User login
Short Takes
Comparison of the number of major complications of laparoscopic cholecystectomy versus percutaneous catheter drainage in the treatment of acute cholecystitis
This randomized, controlled trial showed that 65% of high-risk patients (APACHE II score of at least 7) with acute cholecystitis experienced major complications after undergoing percutaneous catheter drainage, compared with 12% of patients who underwent laparoscopic cholecystectomy. Major complications included reintervention and recurrent biliary disease. The rate of death was the same in both groups.
Citation: Loozen CS et al. Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high-risk patients (CHOCOLATE): Multicentre randomised clinical trial. BMJ. 2018 Aug 28;363:k3965.
Food and Drug Administration approves new drug to treat influenza
Two randomized, controlled trials showed that Xofluza (baloxavir marboxil) taken as a single dose decreased symptoms in uncomplicated influenza, compared with placebo. The medication also was associated with a lower viral load on day 1 after administration, compared with both placebo and oseltamivir, the most commonly used medication to treat influenza.
Citation: Hayden FG et al. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Eng J Med. 2018 Sep 6;379:913-23.
Effects of missed hemodialysis treatments
Researchers used a prospective cohort of 8,501 patients from hemodialysis (HD) centers in 20 countries to identify patients who missed one or more HD sessions in 4 months. In the United States, 24% of HD patients missed one or more sessions in 4 months, compared with 10% in Canada and 9% in the United Kingdom. Moreover, 12.2% of U.S. HD patients missed at least one session per month. All-cause mortality was 68% higher in patients who missed one or more sessions in 4 months. Risk factors associated with missing dialysis treatments were travel time of more than 1 hour to the facility, depression, younger age, being on dialysis for a shorter vintage, lower perceived burden of kidney disease, and shorter treatment times.
Citation: Al Salmi I et al. Missed hemodialysis treatments: International variation, predictors, and outcomes in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2018 Nov;72(5)634-43.
Do in situ mock codes affect in-hospital cardiac arrest mortality?
This ecological study included multiple hospital systems and showed that hospitals with a higher proportion of in situ mock codes had an in-hospital cardiac arrest survival rate of 42.8% versus 31.8% in hospitals with fewer mock codes (P greater than .0001).
Citation: Josey K et al. Hospitals with more-active participation in conducting standardized in-situ mock codes have improved survival after in-hospital cardiopulmonary arrest. Resuscitation. 2018 Dec;133:47-52.
New oxygen guidelines
In patients admitted with acute stroke or MI, an international expert panel made a strong recommendation against initiating supplemental oxygen when the SpO2 is greater than 92% and a weak recommendation against initiating supplemental oxygen when the SpO2 is 90%-92%. In acutely ill medical patients receiving supplemental oxygen, the panel makes a strong recommendation to maintain an upper limit oxygen saturation of less than 96%.
Citation: Siemieniuk RAC et al. Oxygen therapy for acutely ill medical patients: A clinical practice guideline. BMJ. 2018 Oct 24;363:k4169.
Comparison of the number of major complications of laparoscopic cholecystectomy versus percutaneous catheter drainage in the treatment of acute cholecystitis
This randomized, controlled trial showed that 65% of high-risk patients (APACHE II score of at least 7) with acute cholecystitis experienced major complications after undergoing percutaneous catheter drainage, compared with 12% of patients who underwent laparoscopic cholecystectomy. Major complications included reintervention and recurrent biliary disease. The rate of death was the same in both groups.
Citation: Loozen CS et al. Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high-risk patients (CHOCOLATE): Multicentre randomised clinical trial. BMJ. 2018 Aug 28;363:k3965.
Food and Drug Administration approves new drug to treat influenza
Two randomized, controlled trials showed that Xofluza (baloxavir marboxil) taken as a single dose decreased symptoms in uncomplicated influenza, compared with placebo. The medication also was associated with a lower viral load on day 1 after administration, compared with both placebo and oseltamivir, the most commonly used medication to treat influenza.
Citation: Hayden FG et al. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Eng J Med. 2018 Sep 6;379:913-23.
Effects of missed hemodialysis treatments
Researchers used a prospective cohort of 8,501 patients from hemodialysis (HD) centers in 20 countries to identify patients who missed one or more HD sessions in 4 months. In the United States, 24% of HD patients missed one or more sessions in 4 months, compared with 10% in Canada and 9% in the United Kingdom. Moreover, 12.2% of U.S. HD patients missed at least one session per month. All-cause mortality was 68% higher in patients who missed one or more sessions in 4 months. Risk factors associated with missing dialysis treatments were travel time of more than 1 hour to the facility, depression, younger age, being on dialysis for a shorter vintage, lower perceived burden of kidney disease, and shorter treatment times.
Citation: Al Salmi I et al. Missed hemodialysis treatments: International variation, predictors, and outcomes in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2018 Nov;72(5)634-43.
Do in situ mock codes affect in-hospital cardiac arrest mortality?
This ecological study included multiple hospital systems and showed that hospitals with a higher proportion of in situ mock codes had an in-hospital cardiac arrest survival rate of 42.8% versus 31.8% in hospitals with fewer mock codes (P greater than .0001).
Citation: Josey K et al. Hospitals with more-active participation in conducting standardized in-situ mock codes have improved survival after in-hospital cardiopulmonary arrest. Resuscitation. 2018 Dec;133:47-52.
New oxygen guidelines
In patients admitted with acute stroke or MI, an international expert panel made a strong recommendation against initiating supplemental oxygen when the SpO2 is greater than 92% and a weak recommendation against initiating supplemental oxygen when the SpO2 is 90%-92%. In acutely ill medical patients receiving supplemental oxygen, the panel makes a strong recommendation to maintain an upper limit oxygen saturation of less than 96%.
Citation: Siemieniuk RAC et al. Oxygen therapy for acutely ill medical patients: A clinical practice guideline. BMJ. 2018 Oct 24;363:k4169.
Comparison of the number of major complications of laparoscopic cholecystectomy versus percutaneous catheter drainage in the treatment of acute cholecystitis
This randomized, controlled trial showed that 65% of high-risk patients (APACHE II score of at least 7) with acute cholecystitis experienced major complications after undergoing percutaneous catheter drainage, compared with 12% of patients who underwent laparoscopic cholecystectomy. Major complications included reintervention and recurrent biliary disease. The rate of death was the same in both groups.
Citation: Loozen CS et al. Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high-risk patients (CHOCOLATE): Multicentre randomised clinical trial. BMJ. 2018 Aug 28;363:k3965.
