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Study: No increased risk of serious AEs with combined urogyn/gyn onc surgery
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
REPORTING FROM SGS 2018
Key clinical point: Concurrent urogynecologic/gynecologic oncology surgery does not increase the risk of serious adverse events.
Major finding: Concurrent surgery patients had more grade 2 complications (44% vs. 19%).
Study details: A retrospective study of 108 cases and 216 matched controls.
Disclosures: Dr. Davidson and Dr. Noone each reported having no disclosures.
Source: Davidson ER et al. SGS 2018, Oral Presentation 13.
Early trauma exposure tied to telomere shortening in men with schizophrenia
Men with schizophrenia and healthy women who were exposed to childhood trauma have shorter leukocyte telomere length (LTL) than do their counterparts in both groups, a small study shows.
“This converse sex-association in schizophrenia compared to the healthy controls is yet another measure suggesting that the pathobiology of schizophrenia may lie, in part, in the mechanisms related to sexual differentiation,” wrote Gabriella Riley, MD, of the department of psychiatry at New York University, and her associates.
To conduct the study, Dr. Riley and her associates recruited 48 inpatients and outpatients with schizophrenia and schizoaffective disorders, as defined by the DSM-5, who were stabilized on medication. Eighteen controls were recruited from postings in the area and Internet recruitment efforts, the researchers reported (Schizophr Res. 2018. doi: 10.1016/j.schres.2018.02.059).
After analyzing the data, Dr. Riley and her associates found that the They also found larger correlations between LTL reductions among men with schizophrenia who had been exposed to early trauma but not in women with schizophrenia (–0.320 vs. 0.447) with such exposure. Conversely, larger correlations in LTL reductions were found among healthy women who had been exposed to early trauma, compared with the male controls (–0.275 vs. 0.688).
To read the full study, click here.
Men with schizophrenia and healthy women who were exposed to childhood trauma have shorter leukocyte telomere length (LTL) than do their counterparts in both groups, a small study shows.
“This converse sex-association in schizophrenia compared to the healthy controls is yet another measure suggesting that the pathobiology of schizophrenia may lie, in part, in the mechanisms related to sexual differentiation,” wrote Gabriella Riley, MD, of the department of psychiatry at New York University, and her associates.
To conduct the study, Dr. Riley and her associates recruited 48 inpatients and outpatients with schizophrenia and schizoaffective disorders, as defined by the DSM-5, who were stabilized on medication. Eighteen controls were recruited from postings in the area and Internet recruitment efforts, the researchers reported (Schizophr Res. 2018. doi: 10.1016/j.schres.2018.02.059).
After analyzing the data, Dr. Riley and her associates found that the They also found larger correlations between LTL reductions among men with schizophrenia who had been exposed to early trauma but not in women with schizophrenia (–0.320 vs. 0.447) with such exposure. Conversely, larger correlations in LTL reductions were found among healthy women who had been exposed to early trauma, compared with the male controls (–0.275 vs. 0.688).
To read the full study, click here.
Men with schizophrenia and healthy women who were exposed to childhood trauma have shorter leukocyte telomere length (LTL) than do their counterparts in both groups, a small study shows.
“This converse sex-association in schizophrenia compared to the healthy controls is yet another measure suggesting that the pathobiology of schizophrenia may lie, in part, in the mechanisms related to sexual differentiation,” wrote Gabriella Riley, MD, of the department of psychiatry at New York University, and her associates.
To conduct the study, Dr. Riley and her associates recruited 48 inpatients and outpatients with schizophrenia and schizoaffective disorders, as defined by the DSM-5, who were stabilized on medication. Eighteen controls were recruited from postings in the area and Internet recruitment efforts, the researchers reported (Schizophr Res. 2018. doi: 10.1016/j.schres.2018.02.059).
After analyzing the data, Dr. Riley and her associates found that the They also found larger correlations between LTL reductions among men with schizophrenia who had been exposed to early trauma but not in women with schizophrenia (–0.320 vs. 0.447) with such exposure. Conversely, larger correlations in LTL reductions were found among healthy women who had been exposed to early trauma, compared with the male controls (–0.275 vs. 0.688).
To read the full study, click here.
FROM SCHIZOPHRENIA RESEARCH
Posttransplant skin conditions vary widely by ethnicity
SAN DIEGO – A new study finds that the risk of skin cancers in organ transplant recipients may vary widely by ethnicity.
“The most important findings from our study are the high rates of keratinocyte neoplasms observed in our white Northern European patients, but also in those of Far East Asian descent. Dermatologists should also appreciate the high risk of Kaposi’s sarcoma (KS) in patients originating from Sub-Saharan Africa,” Jonathan Kentley, MBBS, of Royal London Hospital, said in an interview. He presented the study findings at the annual meeting of the American Academy of Dermatology.
For the study, Dr. Kentley and colleagues sought to better understand .
They analyzed an organ transplant center database for the years 1989-2016, and tracked 1,304 consecutive patients – which included 1,125 with skin problems. The overall population was 64% male with a median age in the early 40s, and almost all (1,276) had undergone renal transplants. A relative handful underwent liver, lung, heart, and pancreas transplants.
The majority of patients (885) were white Northern Europeans, but there were also significant numbers of people with South Asian (202), black African/Caribbean (131) and white/Mediterranean (52) heritage. A small number were Far East Asian (26) and Middle Eastern (8). The median follow-up time for the ethnic groups varied from about 5 years to about 12 years.
The researchers found that basal cell carcinoma was most common in white Northern European patients, at nearly 25%, with other groups under 10%. SCC was common in white Northern European patients and Far East Asians, both at nearly 25%.
By far, KS was the most common in black African/Caribbean patients, at nearly 11%. According to Dr. Kentley, researchers found the number of KS cases to be surprisingly high in this group, “compounded by the fact that we have had a number of additional cases in the past year after we had collected the data for this study.” He attributes the higher number of KS cases in these patients to an increased seroprevalence of its causative agent, human herpesvirus-8, in Sub-Saharan Africa. The rate of KS in the second most commonly affected group – white Mediterranean patients – was almost 2%.
Viral warts were common in most groups, with the rate in both white groups (white Northern European and white Mediterranean) at nearly 60%, and Far East Asians at about 65%. Porokeratosis was by far the most common in white Norther Europeans, at nearly 8%, and sebaceous hyperplasia was common in all groups (more than 20% to about 27%) except in the black African/Caribbean and South Asian groups.
All these results were statistically significant with P values less than .05.
“Our study has confirmed the increased risk of keratinocyte cancers in patients of white Northern European descent, as well as providing more information on the increased risk in patients of Far East Asian descent,” Dr. Kentley said. “We have also confirmed the propensity of black African/Caribbean patients to develop Kaposi’s sarcoma in the first 5 years post transplant and highlighted that white Mediterranean patients are also at high risk. Beyond this, we have been able to review the prevalence of rare malignancies, such as Merkel cell carcinoma and appendageal tumors, and highlight that white Northern European patients remain at high risk of developing these conditions.”
As for the impact on clinical practice, “the patterns of skin disease susceptibility we have identified have important implications for rational design of transplant skin surveillance programs, targeted patient (and provider) education, and optimized clinical management,” Dr. Kentley said. “Ultimately, this is likely to have a significant impact on strategic deployment of limited dermatology health care resources.”
Specifically, the study suggests that all organ transplant patients receive a baseline skin assessment visit and nurse-led targeted education. Black African/Caribbean patients should be followed up for at least 5 years after transplant.
In the United States, at least 724,000 people have undergone organ transplants since 1988, with most getting kidney transplants, according to the United Network for Organ Sharing (UNOS).
No study funding was reported. The authors had no disclosures.
SOURCE: Kentley J et al. AAD 2018, Session F055.
SAN DIEGO – A new study finds that the risk of skin cancers in organ transplant recipients may vary widely by ethnicity.
“The most important findings from our study are the high rates of keratinocyte neoplasms observed in our white Northern European patients, but also in those of Far East Asian descent. Dermatologists should also appreciate the high risk of Kaposi’s sarcoma (KS) in patients originating from Sub-Saharan Africa,” Jonathan Kentley, MBBS, of Royal London Hospital, said in an interview. He presented the study findings at the annual meeting of the American Academy of Dermatology.
For the study, Dr. Kentley and colleagues sought to better understand .
