forces us to form families and clans. This drive can explain much of the need for identifying people as “in or out” of the family. The Amish intentionally address this dilemma. At adolescence, the ritual of Rumspringa allows the young person to experience 1 year out of Amish life in Western life. The adolescent can then decide to be in or out. If the adolescent decides to be in, conformity to Amish lifestyle is required (“Serving the Amish,” Baltimore: Johns Hopkins University Press, 2014).
Lastly, our families provide memories of where we have come from and where we are going, both as individuals and as a clan. Powerful stories serve the next generation with a sense of belonging and a specific orientation to the world. The studies of third-generation Holocaust survivors attest to the power of family narratives. Individuals can choose to embrace the family narrative or alter it to allow individual growth.
Explaining families to families
When helping patients work through issues with their families, it is helpful to provide them with context. Among the important points we can make are:
● Families came into existence as a way to protect our young; this is true across the animal kingdom. Humans congregated into clans or tribes that demanded conformity and obedience to the chief. There was a clear sense of who was in and who was out. Many of the difficulties that we experience are tied to the primitive tension of needing to decide who is in and who is out. This is a normal function of families.
● These days, families have much looser boundaries, and individuals have the freedom to strike out on their own. Families have to grapple with their collective identity only when they get together at holiday times or transitional events like marriages, births, and deaths. So, is it worth getting upset about this? If so, ask patients what they would like to change – and why.
● With this background, the family can dive deeper. Ask your patients, “Is the issue a problem with roles within the family? Has there been a role transition? Has there been a death, serious illness, or birth? Has someone left, retired, or joined the family? How would you as a family like to proceed?”
● Lastly, is there a complicated tangled web or relationship that might be explained by mutual projective identifications? If so, refer to a colleague with family therapy skills.
Key points to keep in mind
1. Families should be placed in the context of clans and tribes.
2. Transitions and family events cause families to question their family identity, boundaries, and values.
3. Patients should explore their individual expectations about what families should do. This conversation can be extensive, and include cultural and generational flash points.
4. If there is a tangled web that makes no sense to you, refer to a colleague with family therapy skills.
Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.
What is it about families that makes our patients so upset? Why can our patients not just walk away from conflict? Why do they get so bent out of shape when family members do not say or do what they expect them to do? We all have families that are less than ideal and struggle with how to manage difference.
This column gives psychiatrists a framework for thinking with families about the universal dilemma of managing difference. This dilemma can be viewed from the perspectives of the individual, the family, and society: Identity is formed in the crucible of the family, where parental introjects become a model for the child’s development and can be rejected as an adolescent or adult as individuals shape their own identity. Processes within the family shape family members’ relationships and, therefore, their expectations of one another. Strong boundaries provide safety for those inside the family versus those outside the family.
Individual perspective
Family members’ perspective and expectations of others depend on their family position. Children or young adults want to please the parent, and to be accepted and recognized for who they are. They want their unique qualities to be valued, they want to be loved, and they want to feel that they belong.
Parents want their young adult to reach what they consider a successful life, and to be fulfilled and healthy. When their child strikes out on his or her own, the parent may not understand, and may feel let down or angry. The parent may say: “She married him to get back at me.” “Why is my son so rejecting of the business our family spent generations to build?” “How can my child reject our family values that we brought from the old country?” “How did it happen that my son is gay?”
Siblings have an idea of who their sibling should be, and this idea often is fixed and immutable. They may ask, “Why won’t my sister help me out?” “Why can’t she be a good sister?” “Why is my brother so jealous of me?”
Family elders may wonder why their adult children do not want to return home to care for them or why they want their parents to go into a nursing home.
These dilemmas are easy to understand as conscious expectations. More difficult to understand are the unconscious projections that tangle up families.
Unconscious psychological processes
The two main unconscious psychological processes that tangle up families are projection and projective identification. Projective identification is an unconscious process in which aspects of the self are split off and projected onto another person. In 1946, Melanie Klein introduced the term “projective identification” as follows: “Much of the hatred against parts of the self is now directed toward the mother. This leads to a particular form of identification which establishes the prototype of an aggressive object-relation. I suggest for these processes the term ‘projective identification’ ” (Int J Psychoanal. 1946;27[pt 3-4]:99-110).
Mutual projective processes can occur in committed relationships. The following scenario helps illustrate this: Ms. A. projects onto her husband her own feared and unwanted aggressive, dominating aspects of herself. The result is that she fears and respects him. He, in turn, comes to feel aggressive and dominating toward her, not only because of his own resources but because of her projections, which she forces onto him. He may, in turn, despise and disown timid and fearful aspects of his own personality and by a similar mechanism of projective identification force these unwanted aspects of himself onto his wife. Ms. A. is then composed of timid unaggressive parts of herself as well as his projections, and she carries these feelings as her part in the relationship. Some couples, like Mr. and Ms. A., live in such locked systems, dominated by mutual projections, with each not truly married to the other person but to the unwanted, split-off, and projected parts of themselves.
In this scenario, the husband becomes dominant and cruel, and the wife becomes stupidly timid and respectful. These marriages are stable, because each partner needs the other for narcissistic pathologic purposes (see “Some Psychodynamics of Large Groups” in “The Large Group: Dynamics and Therapy” [London: Karnac Books, 1975] and “The Ailment and Other Psychoanalytic Essays” [London: Free Association Books, 2015]).
Marriage offers an opportunity for individuals to work out these types of issues, or, in the case of Mr. and Ms. A, not work through them. Instead, they exist in tight mutual projections.
Family process perspective
Families function as a system or unit, and each person in the family has a role or function. When change occurs, basic rules of systems theory apply. For example, if the mother functions as the emotional barometer, no one else needs to pay attention to emotions, as that is the mother’s job. If she leaves or becomes ill, someone else will take on that role or the family will fall apart. If the father becomes depressed and unable to function in his role as a parent, the oldest child may have to step up to become the parent. When he gets better and his depression resolves, there may be tension – as the older child may not want to give up that role. There may be a disagreement in the family vision.
When the children grow and develop their own identities and lifestyles, the family has to adjust to include the adult children or cut them off. Individuals also may cut themselves off from the family if there are significant disagreements. There are variations, such as “semi-cutoffs,” where there is little contact except at ritualized holidays and significant family events. Therefore, tensions arise most clearly at these times when family members come together.
Boundaries protect the family
A family functions like a pack. As with most species, families and parents protect the young until they are able to care for themselves. The marriage contract specifies that spouses care for each other but additionally that they join extended families together. Family cares for family before caring for strangers. It is the elder’s role and responsibility to keep the family together, or the family members may drift apart or be subsumed into other family groups.
A clan is made up of related families that form a larger extended family unit. Historically, strong alliances, as in clans or family dynasties, become dominant socially. In recent history, the idea of clans has become less attractive as the idea of individualism has become the American ideal.
Modern families tend to be individually oriented and do not need their families for protection as much as primitive tribes did. Modern families have fairly loose boundaries, and problems can arise when the family tries to define boundaries and values.
Families also change composition with the impact of sociocultural influences, such as migration. However, the primitive social drive still forces us to form families and clans. This drive can explain much of the need for identifying people as “in or out” of the family. The Amish intentionally address this dilemma. At adolescence, the ritual of Rumspringa allows the young person to experience 1 year out of Amish life in Western life. The adolescent can then decide to be in or out. If the adolescent decides to be in, conformity to Amish lifestyle is required (“Serving the Amish,” Baltimore: Johns Hopkins University Press, 2014).
Lastly, our families provide memories of where we have come from and where we are going, both as individuals and as a clan. Powerful stories serve the next generation with a sense of belonging and a specific orientation to the world. The studies of third-generation Holocaust survivors attest to the power of family narratives. Individuals can choose to embrace the family narrative or alter it to allow individual growth.
Explaining families to families
When helping patients work through issues with their families, it is helpful to provide them with context. Among the important points we can make are:
● Families came into existence as a way to protect our young; this is true across the animal kingdom. Humans congregated into clans or tribes that demanded conformity and obedience to the chief. There was a clear sense of who was in and who was out. Many of the difficulties that we experience are tied to the primitive tension of needing to decide who is in and who is out. This is a normal function of families.
● These days, families have much looser boundaries, and individuals have the freedom to strike out on their own. Families have to grapple with their collective identity only when they get together at holiday times or transitional events like marriages, births, and deaths. So, is it worth getting upset about this? If so, ask patients what they would like to change – and why.
● With this background, the family can dive deeper. Ask your patients, “Is the issue a problem with roles within the family? Has there been a role transition? Has there been a death, serious illness, or birth? Has someone left, retired, or joined the family? How would you as a family like to proceed?”
● Lastly, is there a complicated tangled web or relationship that might be explained by mutual projective identifications? If so, refer to a colleague with family therapy skills.
Key points to keep in mind
1. Families should be placed in the context of clans and tribes.
2. Transitions and family events cause families to question their family identity, boundaries, and values.
3. Patients should explore their individual expectations about what families should do. This conversation can be extensive, and include cultural and generational flash points.
4. If there is a tangled web that makes no sense to you, refer to a colleague with family therapy skills.
Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.
WPR may benefit patients with stage IVB cervical cancer
NATIONAL HARBOR, MD. – Whole pelvic radiation delivered in addition to chemotherapy in women who present with stage IVB cervical cancer confers significant 12-month overall and progression-free survival benefits, according to findings from a multi-institutional retrospective review.
Of 127 patients diagnosed during 2005-2015 at four academic high-volume centers, 31 received no treatment or elected hospice care and, of the remaining patients, 34 received whole pelvic radiation (WPR) in addition to chemotherapy, and 62 received chemotherapy alone, which is the standard of care. The median overall survival was 14.1 vs. 6.9 months with vs. without WPR, and the median progression-free survival was 10 vs. 5 months, respectively, Victoria B. Perkins, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Of note, the rates of pelvic-related morbidity, including ureteral obstruction, vaginal or rectal bleeding, pelvic infection, pelvic pain, and fistula, did not differ significantly between the groups, said Dr. Perkins of the University of Oklahoma Health Sciences Center, Oklahoma City.
Study subjects were women with a median age of 54 years. A little more than a third (36%) were white, 35% were Hispanic, and 16% were black. Most (75%) had squamous cell carcinoma, and 95% were grade 2 or 3.
There were no significant differences in the demographics, location of [metastatic] disease, or distribution of chemotherapy type between the two groups, she said, noting that “interestingly, 26% of patients in the chemotherapy alone group received additional bevacizumab, compared to only 12% in the whole pelvic radiation with chemotherapy group.
“This could reflect the change in treatment strategy with the approval of bevacizumab during the treatment period,” Dr. Perkins noted.
About 5% of women have stage IVB cervical cancer at the time of diagnosis, but 5-year survival in these women is only about 15%.
“The mainstay of treatment is platinum and taxane with or without bevacizumab. In clinical practice, treatment of stage IVB disease varies,” Dr. Perkins said.
One strategy follows the guidance of phase III trials looking at chemotherapy with palliative radiation as needed.
“However, a significant number of patients experience morbidity and mortality directly related to their pelvic disease, such as vaginal bleeding, ureteral obstruction, fistulization, infections, and pain. Thus, an alternative approach is aimed at treating bulky pelvic disease with whole pelvic radiation followed by systemic chemotherapy with the goal to control symptoms and theoretically reduce recurrences in the pelvic field, which can be highly problematic in terms of symptomatic control,” she said, noting that this novel approach has not been formally studied.
The aim of the current review was to determine if WPR with chemotherapy would reduce pelvic morbidity and improve overall and progression-free survival.
“Survival in stage IVB disease remains extremely poor. Perhaps adding whole pelvic radiation to systemic chemotherapy has utility without increasing morbidity. However, the addition of whole pelvic radiation did not improve pelvic-related morbidity as previously hypothesized,” she said.
The study was limited by varied chemotherapy regimens in both groups and by changes in standard treatment practice during the span of study. It also was limited by the retrospective design, small sample size, and lack of quality of life data, but the findings support further study regarding subgroups of patients who could benefit the most from this treatment strategy, she concluded, noting, however, that such study is challenging because of the rarity of stage IVB disease.