Food and Drug Administration approves new drug to treat influenza
Two randomized, controlled trials showed that Xofluza (baloxavir marboxil) taken as a single dose decreased symptoms in uncomplicated influenza, compared with placebo. The medication also was associated with a lower viral load on day 1 after administration, compared with both placebo and oseltamivir, the most commonly used medication to treat influenza.
Citation: Hayden FG et al. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Eng J Med. 2018 Sep 6;379:913-23.
Effects of missed hemodialysis treatments
Researchers used a prospective cohort of 8,501 patients from hemodialysis (HD) centers in 20 countries to identify patients who missed one or more HD sessions in 4 months. In the United States, 24% of HD patients missed one or more sessions in 4 months, compared with 10% in Canada and 9% in the United Kingdom. Moreover, 12.2% of U.S. HD patients missed at least one session per month. All-cause mortality was 68% higher in patients who missed one or more sessions in 4 months. Risk factors associated with missing dialysis treatments were travel time of more than 1 hour to the facility, depression, younger age, being on dialysis for a shorter vintage, lower perceived burden of kidney disease, and shorter treatment times.
Citation: Al Salmi I et al. Missed hemodialysis treatments: International variation, predictors, and outcomes in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2018 Nov;72(5)634-43.
Do in situ mock codes affect in-hospital cardiac arrest mortality?
This ecological study included multiple hospital systems and showed that hospitals with a higher proportion of in situ mock codes had an in-hospital cardiac arrest survival rate of 42.8% versus 31.8% in hospitals with fewer mock codes (P greater than .0001).
Citation: Josey K et al. Hospitals with more-active participation in conducting standardized in-situ mock codes have improved survival after in-hospital cardiopulmonary arrest. Resuscitation. 2018 Dec;133:47-52.
New oxygen guidelines
In patients admitted with acute stroke or MI, an international expert panel made a strong recommendation against initiating supplemental oxygen when the SpO2 is greater than 92% and a weak recommendation against initiating supplemental oxygen when the SpO2 is 90%-92%. In acutely ill medical patients receiving supplemental oxygen, the panel makes a strong recommendation to maintain an upper limit oxygen saturation of less than 96%.
Citation: Siemieniuk RAC et al. Oxygen therapy for acutely ill medical patients: A clinical practice guideline. BMJ. 2018 Oct 24;363:k4169.
Acid-suppressing drug use associated with increased antiallergy drug use
Gastric acid–suppressing medications such as proton pump inhibitors are associated with a significant increase in subsequent antiallergy medication use, particularly in older individuals.
In a population-based study of health insurance data from 8.2 million people, Austrian researchers looked for prescriptions of gastric acid inhibitors, antiallergy drugs, or other commonly prescribed (lipid-modifying and antihypertensive) drugs as controls from 2009-2013.
According to results published in Nature Communications, gastric acid–suppressing drugs were associated with an overall 96% higher rate of subsequent prescriptions for antiallergy medications than among the general population not taking gastric acid–suppressing drugs (P less than .001). Among individuals aged 60 years or older, the rate of allergy medication prescriptions after acid-suppressing treatment was more than five times higher than that in the general population.
The rate of antiallergy medication use after acid-suppressing medication prescription was threefold higher than the rate seen after lipid-modifying or antihypertensive drug prescription.
“Our findings confirm an epidemiological association between gastric acid suppression and development of allergic symptoms, in line with previous mechanistic animal trials and human observational studies,” wrote Galateja Jordakieva, PhD, of the department of physical medicine, rehabilitation, and occupational medicine at the Medical University of Vienna, and coauthors.
All groups of acid-inhibiting medications were associated with a higher rate of subsequent antiallergy medication prescriptions. The only exception was prostaglandin E2 medications, but the authors said that here the numbers were too low to draw conclusions.
The hazard rate for antiallergy medications also increased with increasing numbers of daily doses of acid-suppressing medication, the study showed. The hazard rate for the lowest quartile – up to 20 daily doses per year – was a significant 28% higher than that of the general population, while the third quartile (68-213 daily dose per year) was associated with a 2.67-fold higher hazard. A similar increase was seen for the fourth quartile of acid suppression–medication dosing.
The authors established that just six daily doses of acid-suppressing drugs in a year were associated with significantly earlier prescriptions of antiallergy medication.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, emphasized in an associated commentary that the findings reflect association, not causation. “There are many possible explanations for the observed association ... In fact, the data make other explanations more than likely to be the cause of allergies.”
Coprescriptions of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) are common among PPI users and “are among the drugs that are very well known to increase the risk of an allergic reaction.” The data show that antiallergy medicines are prescribed at a relatively similar rate at all ages, while PPI prescribing increases in the elderly.
“If the rate of prescription of PPIs shows a steep rise with age and they are a significant cause of allergies, then the anti-allergy medicines ... should also show a steep rise with age. The fact that they don’t, either means they show no relation or that any relation has a minimal effect on allergies,” Dr. Evans said. “Nearly all drugs can have very rare allergic reactions, including PPIs, but this paper does not help to show what the true rate is of these very rare reactions, or whether they are caused by PPIs alone. The design and analysis methods in the paper are likely to exaggerate their apparent occurrence.”
The study was supported by Burgenländische Gebietskrankenkasse and the Austrian Science Fund. No conflicts of interest were declared.
SOURCE: Jordakieva G et al. Nat Commun. 2019 Jul 30. doi: 10.1038/s41467-019-10914-6.
Gastric acid–suppressing medications such as proton pump inhibitors are associated with a significant increase in subsequent antiallergy medication use, particularly in older individuals.
In a population-based study of health insurance data from 8.2 million people, Austrian researchers looked for prescriptions of gastric acid inhibitors, antiallergy drugs, or other commonly prescribed (lipid-modifying and antihypertensive) drugs as controls from 2009-2013.
According to results published in Nature Communications, gastric acid–suppressing drugs were associated with an overall 96% higher rate of subsequent prescriptions for antiallergy medications than among the general population not taking gastric acid–suppressing drugs (P less than .001). Among individuals aged 60 years or older, the rate of allergy medication prescriptions after acid-suppressing treatment was more than five times higher than that in the general population.
The rate of antiallergy medication use after acid-suppressing medication prescription was threefold higher than the rate seen after lipid-modifying or antihypertensive drug prescription.
“Our findings confirm an epidemiological association between gastric acid suppression and development of allergic symptoms, in line with previous mechanistic animal trials and human observational studies,” wrote Galateja Jordakieva, PhD, of the department of physical medicine, rehabilitation, and occupational medicine at the Medical University of Vienna, and coauthors.