They analyzed an organ transplant center database for the years 1989-2016, and tracked 1,304 consecutive patients – which included 1,125 with skin problems. The overall population was 64% male with a median age in the early 40s, and almost all (1,276) had undergone renal transplants. A relative handful underwent liver, lung, heart, and pancreas transplants.
The majority of patients (885) were white Northern Europeans, but there were also significant numbers of people with South Asian (202), black African/Caribbean (131) and white/Mediterranean (52) heritage. A small number were Far East Asian (26) and Middle Eastern (8). The median follow-up time for the ethnic groups varied from about 5 years to about 12 years.
The researchers found that basal cell carcinoma was most common in white Northern European patients, at nearly 25%, with other groups under 10%. SCC was common in white Northern European patients and Far East Asians, both at nearly 25%.
By far, KS was the most common in black African/Caribbean patients, at nearly 11%. According to Dr. Kentley, researchers found the number of KS cases to be surprisingly high in this group, “compounded by the fact that we have had a number of additional cases in the past year after we had collected the data for this study.” He attributes the higher number of KS cases in these patients to an increased seroprevalence of its causative agent, human herpesvirus-8, in Sub-Saharan Africa. The rate of KS in the second most commonly affected group – white Mediterranean patients – was almost 2%.
Viral warts were common in most groups, with the rate in both white groups (white Northern European and white Mediterranean) at nearly 60%, and Far East Asians at about 65%. Porokeratosis was by far the most common in white Norther Europeans, at nearly 8%, and sebaceous hyperplasia was common in all groups (more than 20% to about 27%) except in the black African/Caribbean and South Asian groups.
All these results were statistically significant with P values less than .05.
“Our study has confirmed the increased risk of keratinocyte cancers in patients of white Northern European descent, as well as providing more information on the increased risk in patients of Far East Asian descent,” Dr. Kentley said. “We have also confirmed the propensity of black African/Caribbean patients to develop Kaposi’s sarcoma in the first 5 years post transplant and highlighted that white Mediterranean patients are also at high risk. Beyond this, we have been able to review the prevalence of rare malignancies, such as Merkel cell carcinoma and appendageal tumors, and highlight that white Northern European patients remain at high risk of developing these conditions.”
As for the impact on clinical practice, “the patterns of skin disease susceptibility we have identified have important implications for rational design of transplant skin surveillance programs, targeted patient (and provider) education, and optimized clinical management,” Dr. Kentley said. “Ultimately, this is likely to have a significant impact on strategic deployment of limited dermatology health care resources.”
Specifically, the study suggests that all organ transplant patients receive a baseline skin assessment visit and nurse-led targeted education. Black African/Caribbean patients should be followed up for at least 5 years after transplant.
In the United States, at least 724,000 people have undergone organ transplants since 1988, with most getting kidney transplants, according to the United Network for Organ Sharing (UNOS).
No study funding was reported. The authors had no disclosures.
SOURCE: Kentley J et al. AAD 2018, Session F055.
SAN DIEGO – A new study finds that the risk of skin cancers in organ transplant recipients may vary widely by ethnicity.
“The most important findings from our study are the high rates of keratinocyte neoplasms observed in our white Northern European patients, but also in those of Far East Asian descent. Dermatologists should also appreciate the high risk of Kaposi’s sarcoma (KS) in patients originating from Sub-Saharan Africa,” Jonathan Kentley, MBBS, of Royal London Hospital, said in an interview. He presented the study findings at the annual meeting of the American Academy of Dermatology.
For the study, Dr. Kentley and colleagues sought to better understand .
They analyzed an organ transplant center database for the years 1989-2016, and tracked 1,304 consecutive patients – which included 1,125 with skin problems. The overall population was 64% male with a median age in the early 40s, and almost all (1,276) had undergone renal transplants. A relative handful underwent liver, lung, heart, and pancreas transplants.
The majority of patients (885) were white Northern Europeans, but there were also significant numbers of people with South Asian (202), black African/Caribbean (131) and white/Mediterranean (52) heritage. A small number were Far East Asian (26) and Middle Eastern (8). The median follow-up time for the ethnic groups varied from about 5 years to about 12 years.
The researchers found that basal cell carcinoma was most common in white Northern European patients, at nearly 25%, with other groups under 10%. SCC was common in white Northern European patients and Far East Asians, both at nearly 25%.
By far, KS was the most common in black African/Caribbean patients, at nearly 11%. According to Dr. Kentley, researchers found the number of KS cases to be surprisingly high in this group, “compounded by the fact that we have had a number of additional cases in the past year after we had collected the data for this study.” He attributes the higher number of KS cases in these patients to an increased seroprevalence of its causative agent, human herpesvirus-8, in Sub-Saharan Africa. The rate of KS in the second most commonly affected group – white Mediterranean patients – was almost 2%.
Viral warts were common in most groups, with the rate in both white groups (white Northern European and white Mediterranean) at nearly 60%, and Far East Asians at about 65%. Porokeratosis was by far the most common in white Norther Europeans, at nearly 8%, and sebaceous hyperplasia was common in all groups (more than 20% to about 27%) except in the black African/Caribbean and South Asian groups.
All these results were statistically significant with P values less than .05.
“Our study has confirmed the increased risk of keratinocyte cancers in patients of white Northern European descent, as well as providing more information on the increased risk in patients of Far East Asian descent,” Dr. Kentley said. “We have also confirmed the propensity of black African/Caribbean patients to develop Kaposi’s sarcoma in the first 5 years post transplant and highlighted that white Mediterranean patients are also at high risk. Beyond this, we have been able to review the prevalence of rare malignancies, such as Merkel cell carcinoma and appendageal tumors, and highlight that white Northern European patients remain at high risk of developing these conditions.”
As for the impact on clinical practice, “the patterns of skin disease susceptibility we have identified have important implications for rational design of transplant skin surveillance programs, targeted patient (and provider) education, and optimized clinical management,” Dr. Kentley said. “Ultimately, this is likely to have a significant impact on strategic deployment of limited dermatology health care resources.”
Specifically, the study suggests that all organ transplant patients receive a baseline skin assessment visit and nurse-led targeted education. Black African/Caribbean patients should be followed up for at least 5 years after transplant.
In the United States, at least 724,000 people have undergone organ transplants since 1988, with most getting kidney transplants, according to the United Network for Organ Sharing (UNOS).
No study funding was reported. The authors had no disclosures.
SOURCE: Kentley J et al. AAD 2018, Session F055.
REPORTING FROM AAD 18
Key clinical point: Skin disorders after organ transplant differ widely by ethnicity.
Major finding: Posttransplant basal cell and squamous cell carcinomas are most common in white Northern Europeans (at nearly 25%), while Kaposi’s sarcoma was higher than expected (nearly 10%) in black African/Caribbean patients.
Study details: Analysis of 1,125 patients from a single transplant center who received organ transplants and developed skin problems over a median follow-up time of 5 to more than 12 years, depending on ethnicity.
Disclosures: No study funding was reported. The authors had no disclosures.
Source: Kentley J et al. AAD 2018, Session F055.
Unusual antibiotic resistance found in more than 200 bacteria
The Centers for Disease Control and Prevention’s Antibiotic Resistance (AR) Lab Network has detected 221 instances of bacteria with especially rare resistance genes in the United States, according to a Vital Signs report published online and expanded upon in CDC’s MMWR Weekly.
The MMWR Weekly report, “Containment of Novel Multidrug-Resistant Organisms and Resistance Mechanisms,” which goes deeper into the science behind the issue, shows that in 9 months, in all states and Puerto Rico, health department workers in the AR lab network tested 5,776 samples of highly resistant bacteria, according to Anne Schuchat, MD, principal deputy director of the CDC. These bacteria were immediately tested for unusual resistance – “those genes that were highly resistant, or rare, with special resistance that could spread,” she said.
“Of the 5,776, about 1 in 4 of the bacteria had a gene that helped it spread its resistance. And there were 221 instances of an especially rare resistance gene,” she added. This prompted intense screening, revealing “that 1 in 10 tests were also positive. Meaning the unusual resistance may have spread to other patients. And could have continued spreading if left undetected.”
The report looked at carbapenem-resistant Enterobacteriaceae (CRE) and Enterobacteriaceae with extended-spectrum beta-lactamases (ESBL) infection data from the National Healthcare Safety Network from 2006-2015 to calculate changes in the year over year proportions of these infections and how an enhanced detection and control strategy curbs carbapenem resistance.