Dr. Perkins reported having no disclosures.
NATIONAL HARBOR, MD. – Whole pelvic radiation delivered in addition to chemotherapy in women who present with stage IVB cervical cancer confers significant 12-month overall and progression-free survival benefits, according to findings from a multi-institutional retrospective review.
Of 127 patients diagnosed during 2005-2015 at four academic high-volume centers, 31 received no treatment or elected hospice care and, of the remaining patients, 34 received whole pelvic radiation (WPR) in addition to chemotherapy, and 62 received chemotherapy alone, which is the standard of care. The median overall survival was 14.1 vs. 6.9 months with vs. without WPR, and the median progression-free survival was 10 vs. 5 months, respectively, Victoria B. Perkins, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Of note, the rates of pelvic-related morbidity, including ureteral obstruction, vaginal or rectal bleeding, pelvic infection, pelvic pain, and fistula, did not differ significantly between the groups, said Dr. Perkins of the University of Oklahoma Health Sciences Center, Oklahoma City.
Study subjects were women with a median age of 54 years. A little more than a third (36%) were white, 35% were Hispanic, and 16% were black. Most (75%) had squamous cell carcinoma, and 95% were grade 2 or 3.
There were no significant differences in the demographics, location of [metastatic] disease, or distribution of chemotherapy type between the two groups, she said, noting that “interestingly, 26% of patients in the chemotherapy alone group received additional bevacizumab, compared to only 12% in the whole pelvic radiation with chemotherapy group.
“This could reflect the change in treatment strategy with the approval of bevacizumab during the treatment period,” Dr. Perkins noted.
About 5% of women have stage IVB cervical cancer at the time of diagnosis, but 5-year survival in these women is only about 15%.
“The mainstay of treatment is platinum and taxane with or without bevacizumab. In clinical practice, treatment of stage IVB disease varies,” Dr. Perkins said.
One strategy follows the guidance of phase III trials looking at chemotherapy with palliative radiation as needed.
“However, a significant number of patients experience morbidity and mortality directly related to their pelvic disease, such as vaginal bleeding, ureteral obstruction, fistulization, infections, and pain. Thus, an alternative approach is aimed at treating bulky pelvic disease with whole pelvic radiation followed by systemic chemotherapy with the goal to control symptoms and theoretically reduce recurrences in the pelvic field, which can be highly problematic in terms of symptomatic control,” she said, noting that this novel approach has not been formally studied.
The aim of the current review was to determine if WPR with chemotherapy would reduce pelvic morbidity and improve overall and progression-free survival.
“Survival in stage IVB disease remains extremely poor. Perhaps adding whole pelvic radiation to systemic chemotherapy has utility without increasing morbidity. However, the addition of whole pelvic radiation did not improve pelvic-related morbidity as previously hypothesized,” she said.
The study was limited by varied chemotherapy regimens in both groups and by changes in standard treatment practice during the span of study. It also was limited by the retrospective design, small sample size, and lack of quality of life data, but the findings support further study regarding subgroups of patients who could benefit the most from this treatment strategy, she concluded, noting, however, that such study is challenging because of the rarity of stage IVB disease.
Dr. Perkins reported having no disclosures.
NATIONAL HARBOR, MD. – Whole pelvic radiation delivered in addition to chemotherapy in women who present with stage IVB cervical cancer confers significant 12-month overall and progression-free survival benefits, according to findings from a multi-institutional retrospective review.
Of 127 patients diagnosed during 2005-2015 at four academic high-volume centers, 31 received no treatment or elected hospice care and, of the remaining patients, 34 received whole pelvic radiation (WPR) in addition to chemotherapy, and 62 received chemotherapy alone, which is the standard of care. The median overall survival was 14.1 vs. 6.9 months with vs. without WPR, and the median progression-free survival was 10 vs. 5 months, respectively, Victoria B. Perkins, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Of note, the rates of pelvic-related morbidity, including ureteral obstruction, vaginal or rectal bleeding, pelvic infection, pelvic pain, and fistula, did not differ significantly between the groups, said Dr. Perkins of the University of Oklahoma Health Sciences Center, Oklahoma City.
Study subjects were women with a median age of 54 years. A little more than a third (36%) were white, 35% were Hispanic, and 16% were black. Most (75%) had squamous cell carcinoma, and 95% were grade 2 or 3.
There were no significant differences in the demographics, location of [metastatic] disease, or distribution of chemotherapy type between the two groups, she said, noting that “interestingly, 26% of patients in the chemotherapy alone group received additional bevacizumab, compared to only 12% in the whole pelvic radiation with chemotherapy group.
“This could reflect the change in treatment strategy with the approval of bevacizumab during the treatment period,” Dr. Perkins noted.
About 5% of women have stage IVB cervical cancer at the time of diagnosis, but 5-year survival in these women is only about 15%.
“The mainstay of treatment is platinum and taxane with or without bevacizumab. In clinical practice, treatment of stage IVB disease varies,” Dr. Perkins said.
One strategy follows the guidance of phase III trials looking at chemotherapy with palliative radiation as needed.
“However, a significant number of patients experience morbidity and mortality directly related to their pelvic disease, such as vaginal bleeding, ureteral obstruction, fistulization, infections, and pain. Thus, an alternative approach is aimed at treating bulky pelvic disease with whole pelvic radiation followed by systemic chemotherapy with the goal to control symptoms and theoretically reduce recurrences in the pelvic field, which can be highly problematic in terms of symptomatic control,” she said, noting that this novel approach has not been formally studied.
The aim of the current review was to determine if WPR with chemotherapy would reduce pelvic morbidity and improve overall and progression-free survival.
“Survival in stage IVB disease remains extremely poor. Perhaps adding whole pelvic radiation to systemic chemotherapy has utility without increasing morbidity. However, the addition of whole pelvic radiation did not improve pelvic-related morbidity as previously hypothesized,” she said.
The study was limited by varied chemotherapy regimens in both groups and by changes in standard treatment practice during the span of study. It also was limited by the retrospective design, small sample size, and lack of quality of life data, but the findings support further study regarding subgroups of patients who could benefit the most from this treatment strategy, she concluded, noting, however, that such study is challenging because of the rarity of stage IVB disease.
Dr. Perkins reported having no disclosures.
AT THE ANNUAL MEETING ON WOMEN’S CANCERS
Key clinical point:
Major finding: Median overall and progression-free survival with vs. without WPR: 14.1 vs. 6.9 months and 10 vs. 5 months, respectively, but no difference in pelvic-related morbidity.
Data source: A retrospective review of 127 cases.
Disclosures: Dr. Perkins reported having no disclosures.
Adjuvant chemotherapy alone may suffice for some high-risk early cervical cancers
National Harbor, MD. – Patients, even those with surgically-confirmed risk factors, fared well when they received adjuvant chemotherapy without radiotherapy for early-stage cervical cancer.
In a retrospective review of 101 patients, Kwang-Beom Lee, MD, and his associates found that patients with known surgical risk factors had a posttreatment disease-free survival rate of 94.6%, a 5-year overall survival rate of 90.6%. and a disease-specific 5-year survival rate of 96.2%. These figures compare with survival rates of 79.4%, 90.6%, and 90.6%, respectively, for early-stage cervical cancer patients with lymph node metastasis.
Dr. Lee, professor of obstetrics and gynecology at Gachon University School of Medicine, Incheon, South Korea, said that about 3,600 cases of cervical cancer are diagnosed each year in Korea, and a little more than half (58%) are early-stage cancers. Most Korean patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA2-IIA cancer will receive a radical hysterectomy with lymphadenectomy, he said at the annual meeting of the Society of Gynecologic Oncology.
Dr. Lee and his colleagues sought to ascertain morbidity when patients with early cervical cancer received either adjuvant radiotherapy or concurrent chemoradiotherapy (CCRT), and to explore the potential role that chemotherapy alone might play in these patients.
Accordingly, one of the primary outcomes of the study was to determine outcomes of adjuvant chemotherapy alone for patients with FIGO stage IB-IIA cervical cancer who had surgically-confirmed risk factors, and who received radical surgery.
The surgically-confirmed factors included lymphovascular space invasion, depth of penetration, and tumor size.
Currently, Dr. Lee said, evidence indicates that CCRT for patients with high risk factors improves both progression-free survival and overall survival. For patients with intermediate risk factors, radiotherapy is associated with increased progression-free survival.
The researchers examined 101 patients in this category who were treated between March of 2006 and December of 2014 at two Korean academic medical centers, excluding patients who had positive tumor margins, who received neoadjuvant chemotherapy, or who had microscopic parametrium involvement.
The mean age of the patients was 47.1 years (range, 23-73 years). Their mean body mass index was 23.1, and two thirds of patients were premenopausal. Most patients (73.3%, n = 74) had stage IB1 cancer, while 23 (22.8%) had stage IB2 cancer, and 4 (3.9%) had stage IIA cancer. Most patients (74.3%, n = 75) had squamous cell cancer.
The radical procedure performed was a type C radical hysterectomy; patients underwent pelvic lymph node dissection, with or without para-aortic node dissection. Pelvic nodes included all of the common iliac nodes, the external and internal iliac chains, and the obturator nodes. Para-aortic node dissection included dissection up to the level of the inferior mesenteric artery.
A total of 50 patients received pelvic lymph node and para-aortic lymph node dissection, with a mean 54.5 tumors retrieved per patient. A mean of 4.58 pelvic nodes were assessed as metastatic. A mean of 11.2 para-aortic nodes were retrieved, and of these, a mean 5.3 were metastatic.
All together, 76 patients had a combination of three surgically-confirmed risk factors without positive lymph nodes; the remaining 25 patients had positive lymph nodes (4 with pelvic and para-aortic involvement, the remaining with pelvic involvement alone), and were included irrespective of whether they met other risk factor criteria.
Dr. Lee said that the protocol for chemotherapy paralelled Protocol 92 from the Gynecologic Oncology Group; patients received chemotherapy if the combination of tumor diameter, depth of stromal invasion, and lymphovascular space invasion met Protocol 92 criteria for treatment, or if more than one lymph node metastasis was found.
The chemotherapy regime for intermediate-risk patients called for six cycles of either platinum alone (n = 47), or platinum with paclitaxel (n = 54). High-risk patients received six cycles of paclitaxel and platinum.
Patients were followed for a median of 65 months, and a total of 14 patients had a recurrence.
Dr. Lee reported no conflicts of interest.
[email protected]
On Twitter @karioakes
National Harbor, MD. – Patients, even those with surgically-confirmed risk factors, fared well when they received adjuvant chemotherapy without radiotherapy for early-stage cervical cancer.
In a retrospective review of 101 patients, Kwang-Beom Lee, MD, and his associates found that patients with known surgical risk factors had a posttreatment disease-free survival rate of 94.6%, a 5-year overall survival rate of 90.6%. and a disease-specific 5-year survival rate of 96.2%. These figures compare with survival rates of 79.4%, 90.6%, and 90.6%, respectively, for early-stage cervical cancer patients with lymph node metastasis.
Dr. Lee, professor of obstetrics and gynecology at Gachon University School of Medicine, Incheon, South Korea, said that about 3,600 cases of cervical cancer are diagnosed each year in Korea, and a little more than half (58%) are early-stage cancers. Most Korean patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA2-IIA cancer will receive a radical hysterectomy with lymphadenectomy, he said at the annual meeting of the Society of Gynecologic Oncology.
Dr. Lee and his colleagues sought to ascertain morbidity when patients with early cervical cancer received either adjuvant radiotherapy or concurrent chemoradiotherapy (CCRT), and to explore the potential role that chemotherapy alone might play in these patients.
Accordingly, one of the primary outcomes of the study was to determine outcomes of adjuvant chemotherapy alone for patients with FIGO stage IB-IIA cervical cancer who had surgically-confirmed risk factors, and who received radical surgery.
The surgically-confirmed factors included lymphovascular space invasion, depth of penetration, and tumor size.
Currently, Dr. Lee said, evidence indicates that CCRT for patients with high risk factors improves both progression-free survival and overall survival. For patients with intermediate risk factors, radiotherapy is associated with increased progression-free survival.
