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Influenza: All that and MI too
Myocardial infarction admissions were six times more likely to occur in the week after a positive test for influenza than in the year before or the 51 weeks after the infection, according to analysis of a Canadian cohort that links laboratories with administrative databases.
The investigators used this cohort data to define definitions of “risk interval” – the first 7 days after flu detection – and a combined “control interval” – 52 weeks before the flu detection and 51 weeks after the end of the risk interval.
Among the total of 364 hospital admissions for MI in patients with confirmed influenza, 20 occurred during the defined 1-week risk interval (20 admissions/week) and 344 occurred during the control interval (3.3 admissions/week), giving an incidence ratio (IR) of 6.05, Jeffrey C. Kwong, MD, of the University of Toronto and his associates reported in the New England Journal of Medicine.
There was little difference between days 1 and 3 after flu confirmation (IR, 6.3) and days 4-7 (IR, 5.8), but risk dropped off quickly after that, with IRs of 0.6 at days 8-14 and 0.75 at days 15-28. Risk was increased for older adults, those with influenza B infection, and those who had their first MI, the investigators said.
MI incidence also was elevated after infection with noninfluenza respiratory viruses, although to a lesser extent than with influenza, which suggests that “influenza is illustrative of the role that acute respiratory infections have in precipitating acute myocardial infarction,” Dr. Kwong and his associates wrote.
The study was supported by the Canadian Institutes of Health Research, by Public Health Ontario, and by the Institute for Clinical Evaluative Sciences. Dr. Kwong reported grants from Canadian Institutes of Health Research during the conduct of the study, as well as grants from Canadian Institutes of Health Research and University of Toronto.
SOURCE: Kwong JC et al. N Engl J Med. 2018. 378(4):345-53. doi: 10.1056/NEJMoa1702090.
Myocardial infarction admissions were six times more likely to occur in the week after a positive test for influenza than in the year before or the 51 weeks after the infection, according to analysis of a Canadian cohort that links laboratories with administrative databases.
The investigators used this cohort data to define definitions of “risk interval” – the first 7 days after flu detection – and a combined “control interval” – 52 weeks before the flu detection and 51 weeks after the end of the risk interval.
Among the total of 364 hospital admissions for MI in patients with confirmed influenza, 20 occurred during the defined 1-week risk interval (20 admissions/week) and 344 occurred during the control interval (3.3 admissions/week), giving an incidence ratio (IR) of 6.05, Jeffrey C. Kwong, MD, of the University of Toronto and his associates reported in the New England Journal of Medicine.
There was little difference between days 1 and 3 after flu confirmation (IR, 6.3) and days 4-7 (IR, 5.8), but risk dropped off quickly after that, with IRs of 0.6 at days 8-14 and 0.75 at days 15-28. Risk was increased for older adults, those with influenza B infection, and those who had their first MI, the investigators said.
MI incidence also was elevated after infection with noninfluenza respiratory viruses, although to a lesser extent than with influenza, which suggests that “influenza is illustrative of the role that acute respiratory infections have in precipitating acute myocardial infarction,” Dr. Kwong and his associates wrote.
The study was supported by the Canadian Institutes of Health Research, by Public Health Ontario, and by the Institute for Clinical Evaluative Sciences. Dr. Kwong reported grants from Canadian Institutes of Health Research during the conduct of the study, as well as grants from Canadian Institutes of Health Research and University of Toronto.
SOURCE: Kwong JC et al. N Engl J Med. 2018. 378(4):345-53. doi: 10.1056/NEJMoa1702090.
Myocardial infarction admissions were six times more likely to occur in the week after a positive test for influenza than in the year before or the 51 weeks after the infection, according to analysis of a Canadian cohort that links laboratories with administrative databases.
The investigators used this cohort data to define definitions of “risk interval” – the first 7 days after flu detection – and a combined “control interval” – 52 weeks before the flu detection and 51 weeks after the end of the risk interval.
Among the total of 364 hospital admissions for MI in patients with confirmed influenza, 20 occurred during the defined 1-week risk interval (20 admissions/week) and 344 occurred during the control interval (3.3 admissions/week), giving an incidence ratio (IR) of 6.05, Jeffrey C. Kwong, MD, of the University of Toronto and his associates reported in the New England Journal of Medicine.
There was little difference between days 1 and 3 after flu confirmation (IR, 6.3) and days 4-7 (IR, 5.8), but risk dropped off quickly after that, with IRs of 0.6 at days 8-14 and 0.75 at days 15-28. Risk was increased for older adults, those with influenza B infection, and those who had their first MI, the investigators said.
MI incidence also was elevated after infection with noninfluenza respiratory viruses, although to a lesser extent than with influenza, which suggests that “influenza is illustrative of the role that acute respiratory infections have in precipitating acute myocardial infarction,” Dr. Kwong and his associates wrote.
The study was supported by the Canadian Institutes of Health Research, by Public Health Ontario, and by the Institute for Clinical Evaluative Sciences. Dr. Kwong reported grants from Canadian Institutes of Health Research during the conduct of the study, as well as grants from Canadian Institutes of Health Research and University of Toronto.
SOURCE: Kwong JC et al. N Engl J Med. 2018. 378(4):345-53. doi: 10.1056/NEJMoa1702090.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Persistent opioid use a risk after surgery in teens and young adults
For a subset of opioid-naive adolescents and young adults who received perioperative opioid scripts, those prescriptions were filled for months after the surgery, raising concerns about long-term risk for substance use disorder.
To get an idea of the teen opioid problem, from 1997 to 2012 for adolescents aged 15-19 years, the incidence of hospitalizations for opioid poisonings per 100,000 teens increased from 3.69 to 10.17, an increase of 176%, according to a study in JAMA Pediatrics (2016;170[12]:1195-201). Adolescents are at a three to five time higher risk for serious medical outcomes when hospitalized with opioid poisoning, such as life-threatening symptoms or death, compared with younger children, according to a study reporting prescription drug exposures among children (Pediatrics. 2017;139[4]:e20163382).
These figures are concerning in part because “a significant association between medical use of prescription opioids alone in adolescence and subsequent nonmedical use of prescription opioids was observed at age 35 years” in a national longitudinal study reported in the journal Pain (2016 Oct;157[10]:2173-8), said Calista M. Harbaugh, MD, of the University of Michigan, Ann Arbor, and her study coauthors.
The study in Pediatrics, which drew from a large national insurance claims database, found some patient characteristics had independent associations with increased risk of persistent opioid use. These included being female or older, as well as having a prior history of substance use disorder, chronic pain, or filling an opioid prescription preoperatively.
Dr. Harbaugh and her collaborators used a large national research database to select opioid-naive patients aged 13-21 years who received 1 of 13 surgical procedures. A total of 88,637 opioid-naive surgical patients were included in the study, with 110,432 control nonsurgical patients. The control group consisted of 3% of the database’s nonsurgical patients who met age and opioid-naivete criteria. Patients in both groups also had to have continuous insurance for the prior 12 months, not have had an opioid prescription filled within the prior year, and not have received any subsequent surgical procedures during the study period.
To be able to compare medication use among patients receiving different types of opioids, the opioid component of all prescriptions was converted to milligrams, and then used to calculate oral morphine equivalents (OMEs) for each prescription.
Although the most common procedures were tonsillectomy and/or adenoidectomy (35.9% of patients), arthroscopic knee repair (25.3%), and appendectomy, (18.6%), these were not the procedures that were most associated with persistent opioid use.
Overall, 7.1% of patients had an initial daily dosage greater than 100 OMEs for their first postoperative prescription. These high opioid doses were likely to be seen in patients undergoing three procedures known to have considerable postoperative pain: pectus repair, posterior arthrodesis, and supracondylar fracture fixation. However, patients undergoing these procedures weren’t more likely to have persistent opioid use than other surgical patients in the study, the researchers said.
Rather, cholecystectomy and colectomy had the highest risk for persistent opioid use, with adjusted odds ratios of 1.13 and 2.33, respectively. Dr. Harbaugh and her collaborators, in discussing the study’s findings, noted that these two conditions involve high levels of preoperative inflammation and are characterized by visceral pain. This scenario, they said, may set these patients up for visceral and central sensitization and present an increased risk for chronic pain.