This strategy includes components such as timely implementation of appropriate infection control measures, conducting a health care and contact investigation with follow-up, and implementing a system to ensure adherence to infection control measures.
“With independent, or single facility approaches to control spread, a dangerous type of unusual resistance in Enterobacteriaceae [ESBL phenotype] decreased by about 2% per year [(risk ratio [RR] = 0.98, P less than .001)].” With a more aggressive approach, using guidance such as CDC’s CRE toolkit, released in 2009, another type of unusual resistance [CRE] in the same bacteria (Enterobacteriaceae) decreased by nearly 15% per year (RR = 0.85, P less than .01).
The difference may be due in part to the more directed response utilized to slow the spread of the “nightmare bacteria,” once it was identified, said Dr. Schuchat.
These results show massive promise even if only partially effective, specifically for CRE.
“CDC estimates show that if only 20% effective, the containment strategy can reduce the number of nightmare bacteria [CRE] cases by 76% over 3 years in one area.”
Due to the nature of antibiotic resistance and its ability to spread, this poses a significant public health threat. Antibiotics are not simply used to treat infections but are a safety net that is used in cancer treatment, surgery, and ICU care, Dr. Schuchat pointed out. The rise of antibiotic resistance is a threat to that safety net and accounts for nearly 2,000,000 antibiotic resistant infections and approximately 23,000 deaths per year.
But aggressive responses to these infections can control their spread. Dr. Schuchat used the analogy of controlling a fire to illustrate the concept.
“Much like a fire, finding and stopping unusual resistance early when it’s just a spark protects people.”
Dr. Schuchat reiterated that simply identifying the issue is only part of the equation.
“Detection is not enough on its own. When there is a fire, somebody needs to put it out. CDC supports more than 500 local staff across the country to combat antibiotic resistance wherever it emerges.”
While the report highlights the strides that have been made in combating antibiotic resistance, Paul Auwaerter, MD, president of the Infectious Diseases Society of America, released a statement highlighting the need to further fund these efforts.
“The report spells out the need to accelerate efforts to curb resistance or face an increasing burden including novel resistance mutations that threaten health,” stated Dr. Auwaerter. “The efforts detailed in the Vital Signs report were made possible through new congressional funding in 2016 to combat antibiotic resistance. We urge Congress to sustain and to grow that investment so that further progress will prepare us to meet the future challenges of antibiotic resistance from a position of strength,” he added.
A fact sheet with a brief summation of the vital signs report is available here.
The Centers for Disease Control and Prevention’s Antibiotic Resistance (AR) Lab Network has detected 221 instances of bacteria with especially rare resistance genes in the United States, according to a Vital Signs report published online and expanded upon in CDC’s MMWR Weekly.
The MMWR Weekly report, “Containment of Novel Multidrug-Resistant Organisms and Resistance Mechanisms,” which goes deeper into the science behind the issue, shows that in 9 months, in all states and Puerto Rico, health department workers in the AR lab network tested 5,776 samples of highly resistant bacteria, according to Anne Schuchat, MD, principal deputy director of the CDC. These bacteria were immediately tested for unusual resistance – “those genes that were highly resistant, or rare, with special resistance that could spread,” she said.
“Of the 5,776, about 1 in 4 of the bacteria had a gene that helped it spread its resistance. And there were 221 instances of an especially rare resistance gene,” she added. This prompted intense screening, revealing “that 1 in 10 tests were also positive. Meaning the unusual resistance may have spread to other patients. And could have continued spreading if left undetected.”
The report looked at carbapenem-resistant Enterobacteriaceae (CRE) and Enterobacteriaceae with extended-spectrum beta-lactamases (ESBL) infection data from the National Healthcare Safety Network from 2006-2015 to calculate changes in the year over year proportions of these infections and how an enhanced detection and control strategy curbs carbapenem resistance.
This strategy includes components such as timely implementation of appropriate infection control measures, conducting a health care and contact investigation with follow-up, and implementing a system to ensure adherence to infection control measures.
“With independent, or single facility approaches to control spread, a dangerous type of unusual resistance in Enterobacteriaceae [ESBL phenotype] decreased by about 2% per year [(risk ratio [RR] = 0.98, P less than .001)].” With a more aggressive approach, using guidance such as CDC’s CRE toolkit, released in 2009, another type of unusual resistance [CRE] in the same bacteria (Enterobacteriaceae) decreased by nearly 15% per year (RR = 0.85, P less than .01).
The difference may be due in part to the more directed response utilized to slow the spread of the “nightmare bacteria,” once it was identified, said Dr. Schuchat.
These results show massive promise even if only partially effective, specifically for CRE.
“CDC estimates show that if only 20% effective, the containment strategy can reduce the number of nightmare bacteria [CRE] cases by 76% over 3 years in one area.”
Due to the nature of antibiotic resistance and its ability to spread, this poses a significant public health threat. Antibiotics are not simply used to treat infections but are a safety net that is used in cancer treatment, surgery, and ICU care, Dr. Schuchat pointed out. The rise of antibiotic resistance is a threat to that safety net and accounts for nearly 2,000,000 antibiotic resistant infections and approximately 23,000 deaths per year.
But aggressive responses to these infections can control their spread. Dr. Schuchat used the analogy of controlling a fire to illustrate the concept.
“Much like a fire, finding and stopping unusual resistance early when it’s just a spark protects people.”
Dr. Schuchat reiterated that simply identifying the issue is only part of the equation.
“Detection is not enough on its own. When there is a fire, somebody needs to put it out. CDC supports more than 500 local staff across the country to combat antibiotic resistance wherever it emerges.”
While the report highlights the strides that have been made in combating antibiotic resistance, Paul Auwaerter, MD, president of the Infectious Diseases Society of America, released a statement highlighting the need to further fund these efforts.
“The report spells out the need to accelerate efforts to curb resistance or face an increasing burden including novel resistance mutations that threaten health,” stated Dr. Auwaerter. “The efforts detailed in the Vital Signs report were made possible through new congressional funding in 2016 to combat antibiotic resistance. We urge Congress to sustain and to grow that investment so that further progress will prepare us to meet the future challenges of antibiotic resistance from a position of strength,” he added.
A fact sheet with a brief summation of the vital signs report is available here.
The Centers for Disease Control and Prevention’s Antibiotic Resistance (AR) Lab Network has detected 221 instances of bacteria with especially rare resistance genes in the United States, according to a Vital Signs report published online and expanded upon in CDC’s MMWR Weekly.
The MMWR Weekly report, “Containment of Novel Multidrug-Resistant Organisms and Resistance Mechanisms,” which goes deeper into the science behind the issue, shows that in 9 months, in all states and Puerto Rico, health department workers in the AR lab network tested 5,776 samples of highly resistant bacteria, according to Anne Schuchat, MD, principal deputy director of the CDC. These bacteria were immediately tested for unusual resistance – “those genes that were highly resistant, or rare, with special resistance that could spread,” she said.
“Of the 5,776, about 1 in 4 of the bacteria had a gene that helped it spread its resistance. And there were 221 instances of an especially rare resistance gene,” she added. This prompted intense screening, revealing “that 1 in 10 tests were also positive. Meaning the unusual resistance may have spread to other patients. And could have continued spreading if left undetected.”
The report looked at carbapenem-resistant Enterobacteriaceae (CRE) and Enterobacteriaceae with extended-spectrum beta-lactamases (ESBL) infection data from the National Healthcare Safety Network from 2006-2015 to calculate changes in the year over year proportions of these infections and how an enhanced detection and control strategy curbs carbapenem resistance.
This strategy includes components such as timely implementation of appropriate infection control measures, conducting a health care and contact investigation with follow-up, and implementing a system to ensure adherence to infection control measures.
“With independent, or single facility approaches to control spread, a dangerous type of unusual resistance in Enterobacteriaceae [ESBL phenotype] decreased by about 2% per year [(risk ratio [RR] = 0.98, P less than .001)].” With a more aggressive approach, using guidance such as CDC’s CRE toolkit, released in 2009, another type of unusual resistance [CRE] in the same bacteria (Enterobacteriaceae) decreased by nearly 15% per year (RR = 0.85, P less than .01).