The researchers examined 101 patients in this category who were treated between March of 2006 and December of 2014 at two Korean academic medical centers, excluding patients who had positive tumor margins, who received neoadjuvant chemotherapy, or who had microscopic parametrium involvement.
The mean age of the patients was 47.1 years (range, 23-73 years). Their mean body mass index was 23.1, and two thirds of patients were premenopausal. Most patients (73.3%, n = 74) had stage IB1 cancer, while 23 (22.8%) had stage IB2 cancer, and 4 (3.9%) had stage IIA cancer. Most patients (74.3%, n = 75) had squamous cell cancer.
The radical procedure performed was a type C radical hysterectomy; patients underwent pelvic lymph node dissection, with or without para-aortic node dissection. Pelvic nodes included all of the common iliac nodes, the external and internal iliac chains, and the obturator nodes. Para-aortic node dissection included dissection up to the level of the inferior mesenteric artery.
A total of 50 patients received pelvic lymph node and para-aortic lymph node dissection, with a mean 54.5 tumors retrieved per patient. A mean of 4.58 pelvic nodes were assessed as metastatic. A mean of 11.2 para-aortic nodes were retrieved, and of these, a mean 5.3 were metastatic.
All together, 76 patients had a combination of three surgically-confirmed risk factors without positive lymph nodes; the remaining 25 patients had positive lymph nodes (4 with pelvic and para-aortic involvement, the remaining with pelvic involvement alone), and were included irrespective of whether they met other risk factor criteria.
Dr. Lee said that the protocol for chemotherapy paralelled Protocol 92 from the Gynecologic Oncology Group; patients received chemotherapy if the combination of tumor diameter, depth of stromal invasion, and lymphovascular space invasion met Protocol 92 criteria for treatment, or if more than one lymph node metastasis was found.
The chemotherapy regime for intermediate-risk patients called for six cycles of either platinum alone (n = 47), or platinum with paclitaxel (n = 54). High-risk patients received six cycles of paclitaxel and platinum.
Patients were followed for a median of 65 months, and a total of 14 patients had a recurrence.
Dr. Lee reported no conflicts of interest.
[email protected]
On Twitter @karioakes
National Harbor, MD. – Patients, even those with surgically-confirmed risk factors, fared well when they received adjuvant chemotherapy without radiotherapy for early-stage cervical cancer.
In a retrospective review of 101 patients, Kwang-Beom Lee, MD, and his associates found that patients with known surgical risk factors had a posttreatment disease-free survival rate of 94.6%, a 5-year overall survival rate of 90.6%. and a disease-specific 5-year survival rate of 96.2%. These figures compare with survival rates of 79.4%, 90.6%, and 90.6%, respectively, for early-stage cervical cancer patients with lymph node metastasis.
Dr. Lee, professor of obstetrics and gynecology at Gachon University School of Medicine, Incheon, South Korea, said that about 3,600 cases of cervical cancer are diagnosed each year in Korea, and a little more than half (58%) are early-stage cancers. Most Korean patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA2-IIA cancer will receive a radical hysterectomy with lymphadenectomy, he said at the annual meeting of the Society of Gynecologic Oncology.
Dr. Lee and his colleagues sought to ascertain morbidity when patients with early cervical cancer received either adjuvant radiotherapy or concurrent chemoradiotherapy (CCRT), and to explore the potential role that chemotherapy alone might play in these patients.
Accordingly, one of the primary outcomes of the study was to determine outcomes of adjuvant chemotherapy alone for patients with FIGO stage IB-IIA cervical cancer who had surgically-confirmed risk factors, and who received radical surgery.
The surgically-confirmed factors included lymphovascular space invasion, depth of penetration, and tumor size.
Currently, Dr. Lee said, evidence indicates that CCRT for patients with high risk factors improves both progression-free survival and overall survival. For patients with intermediate risk factors, radiotherapy is associated with increased progression-free survival.
The researchers examined 101 patients in this category who were treated between March of 2006 and December of 2014 at two Korean academic medical centers, excluding patients who had positive tumor margins, who received neoadjuvant chemotherapy, or who had microscopic parametrium involvement.
The mean age of the patients was 47.1 years (range, 23-73 years). Their mean body mass index was 23.1, and two thirds of patients were premenopausal. Most patients (73.3%, n = 74) had stage IB1 cancer, while 23 (22.8%) had stage IB2 cancer, and 4 (3.9%) had stage IIA cancer. Most patients (74.3%, n = 75) had squamous cell cancer.
The radical procedure performed was a type C radical hysterectomy; patients underwent pelvic lymph node dissection, with or without para-aortic node dissection. Pelvic nodes included all of the common iliac nodes, the external and internal iliac chains, and the obturator nodes. Para-aortic node dissection included dissection up to the level of the inferior mesenteric artery.
A total of 50 patients received pelvic lymph node and para-aortic lymph node dissection, with a mean 54.5 tumors retrieved per patient. A mean of 4.58 pelvic nodes were assessed as metastatic. A mean of 11.2 para-aortic nodes were retrieved, and of these, a mean 5.3 were metastatic.
All together, 76 patients had a combination of three surgically-confirmed risk factors without positive lymph nodes; the remaining 25 patients had positive lymph nodes (4 with pelvic and para-aortic involvement, the remaining with pelvic involvement alone), and were included irrespective of whether they met other risk factor criteria.
Dr. Lee said that the protocol for chemotherapy paralelled Protocol 92 from the Gynecologic Oncology Group; patients received chemotherapy if the combination of tumor diameter, depth of stromal invasion, and lymphovascular space invasion met Protocol 92 criteria for treatment, or if more than one lymph node metastasis was found.
The chemotherapy regime for intermediate-risk patients called for six cycles of either platinum alone (n = 47), or platinum with paclitaxel (n = 54). High-risk patients received six cycles of paclitaxel and platinum.
Patients were followed for a median of 65 months, and a total of 14 patients had a recurrence.
Dr. Lee reported no conflicts of interest.
[email protected]
On Twitter @karioakes
AT THE ANNUAL MEETING ON WOMEN’S CANCERS
Key clinical point:
Major finding: Patients with known surgical risk factors had a posttreatment disease-free survival rate of 94.6%.
Data source: Retrospective, two-center review of patients with early cervical cancer and multiple risk factors or pelvic node involvement.
Disclosures: Dr. Lee reported no conflicts of interest.
Stroke in AF patients often preceded by inadequate anticoagulation
Of the 94,474 ischemic strokes that occurred in a nationwide registry among patients with known atrial fibrillation, 84% were preceded by inadequate anticoagulation, according to a report published online March 14 in JAMA.
Fully 30% of the patients in this retrospective cohort study weren’t taking any form of antithrombotic therapy before their stroke, even though all of them had atrial fibrillation (AF) and most of them had additional risk factors as well. And although nearly 20,000 of the study participants were taking warfarin before their stroke, 64% of them were taking subtherapeutic doses, said Ying Xian, MD, PhD, of the department of neurology at the Duke Clinical Research Institute, Durham, N.C., and his associates.
These findings highlight tens of thousands of missed opportunities for preventing stroke simply by following existing guidelines, the investigators said.
In previous studies, researchers have consistently found underuse of oral anticoagulants in community practice. To examine current trends since the rapid adoption of non–vitamin-K antagonist oral anticoagulants (NOACs), Dr. Xian and his associates analyzed data from the AHA/ASA Get With the Guidelines-Stroke Registry. They determined the prevalence of antithrombotic treatment among AF patients who developed ischemic stroke, focusing on patients (mean age, 79.9 years) enrolled in the registry after being admitted for ischemic stroke to 1,622 participating U.S. hospitals during a 2.5-year period.
A total of 79,008 (83.6%) were not receiving therapeutic anticoagulation at the time of their stroke. This included 28,583 who were not taking any antithrombotic treatment, 12,751 who were taking subtherapeutic doses of warfarin (international normalized ratio,or INR, of less than 2 at the time of their stroke), and 37,674 who were taking only antiplatelet drugs when additional treatment was indicated, the investigators said (JAMA. 2017 Mar 14;317[10]:1057-67).
Among the minority of AF patients who were receiving therapeutic anticoagulation at the time of their stroke, 7,176 were taking adequate warfarin and 8,290 were taking adequate NOACs such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis).
Stroke severity, as measured by median scores on the National Institutes of Health Stroke Scale, was significantly greater among patients receiving no antithrombotic medication, antiplatelet agents alone, or subtherapeutic levels of warfarin, compared with patients receiving therapeutic levels of warfarin or NOACs. Similarly, patients who had adequate anticoagulation before their stroke were significantly more likely to have better functional outcomes than those who did not. “These findings reinforce the importance of INR monitoring and dose adjustment to ... keep the INR in the therapeutic range,” Dr. Xian and his associates wrote.
The reasons why patients weren’t receiving adequate anticoagulation before their stroke – including any direct contraindications to treatment – were not available from the registry data. But such reasons are likely to persist after a stroke, and study clinicians were required to document such reasons in the medical records at hospital discharge. So the investigators examined reasons listed for not prescribing oral anticoagulation at hospital discharge in 58,084 patients.
A striking 38,249 AF patients (65.8%) in this large subgroup of study participants had no documented reason for not receiving oral anticoagulation, even after they were hospitalized for ischemic stroke and even though such documentation was “required.” Among the minority of patients whose records did show such reasons, the most common reason cited was bleeding risk (16.3%), followed by risk of falling (10.3%), the presence of a terminal illness (6.2%), patient or family refusal of the medication (4.3%), the patient’s impaired mental status (1.1%), adverse effects of the medication (1.0%), and allergy to the medication (0.6%).
This study was supported by the Patient-Centered Outcomes Research Institute. Dr. Xian reported that his institution received research funding from the American Heart Association, Daiichi Sankyo, Janssen, and Genentech. His associates reported ties to numerous industry sources.
Of the 94,474 ischemic strokes that occurred in a nationwide registry among patients with known atrial fibrillation, 84% were preceded by inadequate anticoagulation, according to a report published online March 14 in JAMA.
Fully 30% of the patients in this retrospective cohort study weren’t taking any form of antithrombotic therapy before their stroke, even though all of them had atrial fibrillation (AF) and most of them had additional risk factors as well. And although nearly 20,000 of the study participants were taking warfarin before their stroke, 64% of them were taking subtherapeutic doses, said Ying Xian, MD, PhD, of the department of neurology at the Duke Clinical Research Institute, Durham, N.C., and his associates.
These findings highlight tens of thousands of missed opportunities for preventing stroke simply by following existing guidelines, the investigators said.
In previous studies, researchers have consistently found underuse of oral anticoagulants in community practice. To examine current trends since the rapid adoption of non–vitamin-K antagonist oral anticoagulants (NOACs), Dr. Xian and his associates analyzed data from the AHA/ASA Get With the Guidelines-Stroke Registry. They determined the prevalence of antithrombotic treatment among AF patients who developed ischemic stroke, focusing on patients (mean age, 79.9 years) enrolled in the registry after being admitted for ischemic stroke to 1,622 participating U.S. hospitals during a 2.5-year period.
A total of 79,008 (83.6%) were not receiving therapeutic anticoagulation at the time of their stroke. This included 28,583 who were not taking any antithrombotic treatment, 12,751 who were taking subtherapeutic doses of warfarin (international normalized ratio,or INR, of less than 2 at the time of their stroke), and 37,674 who were taking only antiplatelet drugs when additional treatment was indicated, the investigators said (JAMA. 2017 Mar 14;317[10]:1057-67).
Among the minority of AF patients who were receiving therapeutic anticoagulation at the time of their stroke, 7,176 were taking adequate warfarin and 8,290 were taking adequate NOACs such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis).
Stroke severity, as measured by median scores on the National Institutes of Health Stroke Scale, was significantly greater among patients receiving no antithrombotic medication, antiplatelet agents alone, or subtherapeutic levels of warfarin, compared with patients receiving therapeutic levels of warfarin or NOACs. Similarly, patients who had adequate anticoagulation before their stroke were significantly more likely to have better functional outcomes than those who did not. “These findings reinforce the importance of INR monitoring and dose adjustment to ... keep the INR in the therapeutic range,” Dr. Xian and his associates wrote.