Dr. Harbaugh and her colleagues called for preoperative screening for risk factors for persistent opioid use, so that at-risk patients can receive closer monitoring and attention. “We are not suggesting that … pain should be underappreciated or undertreated,” or that at-risk patients should not be prescribed opioids.
The investigators said that their work “points toward the multifactorial etiology of postoperative pain and its complex nature in both the short and long term.” They called for more work to “elucidate the mechanism that underlies new persistent opioid use after certain procedures,” as well as more efforts to better understand how best to use multimodal pharmacologic and nonpharmacologic pain control measures in the adolescent and young adult population.
The study was funded by the Michigan Department of Health and Human Services. Dr. Harbaugh reported that she had no relevant financial disclosures. Some of the other investigators received grants from various agencies.
SOURCE: Harbaugh CM et al. Pediatrics 2018 Jan 1;141(1):e20172439
For a subset of opioid-naive adolescents and young adults who received perioperative opioid scripts, those prescriptions were filled for months after the surgery, raising concerns about long-term risk for substance use disorder.
To get an idea of the teen opioid problem, from 1997 to 2012 for adolescents aged 15-19 years, the incidence of hospitalizations for opioid poisonings per 100,000 teens increased from 3.69 to 10.17, an increase of 176%, according to a study in JAMA Pediatrics (2016;170[12]:1195-201). Adolescents are at a three to five time higher risk for serious medical outcomes when hospitalized with opioid poisoning, such as life-threatening symptoms or death, compared with younger children, according to a study reporting prescription drug exposures among children (Pediatrics. 2017;139[4]:e20163382).
These figures are concerning in part because “a significant association between medical use of prescription opioids alone in adolescence and subsequent nonmedical use of prescription opioids was observed at age 35 years” in a national longitudinal study reported in the journal Pain (2016 Oct;157[10]:2173-8), said Calista M. Harbaugh, MD, of the University of Michigan, Ann Arbor, and her study coauthors.
The study in Pediatrics, which drew from a large national insurance claims database, found some patient characteristics had independent associations with increased risk of persistent opioid use. These included being female or older, as well as having a prior history of substance use disorder, chronic pain, or filling an opioid prescription preoperatively.
Dr. Harbaugh and her collaborators used a large national research database to select opioid-naive patients aged 13-21 years who received 1 of 13 surgical procedures. A total of 88,637 opioid-naive surgical patients were included in the study, with 110,432 control nonsurgical patients. The control group consisted of 3% of the database’s nonsurgical patients who met age and opioid-naivete criteria. Patients in both groups also had to have continuous insurance for the prior 12 months, not have had an opioid prescription filled within the prior year, and not have received any subsequent surgical procedures during the study period.
To be able to compare medication use among patients receiving different types of opioids, the opioid component of all prescriptions was converted to milligrams, and then used to calculate oral morphine equivalents (OMEs) for each prescription.
Although the most common procedures were tonsillectomy and/or adenoidectomy (35.9% of patients), arthroscopic knee repair (25.3%), and appendectomy, (18.6%), these were not the procedures that were most associated with persistent opioid use.
Overall, 7.1% of patients had an initial daily dosage greater than 100 OMEs for their first postoperative prescription. These high opioid doses were likely to be seen in patients undergoing three procedures known to have considerable postoperative pain: pectus repair, posterior arthrodesis, and supracondylar fracture fixation. However, patients undergoing these procedures weren’t more likely to have persistent opioid use than other surgical patients in the study, the researchers said.
Rather, cholecystectomy and colectomy had the highest risk for persistent opioid use, with adjusted odds ratios of 1.13 and 2.33, respectively. Dr. Harbaugh and her collaborators, in discussing the study’s findings, noted that these two conditions involve high levels of preoperative inflammation and are characterized by visceral pain. This scenario, they said, may set these patients up for visceral and central sensitization and present an increased risk for chronic pain.
Dr. Harbaugh and her colleagues called for preoperative screening for risk factors for persistent opioid use, so that at-risk patients can receive closer monitoring and attention. “We are not suggesting that … pain should be underappreciated or undertreated,” or that at-risk patients should not be prescribed opioids.
The investigators said that their work “points toward the multifactorial etiology of postoperative pain and its complex nature in both the short and long term.” They called for more work to “elucidate the mechanism that underlies new persistent opioid use after certain procedures,” as well as more efforts to better understand how best to use multimodal pharmacologic and nonpharmacologic pain control measures in the adolescent and young adult population.
The study was funded by the Michigan Department of Health and Human Services. Dr. Harbaugh reported that she had no relevant financial disclosures. Some of the other investigators received grants from various agencies.
SOURCE: Harbaugh CM et al. Pediatrics 2018 Jan 1;141(1):e20172439
For a subset of opioid-naive adolescents and young adults who received perioperative opioid scripts, those prescriptions were filled for months after the surgery, raising concerns about long-term risk for substance use disorder.
To get an idea of the teen opioid problem, from 1997 to 2012 for adolescents aged 15-19 years, the incidence of hospitalizations for opioid poisonings per 100,000 teens increased from 3.69 to 10.17, an increase of 176%, according to a study in JAMA Pediatrics (2016;170[12]:1195-201). Adolescents are at a three to five time higher risk for serious medical outcomes when hospitalized with opioid poisoning, such as life-threatening symptoms or death, compared with younger children, according to a study reporting prescription drug exposures among children (Pediatrics. 2017;139[4]:e20163382).
These figures are concerning in part because “a significant association between medical use of prescription opioids alone in adolescence and subsequent nonmedical use of prescription opioids was observed at age 35 years” in a national longitudinal study reported in the journal Pain (2016 Oct;157[10]:2173-8), said Calista M. Harbaugh, MD, of the University of Michigan, Ann Arbor, and her study coauthors.
The study in Pediatrics, which drew from a large national insurance claims database, found some patient characteristics had independent associations with increased risk of persistent opioid use. These included being female or older, as well as having a prior history of substance use disorder, chronic pain, or filling an opioid prescription preoperatively.
Dr. Harbaugh and her collaborators used a large national research database to select opioid-naive patients aged 13-21 years who received 1 of 13 surgical procedures. A total of 88,637 opioid-naive surgical patients were included in the study, with 110,432 control nonsurgical patients. The control group consisted of 3% of the database’s nonsurgical patients who met age and opioid-naivete criteria. Patients in both groups also had to have continuous insurance for the prior 12 months, not have had an opioid prescription filled within the prior year, and not have received any subsequent surgical procedures during the study period.
To be able to compare medication use among patients receiving different types of opioids, the opioid component of all prescriptions was converted to milligrams, and then used to calculate oral morphine equivalents (OMEs) for each prescription.
Although the most common procedures were tonsillectomy and/or adenoidectomy (35.9% of patients), arthroscopic knee repair (25.3%), and appendectomy, (18.6%), these were not the procedures that were most associated with persistent opioid use.
Overall, 7.1% of patients had an initial daily dosage greater than 100 OMEs for their first postoperative prescription. These high opioid doses were likely to be seen in patients undergoing three procedures known to have considerable postoperative pain: pectus repair, posterior arthrodesis, and supracondylar fracture fixation. However, patients undergoing these procedures weren’t more likely to have persistent opioid use than other surgical patients in the study, the researchers said.
Rather, cholecystectomy and colectomy had the highest risk for persistent opioid use, with adjusted odds ratios of 1.13 and 2.33, respectively. Dr. Harbaugh and her collaborators, in discussing the study’s findings, noted that these two conditions involve high levels of preoperative inflammation and are characterized by visceral pain. This scenario, they said, may set these patients up for visceral and central sensitization and present an increased risk for chronic pain.
Dr. Harbaugh and her colleagues called for preoperative screening for risk factors for persistent opioid use, so that at-risk patients can receive closer monitoring and attention. “We are not suggesting that … pain should be underappreciated or undertreated,” or that at-risk patients should not be prescribed opioids.
The investigators said that their work “points toward the multifactorial etiology of postoperative pain and its complex nature in both the short and long term.” They called for more work to “elucidate the mechanism that underlies new persistent opioid use after certain procedures,” as well as more efforts to better understand how best to use multimodal pharmacologic and nonpharmacologic pain control measures in the adolescent and young adult population.