All groups of acid-inhibiting medications were associated with a higher rate of subsequent antiallergy medication prescriptions. The only exception was prostaglandin E2 medications, but the authors said that here the numbers were too low to draw conclusions.
The hazard rate for antiallergy medications also increased with increasing numbers of daily doses of acid-suppressing medication, the study showed. The hazard rate for the lowest quartile – up to 20 daily doses per year – was a significant 28% higher than that of the general population, while the third quartile (68-213 daily dose per year) was associated with a 2.67-fold higher hazard. A similar increase was seen for the fourth quartile of acid suppression–medication dosing.
The authors established that just six daily doses of acid-suppressing drugs in a year were associated with significantly earlier prescriptions of antiallergy medication.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, emphasized in an associated commentary that the findings reflect association, not causation. “There are many possible explanations for the observed association ... In fact, the data make other explanations more than likely to be the cause of allergies.”
Coprescriptions of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) are common among PPI users and “are among the drugs that are very well known to increase the risk of an allergic reaction.” The data show that antiallergy medicines are prescribed at a relatively similar rate at all ages, while PPI prescribing increases in the elderly.
“If the rate of prescription of PPIs shows a steep rise with age and they are a significant cause of allergies, then the anti-allergy medicines ... should also show a steep rise with age. The fact that they don’t, either means they show no relation or that any relation has a minimal effect on allergies,” Dr. Evans said. “Nearly all drugs can have very rare allergic reactions, including PPIs, but this paper does not help to show what the true rate is of these very rare reactions, or whether they are caused by PPIs alone. The design and analysis methods in the paper are likely to exaggerate their apparent occurrence.”
The study was supported by Burgenländische Gebietskrankenkasse and the Austrian Science Fund. No conflicts of interest were declared.
SOURCE: Jordakieva G et al. Nat Commun. 2019 Jul 30. doi: 10.1038/s41467-019-10914-6.
Gastric acid–suppressing medications such as proton pump inhibitors are associated with a significant increase in subsequent antiallergy medication use, particularly in older individuals.
In a population-based study of health insurance data from 8.2 million people, Austrian researchers looked for prescriptions of gastric acid inhibitors, antiallergy drugs, or other commonly prescribed (lipid-modifying and antihypertensive) drugs as controls from 2009-2013.
According to results published in Nature Communications, gastric acid–suppressing drugs were associated with an overall 96% higher rate of subsequent prescriptions for antiallergy medications than among the general population not taking gastric acid–suppressing drugs (P less than .001). Among individuals aged 60 years or older, the rate of allergy medication prescriptions after acid-suppressing treatment was more than five times higher than that in the general population.
The rate of antiallergy medication use after acid-suppressing medication prescription was threefold higher than the rate seen after lipid-modifying or antihypertensive drug prescription.
“Our findings confirm an epidemiological association between gastric acid suppression and development of allergic symptoms, in line with previous mechanistic animal trials and human observational studies,” wrote Galateja Jordakieva, PhD, of the department of physical medicine, rehabilitation, and occupational medicine at the Medical University of Vienna, and coauthors.
All groups of acid-inhibiting medications were associated with a higher rate of subsequent antiallergy medication prescriptions. The only exception was prostaglandin E2 medications, but the authors said that here the numbers were too low to draw conclusions.
The hazard rate for antiallergy medications also increased with increasing numbers of daily doses of acid-suppressing medication, the study showed. The hazard rate for the lowest quartile – up to 20 daily doses per year – was a significant 28% higher than that of the general population, while the third quartile (68-213 daily dose per year) was associated with a 2.67-fold higher hazard. A similar increase was seen for the fourth quartile of acid suppression–medication dosing.
The authors established that just six daily doses of acid-suppressing drugs in a year were associated with significantly earlier prescriptions of antiallergy medication.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, emphasized in an associated commentary that the findings reflect association, not causation. “There are many possible explanations for the observed association ... In fact, the data make other explanations more than likely to be the cause of allergies.”
Coprescriptions of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) are common among PPI users and “are among the drugs that are very well known to increase the risk of an allergic reaction.” The data show that antiallergy medicines are prescribed at a relatively similar rate at all ages, while PPI prescribing increases in the elderly.
“If the rate of prescription of PPIs shows a steep rise with age and they are a significant cause of allergies, then the anti-allergy medicines ... should also show a steep rise with age. The fact that they don’t, either means they show no relation or that any relation has a minimal effect on allergies,” Dr. Evans said. “Nearly all drugs can have very rare allergic reactions, including PPIs, but this paper does not help to show what the true rate is of these very rare reactions, or whether they are caused by PPIs alone. The design and analysis methods in the paper are likely to exaggerate their apparent occurrence.”
The study was supported by Burgenländische Gebietskrankenkasse and the Austrian Science Fund. No conflicts of interest were declared.
SOURCE: Jordakieva G et al. Nat Commun. 2019 Jul 30. doi: 10.1038/s41467-019-10914-6.
FROM NATURE COMMUNICATIONS
MMR vaccine maintains effectiveness after 10 years
according to Stephane Carryn, PhD, of GlaxoSmithKline and associates.
In a phase 3, observer-blind, randomized study published in Vaccine, 1,887 children aged 12-22 months received two doses of the MMR plus varicella (MMRV) vaccine Priorix-Tetra, one dose of the MMR vaccine Priorix with one dose of the varicella vaccine Varilrix delivered separately, or two doses of the MMR vaccine. Blood samples were collected at baseline and at days 42 and 84, then at year 1, 2, 4, 6, 8, and 10.
Antimeasles and antirubella antibodies declined moderately over the 10-year study period, but seropositivity remained high at 10 years, with about 94.0% of children remaining seropositive for antimeasles antibodies and about 96.6% remaining seropositive for antirubella antibodies. Children who received Priorix-Tetra had antimeasles antibody titers twice as high as those who received Priorix throughout the study. In addition, children who received a second dose of MMR vaccine later in life saw only a transient benefit in antimeasles and antirubella titers.
Antimumps antibody titer levels remained stable over the course of the study, and the seropositivity rate was about 90.0% at 10 years. Children who received a second MMR vaccine later in life saw a boosting effect in seropositivity and antimumps antibody titer levels.
“The responses obtained after receipt of one or two doses of MMR-containing vaccines remain well above the seropositivity thresholds up to 10 years post vaccination, regardless of the vaccine given and the schedule used,” the investigators concluded.
The study was funded and supported by GlaxoSmithKline. The study authors reported being employed by GlaxoSmithKline; two also reported owning shares in the company.