The reasons why patients weren’t receiving adequate anticoagulation before their stroke – including any direct contraindications to treatment – were not available from the registry data. But such reasons are likely to persist after a stroke, and study clinicians were required to document such reasons in the medical records at hospital discharge. So the investigators examined reasons listed for not prescribing oral anticoagulation at hospital discharge in 58,084 patients.
A striking 38,249 AF patients (65.8%) in this large subgroup of study participants had no documented reason for not receiving oral anticoagulation, even after they were hospitalized for ischemic stroke and even though such documentation was “required.” Among the minority of patients whose records did show such reasons, the most common reason cited was bleeding risk (16.3%), followed by risk of falling (10.3%), the presence of a terminal illness (6.2%), patient or family refusal of the medication (4.3%), the patient’s impaired mental status (1.1%), adverse effects of the medication (1.0%), and allergy to the medication (0.6%).
This study was supported by the Patient-Centered Outcomes Research Institute. Dr. Xian reported that his institution received research funding from the American Heart Association, Daiichi Sankyo, Janssen, and Genentech. His associates reported ties to numerous industry sources.
Of the 94,474 ischemic strokes that occurred in a nationwide registry among patients with known atrial fibrillation, 84% were preceded by inadequate anticoagulation, according to a report published online March 14 in JAMA.
Fully 30% of the patients in this retrospective cohort study weren’t taking any form of antithrombotic therapy before their stroke, even though all of them had atrial fibrillation (AF) and most of them had additional risk factors as well. And although nearly 20,000 of the study participants were taking warfarin before their stroke, 64% of them were taking subtherapeutic doses, said Ying Xian, MD, PhD, of the department of neurology at the Duke Clinical Research Institute, Durham, N.C., and his associates.
These findings highlight tens of thousands of missed opportunities for preventing stroke simply by following existing guidelines, the investigators said.
In previous studies, researchers have consistently found underuse of oral anticoagulants in community practice. To examine current trends since the rapid adoption of non–vitamin-K antagonist oral anticoagulants (NOACs), Dr. Xian and his associates analyzed data from the AHA/ASA Get With the Guidelines-Stroke Registry. They determined the prevalence of antithrombotic treatment among AF patients who developed ischemic stroke, focusing on patients (mean age, 79.9 years) enrolled in the registry after being admitted for ischemic stroke to 1,622 participating U.S. hospitals during a 2.5-year period.
A total of 79,008 (83.6%) were not receiving therapeutic anticoagulation at the time of their stroke. This included 28,583 who were not taking any antithrombotic treatment, 12,751 who were taking subtherapeutic doses of warfarin (international normalized ratio,or INR, of less than 2 at the time of their stroke), and 37,674 who were taking only antiplatelet drugs when additional treatment was indicated, the investigators said (JAMA. 2017 Mar 14;317[10]:1057-67).
Among the minority of AF patients who were receiving therapeutic anticoagulation at the time of their stroke, 7,176 were taking adequate warfarin and 8,290 were taking adequate NOACs such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis).
Stroke severity, as measured by median scores on the National Institutes of Health Stroke Scale, was significantly greater among patients receiving no antithrombotic medication, antiplatelet agents alone, or subtherapeutic levels of warfarin, compared with patients receiving therapeutic levels of warfarin or NOACs. Similarly, patients who had adequate anticoagulation before their stroke were significantly more likely to have better functional outcomes than those who did not. “These findings reinforce the importance of INR monitoring and dose adjustment to ... keep the INR in the therapeutic range,” Dr. Xian and his associates wrote.
The reasons why patients weren’t receiving adequate anticoagulation before their stroke – including any direct contraindications to treatment – were not available from the registry data. But such reasons are likely to persist after a stroke, and study clinicians were required to document such reasons in the medical records at hospital discharge. So the investigators examined reasons listed for not prescribing oral anticoagulation at hospital discharge in 58,084 patients.
A striking 38,249 AF patients (65.8%) in this large subgroup of study participants had no documented reason for not receiving oral anticoagulation, even after they were hospitalized for ischemic stroke and even though such documentation was “required.” Among the minority of patients whose records did show such reasons, the most common reason cited was bleeding risk (16.3%), followed by risk of falling (10.3%), the presence of a terminal illness (6.2%), patient or family refusal of the medication (4.3%), the patient’s impaired mental status (1.1%), adverse effects of the medication (1.0%), and allergy to the medication (0.6%).
This study was supported by the Patient-Centered Outcomes Research Institute. Dr. Xian reported that his institution received research funding from the American Heart Association, Daiichi Sankyo, Janssen, and Genentech. His associates reported ties to numerous industry sources.
FROM JAMA
Key clinical point: 84% of ischemic strokes that occurred in patients with known atrial fibrillation were preceded by inadequate anticoagulation.
Major finding: A total of 30% of AF patients were not taking any antithrombotic treatment before their ischemic stroke, 14% were taking subtherapeutic doses of warfarin, and 40% were taking only antiplatelet drugs when additional treatment was indicated.
Data source: A retrospective observational cohort study involving 94,474 patients with AF enrolled in a nationwide stroke outcomes registry.
Disclosures: This study was supported by the Patient-Centered Outcomes Research Institute. Dr. Xian reported that his institution received research funding from the American Heart Association, Daiichi Sankyo, Janssen, and Genentech. His associates reported ties to numerous industry sources.
Mobile stroke units becoming more common despite cost effectiveness questions
HOUSTON – Mobile stroke units – specially equipped ambulances that bring a diagnostic CT scanner and therapeutic thrombolysis directly to patients in the field – have begun to proliferate across the United States, although they remain investigational, with no clear proof of their incremental clinical value or cost effectiveness.
The first U.S. mobile stroke unit (MSU) launched in Houston in early 2014 (following the world’s first in Berlin, which began running in early 2011), and by early 2017, at least eight other U.S. MSUs were in operation, most of them put into service during the prior 15 months. U.S. MSU locations now include Cleveland; Denver; Memphis; New York; Toledo, Ohio; Trenton, N.J., and Northwestern Medicine and Rush University Medical Center in the western Chicago region. A tenth MSU is slated to start operation at the University of California, Los Angeles later this year.
Early data collected at some of these sites show that initiating care of an acute ischemic stroke patient in an MSU shaves precious minutes off the time it takes to start thrombolytic therapy with tissue plasminogen activator (tPA) compared with that at a hospital, and findings from preliminary analyses suggest better functional outcomes for patients treated this way. However, leaders in the nascent field readily admit that the data needed to clearly prove the benefit patients receive from operating MSUs are still a few years off. This uncertainty about the added benefit to patients from MSUs couples with one clear fact: MSUs are expensive to start up, with a price tag of roughly $1 million to get a MSU on the road for the first time, and also expensive to operate, with one estimate for the annual cost of keeping an MSU on the street at about $500,000 per year for staffing, supplies, and other expenses.
“Every U.S. MSU I know of started with philanthropic gifts, but you need a business model” to keep the program running long-term, James C. Grotta, MD, said during a session focused on MSUs at the International Stroke Conference sponsored by the American Heart Association. “You can’t sustain an MSU with philanthropy,” said Dr. Grotta, professor of neurology at the University of Texas Health Science Center in Houston, director and founder of the Houston MSU, and acknowledged godfather of all U.S. MSUs.
The concept behind MSUs is simple. Each one carries a CT scanner on board so that, once the vehicle’s staff identifies a patient with clinical signs of a significant–acute ischemic stroke in the field and confirms that the timing of the stroke onset suggests eligibility for tPA treatment, a CT scan can immediately be run on site to finalize tPA eligibility. The MSU staff can then begin infusing the drug in the ambulance as it speeds the patient to an appropriate hospital.
Another advantage to MSUs, in addition to quicker initiation of thrombolysis, is “getting patients to where they need to go faster and more directly,” said Dr. Nour.
“Instead of bringing patients first to a hospital that’s unable to do thrombectomy and where treatment gets slowed down, with an MSU you can give tPA on the street and go straight to a thrombectomy center,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at UCLA. “The MSU offers the tantalizing possibility that you can give tPA with no time hit because you can give it on the way directly to a comprehensive stroke center,” Dr. Saver said during a session at the meeting.
Early data on effectiveness
Dr. Nour reported some of the best evidence for the incremental clinical benefit of MSUs based on the reduced time for starting a tPA infusion. She used data collected by the Berlin group and published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU with similar patients managed by conventional ambulance transport for whom CT scan assessment and the start of TPA treatment did not begin until the patient reached a hospital.
The German analysis showed that, in the observational Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients–Study (PHANTOM-S), among 353 patients treated by conventional transport, the median time from stroke onset to thrombolysis was 112 minutes, compared with a median of 73 minutes among 305 patients managed with an MSU, a statistically significant difference. However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 0-1 when measured 90 days after their respective strokes. This outcome occurred in 47% of the control patients managed conventionally and in 53% of those managed by an MSU, a difference that fell short of statistical significance (Lancet Neurol. 2016 Sept;15[10]:1035-43).
Dr. Nour attributed the lack of statistical significance for this primary endpoint to the relatively small number of patients enrolled in PHANTOM-S. “The study was underpowered,” she said.
Dr. Nour presented an analysis at the meeting that extrapolated the results out to 1,000 hypothetical patients and tallied the benefits that a larger number of patients could expect to receive if their outcomes paralleled those seen in the published results. It showed that, among 1,000 stroke patients treated with an MSU, 58 were expected to be free from disability 90 days later, and an additional 124 patients would have some improvement in their 90 day clinical outcome based on their modified Rankin Scale scores when compared with patients undergoing conventional hospitalization.
“If this finding was confirmed in a larger, controlled study, it would suggest that MSU-based thrombolysis has substantial clinical benefit,” she concluded.
Another recent report looked at the first 100 stroke patients treated by the Cleveland MSU during 2014. Researchers at the Cleveland Clinic and Case Western Reserve University said that 16 of those 100 patients received tPA, and the median time from their emergency call to thrombolytic treatment was 38.5 minutes faster than for 53 stroke patients treated during the same period at emergency departments operated by the Cleveland Clinic, a statistically significant difference. However, this report included no data on clinical outcomes (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003786).
Running the financial numbers
Nailing down the incremental clinical benefit from MSUs is clearly a very important part of determining the value of this strategy, but another very practical concern is how much the service costs and whether it is financially sustainable.
“We did a cost-effectiveness analysis based on the PHANTOM-S data, and we were conservative by only looking at the benefit from early tPA treatment,” Heinrich J. Audebert, MD, professor of neurology at Charité Hospital in Berlin and head of the team running Berlin’s MSU, said during the MSU session at the meeting. “We did not take into account saving money by avoiding long-term stroke disability and just considered the cost of [immediate] care and the quality adjusted life years. We calculated a cost of $35,000 per quality adjusted life year, which is absolutely acceptable.”
He cautioned that this analysis was not based on actual outcomes but on the numbers needed to treat calculated from the PHANTOM-S results. “We need to now show this in controlled trials,” he admitted.
Income from transport reimbursement, currently $500 per trip, and reimbursements of $17,000 above costs for administering tPA and of roughly $40,000 above costs for performing thrombectomy are balancing these costs. Based on an estimated additional one thrombolysis case per month and one additional thrombectomy case per month, the MSU yields a potential incremental income to the hospital running the MSU of about $3.8 million over 5 years, enough to balance the operating cost, Dr. Grotta said.
A key part of controlling costs is having the neurologic consult done via a telemedicine link rather than by neurologist at the MSU. “Telemedicine reduces operational costs and improves efficiency,” noted M. Shazam Hussain, MD, interim director of the Cerebrovascular Center at the Cleveland Clinic. “Cost effectiveness is a very important part of the concept” of MSUs, he said at the session.