The study was funded by the Michigan Department of Health and Human Services. Dr. Harbaugh reported that she had no relevant financial disclosures. Some of the other investigators received grants from various agencies.
SOURCE: Harbaugh CM et al. Pediatrics 2018 Jan 1;141(1):e20172439
FROM PEDIATRICS
Key clinical point: Especially for females, older teens, and young adults, there’s a risk for persistent postsurgical opioid use.
Major finding: Opioid use persisted for 4.8% of patients undergoing surgery, compared with 0.1% of patients who did not have surgery.
Study details: Retrospective review of claims database including 88,637 adolescent and young adult patients undergoing surgery, and 110,432 controls who did not have surgery.
Disclosures: The study was funded by the Michigan Department of Health and Human Services. Dr. Harbaugh reported that she had no conflicts of interest. Some of the other investigators received grants from various agencies.
Source: Harbaugh CM et al. Pediatrics. 2018 Jan 1;141(1):e20172439
Hyaluronic Acid for Lip Rejuvenation
Circulating tumor cell assay shows promise for colorectal cancer screening
SAN FRANCISCO – A new blood-based assay that measures circulating tumor cells (CTCs) shows good performance in detecting colorectal cancer and precancer, investigators reported at the 2018 GI Cancers Symposium.
Although colorectal cancer screening is a grade A recommendation of the U.S. Preventive Services Task Force, poor uptake remains problematic and contributes to more advanced disease at diagnosis, noted lead investigator Wen-Sy Tsai, MD, assistant professor at Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
“Currently, one-third of Americans have never been screened for colorectal cancer,” he said, due in part to reluctance to undergo colonoscopy and poor compliance with stool tests. Further complicating matters, the fecal immunochemical test (FIT) has a high false-positive rate.
He and his coinvestigators tested the new assay, called CMx (CTCs in Maximum), among 620 individuals in Taiwan who underwent colonoscopy – some with colorectal cancer, some with precancerous lesions, and some healthy. Results showed the assay’s sensitivity was nearly 87% for cancer and 77% for precancerous lesions. Specificity exceeded 97%.
“The CMx assay is capable of detecting … early-stage cancer with a low false-positive rate. As it is a blood test, higher compliance will lead to better outcomes,” Dr. Tsai proposed. “Because the mechanism of CTC dissemination is similar, the CTC assay can be applied in other cancer types such as prostate, breast, and lung cancer.”
The investigators are also identifying collaborators for testing the new assay among U.S. populations, he noted.
“Screening tests offer some of the greatest potential for getting to zero colorectal cancer deaths,” said invited discussant Douglas A. Corley, MD, PhD, clinical professor and gastroenterologist at the University of California, San Francisco, and a research scientist at Kaiser Permanente, San Francisco.
CTCs are especially attractive for screening because they could be both sensitive and specific, he said. “Unlike something such as fecal immunotesting, which is not testing specifically for cancer, or colonoscopy, which is quite invasive and detects a lot of things that may never progress to cancer, CTCs offer this potential,” said Dr. Corley.
Challenges of interpreting new screening tests include their heavy dependence on the population being tested and the need for replication, according to Dr. Corley. For example, initial results for the septin 9 methylated DNA blood test looked very good, with sensitivity of about 90% (BMC Med. 2011;9:133), but after its testing in 14 populations, a meta-analysis showed that pooled sensitivity was just 67% (Biomed Rep. 2017;7[4]:353-60).
“Circulating tumor markers are an incredibly interesting target for screening, particularly because of their potential for being very specific for what you are looking for, and potentially markedly decreasing the subsequent follow-up that would need to be done for invasive tests such as colonoscopy,” Dr. Corley said. “However, this [CTC assay] really requires confirmation in screening populations, especially given some of the information we have from prior tests.”
Study details
Dr. Tsai’s team studied 327 patients with colorectal cancer of all stages, 111 patients with precancerous lesions (adenomas, advanced adenomas, carcinoma in situ/stage 0), and 182 healthy controls. All had blood drawn for the CTC assay before undergoing colonoscopy. Results of each test were ascertained with blinding to the results of the other.
CTCs are rarely shed into the circulation from precancerous lesions, with approximate density of only 1 per billion blood cells, Dr. Tsai said. The CMx assay (manufactured by CellMax Life) is able to detect these cells with high sensitivity through use of advanced technologies such as affinity-based microfluidics and a biomimetic surface coating.
The assay is performed with just 2 mL of whole blood. CTCs are defined as intact nucleated cells staining positive for CD20 and negative for CD45; they were combined with patient age in an algorithm, ultimately producing a risk score.
Study results showed that the CTC assay had an accuracy of 87.9% in the entire cohort, reported Dr. Tsai. The false-positive rate was just 3.3%, and the false-negative rate was 15.8%.
Sensitivity was 84.0% overall (76.6% for precancer and 86.9% for cancer), specificity was 97.3% overall (97.3% and 97.3%), and area under the receiver operating characteristic curve was 0.87 overall (0.84 and 0.88).
Dr. Tsai noted that the CTC assay’s sensitivity of nearly 77% for precancer compares favorably with that of a variety of other screening tests, such as the stool guaiac test for fecal occult blood (2%-10%), FIT alone (23.8%), and a stool DNA test combined with FIT (42%), and, in fact, falls within the range reported for colonoscopy (76%-94%).
The symposium was sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
SOURCE: Tsai W et al., ASCO GI Abstract 556
SAN FRANCISCO – A new blood-based assay that measures circulating tumor cells (CTCs) shows good performance in detecting colorectal cancer and precancer, investigators reported at the 2018 GI Cancers Symposium.
Although colorectal cancer screening is a grade A recommendation of the U.S. Preventive Services Task Force, poor uptake remains problematic and contributes to more advanced disease at diagnosis, noted lead investigator Wen-Sy Tsai, MD, assistant professor at Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
“Currently, one-third of Americans have never been screened for colorectal cancer,” he said, due in part to reluctance to undergo colonoscopy and poor compliance with stool tests. Further complicating matters, the fecal immunochemical test (FIT) has a high false-positive rate.
He and his coinvestigators tested the new assay, called CMx (CTCs in Maximum), among 620 individuals in Taiwan who underwent colonoscopy – some with colorectal cancer, some with precancerous lesions, and some healthy. Results showed the assay’s sensitivity was nearly 87% for cancer and 77% for precancerous lesions. Specificity exceeded 97%.
“The CMx assay is capable of detecting … early-stage cancer with a low false-positive rate. As it is a blood test, higher compliance will lead to better outcomes,” Dr. Tsai proposed. “Because the mechanism of CTC dissemination is similar, the CTC assay can be applied in other cancer types such as prostate, breast, and lung cancer.”
The investigators are also identifying collaborators for testing the new assay among U.S. populations, he noted.
“Screening tests offer some of the greatest potential for getting to zero colorectal cancer deaths,” said invited discussant Douglas A. Corley, MD, PhD, clinical professor and gastroenterologist at the University of California, San Francisco, and a research scientist at Kaiser Permanente, San Francisco.
CTCs are especially attractive for screening because they could be both sensitive and specific, he said. “Unlike something such as fecal immunotesting, which is not testing specifically for cancer, or colonoscopy, which is quite invasive and detects a lot of things that may never progress to cancer, CTCs offer this potential,” said Dr. Corley.
Challenges of interpreting new screening tests include their heavy dependence on the population being tested and the need for replication, according to Dr. Corley. For example, initial results for the septin 9 methylated DNA blood test looked very good, with sensitivity of about 90% (BMC Med. 2011;9:133), but after its testing in 14 populations, a meta-analysis showed that pooled sensitivity was just 67% (Biomed Rep. 2017;7[4]:353-60).
“Circulating tumor markers are an incredibly interesting target for screening, particularly because of their potential for being very specific for what you are looking for, and potentially markedly decreasing the subsequent follow-up that would need to be done for invasive tests such as colonoscopy,” Dr. Corley said. “However, this [CTC assay] really requires confirmation in screening populations, especially given some of the information we have from prior tests.”