SOURCE: Carryn S et al. Vaccine. 2019 Jul 22. doi: 10.1016/j.vaccine.2019.07.049.
according to Stephane Carryn, PhD, of GlaxoSmithKline and associates.
In a phase 3, observer-blind, randomized study published in Vaccine, 1,887 children aged 12-22 months received two doses of the MMR plus varicella (MMRV) vaccine Priorix-Tetra, one dose of the MMR vaccine Priorix with one dose of the varicella vaccine Varilrix delivered separately, or two doses of the MMR vaccine. Blood samples were collected at baseline and at days 42 and 84, then at year 1, 2, 4, 6, 8, and 10.
Antimeasles and antirubella antibodies declined moderately over the 10-year study period, but seropositivity remained high at 10 years, with about 94.0% of children remaining seropositive for antimeasles antibodies and about 96.6% remaining seropositive for antirubella antibodies. Children who received Priorix-Tetra had antimeasles antibody titers twice as high as those who received Priorix throughout the study. In addition, children who received a second dose of MMR vaccine later in life saw only a transient benefit in antimeasles and antirubella titers.
Antimumps antibody titer levels remained stable over the course of the study, and the seropositivity rate was about 90.0% at 10 years. Children who received a second MMR vaccine later in life saw a boosting effect in seropositivity and antimumps antibody titer levels.
“The responses obtained after receipt of one or two doses of MMR-containing vaccines remain well above the seropositivity thresholds up to 10 years post vaccination, regardless of the vaccine given and the schedule used,” the investigators concluded.
The study was funded and supported by GlaxoSmithKline. The study authors reported being employed by GlaxoSmithKline; two also reported owning shares in the company.
SOURCE: Carryn S et al. Vaccine. 2019 Jul 22. doi: 10.1016/j.vaccine.2019.07.049.
according to Stephane Carryn, PhD, of GlaxoSmithKline and associates.
In a phase 3, observer-blind, randomized study published in Vaccine, 1,887 children aged 12-22 months received two doses of the MMR plus varicella (MMRV) vaccine Priorix-Tetra, one dose of the MMR vaccine Priorix with one dose of the varicella vaccine Varilrix delivered separately, or two doses of the MMR vaccine. Blood samples were collected at baseline and at days 42 and 84, then at year 1, 2, 4, 6, 8, and 10.
Antimeasles and antirubella antibodies declined moderately over the 10-year study period, but seropositivity remained high at 10 years, with about 94.0% of children remaining seropositive for antimeasles antibodies and about 96.6% remaining seropositive for antirubella antibodies. Children who received Priorix-Tetra had antimeasles antibody titers twice as high as those who received Priorix throughout the study. In addition, children who received a second dose of MMR vaccine later in life saw only a transient benefit in antimeasles and antirubella titers.
Antimumps antibody titer levels remained stable over the course of the study, and the seropositivity rate was about 90.0% at 10 years. Children who received a second MMR vaccine later in life saw a boosting effect in seropositivity and antimumps antibody titer levels.
“The responses obtained after receipt of one or two doses of MMR-containing vaccines remain well above the seropositivity thresholds up to 10 years post vaccination, regardless of the vaccine given and the schedule used,” the investigators concluded.
The study was funded and supported by GlaxoSmithKline. The study authors reported being employed by GlaxoSmithKline; two also reported owning shares in the company.
SOURCE: Carryn S et al. Vaccine. 2019 Jul 22. doi: 10.1016/j.vaccine.2019.07.049.
FROM VACCINE
CMS proposes improved E/M payments, additional price transparency for hospitals
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states "that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format" which would allow them to be included in price transparency tools and electronic health records.
"Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers," CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As "deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal," she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association's Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be "rewarding the time that doctors spend with patients," Administrator Verma said.
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
"For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care," she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, "making it easier to participate in MIPS."
Look for in depth analysis of both proposals shortly on this website.
gtwachtman@mdedge.com
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states "that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format" which would allow them to be included in price transparency tools and electronic health records.
"Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers," CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As "deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal," she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association's Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be "rewarding the time that doctors spend with patients," Administrator Verma said.
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
"For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care," she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, "making it easier to participate in MIPS."
Look for in depth analysis of both proposals shortly on this website.
gtwachtman@mdedge.com
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states "that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format" which would allow them to be included in price transparency tools and electronic health records.
"Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers," CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As "deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal," she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association's Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be "rewarding the time that doctors spend with patients," Administrator Verma said.
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
"For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care," she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, "making it easier to participate in MIPS."
Look for in depth analysis of both proposals shortly on this website.
gtwachtman@mdedge.com
CMS proposes improved E/M payments, additional price transparency for hospitals
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states “that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format” which would allow them to be included in price transparency tools and electronic health records.
“Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers,” CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As “deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC). In fact, CMS is walking back the recently proposed plans to collapse E/M levels. The CPT code changes recommended by the AMA allow clinicians to choose the E/M visit level based on either medical decision making or time.
With this update, the agency will be “rewarding the time that doctors spend with patients,” Administrator Verma said.
In a joint statement, the American Gastroenterological Association, the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy welcomed the news as the GI societies opposed CMS’ proposal when it was announced last year. “We worked with the AMA and a coalition of specialty societies in an effort to get CMS to rethink collapsing payment for E/M code levels, and subsequently decided to support the AMA’s proposed E/M changes as they moved through the CPT and RUC processes. In the rule, CMS abandons its proposal and adopts the AMA CPT changes and RUC valuation.”
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
“For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care,” she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, “making it easier to participate in MIPS.” CMS proposed removal of 2 colonoscopy measures from MIPS performance year 2022 because they do not align with MIPS scoring methodology.
The American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy are currently reviewing the details of the proposed rules and will be providing joint comments. CMS will accept comments until Sept. 27, 2019.
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states “that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format” which would allow them to be included in price transparency tools and electronic health records.
“Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers,” CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As “deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC). In fact, CMS is walking back the recently proposed plans to collapse E/M levels. The CPT code changes recommended by the AMA allow clinicians to choose the E/M visit level based on either medical decision making or time.
With this update, the agency will be “rewarding the time that doctors spend with patients,” Administrator Verma said.
In a joint statement, the American Gastroenterological Association, the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy welcomed the news as the GI societies opposed CMS’ proposal when it was announced last year. “We worked with the AMA and a coalition of specialty societies in an effort to get CMS to rethink collapsing payment for E/M code levels, and subsequently decided to support the AMA’s proposed E/M changes as they moved through the CPT and RUC processes. In the rule, CMS abandons its proposal and adopts the AMA CPT changes and RUC valuation.”