The Houston group reported results from a study that directly compared the diagnostic performance of an onboard neurologist with that of a telemedicine neurologist linked in remotely during MSU deployments for 174 patients. For these cases, the two neurologists each made an independent diagnosis that the researchers then compared. The two diagnoses concurred for 88% of the cases, Tzu-Ching Wu, MD, reported at the meeting. This rate of agreement matched the incidence of concordance between two neurologists who independently assessed the same patients at the hospital (Stroke. 2017 Jan;48[1]:222-4), said Dr. Wu, a vascular neurologist and director of the telemedicine program at the University of Texas Health Science Center in Houston.
“The results support using telemedicine as the primary means of assessment on the MSU,” said Dr. Wu. “This may enhance MSU efficiency and reduce costs.” His group’s next study of MSU telemedicine will compare the time needed to make a diagnostic decision using the two approaches, something not formally examined in the study he reported.
However, telemedicine assessment of CT results gathered in a MSU has one major limitation: the time needed to transmit the huge amount of information in a CT angiogram.
The MSU used by clinicians at the University of Tennessee, Memphis, incorporates an extremely powerful battery that enables “full CT scanner capability with a moving gantry,” said Andrei V. Alexandrov, MD, professor and chairman of neurology at the university. With this set up “we can do in-the-field multiphasic CT–angiography from the aortic arch up within 4 minutes. The challenge of doing this is simple. It’s 1.7 gigabytes of data,” which would take a prohibitively long time to transmit from a remote site, he explained. As a result, the complete set of images from the field CT angiogram are delivered on a memory stick to the attending hospital neurologist once the MSU returns.
Waiting for more data
Despite these advances and the steady recent growth of MSUs, significant skepticism remains. “While mobile stroke units seem like a good idea and there is genuine hope that they will improve outcomes for selected stroke patients, there is not yet any evidence that this is the case,” wrote Bryan Bledsoe, DO, in a January 2017 editorial in the Journal of Emergency Medical Services. “They are expensive and financially non-sustainable. Without widespread deployment, they stand to benefit few, if any, patients. The money spent on these devices would be better spent on improving the current EMS system including paramedic education, the availability of stroke centers, and on the early recognition of ELVO [emergent large vessel occlusion] strokes,” wrote Dr. Bledsoe, professor of emergency medicine at the University of Nevada in Las Vegas.
Two other experts voiced concerns about MSUs in an editorial that accompanied a Cleveland Clinic report in March. “Even if MSUs meet an acceptable societal threshold for cost effectiveness, cost efficiency may prove a taller order to achieve return on investment for individual health systems and communities,” wrote Andrew M. Southerland, MD, and Ethan S. Brandler, MD (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003833). They cited the Cleveland report, which noted that the group’s first 100 MSU-treated patients came from a total of 317 MSU deployments and included 217 trips that were canceled prior to the MSU’s arrival at the patient’s location. In Berlin’s initial experience, more than 2,000 MSU deployments led to 200 TPA treatments and 349 cancellations before arrival, noted Dr. Southerland, a neurologist at the University of Virginia in Charlottesville, and Dr. Brandler, an emergency medicine physician at Stony Brook (N.Y.) University.
“Hope remains that future trials may demonstrate the ultimate potential of mobile stroke units to improve long-term outcomes for more patients by treating them more quickly and effectively. In the meantime, ongoing efforts are needed to streamline MSU cost and efficiency,” they wrote.
Proponents of MSUs agree that what’s needed now are more data to prove efficacy and cost effectiveness, as well as better integration into EMS programs. The first opportunity for documenting the clinical impact of MSUs on larger numbers of U.S. patients may be from the BEnefits of Stroke Treatment Delivered using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services (BEST-MSU) Study, funded by the Patient-Centered Outcomes Research Institute. This study is collecting data from the MSU programs in Denver Houston, and Memphis. Although currently designed to enroll 697 patients, Dr. Grotta said he hopes to kick that up to 1,000 patients.
“We are following the healthcare use and its cost for every enrolled MSU and conventional patient for 1 year,” Dr. Grotta explained in an interview. He hopes these results will provide the data needed to move MSUs from investigational status to routine and reimbursable care.
Dr. Southerland and Dr. Brandler suggested that “making MSUs multipurpose vehicles might also enhance cost-effectiveness,” an option that Dr. Grotta and his colleagues embrace. The MSUs on U.S. roads already also treat patients with intracranial hemorrhages using blood pressure reduction medications. Other neurologic diagnoses considered potential targets for MSU interventions include encephalopathy, seizures, central nervous system–tumors, and infections.
Stroke is a prime example of “a disease that is extremely time sensitive, and for the first time the field of stroke is ahead of the rest of the medical world in trying to speed treatment,” Dr. Grotta said. “We could add other diagnostic equipment monitored by telemedicine specialists. The MSU concept could be expanded to make it much more cost effective” and spur wider adoption by EMS, he suggested.
Dr. Grotta is a consultant to Frazer, a company that produces mobile stroke units, and to Stryker Corporation, and he has received research support from Genentech. Dr. Saver has been a consultant to and received research support from St. Jude. Dr. Audebert has received honoraria from Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, and Ever Pharma. He has been a consultant to ReNeuron, and he has served as an expert witness for Pfizer and for Lundbeck. Dr. Hussain has been a consultant to Pulsar. Dr. Alexandrov has been a speaker for Genentech. Dr. Nour, Dr. Wu, Dr. Bledsoe, Dr. Southerland, and Dr. Brandler had no disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Mobile stroke units – specially equipped ambulances that bring a diagnostic CT scanner and therapeutic thrombolysis directly to patients in the field – have begun to proliferate across the United States, although they remain investigational, with no clear proof of their incremental clinical value or cost effectiveness.
The first U.S. mobile stroke unit (MSU) launched in Houston in early 2014 (following the world’s first in Berlin, which began running in early 2011), and by early 2017, at least eight other U.S. MSUs were in operation, most of them put into service during the prior 15 months. U.S. MSU locations now include Cleveland; Denver; Memphis; New York; Toledo, Ohio; Trenton, N.J., and Northwestern Medicine and Rush University Medical Center in the western Chicago region. A tenth MSU is slated to start operation at the University of California, Los Angeles later this year.
Early data collected at some of these sites show that initiating care of an acute ischemic stroke patient in an MSU shaves precious minutes off the time it takes to start thrombolytic therapy with tissue plasminogen activator (tPA) compared with that at a hospital, and findings from preliminary analyses suggest better functional outcomes for patients treated this way. However, leaders in the nascent field readily admit that the data needed to clearly prove the benefit patients receive from operating MSUs are still a few years off. This uncertainty about the added benefit to patients from MSUs couples with one clear fact: MSUs are expensive to start up, with a price tag of roughly $1 million to get a MSU on the road for the first time, and also expensive to operate, with one estimate for the annual cost of keeping an MSU on the street at about $500,000 per year for staffing, supplies, and other expenses.
“Every U.S. MSU I know of started with philanthropic gifts, but you need a business model” to keep the program running long-term, James C. Grotta, MD, said during a session focused on MSUs at the International Stroke Conference sponsored by the American Heart Association. “You can’t sustain an MSU with philanthropy,” said Dr. Grotta, professor of neurology at the University of Texas Health Science Center in Houston, director and founder of the Houston MSU, and acknowledged godfather of all U.S. MSUs.
The concept behind MSUs is simple. Each one carries a CT scanner on board so that, once the vehicle’s staff identifies a patient with clinical signs of a significant–acute ischemic stroke in the field and confirms that the timing of the stroke onset suggests eligibility for tPA treatment, a CT scan can immediately be run on site to finalize tPA eligibility. The MSU staff can then begin infusing the drug in the ambulance as it speeds the patient to an appropriate hospital.
Another advantage to MSUs, in addition to quicker initiation of thrombolysis, is “getting patients to where they need to go faster and more directly,” said Dr. Nour.
“Instead of bringing patients first to a hospital that’s unable to do thrombectomy and where treatment gets slowed down, with an MSU you can give tPA on the street and go straight to a thrombectomy center,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at UCLA. “The MSU offers the tantalizing possibility that you can give tPA with no time hit because you can give it on the way directly to a comprehensive stroke center,” Dr. Saver said during a session at the meeting.
Early data on effectiveness
Dr. Nour reported some of the best evidence for the incremental clinical benefit of MSUs based on the reduced time for starting a tPA infusion. She used data collected by the Berlin group and published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU with similar patients managed by conventional ambulance transport for whom CT scan assessment and the start of TPA treatment did not begin until the patient reached a hospital.
The German analysis showed that, in the observational Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients–Study (PHANTOM-S), among 353 patients treated by conventional transport, the median time from stroke onset to thrombolysis was 112 minutes, compared with a median of 73 minutes among 305 patients managed with an MSU, a statistically significant difference. However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 0-1 when measured 90 days after their respective strokes. This outcome occurred in 47% of the control patients managed conventionally and in 53% of those managed by an MSU, a difference that fell short of statistical significance (Lancet Neurol. 2016 Sept;15[10]:1035-43).
Dr. Nour attributed the lack of statistical significance for this primary endpoint to the relatively small number of patients enrolled in PHANTOM-S. “The study was underpowered,” she said.
Dr. Nour presented an analysis at the meeting that extrapolated the results out to 1,000 hypothetical patients and tallied the benefits that a larger number of patients could expect to receive if their outcomes paralleled those seen in the published results. It showed that, among 1,000 stroke patients treated with an MSU, 58 were expected to be free from disability 90 days later, and an additional 124 patients would have some improvement in their 90 day clinical outcome based on their modified Rankin Scale scores when compared with patients undergoing conventional hospitalization.
“If this finding was confirmed in a larger, controlled study, it would suggest that MSU-based thrombolysis has substantial clinical benefit,” she concluded.
Another recent report looked at the first 100 stroke patients treated by the Cleveland MSU during 2014. Researchers at the Cleveland Clinic and Case Western Reserve University said that 16 of those 100 patients received tPA, and the median time from their emergency call to thrombolytic treatment was 38.5 minutes faster than for 53 stroke patients treated during the same period at emergency departments operated by the Cleveland Clinic, a statistically significant difference. However, this report included no data on clinical outcomes (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003786).
Running the financial numbers
Nailing down the incremental clinical benefit from MSUs is clearly a very important part of determining the value of this strategy, but another very practical concern is how much the service costs and whether it is financially sustainable.
“We did a cost-effectiveness analysis based on the PHANTOM-S data, and we were conservative by only looking at the benefit from early tPA treatment,” Heinrich J. Audebert, MD, professor of neurology at Charité Hospital in Berlin and head of the team running Berlin’s MSU, said during the MSU session at the meeting. “We did not take into account saving money by avoiding long-term stroke disability and just considered the cost of [immediate] care and the quality adjusted life years. We calculated a cost of $35,000 per quality adjusted life year, which is absolutely acceptable.”
He cautioned that this analysis was not based on actual outcomes but on the numbers needed to treat calculated from the PHANTOM-S results. “We need to now show this in controlled trials,” he admitted.
Income from transport reimbursement, currently $500 per trip, and reimbursements of $17,000 above costs for administering tPA and of roughly $40,000 above costs for performing thrombectomy are balancing these costs. Based on an estimated additional one thrombolysis case per month and one additional thrombectomy case per month, the MSU yields a potential incremental income to the hospital running the MSU of about $3.8 million over 5 years, enough to balance the operating cost, Dr. Grotta said.
A key part of controlling costs is having the neurologic consult done via a telemedicine link rather than by neurologist at the MSU. “Telemedicine reduces operational costs and improves efficiency,” noted M. Shazam Hussain, MD, interim director of the Cerebrovascular Center at the Cleveland Clinic. “Cost effectiveness is a very important part of the concept” of MSUs, he said at the session.
The Houston group reported results from a study that directly compared the diagnostic performance of an onboard neurologist with that of a telemedicine neurologist linked in remotely during MSU deployments for 174 patients. For these cases, the two neurologists each made an independent diagnosis that the researchers then compared. The two diagnoses concurred for 88% of the cases, Tzu-Ching Wu, MD, reported at the meeting. This rate of agreement matched the incidence of concordance between two neurologists who independently assessed the same patients at the hospital (Stroke. 2017 Jan;48[1]:222-4), said Dr. Wu, a vascular neurologist and director of the telemedicine program at the University of Texas Health Science Center in Houston.