Study details
Dr. Tsai’s team studied 327 patients with colorectal cancer of all stages, 111 patients with precancerous lesions (adenomas, advanced adenomas, carcinoma in situ/stage 0), and 182 healthy controls. All had blood drawn for the CTC assay before undergoing colonoscopy. Results of each test were ascertained with blinding to the results of the other.
CTCs are rarely shed into the circulation from precancerous lesions, with approximate density of only 1 per billion blood cells, Dr. Tsai said. The CMx assay (manufactured by CellMax Life) is able to detect these cells with high sensitivity through use of advanced technologies such as affinity-based microfluidics and a biomimetic surface coating.
The assay is performed with just 2 mL of whole blood. CTCs are defined as intact nucleated cells staining positive for CD20 and negative for CD45; they were combined with patient age in an algorithm, ultimately producing a risk score.
Study results showed that the CTC assay had an accuracy of 87.9% in the entire cohort, reported Dr. Tsai. The false-positive rate was just 3.3%, and the false-negative rate was 15.8%.
Sensitivity was 84.0% overall (76.6% for precancer and 86.9% for cancer), specificity was 97.3% overall (97.3% and 97.3%), and area under the receiver operating characteristic curve was 0.87 overall (0.84 and 0.88).
Dr. Tsai noted that the CTC assay’s sensitivity of nearly 77% for precancer compares favorably with that of a variety of other screening tests, such as the stool guaiac test for fecal occult blood (2%-10%), FIT alone (23.8%), and a stool DNA test combined with FIT (42%), and, in fact, falls within the range reported for colonoscopy (76%-94%).
The symposium was sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
SOURCE: Tsai W et al., ASCO GI Abstract 556
SAN FRANCISCO – A new blood-based assay that measures circulating tumor cells (CTCs) shows good performance in detecting colorectal cancer and precancer, investigators reported at the 2018 GI Cancers Symposium.
Although colorectal cancer screening is a grade A recommendation of the U.S. Preventive Services Task Force, poor uptake remains problematic and contributes to more advanced disease at diagnosis, noted lead investigator Wen-Sy Tsai, MD, assistant professor at Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
“Currently, one-third of Americans have never been screened for colorectal cancer,” he said, due in part to reluctance to undergo colonoscopy and poor compliance with stool tests. Further complicating matters, the fecal immunochemical test (FIT) has a high false-positive rate.
He and his coinvestigators tested the new assay, called CMx (CTCs in Maximum), among 620 individuals in Taiwan who underwent colonoscopy – some with colorectal cancer, some with precancerous lesions, and some healthy. Results showed the assay’s sensitivity was nearly 87% for cancer and 77% for precancerous lesions. Specificity exceeded 97%.
“The CMx assay is capable of detecting … early-stage cancer with a low false-positive rate. As it is a blood test, higher compliance will lead to better outcomes,” Dr. Tsai proposed. “Because the mechanism of CTC dissemination is similar, the CTC assay can be applied in other cancer types such as prostate, breast, and lung cancer.”
The investigators are also identifying collaborators for testing the new assay among U.S. populations, he noted.
“Screening tests offer some of the greatest potential for getting to zero colorectal cancer deaths,” said invited discussant Douglas A. Corley, MD, PhD, clinical professor and gastroenterologist at the University of California, San Francisco, and a research scientist at Kaiser Permanente, San Francisco.
CTCs are especially attractive for screening because they could be both sensitive and specific, he said. “Unlike something such as fecal immunotesting, which is not testing specifically for cancer, or colonoscopy, which is quite invasive and detects a lot of things that may never progress to cancer, CTCs offer this potential,” said Dr. Corley.
Challenges of interpreting new screening tests include their heavy dependence on the population being tested and the need for replication, according to Dr. Corley. For example, initial results for the septin 9 methylated DNA blood test looked very good, with sensitivity of about 90% (BMC Med. 2011;9:133), but after its testing in 14 populations, a meta-analysis showed that pooled sensitivity was just 67% (Biomed Rep. 2017;7[4]:353-60).
“Circulating tumor markers are an incredibly interesting target for screening, particularly because of their potential for being very specific for what you are looking for, and potentially markedly decreasing the subsequent follow-up that would need to be done for invasive tests such as colonoscopy,” Dr. Corley said. “However, this [CTC assay] really requires confirmation in screening populations, especially given some of the information we have from prior tests.”
Study details
Dr. Tsai’s team studied 327 patients with colorectal cancer of all stages, 111 patients with precancerous lesions (adenomas, advanced adenomas, carcinoma in situ/stage 0), and 182 healthy controls. All had blood drawn for the CTC assay before undergoing colonoscopy. Results of each test were ascertained with blinding to the results of the other.
CTCs are rarely shed into the circulation from precancerous lesions, with approximate density of only 1 per billion blood cells, Dr. Tsai said. The CMx assay (manufactured by CellMax Life) is able to detect these cells with high sensitivity through use of advanced technologies such as affinity-based microfluidics and a biomimetic surface coating.
The assay is performed with just 2 mL of whole blood. CTCs are defined as intact nucleated cells staining positive for CD20 and negative for CD45; they were combined with patient age in an algorithm, ultimately producing a risk score.
Study results showed that the CTC assay had an accuracy of 87.9% in the entire cohort, reported Dr. Tsai. The false-positive rate was just 3.3%, and the false-negative rate was 15.8%.
Sensitivity was 84.0% overall (76.6% for precancer and 86.9% for cancer), specificity was 97.3% overall (97.3% and 97.3%), and area under the receiver operating characteristic curve was 0.87 overall (0.84 and 0.88).
Dr. Tsai noted that the CTC assay’s sensitivity of nearly 77% for precancer compares favorably with that of a variety of other screening tests, such as the stool guaiac test for fecal occult blood (2%-10%), FIT alone (23.8%), and a stool DNA test combined with FIT (42%), and, in fact, falls within the range reported for colonoscopy (76%-94%).
The symposium was sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
SOURCE: Tsai W et al., ASCO GI Abstract 556
REPORTING FROM 2018 GI CANCERS SYMPOSIUM
Key clinical point:
Major finding: The CMx assay had a sensitivity of nearly 87% for colorectal cancer and nearly 77% for precancerous lesions.
Data source: A single-center, blinded, prospective cohort study among 327 patients with colorectal cancer of various stages, 111 patients with precancerous lesions, and 182 healthy individuals.
Disclosures: Dr. Tsai disclosed that he had no relevant relationships.
Source: Tsai W et al. ASCO GI Abstract 556.
FDA grants priority review to multiple myeloma treatment
, a monoclonal antibody treatment for newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant.
The current application is based on the randomized, multicenter, phase 3 ALCYONE study of daratumumab in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) in de novo multiple myeloma patients.
Priority review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The agency has assigned the drug a Prescription Drug User Fee Act date of May 21, which is a target date for an approval decision.
Daratumumab is being developed by Janssen Biotech, in partnership with Genmab.
, a monoclonal antibody treatment for newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant.
The current application is based on the randomized, multicenter, phase 3 ALCYONE study of daratumumab in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) in de novo multiple myeloma patients.
Priority review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The agency has assigned the drug a Prescription Drug User Fee Act date of May 21, which is a target date for an approval decision.
Daratumumab is being developed by Janssen Biotech, in partnership with Genmab.
, a monoclonal antibody treatment for newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant.
The current application is based on the randomized, multicenter, phase 3 ALCYONE study of daratumumab in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) in de novo multiple myeloma patients.
Priority review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The agency has assigned the drug a Prescription Drug User Fee Act date of May 21, which is a target date for an approval decision.
Daratumumab is being developed by Janssen Biotech, in partnership with Genmab.
Slowed growth in prescription drug spending driven by HCV drugs
National health spending amounted to $3.3 trillion or $10,348/person, a 4.3% increase in 2016, according to the Centers for Medicare & Medicaid Services. This was a slower rate of growth than the 5.8% growth in 2015 because of slower insurance enrollment and declines in spending for services and retail prescription drugs.