The difference may be due in part to the more directed response utilized to slow the spread of the “nightmare bacteria,” once it was identified, said Dr. Schuchat.
These results show massive promise even if only partially effective, specifically for CRE.
“CDC estimates show that if only 20% effective, the containment strategy can reduce the number of nightmare bacteria [CRE] cases by 76% over 3 years in one area.”
Due to the nature of antibiotic resistance and its ability to spread, this poses a significant public health threat. Antibiotics are not simply used to treat infections but are a safety net that is used in cancer treatment, surgery, and ICU care, Dr. Schuchat pointed out. The rise of antibiotic resistance is a threat to that safety net and accounts for nearly 2,000,000 antibiotic resistant infections and approximately 23,000 deaths per year.
But aggressive responses to these infections can control their spread. Dr. Schuchat used the analogy of controlling a fire to illustrate the concept.
“Much like a fire, finding and stopping unusual resistance early when it’s just a spark protects people.”
Dr. Schuchat reiterated that simply identifying the issue is only part of the equation.
“Detection is not enough on its own. When there is a fire, somebody needs to put it out. CDC supports more than 500 local staff across the country to combat antibiotic resistance wherever it emerges.”
While the report highlights the strides that have been made in combating antibiotic resistance, Paul Auwaerter, MD, president of the Infectious Diseases Society of America, released a statement highlighting the need to further fund these efforts.
“The report spells out the need to accelerate efforts to curb resistance or face an increasing burden including novel resistance mutations that threaten health,” stated Dr. Auwaerter. “The efforts detailed in the Vital Signs report were made possible through new congressional funding in 2016 to combat antibiotic resistance. We urge Congress to sustain and to grow that investment so that further progress will prepare us to meet the future challenges of antibiotic resistance from a position of strength,” he added.
A fact sheet with a brief summation of the vital signs report is available here.
FROM A CDC TELEBRIEFING
Late Thrombectomy Improves Ischemic Stroke Outcomes
LOS ANGELES—When performed between six and 16 hours after stroke onset, thrombectomy plus standard medical management yields better functional outcomes than medical management alone, according to research presented at the International Stroke Conference 2018. Adjunctive thrombectomy also reduces the rates of death and severe disability, compared with medical management alone.
In 2006, Gregory W. Albers, MD, Coyote Foundation Professor of Neurology and Neurological Sciences and Professor, by courtesy, of Neurosurgery at Stanford University Medical Center in California, and colleagues found that MRI could identify patients with stroke who would benefit from IV t-PA as late as six hours after onset. The investigators developed software called RAPID that could determine how much brain tissue was salvageable in a patient with stroke. In a subsequent study, the software allowed researchers to identify patients who would benefit from thrombectomy at a later point after stroke onset than had been considered possible. 
The DEFUSE 3 Trial
Dr. Albers and colleagues conducted the DEFUSE 3 study to analyze whether patients could benefit from thrombectomy if administered between six and 16 hours after stroke onset. Eligible participants in the open-label trial had an occlusion in the middle cerebral artery or the internal carotid artery, an initial infarct size of less than 70 mL, and a ratio of ischemic tissue volume to infarct volume of 1.8 or more on perfusion imaging. The researchers used the RAPID software to determine how much salvageable tissue each patient had.
“We used fairly broad inclusion criteria,” said Dr. Albers. Patients as old as 90 were included, as were patients with moderate to severe strokes. Participants were required to be free of disability at stroke onset.
Patients were randomized to standard medical management alone or thrombectomy plus standard medical management. Medical management included standard stroke prevention therapies, management of blood pressure, and interventions to prevent complications for stroke such as deep venous thrombosis. The primary efficacy end point was modified Rankin scale score at 90 days. The secondary efficacy outcome was modified Rankin scale score of 0 to 2 at 90 days (ie, functional independence). The primary safety outcomes were death within 90 days and symptomatic intracranial hemorrhage within 36 hours.
Study Was Terminated Early
The patients in DEFUSE 3 were similar to those included in trials of thrombectomy administered within six hours, said Dr. Albers. Median age was about 70 in both study arms. About 50% of the study population was female, and median NIH Stroke Scale score was 16.
The researchers conducted an interim analysis when 182 patients had been enrolled at 38 sites, including 92 randomized to thrombectomy. The results of the analysis prompted them to end the study early because of treatment efficacy.
The unadjusted odds ratio (OR) of a favorable outcome on the modified Rankin scale at 90 days was 2.77 in the thrombectomy group, compared with the medical management group. After adjusting for between-group differences, the OR was 3.36. This result “is the largest odds ratio ever reported for a thrombectomy study,” said Dr. Albers. Approximately 45% of participants in the thrombectomy group achieved functional independence, compared with 17% in the medical management group.
The rate of mortality at 90 days was 14% in the thrombectomy arm and 26% in the medical management arm. The combined rate of death or severe disability was 22% in the thrombectomy group and 42% in the medical management group. The rate of symptomatic intracranial hemorrhage did not differ significantly between groups.
The benefit of thrombectomy on the primary and secondary end points was similar for patients with wake-up stroke and patients for whom stroke onset had been witnessed. “This [result] demonstrates that the DEFUSE 3 treatment benefit is not explained by a potentially shorter onset to treatment time in the wake-up group,” said Dr. Albers. The rate of good outcome was also similar in all three prespecified time periods that the investigators examined (ie, treatment at six to nine hours, nine to 12 hours, and 12 to 16 hours after onset).
Results Informed New Stroke Guidelines
The treatment benefits in this study are “even more significant” than when patients receive treatment within six hours of stroke onset, said Dr. Albers. Part of the reason for this difference is that the doctors who performed thrombectomy were successful at reperfusing the brain. About 80% of patients in the thrombectomy arm had excellent reperfusion, but spontaneous reperfusion occurred in less than 20% of the medical arm.
The updated guidelines from the American Heart Association and American Stroke Association for the management of acute ischemic stroke, which were published in the March issue of Stroke, recommend that neurologists use the DEFUSE 3 criteria to select patients for thrombectomy at six to 16 hours after stroke onset.
“Now that we know that we can successfully treat patients in later time windows, it is going to be important for primary stroke centers to be able to do the type of imaging that was done in the DEFUSE 3 and DAWN trials,” said Dr. Albers.
He added that it is still important to rush as quickly as possible to evaluate stroke patients. “Every minute still counts, and there are some unfortunate individuals whose minutes run dry even when they present during the golden hours after symptom onset. But more importantly, we now know that many stroke patients are considerably more fortunate; their hourglass is much kinder and affords medical providers with a golden opportunity to improve outcomes even in time frames that were once thought to be impossible.”
—Erik Greb
Suggested Reading
Albers GW, Marks MP, Kemp S, et al. Thrombectomy for stroke at 6 to 16 hours with selection by perfusion imaging. N Engl J Med. 2018;378(8):708-718.
Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the early management of patients with acute ischemic stroke: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2018;49(3):e46-e110.
LOS ANGELES—When performed between six and 16 hours after stroke onset, thrombectomy plus standard medical management yields better functional outcomes than medical management alone, according to research presented at the International Stroke Conference 2018. Adjunctive thrombectomy also reduces the rates of death and severe disability, compared with medical management alone.
In 2006, Gregory W. Albers, MD, Coyote Foundation Professor of Neurology and Neurological Sciences and Professor, by courtesy, of Neurosurgery at Stanford University Medical Center in California, and colleagues found that MRI could identify patients with stroke who would benefit from IV t-PA as late as six hours after onset. The investigators developed software called RAPID that could determine how much brain tissue was salvageable in a patient with stroke. In a subsequent study, the software allowed researchers to identify patients who would benefit from thrombectomy at a later point after stroke onset than had been considered possible.
The DEFUSE 3 Trial
Dr. Albers and colleagues conducted the DEFUSE 3 study to analyze whether patients could benefit from thrombectomy if administered between six and 16 hours after stroke onset. Eligible participants in the open-label trial had an occlusion in the middle cerebral artery or the internal carotid artery, an initial infarct size of less than 70 mL, and a ratio of ischemic tissue volume to infarct volume of 1.8 or more on perfusion imaging. The researchers used the RAPID software to determine how much salvageable tissue each patient had.
“We used fairly broad inclusion criteria,” said Dr. Albers. Patients as old as 90 were included, as were patients with moderate to severe strokes. Participants were required to be free of disability at stroke onset.