“The results support using telemedicine as the primary means of assessment on the MSU,” said Dr. Wu. “This may enhance MSU efficiency and reduce costs.” His group’s next study of MSU telemedicine will compare the time needed to make a diagnostic decision using the two approaches, something not formally examined in the study he reported.
However, telemedicine assessment of CT results gathered in a MSU has one major limitation: the time needed to transmit the huge amount of information in a CT angiogram.
The MSU used by clinicians at the University of Tennessee, Memphis, incorporates an extremely powerful battery that enables “full CT scanner capability with a moving gantry,” said Andrei V. Alexandrov, MD, professor and chairman of neurology at the university. With this set up “we can do in-the-field multiphasic CT–angiography from the aortic arch up within 4 minutes. The challenge of doing this is simple. It’s 1.7 gigabytes of data,” which would take a prohibitively long time to transmit from a remote site, he explained. As a result, the complete set of images from the field CT angiogram are delivered on a memory stick to the attending hospital neurologist once the MSU returns.
Waiting for more data
Despite these advances and the steady recent growth of MSUs, significant skepticism remains. “While mobile stroke units seem like a good idea and there is genuine hope that they will improve outcomes for selected stroke patients, there is not yet any evidence that this is the case,” wrote Bryan Bledsoe, DO, in a January 2017 editorial in the Journal of Emergency Medical Services. “They are expensive and financially non-sustainable. Without widespread deployment, they stand to benefit few, if any, patients. The money spent on these devices would be better spent on improving the current EMS system including paramedic education, the availability of stroke centers, and on the early recognition of ELVO [emergent large vessel occlusion] strokes,” wrote Dr. Bledsoe, professor of emergency medicine at the University of Nevada in Las Vegas.
Two other experts voiced concerns about MSUs in an editorial that accompanied a Cleveland Clinic report in March. “Even if MSUs meet an acceptable societal threshold for cost effectiveness, cost efficiency may prove a taller order to achieve return on investment for individual health systems and communities,” wrote Andrew M. Southerland, MD, and Ethan S. Brandler, MD (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003833). They cited the Cleveland report, which noted that the group’s first 100 MSU-treated patients came from a total of 317 MSU deployments and included 217 trips that were canceled prior to the MSU’s arrival at the patient’s location. In Berlin’s initial experience, more than 2,000 MSU deployments led to 200 TPA treatments and 349 cancellations before arrival, noted Dr. Southerland, a neurologist at the University of Virginia in Charlottesville, and Dr. Brandler, an emergency medicine physician at Stony Brook (N.Y.) University.
“Hope remains that future trials may demonstrate the ultimate potential of mobile stroke units to improve long-term outcomes for more patients by treating them more quickly and effectively. In the meantime, ongoing efforts are needed to streamline MSU cost and efficiency,” they wrote.
Proponents of MSUs agree that what’s needed now are more data to prove efficacy and cost effectiveness, as well as better integration into EMS programs. The first opportunity for documenting the clinical impact of MSUs on larger numbers of U.S. patients may be from the BEnefits of Stroke Treatment Delivered using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services (BEST-MSU) Study, funded by the Patient-Centered Outcomes Research Institute. This study is collecting data from the MSU programs in Denver Houston, and Memphis. Although currently designed to enroll 697 patients, Dr. Grotta said he hopes to kick that up to 1,000 patients.
“We are following the healthcare use and its cost for every enrolled MSU and conventional patient for 1 year,” Dr. Grotta explained in an interview. He hopes these results will provide the data needed to move MSUs from investigational status to routine and reimbursable care.
Dr. Southerland and Dr. Brandler suggested that “making MSUs multipurpose vehicles might also enhance cost-effectiveness,” an option that Dr. Grotta and his colleagues embrace. The MSUs on U.S. roads already also treat patients with intracranial hemorrhages using blood pressure reduction medications. Other neurologic diagnoses considered potential targets for MSU interventions include encephalopathy, seizures, central nervous system–tumors, and infections.
Stroke is a prime example of “a disease that is extremely time sensitive, and for the first time the field of stroke is ahead of the rest of the medical world in trying to speed treatment,” Dr. Grotta said. “We could add other diagnostic equipment monitored by telemedicine specialists. The MSU concept could be expanded to make it much more cost effective” and spur wider adoption by EMS, he suggested.
Dr. Grotta is a consultant to Frazer, a company that produces mobile stroke units, and to Stryker Corporation, and he has received research support from Genentech. Dr. Saver has been a consultant to and received research support from St. Jude. Dr. Audebert has received honoraria from Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, and Ever Pharma. He has been a consultant to ReNeuron, and he has served as an expert witness for Pfizer and for Lundbeck. Dr. Hussain has been a consultant to Pulsar. Dr. Alexandrov has been a speaker for Genentech. Dr. Nour, Dr. Wu, Dr. Bledsoe, Dr. Southerland, and Dr. Brandler had no disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Mobile stroke units – specially equipped ambulances that bring a diagnostic CT scanner and therapeutic thrombolysis directly to patients in the field – have begun to proliferate across the United States, although they remain investigational, with no clear proof of their incremental clinical value or cost effectiveness.
The first U.S. mobile stroke unit (MSU) launched in Houston in early 2014 (following the world’s first in Berlin, which began running in early 2011), and by early 2017, at least eight other U.S. MSUs were in operation, most of them put into service during the prior 15 months. U.S. MSU locations now include Cleveland; Denver; Memphis; New York; Toledo, Ohio; Trenton, N.J., and Northwestern Medicine and Rush University Medical Center in the western Chicago region. A tenth MSU is slated to start operation at the University of California, Los Angeles later this year.
Early data collected at some of these sites show that initiating care of an acute ischemic stroke patient in an MSU shaves precious minutes off the time it takes to start thrombolytic therapy with tissue plasminogen activator (tPA) compared with that at a hospital, and findings from preliminary analyses suggest better functional outcomes for patients treated this way. However, leaders in the nascent field readily admit that the data needed to clearly prove the benefit patients receive from operating MSUs are still a few years off. This uncertainty about the added benefit to patients from MSUs couples with one clear fact: MSUs are expensive to start up, with a price tag of roughly $1 million to get a MSU on the road for the first time, and also expensive to operate, with one estimate for the annual cost of keeping an MSU on the street at about $500,000 per year for staffing, supplies, and other expenses.
“Every U.S. MSU I know of started with philanthropic gifts, but you need a business model” to keep the program running long-term, James C. Grotta, MD, said during a session focused on MSUs at the International Stroke Conference sponsored by the American Heart Association. “You can’t sustain an MSU with philanthropy,” said Dr. Grotta, professor of neurology at the University of Texas Health Science Center in Houston, director and founder of the Houston MSU, and acknowledged godfather of all U.S. MSUs.
The concept behind MSUs is simple. Each one carries a CT scanner on board so that, once the vehicle’s staff identifies a patient with clinical signs of a significant–acute ischemic stroke in the field and confirms that the timing of the stroke onset suggests eligibility for tPA treatment, a CT scan can immediately be run on site to finalize tPA eligibility. The MSU staff can then begin infusing the drug in the ambulance as it speeds the patient to an appropriate hospital.
Another advantage to MSUs, in addition to quicker initiation of thrombolysis, is “getting patients to where they need to go faster and more directly,” said Dr. Nour.
“Instead of bringing patients first to a hospital that’s unable to do thrombectomy and where treatment gets slowed down, with an MSU you can give tPA on the street and go straight to a thrombectomy center,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at UCLA. “The MSU offers the tantalizing possibility that you can give tPA with no time hit because you can give it on the way directly to a comprehensive stroke center,” Dr. Saver said during a session at the meeting.
Early data on effectiveness
Dr. Nour reported some of the best evidence for the incremental clinical benefit of MSUs based on the reduced time for starting a tPA infusion. She used data collected by the Berlin group and published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU with similar patients managed by conventional ambulance transport for whom CT scan assessment and the start of TPA treatment did not begin until the patient reached a hospital.
The German analysis showed that, in the observational Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients–Study (PHANTOM-S), among 353 patients treated by conventional transport, the median time from stroke onset to thrombolysis was 112 minutes, compared with a median of 73 minutes among 305 patients managed with an MSU, a statistically significant difference. However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 0-1 when measured 90 days after their respective strokes. This outcome occurred in 47% of the control patients managed conventionally and in 53% of those managed by an MSU, a difference that fell short of statistical significance (Lancet Neurol. 2016 Sept;15[10]:1035-43).
Dr. Nour attributed the lack of statistical significance for this primary endpoint to the relatively small number of patients enrolled in PHANTOM-S. “The study was underpowered,” she said.
Dr. Nour presented an analysis at the meeting that extrapolated the results out to 1,000 hypothetical patients and tallied the benefits that a larger number of patients could expect to receive if their outcomes paralleled those seen in the published results. It showed that, among 1,000 stroke patients treated with an MSU, 58 were expected to be free from disability 90 days later, and an additional 124 patients would have some improvement in their 90 day clinical outcome based on their modified Rankin Scale scores when compared with patients undergoing conventional hospitalization.
“If this finding was confirmed in a larger, controlled study, it would suggest that MSU-based thrombolysis has substantial clinical benefit,” she concluded.
Another recent report looked at the first 100 stroke patients treated by the Cleveland MSU during 2014. Researchers at the Cleveland Clinic and Case Western Reserve University said that 16 of those 100 patients received tPA, and the median time from their emergency call to thrombolytic treatment was 38.5 minutes faster than for 53 stroke patients treated during the same period at emergency departments operated by the Cleveland Clinic, a statistically significant difference. However, this report included no data on clinical outcomes (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003786).
Running the financial numbers
Nailing down the incremental clinical benefit from MSUs is clearly a very important part of determining the value of this strategy, but another very practical concern is how much the service costs and whether it is financially sustainable.
“We did a cost-effectiveness analysis based on the PHANTOM-S data, and we were conservative by only looking at the benefit from early tPA treatment,” Heinrich J. Audebert, MD, professor of neurology at Charité Hospital in Berlin and head of the team running Berlin’s MSU, said during the MSU session at the meeting. “We did not take into account saving money by avoiding long-term stroke disability and just considered the cost of [immediate] care and the quality adjusted life years. We calculated a cost of $35,000 per quality adjusted life year, which is absolutely acceptable.”
He cautioned that this analysis was not based on actual outcomes but on the numbers needed to treat calculated from the PHANTOM-S results. “We need to now show this in controlled trials,” he admitted.
Income from transport reimbursement, currently $500 per trip, and reimbursements of $17,000 above costs for administering tPA and of roughly $40,000 above costs for performing thrombectomy are balancing these costs. Based on an estimated additional one thrombolysis case per month and one additional thrombectomy case per month, the MSU yields a potential incremental income to the hospital running the MSU of about $3.8 million over 5 years, enough to balance the operating cost, Dr. Grotta said.
A key part of controlling costs is having the neurologic consult done via a telemedicine link rather than by neurologist at the MSU. “Telemedicine reduces operational costs and improves efficiency,” noted M. Shazam Hussain, MD, interim director of the Cerebrovascular Center at the Cleveland Clinic. “Cost effectiveness is a very important part of the concept” of MSUs, he said at the session.
The Houston group reported results from a study that directly compared the diagnostic performance of an onboard neurologist with that of a telemedicine neurologist linked in remotely during MSU deployments for 174 patients. For these cases, the two neurologists each made an independent diagnosis that the researchers then compared. The two diagnoses concurred for 88% of the cases, Tzu-Ching Wu, MD, reported at the meeting. This rate of agreement matched the incidence of concordance between two neurologists who independently assessed the same patients at the hospital (Stroke. 2017 Jan;48[1]:222-4), said Dr. Wu, a vascular neurologist and director of the telemedicine program at the University of Texas Health Science Center in Houston.
“The results support using telemedicine as the primary means of assessment on the MSU,” said Dr. Wu. “This may enhance MSU efficiency and reduce costs.” His group’s next study of MSU telemedicine will compare the time needed to make a diagnostic decision using the two approaches, something not formally examined in the study he reported.