The growth in spending on prescription drugs in 2016 declined significantly – 1.3% in 2016 vs. 8.9% in 2015. Strong growth in spending for drugs used to treat hepatitis C contributed to high overall spending growth in 2014 and 2015, which changed in 2016. Prescription drug spending in 2016 grew more slowly partially because spending for drugs used to treat hepatitis C decreased, as fewer patients received treatment and net prices for these drugs declined, the report stated.
"The 2016 rate of prescription drug spending growth is more in line with the lower average annual growth during the period 2010–13 of 1.2 percent—a rate that was driven by the shift to more consumption of generic drugs, which was partly influenced by the loss of patent protection of major brand-name drugs," the authors noted.
National health spending amounted to $3.3 trillion or $10,348/person, a 4.3% increase in 2016, according to the Centers for Medicare & Medicaid Services. This was a slower rate of growth than the 5.8% growth in 2015 because of slower insurance enrollment and declines in spending for services and retail prescription drugs.
The growth in spending on prescription drugs in 2016 declined significantly – 1.3% in 2016 vs. 8.9% in 2015. Strong growth in spending for drugs used to treat hepatitis C contributed to high overall spending growth in 2014 and 2015, which changed in 2016. Prescription drug spending in 2016 grew more slowly partially because spending for drugs used to treat hepatitis C decreased, as fewer patients received treatment and net prices for these drugs declined, the report stated.
"The 2016 rate of prescription drug spending growth is more in line with the lower average annual growth during the period 2010–13 of 1.2 percent—a rate that was driven by the shift to more consumption of generic drugs, which was partly influenced by the loss of patent protection of major brand-name drugs," the authors noted.
National health spending amounted to $3.3 trillion or $10,348/person, a 4.3% increase in 2016, according to the Centers for Medicare & Medicaid Services. This was a slower rate of growth than the 5.8% growth in 2015 because of slower insurance enrollment and declines in spending for services and retail prescription drugs.
The growth in spending on prescription drugs in 2016 declined significantly – 1.3% in 2016 vs. 8.9% in 2015. Strong growth in spending for drugs used to treat hepatitis C contributed to high overall spending growth in 2014 and 2015, which changed in 2016. Prescription drug spending in 2016 grew more slowly partially because spending for drugs used to treat hepatitis C decreased, as fewer patients received treatment and net prices for these drugs declined, the report stated.
"The 2016 rate of prescription drug spending growth is more in line with the lower average annual growth during the period 2010–13 of 1.2 percent—a rate that was driven by the shift to more consumption of generic drugs, which was partly influenced by the loss of patent protection of major brand-name drugs," the authors noted.
Journal of Hospital Medicine – Jan. 2018
BACKGROUND: Hospital charges and lengths of stay may be greater when adults with chronic conditions are admitted to children’s hospitals. Despite multiple efforts to improve pediatric-adult health care transitions, little guidance exists for transitioning inpatient care.
OBJECTIVE: This study sought to characterize pediatric-adult inpatient care transitions across general pediatric services at U.S. children’s hospitals.
DESIGN and SETTING: National survey of inpatient general pediatric service leaders at U.S. children’s hospitals from January 2016 to July 2016.
MEASUREMENT: Questionnaires assessed institutional characteristics, presence of inpatient transition initiatives (having a specific process and/or leader), and 22 inpatient transition activities. Scales of highly correlated activities were created using exploratory factor analysis. Logistic regression identified associations among institutional characteristics, transition activities, and presence of an inpatient transition initiative.
RESULTS: Of 195 children’s hospitals, 96 responded (49.2% response rate). Transition initiatives were present at 38% of children’s hospitals, more often where there were providers who were trained in both internal medicine and pediatrics or where there were outpatient transition processes. Specific activities were infrequent and varied widely from 2.1% (systems to track youth in transition) to 40.5% (addressing potential insurance problems). Institutions with initiatives more often consistently performed the majority of activities, including using checklists and creating patient-centered transition care plans. Of remaining activities, half involved transition planning, the essential step between readiness and transfer.
CONCLUSION: Relatively few inpatient general pediatric services at U.S. children’s hospitals have leaders or dedicated processes to shepherd transitions to adult-oriented inpatient care. Across institutions, there is wide variability in performance of activities to facilitate this transition. Feasible process and outcome measures are needed.
Also in JHM this month
Characterizing hospitalist practice and perceptions of critical care delivery
AUTHORS: Joseph R. Sweigart, MD, FACP, FHM; David Aymond, MD; Alfred Burger, MD, FACP, SFHM; Andy Kelly, MAS, MS; Nick Marzano, Med; Thomas McIlraith, MD, SFHM; Peter Morris, MD; Mark V. Williams, MD, FACP, MHM; and Eric M. Siegal, MD, SFHM, FCCM
Clinical decision making: Observing the smartphone user an observational study in predicting acute surgical patients’ suitability for discharge
AUTHORS: Richard Hoffmann, MBBS; Simon Harley, MBBS; Samuel Ellison, MBBS; and Peter G. Devitt, MBBS, FRACS
BACKGROUND: Hospital charges and lengths of stay may be greater when adults with chronic conditions are admitted to children’s hospitals. Despite multiple efforts to improve pediatric-adult health care transitions, little guidance exists for transitioning inpatient care.
OBJECTIVE: This study sought to characterize pediatric-adult inpatient care transitions across general pediatric services at U.S. children’s hospitals.
DESIGN and SETTING: National survey of inpatient general pediatric service leaders at U.S. children’s hospitals from January 2016 to July 2016.
MEASUREMENT: Questionnaires assessed institutional characteristics, presence of inpatient transition initiatives (having a specific process and/or leader), and 22 inpatient transition activities. Scales of highly correlated activities were created using exploratory factor analysis. Logistic regression identified associations among institutional characteristics, transition activities, and presence of an inpatient transition initiative.
RESULTS: Of 195 children’s hospitals, 96 responded (49.2% response rate). Transition initiatives were present at 38% of children’s hospitals, more often where there were providers who were trained in both internal medicine and pediatrics or where there were outpatient transition processes. Specific activities were infrequent and varied widely from 2.1% (systems to track youth in transition) to 40.5% (addressing potential insurance problems). Institutions with initiatives more often consistently performed the majority of activities, including using checklists and creating patient-centered transition care plans. Of remaining activities, half involved transition planning, the essential step between readiness and transfer.
CONCLUSION: Relatively few inpatient general pediatric services at U.S. children’s hospitals have leaders or dedicated processes to shepherd transitions to adult-oriented inpatient care. Across institutions, there is wide variability in performance of activities to facilitate this transition. Feasible process and outcome measures are needed.
Also in JHM this month
Characterizing hospitalist practice and perceptions of critical care delivery
AUTHORS: Joseph R. Sweigart, MD, FACP, FHM; David Aymond, MD; Alfred Burger, MD, FACP, SFHM; Andy Kelly, MAS, MS; Nick Marzano, Med; Thomas McIlraith, MD, SFHM; Peter Morris, MD; Mark V. Williams, MD, FACP, MHM; and Eric M. Siegal, MD, SFHM, FCCM
Clinical decision making: Observing the smartphone user an observational study in predicting acute surgical patients’ suitability for discharge
AUTHORS: Richard Hoffmann, MBBS; Simon Harley, MBBS; Samuel Ellison, MBBS; and Peter G. Devitt, MBBS, FRACS
BACKGROUND: Hospital charges and lengths of stay may be greater when adults with chronic conditions are admitted to children’s hospitals. Despite multiple efforts to improve pediatric-adult health care transitions, little guidance exists for transitioning inpatient care.
OBJECTIVE: This study sought to characterize pediatric-adult inpatient care transitions across general pediatric services at U.S. children’s hospitals.
DESIGN and SETTING: National survey of inpatient general pediatric service leaders at U.S. children’s hospitals from January 2016 to July 2016.
MEASUREMENT: Questionnaires assessed institutional characteristics, presence of inpatient transition initiatives (having a specific process and/or leader), and 22 inpatient transition activities. Scales of highly correlated activities were created using exploratory factor analysis. Logistic regression identified associations among institutional characteristics, transition activities, and presence of an inpatient transition initiative.