Patients were randomized to standard medical management alone or thrombectomy plus standard medical management. Medical management included standard stroke prevention therapies, management of blood pressure, and interventions to prevent complications for stroke such as deep venous thrombosis. The primary efficacy end point was modified Rankin scale score at 90 days. The secondary efficacy outcome was modified Rankin scale score of 0 to 2 at 90 days (ie, functional independence). The primary safety outcomes were death within 90 days and symptomatic intracranial hemorrhage within 36 hours.
Study Was Terminated Early
The patients in DEFUSE 3 were similar to those included in trials of thrombectomy administered within six hours, said Dr. Albers. Median age was about 70 in both study arms. About 50% of the study population was female, and median NIH Stroke Scale score was 16.
The researchers conducted an interim analysis when 182 patients had been enrolled at 38 sites, including 92 randomized to thrombectomy. The results of the analysis prompted them to end the study early because of treatment efficacy.
The unadjusted odds ratio (OR) of a favorable outcome on the modified Rankin scale at 90 days was 2.77 in the thrombectomy group, compared with the medical management group. After adjusting for between-group differences, the OR was 3.36. This result “is the largest odds ratio ever reported for a thrombectomy study,” said Dr. Albers. Approximately 45% of participants in the thrombectomy group achieved functional independence, compared with 17% in the medical management group.
The rate of mortality at 90 days was 14% in the thrombectomy arm and 26% in the medical management arm. The combined rate of death or severe disability was 22% in the thrombectomy group and 42% in the medical management group. The rate of symptomatic intracranial hemorrhage did not differ significantly between groups.
The benefit of thrombectomy on the primary and secondary end points was similar for patients with wake-up stroke and patients for whom stroke onset had been witnessed. “This [result] demonstrates that the DEFUSE 3 treatment benefit is not explained by a potentially shorter onset to treatment time in the wake-up group,” said Dr. Albers. The rate of good outcome was also similar in all three prespecified time periods that the investigators examined (ie, treatment at six to nine hours, nine to 12 hours, and 12 to 16 hours after onset).
Results Informed New Stroke Guidelines
The treatment benefits in this study are “even more significant” than when patients receive treatment within six hours of stroke onset, said Dr. Albers. Part of the reason for this difference is that the doctors who performed thrombectomy were successful at reperfusing the brain. About 80% of patients in the thrombectomy arm had excellent reperfusion, but spontaneous reperfusion occurred in less than 20% of the medical arm.
The updated guidelines from the American Heart Association and American Stroke Association for the management of acute ischemic stroke, which were published in the March issue of Stroke, recommend that neurologists use the DEFUSE 3 criteria to select patients for thrombectomy at six to 16 hours after stroke onset.
“Now that we know that we can successfully treat patients in later time windows, it is going to be important for primary stroke centers to be able to do the type of imaging that was done in the DEFUSE 3 and DAWN trials,” said Dr. Albers.
He added that it is still important to rush as quickly as possible to evaluate stroke patients. “Every minute still counts, and there are some unfortunate individuals whose minutes run dry even when they present during the golden hours after symptom onset. But more importantly, we now know that many stroke patients are considerably more fortunate; their hourglass is much kinder and affords medical providers with a golden opportunity to improve outcomes even in time frames that were once thought to be impossible.”
—Erik Greb
Suggested Reading
Albers GW, Marks MP, Kemp S, et al. Thrombectomy for stroke at 6 to 16 hours with selection by perfusion imaging. N Engl J Med. 2018;378(8):708-718.
Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the early management of patients with acute ischemic stroke: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2018;49(3):e46-e110.
LOS ANGELES—When performed between six and 16 hours after stroke onset, thrombectomy plus standard medical management yields better functional outcomes than medical management alone, according to research presented at the International Stroke Conference 2018. Adjunctive thrombectomy also reduces the rates of death and severe disability, compared with medical management alone.
In 2006, Gregory W. Albers, MD, Coyote Foundation Professor of Neurology and Neurological Sciences and Professor, by courtesy, of Neurosurgery at Stanford University Medical Center in California, and colleagues found that MRI could identify patients with stroke who would benefit from IV t-PA as late as six hours after onset. The investigators developed software called RAPID that could determine how much brain tissue was salvageable in a patient with stroke. In a subsequent study, the software allowed researchers to identify patients who would benefit from thrombectomy at a later point after stroke onset than had been considered possible.
The DEFUSE 3 Trial
Dr. Albers and colleagues conducted the DEFUSE 3 study to analyze whether patients could benefit from thrombectomy if administered between six and 16 hours after stroke onset. Eligible participants in the open-label trial had an occlusion in the middle cerebral artery or the internal carotid artery, an initial infarct size of less than 70 mL, and a ratio of ischemic tissue volume to infarct volume of 1.8 or more on perfusion imaging. The researchers used the RAPID software to determine how much salvageable tissue each patient had.
“We used fairly broad inclusion criteria,” said Dr. Albers. Patients as old as 90 were included, as were patients with moderate to severe strokes. Participants were required to be free of disability at stroke onset.
Patients were randomized to standard medical management alone or thrombectomy plus standard medical management. Medical management included standard stroke prevention therapies, management of blood pressure, and interventions to prevent complications for stroke such as deep venous thrombosis. The primary efficacy end point was modified Rankin scale score at 90 days. The secondary efficacy outcome was modified Rankin scale score of 0 to 2 at 90 days (ie, functional independence). The primary safety outcomes were death within 90 days and symptomatic intracranial hemorrhage within 36 hours.
Study Was Terminated Early
The patients in DEFUSE 3 were similar to those included in trials of thrombectomy administered within six hours, said Dr. Albers. Median age was about 70 in both study arms. About 50% of the study population was female, and median NIH Stroke Scale score was 16.
The researchers conducted an interim analysis when 182 patients had been enrolled at 38 sites, including 92 randomized to thrombectomy. The results of the analysis prompted them to end the study early because of treatment efficacy.
The unadjusted odds ratio (OR) of a favorable outcome on the modified Rankin scale at 90 days was 2.77 in the thrombectomy group, compared with the medical management group. After adjusting for between-group differences, the OR was 3.36. This result “is the largest odds ratio ever reported for a thrombectomy study,” said Dr. Albers. Approximately 45% of participants in the thrombectomy group achieved functional independence, compared with 17% in the medical management group.
The rate of mortality at 90 days was 14% in the thrombectomy arm and 26% in the medical management arm. The combined rate of death or severe disability was 22% in the thrombectomy group and 42% in the medical management group. The rate of symptomatic intracranial hemorrhage did not differ significantly between groups.
The benefit of thrombectomy on the primary and secondary end points was similar for patients with wake-up stroke and patients for whom stroke onset had been witnessed. “This [result] demonstrates that the DEFUSE 3 treatment benefit is not explained by a potentially shorter onset to treatment time in the wake-up group,” said Dr. Albers. The rate of good outcome was also similar in all three prespecified time periods that the investigators examined (ie, treatment at six to nine hours, nine to 12 hours, and 12 to 16 hours after onset).
Results Informed New Stroke Guidelines
The treatment benefits in this study are “even more significant” than when patients receive treatment within six hours of stroke onset, said Dr. Albers. Part of the reason for this difference is that the doctors who performed thrombectomy were successful at reperfusing the brain. About 80% of patients in the thrombectomy arm had excellent reperfusion, but spontaneous reperfusion occurred in less than 20% of the medical arm.
The updated guidelines from the American Heart Association and American Stroke Association for the management of acute ischemic stroke, which were published in the March issue of Stroke, recommend that neurologists use the DEFUSE 3 criteria to select patients for thrombectomy at six to 16 hours after stroke onset.
“Now that we know that we can successfully treat patients in later time windows, it is going to be important for primary stroke centers to be able to do the type of imaging that was done in the DEFUSE 3 and DAWN trials,” said Dr. Albers.
He added that it is still important to rush as quickly as possible to evaluate stroke patients. “Every minute still counts, and there are some unfortunate individuals whose minutes run dry even when they present during the golden hours after symptom onset. But more importantly, we now know that many stroke patients are considerably more fortunate; their hourglass is much kinder and affords medical providers with a golden opportunity to improve outcomes even in time frames that were once thought to be impossible.”