However, telemedicine assessment of CT results gathered in a MSU has one major limitation: the time needed to transmit the huge amount of information in a CT angiogram.
The MSU used by clinicians at the University of Tennessee, Memphis, incorporates an extremely powerful battery that enables “full CT scanner capability with a moving gantry,” said Andrei V. Alexandrov, MD, professor and chairman of neurology at the university. With this set up “we can do in-the-field multiphasic CT–angiography from the aortic arch up within 4 minutes. The challenge of doing this is simple. It’s 1.7 gigabytes of data,” which would take a prohibitively long time to transmit from a remote site, he explained. As a result, the complete set of images from the field CT angiogram are delivered on a memory stick to the attending hospital neurologist once the MSU returns.
Waiting for more data
Despite these advances and the steady recent growth of MSUs, significant skepticism remains. “While mobile stroke units seem like a good idea and there is genuine hope that they will improve outcomes for selected stroke patients, there is not yet any evidence that this is the case,” wrote Bryan Bledsoe, DO, in a January 2017 editorial in the Journal of Emergency Medical Services. “They are expensive and financially non-sustainable. Without widespread deployment, they stand to benefit few, if any, patients. The money spent on these devices would be better spent on improving the current EMS system including paramedic education, the availability of stroke centers, and on the early recognition of ELVO [emergent large vessel occlusion] strokes,” wrote Dr. Bledsoe, professor of emergency medicine at the University of Nevada in Las Vegas.
Two other experts voiced concerns about MSUs in an editorial that accompanied a Cleveland Clinic report in March. “Even if MSUs meet an acceptable societal threshold for cost effectiveness, cost efficiency may prove a taller order to achieve return on investment for individual health systems and communities,” wrote Andrew M. Southerland, MD, and Ethan S. Brandler, MD (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003833). They cited the Cleveland report, which noted that the group’s first 100 MSU-treated patients came from a total of 317 MSU deployments and included 217 trips that were canceled prior to the MSU’s arrival at the patient’s location. In Berlin’s initial experience, more than 2,000 MSU deployments led to 200 TPA treatments and 349 cancellations before arrival, noted Dr. Southerland, a neurologist at the University of Virginia in Charlottesville, and Dr. Brandler, an emergency medicine physician at Stony Brook (N.Y.) University.
“Hope remains that future trials may demonstrate the ultimate potential of mobile stroke units to improve long-term outcomes for more patients by treating them more quickly and effectively. In the meantime, ongoing efforts are needed to streamline MSU cost and efficiency,” they wrote.
Proponents of MSUs agree that what’s needed now are more data to prove efficacy and cost effectiveness, as well as better integration into EMS programs. The first opportunity for documenting the clinical impact of MSUs on larger numbers of U.S. patients may be from the BEnefits of Stroke Treatment Delivered using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services (BEST-MSU) Study, funded by the Patient-Centered Outcomes Research Institute. This study is collecting data from the MSU programs in Denver Houston, and Memphis. Although currently designed to enroll 697 patients, Dr. Grotta said he hopes to kick that up to 1,000 patients.
“We are following the healthcare use and its cost for every enrolled MSU and conventional patient for 1 year,” Dr. Grotta explained in an interview. He hopes these results will provide the data needed to move MSUs from investigational status to routine and reimbursable care.
Dr. Southerland and Dr. Brandler suggested that “making MSUs multipurpose vehicles might also enhance cost-effectiveness,” an option that Dr. Grotta and his colleagues embrace. The MSUs on U.S. roads already also treat patients with intracranial hemorrhages using blood pressure reduction medications. Other neurologic diagnoses considered potential targets for MSU interventions include encephalopathy, seizures, central nervous system–tumors, and infections.
Stroke is a prime example of “a disease that is extremely time sensitive, and for the first time the field of stroke is ahead of the rest of the medical world in trying to speed treatment,” Dr. Grotta said. “We could add other diagnostic equipment monitored by telemedicine specialists. The MSU concept could be expanded to make it much more cost effective” and spur wider adoption by EMS, he suggested.
Dr. Grotta is a consultant to Frazer, a company that produces mobile stroke units, and to Stryker Corporation, and he has received research support from Genentech. Dr. Saver has been a consultant to and received research support from St. Jude. Dr. Audebert has received honoraria from Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, and Ever Pharma. He has been a consultant to ReNeuron, and he has served as an expert witness for Pfizer and for Lundbeck. Dr. Hussain has been a consultant to Pulsar. Dr. Alexandrov has been a speaker for Genentech. Dr. Nour, Dr. Wu, Dr. Bledsoe, Dr. Southerland, and Dr. Brandler had no disclosures.
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EXPERT ANALYSIS FROM THE INTERNATIONAL STROKE CONFERENCE
Synthetic cannabinoid use linked to multiple risk factors
An estimated 1 in 10 high school students uses synthetic cannabinoids, which are linked to multiple other risk behaviors, and use is more likely among students with depressive symptoms, marijuana use, and alcohol use, investigators in two studies reported.
Synthetic cannabinoids are structurally similar to delta-9-tetrahydrocannabinol, but they may be more potent, with adverse health effects not seen with natural tetrahydrocannabinol in marijuana. These synthetic products are accessible to teens online, in convenience stores, and in smoke shops. Past research has suggested that adolescents aren’t aware of the possible negative effects of these products, such as tachycardia, hypertension, lethargy, nausea, vomiting, irritability, chest pain, hallucinations, confusion, and vertigo.
“Overall, we observed that ever use of synthetic cannabinoids was associated with the majority of health risk behaviors included in our study and that those associations tended to be more pronounced for ever use of synthetic cannabinoids than for ever use of marijuana only, particularly for substance use behaviors and sexual risk behaviors,” they wrote (Pediatrics. 2017 March 13. doi: 10.1542/peds.2016-2675).
Dr. Clayton’s team analyzed data from 15,624 students in grades 9-12 from the cross-sectional 2015 Youth Risk Behavior Survey, including all 50 states and Washington. The questions asked about use of marijuana, synthetic cannabinoids, or both. The question about synthetic cannabinoids included reference to street names of the drug, such as K2, Spice, fake weed, King Kong, Yucatan Fire, Skunk, or Moon Rocks. Another three dozen questions asked about risk behaviors related to substance use, violence and injury, mental health, and sexual health.
The results revealed that 29% of students had ever used only marijuana and 9% had ever used synthetic cannabinoids. Most of the students, 61%, had never used either. Although 23% of marijuana users had used synthetic cannabinoids, nearly all (98%) of the cannabinoids users had used marijuana.
Compared with those who had used only marijuana, adolescents who had ever used synthetic cannabinoids were considerably more likely to engage in substance use (adjusted prevalence ratio [aPR] = 4.85 for current alcohol use; aPR =151.90 for ever use of heroin) or sexual risk behaviors (had sexual intercourse with four or more persons during their life; aPR = 6.20). They also were more than twice as likely to have tried marijuana before age 13 years (aPR = 2.35) and were more likely to have used marijuana at least once in the past month (aPR = 1.36) and to have used marijuana 20 or more times in the past month (aPR = 1.88).
“Youth may progress from marijuana use only to the use of synthetic cannabinoids for a variety of reasons, such as ease of access, perception of safety, and ability to be undetected by many drug tests,” Dr. Clayton and her associates wrote.
The second study found similar associations between marijuana use and later use of synthetic cannabinoids. Andrew L. Ninnemann of the University of Missouri–Columbia, and his associates collected data twice over a 12-month period from 964 high school students at seven public schools in Southeast Texas (Pediatrics. 2017 March 13. doi: 10.1542/peds.2016-3009), to examine the relationship of synthetic cannabinoid use with anxiety, depression, impulsivity, and marijuana use.
The first assessment occurred in spring of 2011 and the second in spring of 2012. Most respondents (response rate, 62%) were sophomores (73%) or juniors (24%), with only 1% each of freshmen and seniors; 1% reported “other.” The sample included 31% African American students, 29% white students, 28% Hispanic students, and 12% of other ethnicities.
Males were more likely than females to use synthetic cannabinoids, and African American students were less likely to use them than teens of other ethnicities. Depression at baseline predicted use of synthetic cannabinoids a year later (adjusted odds ratio [aOR] = 1.42, P = .04), as did alcohol use (aOR = 1.85, P = .02), marijuana use (aOR = 2.47, P less than .001), and synthetic cannabinoid use at baseline (aOR = 2.36, P less than .001).
Students also were more likely to use marijuana at follow-up if they had used alcohol (aOR = 1.96, P less than .001) or marijuana (aOR = 4.52, P less than .001) at baseline. However, neither demographic variables nor anxiety, impulsivity, synthetic cannabinoid use, or other drug use significantly predicted marijuana use 1 year later.
Mr. Ninnemann’s study also found a slightly higher prevalence of synthetic cannabinoid use at baseline than the Clayton study did, with 13% of the Texas sample reporting use.
“The substantial risks associated with even a single episode of synthetic cannabinoid use emphasize the critical importance of identifying and targeting potential risk factors,” Mr. Ninnemann and his coauthors wrote. “Our findings indicate that prevention and intervention efforts may benefit from targeting depressive symptoms and alcohol and marijuana use to potentially reduce adolescent use of synthetic cannabinoids.”
Dr. Clayton and her colleagues mentioned a past study finding that 50% of elementary schools, 33% of middle schools, and 13% of high schools do not require instruction on alcohol or other drug use prevention. The U.S. trend of cannabis legalization also introduces uncertainty, the investigators noted.
“It is unclear what impact the legalization of marijuana will have on the use of synthetic cannabinoids,” Dr. Clayton’s team wrote. The evidence is contradictory on the likelihood of teens trying marijuana in these environments, but “there is a concern that if marijuana use increases, the use of synthetic marijuana may also increase,” they noted.
The Clayton study did not have external funding. The Ninnemann study received funding from the National Science Foundation, the National Institute of Child Health and Human Development, and the National Institute of Justice. The authors of both studies reported that they had no disclosures.
Synthetic cannabinoids are made in a lab to have marijuanalike properties, but often have more short-term medical and behavioral toxicities. We at the University of Florida McKnight Brain Institute in Gainesville have studied bath salts and synthetics in the laboratory, but there have been few human studies. The current studies by Clayton et al. and Ninnemann et al., following shortly after the American Academy of Pediatrics warning about the effects of cannabis smoking in adolescents (Pediatrics. 2017 10.1542/peds.2016-4069), are a grim reminder that adolescence is a period of extreme vulnerability to drugs of abuse. Synthetic cannabinoids, as addiction specialists will attest, produce some signs and symptoms of cannabis intoxication, but often with more acute problems, with greater intensity, and of longer duration. In the current two studies, it is clear that the reported consequences of synthetic cannabinoids are greater in terms of risk behaviors and depression than in marijuana smokers.
Mark S. Gold, MD, is the 17th Distinguished Alumni Professor at the University of Florida, Gainesville. He also is chairman of the scientific advisory boards for RiverMend Health, Atlanta.
Synthetic cannabinoids are made in a lab to have marijuanalike properties, but often have more short-term medical and behavioral toxicities. We at the University of Florida McKnight Brain Institute in Gainesville have studied bath salts and synthetics in the laboratory, but there have been few human studies. The current studies by Clayton et al. and Ninnemann et al., following shortly after the American Academy of Pediatrics warning about the effects of cannabis smoking in adolescents (Pediatrics. 2017 10.1542/peds.2016-4069), are a grim reminder that adolescence is a period of extreme vulnerability to drugs of abuse. Synthetic cannabinoids, as addiction specialists will attest, produce some signs and symptoms of cannabis intoxication, but often with more acute problems, with greater intensity, and of longer duration. In the current two studies, it is clear that the reported consequences of synthetic cannabinoids are greater in terms of risk behaviors and depression than in marijuana smokers.
Mark S. Gold, MD, is the 17th Distinguished Alumni Professor at the University of Florida, Gainesville. He also is chairman of the scientific advisory boards for RiverMend Health, Atlanta.