RESULTS: Of 195 children’s hospitals, 96 responded (49.2% response rate). Transition initiatives were present at 38% of children’s hospitals, more often where there were providers who were trained in both internal medicine and pediatrics or where there were outpatient transition processes. Specific activities were infrequent and varied widely from 2.1% (systems to track youth in transition) to 40.5% (addressing potential insurance problems). Institutions with initiatives more often consistently performed the majority of activities, including using checklists and creating patient-centered transition care plans. Of remaining activities, half involved transition planning, the essential step between readiness and transfer.
CONCLUSION: Relatively few inpatient general pediatric services at U.S. children’s hospitals have leaders or dedicated processes to shepherd transitions to adult-oriented inpatient care. Across institutions, there is wide variability in performance of activities to facilitate this transition. Feasible process and outcome measures are needed.
Also in JHM this month
Characterizing hospitalist practice and perceptions of critical care delivery
AUTHORS: Joseph R. Sweigart, MD, FACP, FHM; David Aymond, MD; Alfred Burger, MD, FACP, SFHM; Andy Kelly, MAS, MS; Nick Marzano, Med; Thomas McIlraith, MD, SFHM; Peter Morris, MD; Mark V. Williams, MD, FACP, MHM; and Eric M. Siegal, MD, SFHM, FCCM
Clinical decision making: Observing the smartphone user an observational study in predicting acute surgical patients’ suitability for discharge
AUTHORS: Richard Hoffmann, MBBS; Simon Harley, MBBS; Samuel Ellison, MBBS; and Peter G. Devitt, MBBS, FRACS
Isotretinoin and shea butter
It took Jared till the end of his third month on isotretinoin to tell me he was two-timing me with another skin doctor.
“She calls herself a cosmetic dermatologist,” he said, naming a nearby practitioner I didn’t know. “She formulates special skin care products tailored to my particular skin. The one she came up with for me is based on shea butter, and it feels great.”
I am always amazed at people’s capacity to believe that there is a unique regimen just right for them, preferably one specially formulated by an expert who is privy to a secret no one else knows. Shea butter, it turns out, comes from the African shea tree (Ugandan trees are best). Africans eat the shea nuts; Westerners smear on ground-up nut contents.
Nut of shea. Tree of tea. Eye of newt. Toe of frog. The list goes on.
But I digress.
That didn’t seem very nice of her. I hadn’t murmured about her moisturizer, had I?
“What did she object to?” I asked. “Did her patients have problems with it?”
“She just said the drug is very bad,” said Jared. “She doesn’t like it at all. I was a little taken aback. I wasn’t expecting her to object so strongly.”
“But you’re still OK with taking isotretinoin?” I asked.
“Oh, yes,” said Jared. “It seems to be working, and I trust you.”
That was good to hear. I wondered whether Jared’s trust was based on the rigor of my scientific background or on my kindly smile and reassuring beard.
“Thank you, Jared,” I said. “I like isotretinoin a lot. It’s not for everybody, but for the last 35 years, I’ve seen it do excellent things for the appearance and self-image of many people.”
When I teach medical students, I often emphasize, as a point of professional etiquette, the impropriety of snorting or rolling your eyes at what patients report that other colleagues said and did. First of all, patient accounts may be imprecise or colored by their wish to build you up and flatter themselves for picking you. Second, just imagine what they might say about you at the next office they visit.
Reputation aside (you can hire folks to buff yours, if you like), my little exchange with Jared points up a basic difference between the way doctors think and the way our patients do.
What’s behind doctors’ professional lives is our assumption that diseases exist outside the bodies that the diseases inhabit. We therefore can offer a “treatment of choice” (or maybe a couple of them) that is best for treating a disease, regardless of who has it. This assumption is so obvious that we rarely think about it.
Obvious to us, that is, but not to our patients, to whom every patient has (to a large if not exclusive extent) his or her own disease. If possible, every patient wants a treatment tailored to each person’s unique makeup and predicament.
Jared is far from alone in playing both ends at the same time. From me he gets universal, evidence-based truths. From his other (more jealous!) medical mistress, he gets a skin care regimen tailored lovingly just for him.
Test your unique genes, get the treatment tailored just for you. Some rigorous scientists are trying not to so much debunk this effort as to point out how its promise is massively overhyped and unlikely to be worthy of the massive research investment it attracts. Perhaps their rigorous rationality will bear fruit, but they’re up against not just vested medical/industrial/venture capital interests, but the expectations of sick people who have always known that there is – that there simply has to be – a treatment out there that’s just for them.
Mock if you must, but tell me this: If people can prosper marketing a moisturizer called Kiss My Face or rake in the bucks with a skin care line named Urban Decay, then what’s your problem with Eye of Newt? You want focus groups?
Crowdfunding, anyone?
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
It took Jared till the end of his third month on isotretinoin to tell me he was two-timing me with another skin doctor.
“She calls herself a cosmetic dermatologist,” he said, naming a nearby practitioner I didn’t know. “She formulates special skin care products tailored to my particular skin. The one she came up with for me is based on shea butter, and it feels great.”
I am always amazed at people’s capacity to believe that there is a unique regimen just right for them, preferably one specially formulated by an expert who is privy to a secret no one else knows. Shea butter, it turns out, comes from the African shea tree (Ugandan trees are best). Africans eat the shea nuts; Westerners smear on ground-up nut contents.
Nut of shea. Tree of tea. Eye of newt. Toe of frog. The list goes on.
But I digress.
That didn’t seem very nice of her. I hadn’t murmured about her moisturizer, had I?
“What did she object to?” I asked. “Did her patients have problems with it?”
“She just said the drug is very bad,” said Jared. “She doesn’t like it at all. I was a little taken aback. I wasn’t expecting her to object so strongly.”
“But you’re still OK with taking isotretinoin?” I asked.
“Oh, yes,” said Jared. “It seems to be working, and I trust you.”
That was good to hear. I wondered whether Jared’s trust was based on the rigor of my scientific background or on my kindly smile and reassuring beard.
“Thank you, Jared,” I said. “I like isotretinoin a lot. It’s not for everybody, but for the last 35 years, I’ve seen it do excellent things for the appearance and self-image of many people.”
When I teach medical students, I often emphasize, as a point of professional etiquette, the impropriety of snorting or rolling your eyes at what patients report that other colleagues said and did. First of all, patient accounts may be imprecise or colored by their wish to build you up and flatter themselves for picking you. Second, just imagine what they might say about you at the next office they visit.
Reputation aside (you can hire folks to buff yours, if you like), my little exchange with Jared points up a basic difference between the way doctors think and the way our patients do.
What’s behind doctors’ professional lives is our assumption that diseases exist outside the bodies that the diseases inhabit. We therefore can offer a “treatment of choice” (or maybe a couple of them) that is best for treating a disease, regardless of who has it. This assumption is so obvious that we rarely think about it.
Obvious to us, that is, but not to our patients, to whom every patient has (to a large if not exclusive extent) his or her own disease. If possible, every patient wants a treatment tailored to each person’s unique makeup and predicament.
Jared is far from alone in playing both ends at the same time. From me he gets universal, evidence-based truths. From his other (more jealous!) medical mistress, he gets a skin care regimen tailored lovingly just for him.
Test your unique genes, get the treatment tailored just for you. Some rigorous scientists are trying not to so much debunk this effort as to point out how its promise is massively overhyped and unlikely to be worthy of the massive research investment it attracts. Perhaps their rigorous rationality will bear fruit, but they’re up against not just vested medical/industrial/venture capital interests, but the expectations of sick people who have always known that there is – that there simply has to be – a treatment out there that’s just for them.
Mock if you must, but tell me this: If people can prosper marketing a moisturizer called Kiss My Face or rake in the bucks with a skin care line named Urban Decay, then what’s your problem with Eye of Newt? You want focus groups?
Crowdfunding, anyone?
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
It took Jared till the end of his third month on isotretinoin to tell me he was two-timing me with another skin doctor.
“She calls herself a cosmetic dermatologist,” he said, naming a nearby practitioner I didn’t know. “She formulates special skin care products tailored to my particular skin. The one she came up with for me is based on shea butter, and it feels great.”