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
“For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care,” she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, “making it easier to participate in MIPS.” CMS proposed removal of 2 colonoscopy measures from MIPS performance year 2022 because they do not align with MIPS scoring methodology.
The American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy are currently reviewing the details of the proposed rules and will be providing joint comments. CMS will accept comments until Sept. 27, 2019.
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states “that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format” which would allow them to be included in price transparency tools and electronic health records.
“Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers,” CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As “deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC). In fact, CMS is walking back the recently proposed plans to collapse E/M levels. The CPT code changes recommended by the AMA allow clinicians to choose the E/M visit level based on either medical decision making or time.
With this update, the agency will be “rewarding the time that doctors spend with patients,” Administrator Verma said.
In a joint statement, the American Gastroenterological Association, the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy welcomed the news as the GI societies opposed CMS’ proposal when it was announced last year. “We worked with the AMA and a coalition of specialty societies in an effort to get CMS to rethink collapsing payment for E/M code levels, and subsequently decided to support the AMA’s proposed E/M changes as they moved through the CPT and RUC processes. In the rule, CMS abandons its proposal and adopts the AMA CPT changes and RUC valuation.”
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
“For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care,” she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, “making it easier to participate in MIPS.” CMS proposed removal of 2 colonoscopy measures from MIPS performance year 2022 because they do not align with MIPS scoring methodology.
The American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy are currently reviewing the details of the proposed rules and will be providing joint comments. CMS will accept comments until Sept. 27, 2019.
FDA approvals permit double-immunoassay approach to Lyme disease diagnosis
Concurrent or sequential enzyme immunoassays can now be conducted to diagnose Lyme disease, according to the U.S. Food and Drug Administration.
Four previously cleared tests are now approved by the agency for marketing with new indications as part of the revised diagnostic approach. Previously, the two-step diagnostic process consisted of an initial enzyme immunoassay followed by a Western blot test.
“With today’s action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiologic Health, said in a press release announcing the newly approved approach.
The modified two-tier enzyme immunoassay approach was found to be as accurate for assessing exposure to Borrelia burgdorferi as the standard immunoassay followed by Western blot test in an FDA review of data from clinical studies using the following ZEUS Scientific ELISA Test Systems: Borrelia VlsE1/pepC10 IgG/IgM; Borrelia burgdorferi IgG/IgM; Borrelia burgdorferi IgM; and Borrelia burgdorferi IgG.
The recommendations of the Centers for Disease Control and Prevention should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate, the FDA statement said. In 2017, the last year for which the CDC published data, a total of 42,743 confirmed and probable cases of Lyme disease were reported, an increase of 17% from 2016.
The FDA granted clearance of the ZEUS ELISA enzyme immunoassay tests to ZEUS Scientific.
Concurrent or sequential enzyme immunoassays can now be conducted to diagnose Lyme disease, according to the U.S. Food and Drug Administration.
Four previously cleared tests are now approved by the agency for marketing with new indications as part of the revised diagnostic approach. Previously, the two-step diagnostic process consisted of an initial enzyme immunoassay followed by a Western blot test.
“With today’s action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiologic Health, said in a press release announcing the newly approved approach.
The modified two-tier enzyme immunoassay approach was found to be as accurate for assessing exposure to Borrelia burgdorferi as the standard immunoassay followed by Western blot test in an FDA review of data from clinical studies using the following ZEUS Scientific ELISA Test Systems: Borrelia VlsE1/pepC10 IgG/IgM; Borrelia burgdorferi IgG/IgM; Borrelia burgdorferi IgM; and Borrelia burgdorferi IgG.
The recommendations of the Centers for Disease Control and Prevention should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate, the FDA statement said. In 2017, the last year for which the CDC published data, a total of 42,743 confirmed and probable cases of Lyme disease were reported, an increase of 17% from 2016.
The FDA granted clearance of the ZEUS ELISA enzyme immunoassay tests to ZEUS Scientific.
Concurrent or sequential enzyme immunoassays can now be conducted to diagnose Lyme disease, according to the U.S. Food and Drug Administration.
Four previously cleared tests are now approved by the agency for marketing with new indications as part of the revised diagnostic approach. Previously, the two-step diagnostic process consisted of an initial enzyme immunoassay followed by a Western blot test.
“With today’s action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiologic Health, said in a press release announcing the newly approved approach.
The modified two-tier enzyme immunoassay approach was found to be as accurate for assessing exposure to Borrelia burgdorferi as the standard immunoassay followed by Western blot test in an FDA review of data from clinical studies using the following ZEUS Scientific ELISA Test Systems: Borrelia VlsE1/pepC10 IgG/IgM; Borrelia burgdorferi IgG/IgM; Borrelia burgdorferi IgM; and Borrelia burgdorferi IgG.
The recommendations of the Centers for Disease Control and Prevention should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate, the FDA statement said. In 2017, the last year for which the CDC published data, a total of 42,743 confirmed and probable cases of Lyme disease were reported, an increase of 17% from 2016.
The FDA granted clearance of the ZEUS ELISA enzyme immunoassay tests to ZEUS Scientific.
Large prospective trial offers reassurance for long-term PPI use
Aside from a possible increased risk of enteric infections, long-term use of the proton pump inhibitor (PPI) pantoprazole appears safe in patients with stable atherosclerotic vascular disease, according to a prospective trial involving more than 17,000 participants.
In contrast with published observational studies, the present trial found no associations between long-term PPI use and previously reported risks such as pneumonia, fracture, or cerebrovascular events, according to lead author Paul Moayyedi, MB ChB, PhD, of McMaster University in Hamilton, Ont., and colleagues.
“To our knowledge, this is the largest PPI trial for any indication and the first prospective randomized trial to evaluate the many long-term safety concerns related to PPI therapy,” the investigators wrote in Gastroenterology. “It is reassuring that there was no evidence for harm for most of these events other than an excess of enteric infections.”
“Given how commonly acid suppressive medications are used, it is important to ensure that this class of drugs is safe,” the investigators wrote. They noted that patients are often alarmed by “sensational headlines” about PPI safety. “There are balancing articles that more carefully discuss the risks and benefits of taking PPI therapy but these receive less media attention,” the investigators added.
The present, prospective trial, COMPASS, involved 17,598 participants from 33 countries with stable peripheral artery disease and cardiovascular disease. “We use the term participants, rather than patients, as not all of those taking part in this research would have been patients throughout the trial but all participated in the randomized controlled trial,” the investigators wrote.