—Erik Greb
Suggested Reading
Albers GW, Marks MP, Kemp S, et al. Thrombectomy for stroke at 6 to 16 hours with selection by perfusion imaging. N Engl J Med. 2018;378(8):708-718.
Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the early management of patients with acute ischemic stroke: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2018;49(3):e46-e110.
Lower heart disease mortality brings increased disparity
The overall death rate from heart disease is down 68% since 1968 in the United States, but the disparity between blacks and whites has increased over that time, according to the Centers for Disease Control and Prevention.
Overall, heart disease mortality for adults aged 35 years and older went from 1,035 per 100,000 population in 1968 to 327 per 100,000 in 2015, a drop of 68%. For whites, the story was very similar: The death rate dropped from 1,032 to 326, or 68%. For blacks, who had a higher death rate to begin with, at 1,072 per 100,000, the drop was 63% to 396 per 100,000, Miriam Van Dyke, MPH, of Emory University, Atlanta, and her associates reported in MMWR Surveillance Summaries.
Disparities can be seen at the state level as well. For blacks aged 35 years and older, heart disease death rates ranged from 200 per 100,000 in Oregon to 516 per 100,000 in Arkansas in 2015. For whites in that age group, the death rate was lowest in the District of Columbia (198 per 100,000) and highest in Oklahoma (446 per 100,000), Ms. Van Dyke and her associates wrote.
To help them pinpoint differences by race within geographic areas, the investigators calculated ratios of black to white heart disease death rates. In 1968, the state with the highest ratio, or the largest excess of black mortality, was Rhode Island at 1.38, and the state with the lowest ratio, meaning the largest excess of white mortality, was Minnesota at 0.64. There were 27 states that year with a ratio over 1.0, 12 states with a ratio below 1.0, 1 state with a ratio of 1.0 (Wisconsin), and 11 states that did not have a black population large enough to make a reliable estimate, they said.
In 2015, the jurisdiction with the largest excess of black mortality was D.C., with a ratio of 2.42; the state with the lowest ratio was Rhode Island, at 0.69. That year, there were 34 states with a ratio over 1.0, 6 states with a ratio below 1.0, and 11 states – the same 11 as in 1968 – with black populations too small to reliably estimate death rates, the investigators noted.
“The elimination of racial disparities in heart disease death rates, along with continued decreases in heart disease death rates for all persons in the United States, is important for the overall state of health. The trends in black-white disparities in heart disease death rates … highlight the importance of continued surveillance of these trends at the national and state level,” the investigators wrote.
SOURCE: Van Dyke M et al. MMWR Surveill Summ. 2018 Mar 30;67(5):1-11.
The overall death rate from heart disease is down 68% since 1968 in the United States, but the disparity between blacks and whites has increased over that time, according to the Centers for Disease Control and Prevention.
Overall, heart disease mortality for adults aged 35 years and older went from 1,035 per 100,000 population in 1968 to 327 per 100,000 in 2015, a drop of 68%. For whites, the story was very similar: The death rate dropped from 1,032 to 326, or 68%. For blacks, who had a higher death rate to begin with, at 1,072 per 100,000, the drop was 63% to 396 per 100,000, Miriam Van Dyke, MPH, of Emory University, Atlanta, and her associates reported in MMWR Surveillance Summaries.
Disparities can be seen at the state level as well. For blacks aged 35 years and older, heart disease death rates ranged from 200 per 100,000 in Oregon to 516 per 100,000 in Arkansas in 2015. For whites in that age group, the death rate was lowest in the District of Columbia (198 per 100,000) and highest in Oklahoma (446 per 100,000), Ms. Van Dyke and her associates wrote.
To help them pinpoint differences by race within geographic areas, the investigators calculated ratios of black to white heart disease death rates. In 1968, the state with the highest ratio, or the largest excess of black mortality, was Rhode Island at 1.38, and the state with the lowest ratio, meaning the largest excess of white mortality, was Minnesota at 0.64. There were 27 states that year with a ratio over 1.0, 12 states with a ratio below 1.0, 1 state with a ratio of 1.0 (Wisconsin), and 11 states that did not have a black population large enough to make a reliable estimate, they said.
In 2015, the jurisdiction with the largest excess of black mortality was D.C., with a ratio of 2.42; the state with the lowest ratio was Rhode Island, at 0.69. That year, there were 34 states with a ratio over 1.0, 6 states with a ratio below 1.0, and 11 states – the same 11 as in 1968 – with black populations too small to reliably estimate death rates, the investigators noted.
“The elimination of racial disparities in heart disease death rates, along with continued decreases in heart disease death rates for all persons in the United States, is important for the overall state of health. The trends in black-white disparities in heart disease death rates … highlight the importance of continued surveillance of these trends at the national and state level,” the investigators wrote.
SOURCE: Van Dyke M et al. MMWR Surveill Summ. 2018 Mar 30;67(5):1-11.
The overall death rate from heart disease is down 68% since 1968 in the United States, but the disparity between blacks and whites has increased over that time, according to the Centers for Disease Control and Prevention.
Overall, heart disease mortality for adults aged 35 years and older went from 1,035 per 100,000 population in 1968 to 327 per 100,000 in 2015, a drop of 68%. For whites, the story was very similar: The death rate dropped from 1,032 to 326, or 68%. For blacks, who had a higher death rate to begin with, at 1,072 per 100,000, the drop was 63% to 396 per 100,000, Miriam Van Dyke, MPH, of Emory University, Atlanta, and her associates reported in MMWR Surveillance Summaries.
Disparities can be seen at the state level as well. For blacks aged 35 years and older, heart disease death rates ranged from 200 per 100,000 in Oregon to 516 per 100,000 in Arkansas in 2015. For whites in that age group, the death rate was lowest in the District of Columbia (198 per 100,000) and highest in Oklahoma (446 per 100,000), Ms. Van Dyke and her associates wrote.
To help them pinpoint differences by race within geographic areas, the investigators calculated ratios of black to white heart disease death rates. In 1968, the state with the highest ratio, or the largest excess of black mortality, was Rhode Island at 1.38, and the state with the lowest ratio, meaning the largest excess of white mortality, was Minnesota at 0.64. There were 27 states that year with a ratio over 1.0, 12 states with a ratio below 1.0, 1 state with a ratio of 1.0 (Wisconsin), and 11 states that did not have a black population large enough to make a reliable estimate, they said.
In 2015, the jurisdiction with the largest excess of black mortality was D.C., with a ratio of 2.42; the state with the lowest ratio was Rhode Island, at 0.69. That year, there were 34 states with a ratio over 1.0, 6 states with a ratio below 1.0, and 11 states – the same 11 as in 1968 – with black populations too small to reliably estimate death rates, the investigators noted.
“The elimination of racial disparities in heart disease death rates, along with continued decreases in heart disease death rates for all persons in the United States, is important for the overall state of health. The trends in black-white disparities in heart disease death rates … highlight the importance of continued surveillance of these trends at the national and state level,” the investigators wrote.
SOURCE: Van Dyke M et al. MMWR Surveill Summ. 2018 Mar 30;67(5):1-11.
FROM MMWR SURVEILLANCE SUMMARIES
Senators seek answers on Gleostine price hike
The drug, which is used to treat Hodgkin lymphoma and brain cancer, has seen its price increase by 1,400% ($50 to $786) since NextSource acquired it. Gleostine, which was approved by the Food and Drug Administration in 1976 and has long been off patent, has no generic competition.
“Recent reports of price increases for off-patent drugs have demonstrated the need for continued oversight by the United States Senate,” Sen. Susan Collins (R-Maine), Sen. Claire McCaskill (D-Mo.), and Sen. Catherine Cortez Masto (D-Nev.) wrote in a letter to Tri-Source Pharma CEO Robert DiCrisci. Tri-Source is the parent company of NextSource.
The senators requested information on the gross and net revenues of the drug; expenses related to the sale of the drug; annual profit data; internal and external communications related to current and future sales of the drug, including cost estimates, profit projections, and market share analysis; and a list of other drugs sold by the company along with relevant pricing information.
The manufacturer has previously defended its price increases, citing the increased cost of a key manufacturing component, the cost of providing discounted drugs to Medicaid and uninsured patients, and higher regulatory fees, as well as the maintenance of a year’s worth of “safety stock” to prevent shortages.