I am always amazed at people’s capacity to believe that there is a unique regimen just right for them, preferably one specially formulated by an expert who is privy to a secret no one else knows. Shea butter, it turns out, comes from the African shea tree (Ugandan trees are best). Africans eat the shea nuts; Westerners smear on ground-up nut contents.
Nut of shea. Tree of tea. Eye of newt. Toe of frog. The list goes on.
But I digress.
That didn’t seem very nice of her. I hadn’t murmured about her moisturizer, had I?
“What did she object to?” I asked. “Did her patients have problems with it?”
“She just said the drug is very bad,” said Jared. “She doesn’t like it at all. I was a little taken aback. I wasn’t expecting her to object so strongly.”
“But you’re still OK with taking isotretinoin?” I asked.
“Oh, yes,” said Jared. “It seems to be working, and I trust you.”
That was good to hear. I wondered whether Jared’s trust was based on the rigor of my scientific background or on my kindly smile and reassuring beard.
“Thank you, Jared,” I said. “I like isotretinoin a lot. It’s not for everybody, but for the last 35 years, I’ve seen it do excellent things for the appearance and self-image of many people.”
When I teach medical students, I often emphasize, as a point of professional etiquette, the impropriety of snorting or rolling your eyes at what patients report that other colleagues said and did. First of all, patient accounts may be imprecise or colored by their wish to build you up and flatter themselves for picking you. Second, just imagine what they might say about you at the next office they visit.
Reputation aside (you can hire folks to buff yours, if you like), my little exchange with Jared points up a basic difference between the way doctors think and the way our patients do.
What’s behind doctors’ professional lives is our assumption that diseases exist outside the bodies that the diseases inhabit. We therefore can offer a “treatment of choice” (or maybe a couple of them) that is best for treating a disease, regardless of who has it. This assumption is so obvious that we rarely think about it.
Obvious to us, that is, but not to our patients, to whom every patient has (to a large if not exclusive extent) his or her own disease. If possible, every patient wants a treatment tailored to each person’s unique makeup and predicament.
Jared is far from alone in playing both ends at the same time. From me he gets universal, evidence-based truths. From his other (more jealous!) medical mistress, he gets a skin care regimen tailored lovingly just for him.
Test your unique genes, get the treatment tailored just for you. Some rigorous scientists are trying not to so much debunk this effort as to point out how its promise is massively overhyped and unlikely to be worthy of the massive research investment it attracts. Perhaps their rigorous rationality will bear fruit, but they’re up against not just vested medical/industrial/venture capital interests, but the expectations of sick people who have always known that there is – that there simply has to be – a treatment out there that’s just for them.
Mock if you must, but tell me this: If people can prosper marketing a moisturizer called Kiss My Face or rake in the bucks with a skin care line named Urban Decay, then what’s your problem with Eye of Newt? You want focus groups?
Crowdfunding, anyone?
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
Doctors to Congress: Keep Part B drug payments out of MIPS adjustment
Physician specialists are calling on Congress to isolate Medicare Part B drug reimbursements from payment adjustments under the Merit-Based Incentive Payment System (MIPS).
A coalition of medical societies, large group practices, and patient advocacy groups has asked for an “intervention this year with a technical correction that ensures the [MIPS] score adjustment is not applied to Part B drug payments,” according to Jan. 18 letter sent to the leaders of the Senate Finance Committee, House Energy and Commerce Committee, and the House Ways and Means Committee. “Since the 2018 MIPS year has begun, it is imperative that Congress acts quickly to ensure that patient access to critical treatments is not negatively impacted.”
Under MIPS, physicians are scored based on their performance across three categories: quality, improvement activities, and advancing care information. A fourth category, cost, is planned but not yet included in the score. Medicare payments, which currently include Part B drug reimbursements, are subject to bonuses and penalties based on performance scores.
In their November 2017 update to the Quality Payment Program, which includes MIPS, officials at the Centers for Medicare & Medicaid Services said they would be moving forward with including Part B drug payments in the MIPS adjustment.
“This application of the adjustment ... is a significant departure from current policy and would disproportionately affect certain specialties,” according to the coalition’s letter.
Certain specialties, including rheumatology, oncology, and ophthalmology, have more to lose under the current policy because these specialists administer more Part B drugs than other specialists, according to health care consultancy Avalere Health.
“Certain specialists administer more Part B drugs than others and, therefore, may be exposed to significant financial risk and payment swings year-over-year under the CMS [Centers for Medicare & Medicaid Services] proposal,” John Feore, director at Avalere, said in a statement.
In 2018, physicians in those specialties could see drug payments increase or decrease by as much as 16%, according to Avalere research.
The policy likely will have an even greater effect on smaller practices and those in rural settings and could lead to access issues, according to the coalition letter.
“Some patients already face access challenges because the budget sequester has eroded reimbursements to physicians, and this policy would exacerbate these problems,” the letter states. “Patients would be left with fewer locations where they could receive care, resulting in less access and higher costs. A growing number of patients would then have to seek care in a hospital, which would result in higher out-of-pocket expenses and, particularly in rural communities, may require traveling longer distances to receive care.”
Physician specialists are calling on Congress to isolate Medicare Part B drug reimbursements from payment adjustments under the Merit-Based Incentive Payment System (MIPS).
A coalition of medical societies, large group practices, and patient advocacy groups has asked for an “intervention this year with a technical correction that ensures the [MIPS] score adjustment is not applied to Part B drug payments,” according to Jan. 18 letter sent to the leaders of the Senate Finance Committee, House Energy and Commerce Committee, and the House Ways and Means Committee. “Since the 2018 MIPS year has begun, it is imperative that Congress acts quickly to ensure that patient access to critical treatments is not negatively impacted.”
Under MIPS, physicians are scored based on their performance across three categories: quality, improvement activities, and advancing care information. A fourth category, cost, is planned but not yet included in the score. Medicare payments, which currently include Part B drug reimbursements, are subject to bonuses and penalties based on performance scores.
In their November 2017 update to the Quality Payment Program, which includes MIPS, officials at the Centers for Medicare & Medicaid Services said they would be moving forward with including Part B drug payments in the MIPS adjustment.
“This application of the adjustment ... is a significant departure from current policy and would disproportionately affect certain specialties,” according to the coalition’s letter.
Certain specialties, including rheumatology, oncology, and ophthalmology, have more to lose under the current policy because these specialists administer more Part B drugs than other specialists, according to health care consultancy Avalere Health.
“Certain specialists administer more Part B drugs than others and, therefore, may be exposed to significant financial risk and payment swings year-over-year under the CMS [Centers for Medicare & Medicaid Services] proposal,” John Feore, director at Avalere, said in a statement.
In 2018, physicians in those specialties could see drug payments increase or decrease by as much as 16%, according to Avalere research.
The policy likely will have an even greater effect on smaller practices and those in rural settings and could lead to access issues, according to the coalition letter.
“Some patients already face access challenges because the budget sequester has eroded reimbursements to physicians, and this policy would exacerbate these problems,” the letter states. “Patients would be left with fewer locations where they could receive care, resulting in less access and higher costs. A growing number of patients would then have to seek care in a hospital, which would result in higher out-of-pocket expenses and, particularly in rural communities, may require traveling longer distances to receive care.”
Physician specialists are calling on Congress to isolate Medicare Part B drug reimbursements from payment adjustments under the Merit-Based Incentive Payment System (MIPS).
A coalition of medical societies, large group practices, and patient advocacy groups has asked for an “intervention this year with a technical correction that ensures the [MIPS] score adjustment is not applied to Part B drug payments,” according to Jan. 18 letter sent to the leaders of the Senate Finance Committee, House Energy and Commerce Committee, and the House Ways and Means Committee. “Since the 2018 MIPS year has begun, it is imperative that Congress acts quickly to ensure that patient access to critical treatments is not negatively impacted.”
Under MIPS, physicians are scored based on their performance across three categories: quality, improvement activities, and advancing care information. A fourth category, cost, is planned but not yet included in the score. Medicare payments, which currently include Part B drug reimbursements, are subject to bonuses and penalties based on performance scores.
In their November 2017 update to the Quality Payment Program, which includes MIPS, officials at the Centers for Medicare & Medicaid Services said they would be moving forward with including Part B drug payments in the MIPS adjustment.