In addition to evaluating the safety of pantoprazole, the study was initially designed to measure the efficacy of pantoprazole for preventing upper gastrointestinal events in participants taking rivaroxaban and/or aspirin, which, in combination, were recently shown to reduce cardiovascular outcomes among patients with stable cardiovascular conditions. As such, participants in the trial were randomized to one of three groups: 100-mg aspirin once daily, 5-mg rivaroxaban twice daily, or 2.5-mg rivaroxaban twice daily combined with 100-mg aspirin once daily. The primary efficacy outcomes for these three groups were stroke, myocardial infarction, and cardiovascular death. This portion of the trial was discontinued early because of evidence that showed the superiority of combination therapy over aspirin alone; however, the pantoprazole component of the trial continued, as planned, for 3 years.
At baseline, about two-thirds of participants (64%) were not taking a PPI, requiring randomization to either 40-mg pantoprazole once daily or matching placebo. Pantoprazole safety outcomes centered on those previously reported by observational studies, including dementia, chronic kidney disease, gastric atrophy, fracture, cancer, pneumonia, diabetes mellitus, chronic obstructive lung disease, Clostrididoides difficile infection, and other enteric infections. Hospitalization rates for noncardiovascular and cardiovascular events were also reported. Data were gathered via questionnaires, which were conducted every 6 months.
Most patients in the trial (78%) were male, and 23% were current smokers. Smaller proportions of the population were taking an NSAID (5%) and/or had a history of peptic ulcer disease (2.6%). The median follow-up was 3.01 years, ranging from 2.49 to 3.59 years. Permanent discontinuations occurred at approximately equal rates in the pantoprazole (21%) and placebo (22%) group after a median of 11 months (338 days). In both groups, more than 96% of participants who continued treatment took their medications as prescribed at least 80% of the time.
Analysis of cardiovascular outcomes revealed no significant differences between placebo and pantoprazole groups. Of all the evaluated safety measures, only enteric infections differed significantly between groups, occurring at a higher rate in the pantoprazole group than in the placebo group (1.4% vs. 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Although C. difficile infection was more common among pantoprazole users, only 13 such events occurred, precluding statistical significance.
According to the investigators, these findings should offer reassurance to PPI prescribers and users; they noted that previous findings from observational studies warrant skepticism. “A significant proportion of patients are prescribed PPI therapy inappropriately, and in these cases, it is reasonable to advocate strategies to discontinue acid suppression. However, when there is a clinical need for PPI therapy, these data suggest that the benefits are likely to outweigh any putative risks.”
In regard to the possible increased risk of enteric infection, the investigators again urged a conservative interpretation, as the increased rate of enteric infection among PPI users was still lower than rates reported by systematic reviews. “The data in the current randomized trial were not adjusted for multiple testing so this result should be interpreted with caution,” the investigators wrote. Although acid suppression may allow for increased ingestion of pathogenic organisms, which could theoretically increase the risk of enteric infection, the investigators stated that the benefits of PPIs likely outweigh their risks.
The COMPASS trial was funded by Bayer AG. The investigators disclosed additional relationships with Bayer, Allergan, Takeda, Janssen, and others.
SOURCE: Moayyedi P et al. Gastro. 2019 May 29. doi: 10.1053/j.gastro.2019.05.056.
Aside from a possible increased risk of enteric infections, long-term use of the proton pump inhibitor (PPI) pantoprazole appears safe in patients with stable atherosclerotic vascular disease, according to a prospective trial involving more than 17,000 participants.
In contrast with published observational studies, the present trial found no associations between long-term PPI use and previously reported risks such as pneumonia, fracture, or cerebrovascular events, according to lead author Paul Moayyedi, MB ChB, PhD, of McMaster University in Hamilton, Ont., and colleagues.
“To our knowledge, this is the largest PPI trial for any indication and the first prospective randomized trial to evaluate the many long-term safety concerns related to PPI therapy,” the investigators wrote in Gastroenterology. “It is reassuring that there was no evidence for harm for most of these events other than an excess of enteric infections.”
“Given how commonly acid suppressive medications are used, it is important to ensure that this class of drugs is safe,” the investigators wrote. They noted that patients are often alarmed by “sensational headlines” about PPI safety. “There are balancing articles that more carefully discuss the risks and benefits of taking PPI therapy but these receive less media attention,” the investigators added.
The present, prospective trial, COMPASS, involved 17,598 participants from 33 countries with stable peripheral artery disease and cardiovascular disease. “We use the term participants, rather than patients, as not all of those taking part in this research would have been patients throughout the trial but all participated in the randomized controlled trial,” the investigators wrote.
In addition to evaluating the safety of pantoprazole, the study was initially designed to measure the efficacy of pantoprazole for preventing upper gastrointestinal events in participants taking rivaroxaban and/or aspirin, which, in combination, were recently shown to reduce cardiovascular outcomes among patients with stable cardiovascular conditions. As such, participants in the trial were randomized to one of three groups: 100-mg aspirin once daily, 5-mg rivaroxaban twice daily, or 2.5-mg rivaroxaban twice daily combined with 100-mg aspirin once daily. The primary efficacy outcomes for these three groups were stroke, myocardial infarction, and cardiovascular death. This portion of the trial was discontinued early because of evidence that showed the superiority of combination therapy over aspirin alone; however, the pantoprazole component of the trial continued, as planned, for 3 years.
At baseline, about two-thirds of participants (64%) were not taking a PPI, requiring randomization to either 40-mg pantoprazole once daily or matching placebo. Pantoprazole safety outcomes centered on those previously reported by observational studies, including dementia, chronic kidney disease, gastric atrophy, fracture, cancer, pneumonia, diabetes mellitus, chronic obstructive lung disease, Clostrididoides difficile infection, and other enteric infections. Hospitalization rates for noncardiovascular and cardiovascular events were also reported. Data were gathered via questionnaires, which were conducted every 6 months.
Most patients in the trial (78%) were male, and 23% were current smokers. Smaller proportions of the population were taking an NSAID (5%) and/or had a history of peptic ulcer disease (2.6%). The median follow-up was 3.01 years, ranging from 2.49 to 3.59 years. Permanent discontinuations occurred at approximately equal rates in the pantoprazole (21%) and placebo (22%) group after a median of 11 months (338 days). In both groups, more than 96% of participants who continued treatment took their medications as prescribed at least 80% of the time.