The drug, which is used to treat Hodgkin lymphoma and brain cancer, has seen its price increase by 1,400% ($50 to $786) since NextSource acquired it. Gleostine, which was approved by the Food and Drug Administration in 1976 and has long been off patent, has no generic competition.
“Recent reports of price increases for off-patent drugs have demonstrated the need for continued oversight by the United States Senate,” Sen. Susan Collins (R-Maine), Sen. Claire McCaskill (D-Mo.), and Sen. Catherine Cortez Masto (D-Nev.) wrote in a letter to Tri-Source Pharma CEO Robert DiCrisci. Tri-Source is the parent company of NextSource.
The senators requested information on the gross and net revenues of the drug; expenses related to the sale of the drug; annual profit data; internal and external communications related to current and future sales of the drug, including cost estimates, profit projections, and market share analysis; and a list of other drugs sold by the company along with relevant pricing information.
The manufacturer has previously defended its price increases, citing the increased cost of a key manufacturing component, the cost of providing discounted drugs to Medicaid and uninsured patients, and higher regulatory fees, as well as the maintenance of a year’s worth of “safety stock” to prevent shortages.
The drug, which is used to treat Hodgkin lymphoma and brain cancer, has seen its price increase by 1,400% ($50 to $786) since NextSource acquired it. Gleostine, which was approved by the Food and Drug Administration in 1976 and has long been off patent, has no generic competition.
“Recent reports of price increases for off-patent drugs have demonstrated the need for continued oversight by the United States Senate,” Sen. Susan Collins (R-Maine), Sen. Claire McCaskill (D-Mo.), and Sen. Catherine Cortez Masto (D-Nev.) wrote in a letter to Tri-Source Pharma CEO Robert DiCrisci. Tri-Source is the parent company of NextSource.
The senators requested information on the gross and net revenues of the drug; expenses related to the sale of the drug; annual profit data; internal and external communications related to current and future sales of the drug, including cost estimates, profit projections, and market share analysis; and a list of other drugs sold by the company along with relevant pricing information.
The manufacturer has previously defended its price increases, citing the increased cost of a key manufacturing component, the cost of providing discounted drugs to Medicaid and uninsured patients, and higher regulatory fees, as well as the maintenance of a year’s worth of “safety stock” to prevent shortages.
Medicare Part D plans get more flexibility to make midyear changes
Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.
Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.
Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.
Sonified EEG could be useful triage tool
Medical students and nurses who listened to 15 seconds of single-channel sonified electroencephalograms detected seizures with 95%-98% sensitivity, outperforming neurologists who reviewed traditional visual EEG displays, according to the results of a single-center study.
“We confirm that individuals without EEG training can detect ongoing seizures or seizurelike rhythmic and periodic patterns by merely listening to short clips of sonified EEG,” wrote Josef Parvizi, MD, PhD, and his associates at Stanford (Calif.) University. “Ours is also the first study to test the capability of a sonification method to detect a range of significant abnormalities when it is used by clinical staff (e.g., physicians, nurses, and students).” The findings were published online March 20 in Epilepsia.
To test the method, 34 medical students and 30 nurses watched a 4-minute training video before listening to 84 sonified EEGs: seven seizures, 52 slowing or normal patterns, and 25 seizurelike abnormalities (generalized periodic discharges, lateralized periodic discharges, triphasic waves, or burst suppression). For each patient, listeners heard two sonified EEG clips, one from each hemisphere, and designated them as “seizure,” “nonseizure,” or “don’t know.” For comparison, 12 EEG-trained neurologists and 29 EEG-trained medical students reviewed traditional visual displays of the same EEGs.
Sonified EEGs identified seizures with a sensitivity of 95% (standard deviation, 14%) when heard by nurses and 98% (SD, 5%) when heard by medical students. In contrast, the sensitivity of visual displays was only 88% (SD, 11%) when reviewed by neurologists and 76% (SD, 19%) when reviewed by EEG-trained medical students. Specificity of sonified EEGs was 85% when heard by the medical students and 82% when heard by the nurses. Specificity of traditional review was 90% for neurologists and 65% for medical students.
The study was based on a representative sample, not a prospectively and consecutively recruited cohort, which constrains insights into how this technique might perform “at the bedside,” the researchers said. Additionally, the sonification method would not identify focal seizures occurring outside the individual channels selected (in this study, T3-T5 or T4-T6).
The study was funded by a Stanford University BioX Seed Grant. Dr. Parvizi and one coinvestigator invented the sonification method described and cofounded a startup that has licensed the technology from Stanford University. The other two investigators had no conflicts.
SOURCE: Parvizi J et al. Epilepsia. 2018 Mar 20. doi: 10.1111/epi.14043.
Medical students and nurses who listened to 15 seconds of single-channel sonified electroencephalograms detected seizures with 95%-98% sensitivity, outperforming neurologists who reviewed traditional visual EEG displays, according to the results of a single-center study.
“We confirm that individuals without EEG training can detect ongoing seizures or seizurelike rhythmic and periodic patterns by merely listening to short clips of sonified EEG,” wrote Josef Parvizi, MD, PhD, and his associates at Stanford (Calif.) University. “Ours is also the first study to test the capability of a sonification method to detect a range of significant abnormalities when it is used by clinical staff (e.g., physicians, nurses, and students).” The findings were published online March 20 in Epilepsia.
To test the method, 34 medical students and 30 nurses watched a 4-minute training video before listening to 84 sonified EEGs: seven seizures, 52 slowing or normal patterns, and 25 seizurelike abnormalities (generalized periodic discharges, lateralized periodic discharges, triphasic waves, or burst suppression). For each patient, listeners heard two sonified EEG clips, one from each hemisphere, and designated them as “seizure,” “nonseizure,” or “don’t know.” For comparison, 12 EEG-trained neurologists and 29 EEG-trained medical students reviewed traditional visual displays of the same EEGs.
Sonified EEGs identified seizures with a sensitivity of 95% (standard deviation, 14%) when heard by nurses and 98% (SD, 5%) when heard by medical students. In contrast, the sensitivity of visual displays was only 88% (SD, 11%) when reviewed by neurologists and 76% (SD, 19%) when reviewed by EEG-trained medical students. Specificity of sonified EEGs was 85% when heard by the medical students and 82% when heard by the nurses. Specificity of traditional review was 90% for neurologists and 65% for medical students.
The study was based on a representative sample, not a prospectively and consecutively recruited cohort, which constrains insights into how this technique might perform “at the bedside,” the researchers said. Additionally, the sonification method would not identify focal seizures occurring outside the individual channels selected (in this study, T3-T5 or T4-T6).
The study was funded by a Stanford University BioX Seed Grant. Dr. Parvizi and one coinvestigator invented the sonification method described and cofounded a startup that has licensed the technology from Stanford University. The other two investigators had no conflicts.
SOURCE: Parvizi J et al. Epilepsia. 2018 Mar 20. doi: 10.1111/epi.14043.
Medical students and nurses who listened to 15 seconds of single-channel sonified electroencephalograms detected seizures with 95%-98% sensitivity, outperforming neurologists who reviewed traditional visual EEG displays, according to the results of a single-center study.
“We confirm that individuals without EEG training can detect ongoing seizures or seizurelike rhythmic and periodic patterns by merely listening to short clips of sonified EEG,” wrote Josef Parvizi, MD, PhD, and his associates at Stanford (Calif.) University. “Ours is also the first study to test the capability of a sonification method to detect a range of significant abnormalities when it is used by clinical staff (e.g., physicians, nurses, and students).” The findings were published online March 20 in Epilepsia.
To test the method, 34 medical students and 30 nurses watched a 4-minute training video before listening to 84 sonified EEGs: seven seizures, 52 slowing or normal patterns, and 25 seizurelike abnormalities (generalized periodic discharges, lateralized periodic discharges, triphasic waves, or burst suppression). For each patient, listeners heard two sonified EEG clips, one from each hemisphere, and designated them as “seizure,” “nonseizure,” or “don’t know.” For comparison, 12 EEG-trained neurologists and 29 EEG-trained medical students reviewed traditional visual displays of the same EEGs.
Sonified EEGs identified seizures with a sensitivity of 95% (standard deviation, 14%) when heard by nurses and 98% (SD, 5%) when heard by medical students. In contrast, the sensitivity of visual displays was only 88% (SD, 11%) when reviewed by neurologists and 76% (SD, 19%) when reviewed by EEG-trained medical students. Specificity of sonified EEGs was 85% when heard by the medical students and 82% when heard by the nurses. Specificity of traditional review was 90% for neurologists and 65% for medical students.