“This application of the adjustment ... is a significant departure from current policy and would disproportionately affect certain specialties,” according to the coalition’s letter.
Certain specialties, including rheumatology, oncology, and ophthalmology, have more to lose under the current policy because these specialists administer more Part B drugs than other specialists, according to health care consultancy Avalere Health.
“Certain specialists administer more Part B drugs than others and, therefore, may be exposed to significant financial risk and payment swings year-over-year under the CMS [Centers for Medicare & Medicaid Services] proposal,” John Feore, director at Avalere, said in a statement.
In 2018, physicians in those specialties could see drug payments increase or decrease by as much as 16%, according to Avalere research.
The policy likely will have an even greater effect on smaller practices and those in rural settings and could lead to access issues, according to the coalition letter.
“Some patients already face access challenges because the budget sequester has eroded reimbursements to physicians, and this policy would exacerbate these problems,” the letter states. “Patients would be left with fewer locations where they could receive care, resulting in less access and higher costs. A growing number of patients would then have to seek care in a hospital, which would result in higher out-of-pocket expenses and, particularly in rural communities, may require traveling longer distances to receive care.”
Predicting MDR Gram-negative infection mortality risk
Source control, defined as location and elimination of the source of the infection, was critical for patient survival in the case of multidrug resistant bacterial infection, according to the results of a case-control study of 62 critically ill surgical patients who were assessed between 2011 and 2014.
Researchers examined the characteristics of infected patients surviving to hospital discharge compared with those of nonsurvivors to look for predictive factors. Demographically, patients had an overall mean age of 62 years; 30.6% were women; 69.4% were white. The first culture obtained during a surgical ICU admission that grew a carbapenem-resistant Enterobacteriaceae (CRE), MDR Pseudomonas aeruginosa, or MDR Acinetobacter spp. was defined as the index culture.
“In this study, 33.9% [21/62] of critically ill surgical patients with a culture positive for MDR Gram-negative bacteria died prior to hospital discharge,” according to Andrew S. Jarrell, PharmD, of the Johns Hopkins Hospital, Baltimore, and his colleagues.
With multivariate logistic regression, achievement of source control was the only variable associated with decreased in-hospital mortality (odds ratio 0.04, 95% confidence interval, 0.003-0.52); P = .01).
“Source control status was predictive of in-hospital mortality after controlling for other factors. Specifically, the odds of in-hospital mortality were 97% lower when source control was achieved as compared to when source control was not achieved,” the authors stated (J Crit Care. 2018;43:321-6).
Scenarios in which source control was not applicable (pneumonia and urinary tract infection) were also similarly distributed between survivors and nonsurvivors, they reported.
Other than source control, the only significant risk factors for mortality, as seen in univariate analysis, all occurred prior to index culture. They were: vasopressor use (46.3% of survivors, vs. 76.2% of nonsurvivors, P = .03); mechanical ventilation (63.4% vs. 100%, P = .001); and median ICU length of stay (10 days vs. 18 days, P = .001).
“Achievement of source control stands out as a critical factor for patient survival. Clinicians should take this, along with prior ICU LOS, vasopressor use, and mechanical ventilation status, into consideration when evaluating patient prognosis,” Dr. Jarrell and his colleagues concluded.
The authors reported that they had no conflicts or source of funding.
Source: Jarrell, A.S., et al. J Crit Care. 2018;43:321-6.
Source control, defined as location and elimination of the source of the infection, was critical for patient survival in the case of multidrug resistant bacterial infection, according to the results of a case-control study of 62 critically ill surgical patients who were assessed between 2011 and 2014.
Researchers examined the characteristics of infected patients surviving to hospital discharge compared with those of nonsurvivors to look for predictive factors. Demographically, patients had an overall mean age of 62 years; 30.6% were women; 69.4% were white. The first culture obtained during a surgical ICU admission that grew a carbapenem-resistant Enterobacteriaceae (CRE), MDR Pseudomonas aeruginosa, or MDR Acinetobacter spp. was defined as the index culture.
“In this study, 33.9% [21/62] of critically ill surgical patients with a culture positive for MDR Gram-negative bacteria died prior to hospital discharge,” according to Andrew S. Jarrell, PharmD, of the Johns Hopkins Hospital, Baltimore, and his colleagues.
With multivariate logistic regression, achievement of source control was the only variable associated with decreased in-hospital mortality (odds ratio 0.04, 95% confidence interval, 0.003-0.52); P = .01).
“Source control status was predictive of in-hospital mortality after controlling for other factors. Specifically, the odds of in-hospital mortality were 97% lower when source control was achieved as compared to when source control was not achieved,” the authors stated (J Crit Care. 2018;43:321-6).
Scenarios in which source control was not applicable (pneumonia and urinary tract infection) were also similarly distributed between survivors and nonsurvivors, they reported.
Other than source control, the only significant risk factors for mortality, as seen in univariate analysis, all occurred prior to index culture. They were: vasopressor use (46.3% of survivors, vs. 76.2% of nonsurvivors, P = .03); mechanical ventilation (63.4% vs. 100%, P = .001); and median ICU length of stay (10 days vs. 18 days, P = .001).
“Achievement of source control stands out as a critical factor for patient survival. Clinicians should take this, along with prior ICU LOS, vasopressor use, and mechanical ventilation status, into consideration when evaluating patient prognosis,” Dr. Jarrell and his colleagues concluded.
The authors reported that they had no conflicts or source of funding.
Source: Jarrell, A.S., et al. J Crit Care. 2018;43:321-6.
Source control, defined as location and elimination of the source of the infection, was critical for patient survival in the case of multidrug resistant bacterial infection, according to the results of a case-control study of 62 critically ill surgical patients who were assessed between 2011 and 2014.
Researchers examined the characteristics of infected patients surviving to hospital discharge compared with those of nonsurvivors to look for predictive factors. Demographically, patients had an overall mean age of 62 years; 30.6% were women; 69.4% were white. The first culture obtained during a surgical ICU admission that grew a carbapenem-resistant Enterobacteriaceae (CRE), MDR Pseudomonas aeruginosa, or MDR Acinetobacter spp. was defined as the index culture.
“In this study, 33.9% [21/62] of critically ill surgical patients with a culture positive for MDR Gram-negative bacteria died prior to hospital discharge,” according to Andrew S. Jarrell, PharmD, of the Johns Hopkins Hospital, Baltimore, and his colleagues.
With multivariate logistic regression, achievement of source control was the only variable associated with decreased in-hospital mortality (odds ratio 0.04, 95% confidence interval, 0.003-0.52); P = .01).
“Source control status was predictive of in-hospital mortality after controlling for other factors. Specifically, the odds of in-hospital mortality were 97% lower when source control was achieved as compared to when source control was not achieved,” the authors stated (J Crit Care. 2018;43:321-6).
Scenarios in which source control was not applicable (pneumonia and urinary tract infection) were also similarly distributed between survivors and nonsurvivors, they reported.
Other than source control, the only significant risk factors for mortality, as seen in univariate analysis, all occurred prior to index culture. They were: vasopressor use (46.3% of survivors, vs. 76.2% of nonsurvivors, P = .03); mechanical ventilation (63.4% vs. 100%, P = .001); and median ICU length of stay (10 days vs. 18 days, P = .001).
“Achievement of source control stands out as a critical factor for patient survival. Clinicians should take this, along with prior ICU LOS, vasopressor use, and mechanical ventilation status, into consideration when evaluating patient prognosis,” Dr. Jarrell and his colleagues concluded.
The authors reported that they had no conflicts or source of funding.
Source: Jarrell, A.S., et al. J Crit Care. 2018;43:321-6.
FROM THE JOURNAL OF CRITICAL CARE
Key clinical point: Source control was the most important predictor of MDR Gram-negative infection mortality in hospitalized patients.
Major finding: The odds of in-hospital mortality were 97% lower when source control was achieved.
Study details: Case-control study of 62 critically ill surgical patients from 2011 to 2014 who had an MDR infection.
Disclosures: The authors reported that they had no conflicts or source of funding.
Source: Jarrell, A.S., et al. J Crit Care. 2018;43:321-6.