Analysis of cardiovascular outcomes revealed no significant differences between placebo and pantoprazole groups. Of all the evaluated safety measures, only enteric infections differed significantly between groups, occurring at a higher rate in the pantoprazole group than in the placebo group (1.4% vs. 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Although C. difficile infection was more common among pantoprazole users, only 13 such events occurred, precluding statistical significance.
According to the investigators, these findings should offer reassurance to PPI prescribers and users; they noted that previous findings from observational studies warrant skepticism. “A significant proportion of patients are prescribed PPI therapy inappropriately, and in these cases, it is reasonable to advocate strategies to discontinue acid suppression. However, when there is a clinical need for PPI therapy, these data suggest that the benefits are likely to outweigh any putative risks.”
In regard to the possible increased risk of enteric infection, the investigators again urged a conservative interpretation, as the increased rate of enteric infection among PPI users was still lower than rates reported by systematic reviews. “The data in the current randomized trial were not adjusted for multiple testing so this result should be interpreted with caution,” the investigators wrote. Although acid suppression may allow for increased ingestion of pathogenic organisms, which could theoretically increase the risk of enteric infection, the investigators stated that the benefits of PPIs likely outweigh their risks.
The COMPASS trial was funded by Bayer AG. The investigators disclosed additional relationships with Bayer, Allergan, Takeda, Janssen, and others.
SOURCE: Moayyedi P et al. Gastro. 2019 May 29. doi: 10.1053/j.gastro.2019.05.056.
Aside from a possible increased risk of enteric infections, long-term use of the proton pump inhibitor (PPI) pantoprazole appears safe in patients with stable atherosclerotic vascular disease, according to a prospective trial involving more than 17,000 participants.
In contrast with published observational studies, the present trial found no associations between long-term PPI use and previously reported risks such as pneumonia, fracture, or cerebrovascular events, according to lead author Paul Moayyedi, MB ChB, PhD, of McMaster University in Hamilton, Ont., and colleagues.
“To our knowledge, this is the largest PPI trial for any indication and the first prospective randomized trial to evaluate the many long-term safety concerns related to PPI therapy,” the investigators wrote in Gastroenterology. “It is reassuring that there was no evidence for harm for most of these events other than an excess of enteric infections.”
“Given how commonly acid suppressive medications are used, it is important to ensure that this class of drugs is safe,” the investigators wrote. They noted that patients are often alarmed by “sensational headlines” about PPI safety. “There are balancing articles that more carefully discuss the risks and benefits of taking PPI therapy but these receive less media attention,” the investigators added.
The present, prospective trial, COMPASS, involved 17,598 participants from 33 countries with stable peripheral artery disease and cardiovascular disease. “We use the term participants, rather than patients, as not all of those taking part in this research would have been patients throughout the trial but all participated in the randomized controlled trial,” the investigators wrote.
In addition to evaluating the safety of pantoprazole, the study was initially designed to measure the efficacy of pantoprazole for preventing upper gastrointestinal events in participants taking rivaroxaban and/or aspirin, which, in combination, were recently shown to reduce cardiovascular outcomes among patients with stable cardiovascular conditions. As such, participants in the trial were randomized to one of three groups: 100-mg aspirin once daily, 5-mg rivaroxaban twice daily, or 2.5-mg rivaroxaban twice daily combined with 100-mg aspirin once daily. The primary efficacy outcomes for these three groups were stroke, myocardial infarction, and cardiovascular death. This portion of the trial was discontinued early because of evidence that showed the superiority of combination therapy over aspirin alone; however, the pantoprazole component of the trial continued, as planned, for 3 years.
At baseline, about two-thirds of participants (64%) were not taking a PPI, requiring randomization to either 40-mg pantoprazole once daily or matching placebo. Pantoprazole safety outcomes centered on those previously reported by observational studies, including dementia, chronic kidney disease, gastric atrophy, fracture, cancer, pneumonia, diabetes mellitus, chronic obstructive lung disease, Clostrididoides difficile infection, and other enteric infections. Hospitalization rates for noncardiovascular and cardiovascular events were also reported. Data were gathered via questionnaires, which were conducted every 6 months.
Most patients in the trial (78%) were male, and 23% were current smokers. Smaller proportions of the population were taking an NSAID (5%) and/or had a history of peptic ulcer disease (2.6%). The median follow-up was 3.01 years, ranging from 2.49 to 3.59 years. Permanent discontinuations occurred at approximately equal rates in the pantoprazole (21%) and placebo (22%) group after a median of 11 months (338 days). In both groups, more than 96% of participants who continued treatment took their medications as prescribed at least 80% of the time.
Analysis of cardiovascular outcomes revealed no significant differences between placebo and pantoprazole groups. Of all the evaluated safety measures, only enteric infections differed significantly between groups, occurring at a higher rate in the pantoprazole group than in the placebo group (1.4% vs. 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Although C. difficile infection was more common among pantoprazole users, only 13 such events occurred, precluding statistical significance.
According to the investigators, these findings should offer reassurance to PPI prescribers and users; they noted that previous findings from observational studies warrant skepticism. “A significant proportion of patients are prescribed PPI therapy inappropriately, and in these cases, it is reasonable to advocate strategies to discontinue acid suppression. However, when there is a clinical need for PPI therapy, these data suggest that the benefits are likely to outweigh any putative risks.”
In regard to the possible increased risk of enteric infection, the investigators again urged a conservative interpretation, as the increased rate of enteric infection among PPI users was still lower than rates reported by systematic reviews. “The data in the current randomized trial were not adjusted for multiple testing so this result should be interpreted with caution,” the investigators wrote. Although acid suppression may allow for increased ingestion of pathogenic organisms, which could theoretically increase the risk of enteric infection, the investigators stated that the benefits of PPIs likely outweigh their risks.
The COMPASS trial was funded by Bayer AG. The investigators disclosed additional relationships with Bayer, Allergan, Takeda, Janssen, and others.
SOURCE: Moayyedi P et al. Gastro. 2019 May 29. doi: 10.1053/j.gastro.2019.05.056.
FROM GASTROENTEROLOGY
Key clinical point: Aside from a possible increased risk of enteric infections, long-term use of pantoprazole is safe in patients with stable peripheral artery and cardiovascular disease.
Major finding: Enteric infections were 33% more common in the pantoprazole group than in the placebo group.
Study details: A placebo-controlled, double-blind, randomized trial involving 17,598 patients with stable peripheral artery disease and cardiovascular disease.
Disclosures: The COMPASS trial was funded by Bayer AG. The investigators disclosed relationships with Bayer, Allergan, Takeda, Janssen, and others.