The study was based on a representative sample, not a prospectively and consecutively recruited cohort, which constrains insights into how this technique might perform “at the bedside,” the researchers said. Additionally, the sonification method would not identify focal seizures occurring outside the individual channels selected (in this study, T3-T5 or T4-T6).
The study was funded by a Stanford University BioX Seed Grant. Dr. Parvizi and one coinvestigator invented the sonification method described and cofounded a startup that has licensed the technology from Stanford University. The other two investigators had no conflicts.
SOURCE: Parvizi J et al. Epilepsia. 2018 Mar 20. doi: 10.1111/epi.14043.
FROM EPILEPSIA
Key clinical point: Trained nonexperts reliably detected seizures by listening to short clips of sonified electroencephalograms.
Major finding: Sensitivity ranged from 95% (nurses) to 98% (medical students). Specificities were 82% and 85%, respectively.
Study details: Comparative reviews of 84 EEGs, including seven seizures, 25 seizurelike abnormalities, and 52 slowing or normal patterns.
Disclosures: The study was funded by a Stanford University BioX Seed Grant. Dr. Parvizi and one coinvestigator invented the sonification method described and cofounded a startup that has licensed the technology from Stanford University. The other two investigators had no conflicts.
Source: Parvizi J et al., Epilepsia. 2018 Mar 20. doi: 10.1111/epi.14043.
Debunking Atopic Dermatitis Myths: Do Most Children Outgrow Atopic Dermatitis?
Myth: Children eventually outgrow atopic dermatitis and therefore do not need treatment
The negative impact of atopic dermatitis (AD) on quality of life in the pediatric population often prompts parents/guardians to inquire about whether a child with AD will ever outgrow their disease. If remission is expected as the child gets older, many may question if it is necessary to pursue treatment or just let the disease run its course. Although AD often is reported to resolve soon after the first decade of life, symptoms can persist well into the second decade and beyond, suggesting that AD may be a lifelong disease with periods of waxing and waning symptoms that require persistent treatment throughout the patient’s life.
A 2014 study included 7157 children with AD (mean age of disease onset, 1.7 years) who were enrolled in the Pediatric Eczema Elective Registry (PEER) program between the ages of 2 and 17 years with measurement of disease activity at regular 6-month intervals for up to 5 years. The study results indicated that more than 80% of patients at every age (age range, 2–26 years) had symptoms of AD and/or were using medication to treat their disease, and the majority (64%) of patients had never reported a 6-month period during which they achieved clearance of symptoms without medication. At the age of 20 years, 50% of patients reported at least 1 lifetime 6-month period during which they were both symptom and treatment free. In another study of adolescents with AD who also had AD in childhood (N=82), 48% of patients remained in the same AD severity grades and 13% deteriorated from childhood to adolescence; only 39% of patients showed improvement in disease severity from childhood to adolescence. The findings of these reports are contradictory to conventional clinical teaching, which indicates that AD generally resolves by age 12 in 50% to 70% of children.
Even though some children with AD may experience periods of disease clearance, these findings often do not persist and should not be confused with a permanent remission. Most patients require continued treatment with medications to achieve relief of symptoms. Therefore, physicians should not assure parents/guardians that a child can outgrow AD; rather, they should educate pediatric patients and their caregivers about the potentially lifelong disease course and encourage early intervention to mitigate symptoms and manage comorbidities as the patient ages.
Hon KL, Tsang YCK, Poon TCW, et al. Predicating eczema severity beyond childhood. World J Pediatr. 2016;12:44-48.
Margolis JS, Abuabara K, Bilker W, et al. Persistence of mild to moderate atopic dermatitis [published online April 2, 2014]. JAMA Dermatol. 2014;150:593-600.
Myth: Children eventually outgrow atopic dermatitis and therefore do not need treatment
The negative impact of atopic dermatitis (AD) on quality of life in the pediatric population often prompts parents/guardians to inquire about whether a child with AD will ever outgrow their disease. If remission is expected as the child gets older, many may question if it is necessary to pursue treatment or just let the disease run its course. Although AD often is reported to resolve soon after the first decade of life, symptoms can persist well into the second decade and beyond, suggesting that AD may be a lifelong disease with periods of waxing and waning symptoms that require persistent treatment throughout the patient’s life.
A 2014 study included 7157 children with AD (mean age of disease onset, 1.7 years) who were enrolled in the Pediatric Eczema Elective Registry (PEER) program between the ages of 2 and 17 years with measurement of disease activity at regular 6-month intervals for up to 5 years. The study results indicated that more than 80% of patients at every age (age range, 2–26 years) had symptoms of AD and/or were using medication to treat their disease, and the majority (64%) of patients had never reported a 6-month period during which they achieved clearance of symptoms without medication. At the age of 20 years, 50% of patients reported at least 1 lifetime 6-month period during which they were both symptom and treatment free. In another study of adolescents with AD who also had AD in childhood (N=82), 48% of patients remained in the same AD severity grades and 13% deteriorated from childhood to adolescence; only 39% of patients showed improvement in disease severity from childhood to adolescence. The findings of these reports are contradictory to conventional clinical teaching, which indicates that AD generally resolves by age 12 in 50% to 70% of children.
Even though some children with AD may experience periods of disease clearance, these findings often do not persist and should not be confused with a permanent remission. Most patients require continued treatment with medications to achieve relief of symptoms. Therefore, physicians should not assure parents/guardians that a child can outgrow AD; rather, they should educate pediatric patients and their caregivers about the potentially lifelong disease course and encourage early intervention to mitigate symptoms and manage comorbidities as the patient ages.
Myth: Children eventually outgrow atopic dermatitis and therefore do not need treatment
The negative impact of atopic dermatitis (AD) on quality of life in the pediatric population often prompts parents/guardians to inquire about whether a child with AD will ever outgrow their disease. If remission is expected as the child gets older, many may question if it is necessary to pursue treatment or just let the disease run its course. Although AD often is reported to resolve soon after the first decade of life, symptoms can persist well into the second decade and beyond, suggesting that AD may be a lifelong disease with periods of waxing and waning symptoms that require persistent treatment throughout the patient’s life.
A 2014 study included 7157 children with AD (mean age of disease onset, 1.7 years) who were enrolled in the Pediatric Eczema Elective Registry (PEER) program between the ages of 2 and 17 years with measurement of disease activity at regular 6-month intervals for up to 5 years. The study results indicated that more than 80% of patients at every age (age range, 2–26 years) had symptoms of AD and/or were using medication to treat their disease, and the majority (64%) of patients had never reported a 6-month period during which they achieved clearance of symptoms without medication. At the age of 20 years, 50% of patients reported at least 1 lifetime 6-month period during which they were both symptom and treatment free. In another study of adolescents with AD who also had AD in childhood (N=82), 48% of patients remained in the same AD severity grades and 13% deteriorated from childhood to adolescence; only 39% of patients showed improvement in disease severity from childhood to adolescence. The findings of these reports are contradictory to conventional clinical teaching, which indicates that AD generally resolves by age 12 in 50% to 70% of children.
Even though some children with AD may experience periods of disease clearance, these findings often do not persist and should not be confused with a permanent remission. Most patients require continued treatment with medications to achieve relief of symptoms. Therefore, physicians should not assure parents/guardians that a child can outgrow AD; rather, they should educate pediatric patients and their caregivers about the potentially lifelong disease course and encourage early intervention to mitigate symptoms and manage comorbidities as the patient ages.
Hon KL, Tsang YCK, Poon TCW, et al. Predicating eczema severity beyond childhood. World J Pediatr. 2016;12:44-48.
Margolis JS, Abuabara K, Bilker W, et al. Persistence of mild to moderate atopic dermatitis [published online April 2, 2014]. JAMA Dermatol. 2014;150:593-600.
Hon KL, Tsang YCK, Poon TCW, et al. Predicating eczema severity beyond childhood. World J Pediatr. 2016;12:44-48.
Margolis JS, Abuabara K, Bilker W, et al. Persistence of mild to moderate atopic dermatitis [published online April 2, 2014]. JAMA Dermatol. 2014;150:593-600.