Synthetic cannabinoids are made in a lab to have marijuanalike properties, but often have more short-term medical and behavioral toxicities. We at the University of Florida McKnight Brain Institute in Gainesville have studied bath salts and synthetics in the laboratory, but there have been few human studies. The current studies by Clayton et al. and Ninnemann et al., following shortly after the American Academy of Pediatrics warning about the effects of cannabis smoking in adolescents (Pediatrics. 2017 10.1542/peds.2016-4069), are a grim reminder that adolescence is a period of extreme vulnerability to drugs of abuse. Synthetic cannabinoids, as addiction specialists will attest, produce some signs and symptoms of cannabis intoxication, but often with more acute problems, with greater intensity, and of longer duration. In the current two studies, it is clear that the reported consequences of synthetic cannabinoids are greater in terms of risk behaviors and depression than in marijuana smokers.
Mark S. Gold, MD, is the 17th Distinguished Alumni Professor at the University of Florida, Gainesville. He also is chairman of the scientific advisory boards for RiverMend Health, Atlanta.
An estimated 1 in 10 high school students uses synthetic cannabinoids, which are linked to multiple other risk behaviors, and use is more likely among students with depressive symptoms, marijuana use, and alcohol use, investigators in two studies reported.
Synthetic cannabinoids are structurally similar to delta-9-tetrahydrocannabinol, but they may be more potent, with adverse health effects not seen with natural tetrahydrocannabinol in marijuana. These synthetic products are accessible to teens online, in convenience stores, and in smoke shops. Past research has suggested that adolescents aren’t aware of the possible negative effects of these products, such as tachycardia, hypertension, lethargy, nausea, vomiting, irritability, chest pain, hallucinations, confusion, and vertigo.
“Overall, we observed that ever use of synthetic cannabinoids was associated with the majority of health risk behaviors included in our study and that those associations tended to be more pronounced for ever use of synthetic cannabinoids than for ever use of marijuana only, particularly for substance use behaviors and sexual risk behaviors,” they wrote (Pediatrics. 2017 March 13. doi: 10.1542/peds.2016-2675).
Dr. Clayton’s team analyzed data from 15,624 students in grades 9-12 from the cross-sectional 2015 Youth Risk Behavior Survey, including all 50 states and Washington. The questions asked about use of marijuana, synthetic cannabinoids, or both. The question about synthetic cannabinoids included reference to street names of the drug, such as K2, Spice, fake weed, King Kong, Yucatan Fire, Skunk, or Moon Rocks. Another three dozen questions asked about risk behaviors related to substance use, violence and injury, mental health, and sexual health.
The results revealed that 29% of students had ever used only marijuana and 9% had ever used synthetic cannabinoids. Most of the students, 61%, had never used either. Although 23% of marijuana users had used synthetic cannabinoids, nearly all (98%) of the cannabinoids users had used marijuana.
Compared with those who had used only marijuana, adolescents who had ever used synthetic cannabinoids were considerably more likely to engage in substance use (adjusted prevalence ratio [aPR] = 4.85 for current alcohol use; aPR =151.90 for ever use of heroin) or sexual risk behaviors (had sexual intercourse with four or more persons during their life; aPR = 6.20). They also were more than twice as likely to have tried marijuana before age 13 years (aPR = 2.35) and were more likely to have used marijuana at least once in the past month (aPR = 1.36) and to have used marijuana 20 or more times in the past month (aPR = 1.88).
“Youth may progress from marijuana use only to the use of synthetic cannabinoids for a variety of reasons, such as ease of access, perception of safety, and ability to be undetected by many drug tests,” Dr. Clayton and her associates wrote.
The second study found similar associations between marijuana use and later use of synthetic cannabinoids. Andrew L. Ninnemann of the University of Missouri–Columbia, and his associates collected data twice over a 12-month period from 964 high school students at seven public schools in Southeast Texas (Pediatrics. 2017 March 13. doi: 10.1542/peds.2016-3009), to examine the relationship of synthetic cannabinoid use with anxiety, depression, impulsivity, and marijuana use.
The first assessment occurred in spring of 2011 and the second in spring of 2012. Most respondents (response rate, 62%) were sophomores (73%) or juniors (24%), with only 1% each of freshmen and seniors; 1% reported “other.” The sample included 31% African American students, 29% white students, 28% Hispanic students, and 12% of other ethnicities.
Males were more likely than females to use synthetic cannabinoids, and African American students were less likely to use them than teens of other ethnicities. Depression at baseline predicted use of synthetic cannabinoids a year later (adjusted odds ratio [aOR] = 1.42, P = .04), as did alcohol use (aOR = 1.85, P = .02), marijuana use (aOR = 2.47, P less than .001), and synthetic cannabinoid use at baseline (aOR = 2.36, P less than .001).
Students also were more likely to use marijuana at follow-up if they had used alcohol (aOR = 1.96, P less than .001) or marijuana (aOR = 4.52, P less than .001) at baseline. However, neither demographic variables nor anxiety, impulsivity, synthetic cannabinoid use, or other drug use significantly predicted marijuana use 1 year later.
Mr. Ninnemann’s study also found a slightly higher prevalence of synthetic cannabinoid use at baseline than the Clayton study did, with 13% of the Texas sample reporting use.
“The substantial risks associated with even a single episode of synthetic cannabinoid use emphasize the critical importance of identifying and targeting potential risk factors,” Mr. Ninnemann and his coauthors wrote. “Our findings indicate that prevention and intervention efforts may benefit from targeting depressive symptoms and alcohol and marijuana use to potentially reduce adolescent use of synthetic cannabinoids.”
Dr. Clayton and her colleagues mentioned a past study finding that 50% of elementary schools, 33% of middle schools, and 13% of high schools do not require instruction on alcohol or other drug use prevention. The U.S. trend of cannabis legalization also introduces uncertainty, the investigators noted.
“It is unclear what impact the legalization of marijuana will have on the use of synthetic cannabinoids,” Dr. Clayton’s team wrote. The evidence is contradictory on the likelihood of teens trying marijuana in these environments, but “there is a concern that if marijuana use increases, the use of synthetic marijuana may also increase,” they noted.
The Clayton study did not have external funding. The Ninnemann study received funding from the National Science Foundation, the National Institute of Child Health and Human Development, and the National Institute of Justice. The authors of both studies reported that they had no disclosures.
An estimated 1 in 10 high school students uses synthetic cannabinoids, which are linked to multiple other risk behaviors, and use is more likely among students with depressive symptoms, marijuana use, and alcohol use, investigators in two studies reported.
Synthetic cannabinoids are structurally similar to delta-9-tetrahydrocannabinol, but they may be more potent, with adverse health effects not seen with natural tetrahydrocannabinol in marijuana. These synthetic products are accessible to teens online, in convenience stores, and in smoke shops. Past research has suggested that adolescents aren’t aware of the possible negative effects of these products, such as tachycardia, hypertension, lethargy, nausea, vomiting, irritability, chest pain, hallucinations, confusion, and vertigo.
“Overall, we observed that ever use of synthetic cannabinoids was associated with the majority of health risk behaviors included in our study and that those associations tended to be more pronounced for ever use of synthetic cannabinoids than for ever use of marijuana only, particularly for substance use behaviors and sexual risk behaviors,” they wrote (Pediatrics. 2017 March 13. doi: 10.1542/peds.2016-2675).
Dr. Clayton’s team analyzed data from 15,624 students in grades 9-12 from the cross-sectional 2015 Youth Risk Behavior Survey, including all 50 states and Washington. The questions asked about use of marijuana, synthetic cannabinoids, or both. The question about synthetic cannabinoids included reference to street names of the drug, such as K2, Spice, fake weed, King Kong, Yucatan Fire, Skunk, or Moon Rocks. Another three dozen questions asked about risk behaviors related to substance use, violence and injury, mental health, and sexual health.
The results revealed that 29% of students had ever used only marijuana and 9% had ever used synthetic cannabinoids. Most of the students, 61%, had never used either. Although 23% of marijuana users had used synthetic cannabinoids, nearly all (98%) of the cannabinoids users had used marijuana.
Compared with those who had used only marijuana, adolescents who had ever used synthetic cannabinoids were considerably more likely to engage in substance use (adjusted prevalence ratio [aPR] = 4.85 for current alcohol use; aPR =151.90 for ever use of heroin) or sexual risk behaviors (had sexual intercourse with four or more persons during their life; aPR = 6.20). They also were more than twice as likely to have tried marijuana before age 13 years (aPR = 2.35) and were more likely to have used marijuana at least once in the past month (aPR = 1.36) and to have used marijuana 20 or more times in the past month (aPR = 1.88).
“Youth may progress from marijuana use only to the use of synthetic cannabinoids for a variety of reasons, such as ease of access, perception of safety, and ability to be undetected by many drug tests,” Dr. Clayton and her associates wrote.
The second study found similar associations between marijuana use and later use of synthetic cannabinoids. Andrew L. Ninnemann of the University of Missouri–Columbia, and his associates collected data twice over a 12-month period from 964 high school students at seven public schools in Southeast Texas (Pediatrics. 2017 March 13. doi: 10.1542/peds.2016-3009), to examine the relationship of synthetic cannabinoid use with anxiety, depression, impulsivity, and marijuana use.
The first assessment occurred in spring of 2011 and the second in spring of 2012. Most respondents (response rate, 62%) were sophomores (73%) or juniors (24%), with only 1% each of freshmen and seniors; 1% reported “other.” The sample included 31% African American students, 29% white students, 28% Hispanic students, and 12% of other ethnicities.
Males were more likely than females to use synthetic cannabinoids, and African American students were less likely to use them than teens of other ethnicities. Depression at baseline predicted use of synthetic cannabinoids a year later (adjusted odds ratio [aOR] = 1.42, P = .04), as did alcohol use (aOR = 1.85, P = .02), marijuana use (aOR = 2.47, P less than .001), and synthetic cannabinoid use at baseline (aOR = 2.36, P less than .001).
Students also were more likely to use marijuana at follow-up if they had used alcohol (aOR = 1.96, P less than .001) or marijuana (aOR = 4.52, P less than .001) at baseline. However, neither demographic variables nor anxiety, impulsivity, synthetic cannabinoid use, or other drug use significantly predicted marijuana use 1 year later.
Mr. Ninnemann’s study also found a slightly higher prevalence of synthetic cannabinoid use at baseline than the Clayton study did, with 13% of the Texas sample reporting use.
“The substantial risks associated with even a single episode of synthetic cannabinoid use emphasize the critical importance of identifying and targeting potential risk factors,” Mr. Ninnemann and his coauthors wrote. “Our findings indicate that prevention and intervention efforts may benefit from targeting depressive symptoms and alcohol and marijuana use to potentially reduce adolescent use of synthetic cannabinoids.”
Dr. Clayton and her colleagues mentioned a past study finding that 50% of elementary schools, 33% of middle schools, and 13% of high schools do not require instruction on alcohol or other drug use prevention. The U.S. trend of cannabis legalization also introduces uncertainty, the investigators noted.
“It is unclear what impact the legalization of marijuana will have on the use of synthetic cannabinoids,” Dr. Clayton’s team wrote. The evidence is contradictory on the likelihood of teens trying marijuana in these environments, but “there is a concern that if marijuana use increases, the use of synthetic marijuana may also increase,” they noted.
The Clayton study did not have external funding. The Ninnemann study received funding from the National Science Foundation, the National Institute of Child Health and Human Development, and the National Institute of Justice. The authors of both studies reported that they had no disclosures.
FROM PEDIATRICS
Key clinical point: Results of two studies found that 9%-13% of high school students have used synthetic cannabinoids.
Major finding: Depression, alcohol use, and marijuana use increase the likelihood of adolescents’ use of synthetic cannabinoids, which increases the risk of multiple substance use and risky sexual behavior.
Data source: Two studies, one surveying 15,624 high school students nationwide and one surveying 964 Texas public high school students twice over a period of 1 year.
Disclosures: The Clayton study had no external funding. The Ninnemann study received funding from the National Science Foundation, the National Institute of Child Health and Human Development, and the National Institute of Justice. The authors of both studies reported that they had no disclosures.