Source: Moayyedi P et al. Gastroenterology. 2019 May 29. doi: 10.1053/j.gastro.2019.05.056.
Clopidogrel matches aspirin for reducing risk of colorectal cancer
Clopidogrel appears to reduce the risk of colorectal cancer (CRC) as much as low-dose aspirin, based on a case-control study involving more than 15,000 cases.
Source: American Gastroenterological Association
Risk of CRC was reduced by 20%-30% when clopidogrel was given alone or in combination with aspirin, reported lead author Antonio Rodríguez-Miguel of Príncipe de Asturias University Hospital in Madrid and colleagues. This finding adds support to the hypothesis that low-dose aspirin is chemoprotective primarily because of its antiplatelet properties, they noted.
“The mechanism of action of low-dose aspirin to explain its protective effect is subject to debate,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Although aspirin is a nonsteroidal anti-inflammatory drug (NSAID) and these drugs are known to prevent CRC through the inhibition of cyclooxygenase (COX)-2 in epithelial and stromal cells in the large bowel, at low doses (75-300 mg/d) aspirin has only transient effects on this isozyme, while permanently inactivating platelet COX-1 and suppressing thromboxane A2 production. The apparent lack of dose-dependence of the chemoprotective effect of aspirin, as well as the potential role of locally activated platelets in upregulating COX-2 expression in adjacent nucleated cells of the intestinal mucosa, have led [to] the postulation that low-dose aspirin could exert its chemoprotective effect via its antiplatelet action.”
Although previous studies have explored the chemoprotective potential of other antiplatelet agents, such as clopidogrel, the resultant body of evidence remains small. In 2017, for example, Avi Leader, MD, and colleagues reported that the chemoprotective effect of dual-antiplatelet therapy (DAPT) with clopidogrel and aspirin was superior to aspirin monotherapy, based on an additional 8% risk reduction. The present study aimed to build on such findings with evaluation of a Mediterranean cohort, which could reduce confounding lifestyle factors, owing to a lower rate of cardiovascular morbidity than other populations.
The nested, case-control study involved 15,491 cases of CRC and 60,000 controls who were randomly selected and frequency matched by sex, age, and year of indexing. Data were drawn from Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP), a Spanish medical record database with more than 7 million patients. Records of patients involved in the present study were screened for prescription of three antiplatelet agents: low-dose aspirin, clopidogrel, and triflusal. Additional categorization identified current users, recent users, past users, and nonusers. The effects of clopidogrel and aspirin were evaluated separately, as monotherapies, and together, as DAPT.
Demographically, the mean age of the entire study population was 68.6 years, with a slight male predominance (59%). Median follow-up was similar between cases and controls, at approximately 3 years, ranging from about 1.5 to 6 years. Cases showed higher rates of gout, alcohol abuse, acute digestive diseases, and peripheral artery disease, whereas controls were more likely to have histories involving stroke, acute myocardial infarction, chronic digestive diseases, and constipation.
Controls were more likely to be current aspirin users than patients diagnosed with CRC (12.8% vs. 12.2%), giving an associated adjusted odds ratio (AOR) of 0.83. Risk reduction became statistically apparent after 180 days of aspirin usage, with an AOR of 0.79, and more prominent in the 1- to 3-year range, with an AOR of 0.73. This chemoprotective effect faded rapidly with discontinuation.
Current clopidogrel usage led to a comparable level of risk reduction, with an AOR of 0.80. It wasn’t until a year of continuous clopidogrel monotherapy that risk reduction became statistically significant, with an AOR of 0.65, which dropped to 0.57 between years 1 and 3.
Turning to a matched comparison of aspirin or clopidogrel monotherapy versus DAPT, the investigators found similar rates of chemoprotection. Current aspirin usage of any duration offered an adjusted risk reduction of 17%, compared with 25% for clopidogrel, and 29% for DAPT. Beyond 1 year of continuous and current usage, the superiority of DAPT was called into question, as clopidogrel monotherapy offered the greatest risk reduction, at 37%, compared with 22% for aspirin, and 22% for DAPT. Risk analyses involving triflusal lacked statistical significance.
“The results of the present study are compatible with a chemoprotective effect of clopidogrel against CRC, equivalent in magnitude to the one observed for low-dose aspirin,” the investigators wrote. “This finding indirectly supports the hypothesis that the chemoprotective effect of low-dose aspirin is mediated mostly through the permanent inactivation of platelet COX-1.”
The investigators pointed out that the chemoprotective effects of antiplatelet therapy begin to appear early in treatment, independently from lifestyle factors, but risk reduction depends on current usage. Although short-term usage of either aspirin or clopidogrel was associated with an increased risk of CRC, the investigators suggested that this was more likely a perceived risk rather than an actual one. “In our view, this observation could be explained in part by a detection bias, owing to an increased risk of GI bleeding induced by antiplatelet agents that could lead to a greater number of colonoscopies, and, as a result, an early cancer diagnosis,” they wrote.
The study was funded by the Fundación Instituto Teófilo Hernando. Dr. García-Rodríguez disclosed a relationship with CEIFE, which has received funding from Bayer and AstraZeneca.
SOURCE: Rodríguez-Miguel et al. Clin Gastrenterol Hepatol. 2018 Dec 20. doi: 10.1016/j.cgh.2018.12.012.
The role of aspirin in reducing the risk of colorectal cancer is well established, although the mechanisms of actions are not entirely clear. One possible mechanism is through inhibition of the cyclooxygenase-1 (COX-1) pathway. The authors investigated the role of aspirin but also clopidogrel, another antiplatelet drug that works through inhibition of the COX-1 pathway in reducing the risk of CRC in a case-control study from Spain. CRC cases were randomly matched with cancer-free controls, and the use of aspirin and clopidogrel as a risk factor for CRC was studied. Not surprisingly, aspirin use was associated with reduced risk of CRC by 17%, However, what’s new is that the use of clopidogrel was associated with reduced risk of CRC by 20% also but use of dual therapy (aspirin plus clopidogrel) did not confer additional benefit. The results did not differ by patient age or sex. The caveat is that history of CRC screening or colonoscopy was not known for cases or controls, and many other confounders, such as diet, exercise, and other lifestyle and medication history that may account for the differences could not be easily teased apart. If confirmed by others, these data suggest an additional beneficial effect of antiplatelet agent clopidogrel in reducing risk of CRC, if taken for more than 1 year. The study opens the door to exploring mechanisms by which antiplatelet agents may reduce risk of CRC, and the potential role of other antiplatelet agents in reducing risk of CRC.
Aasma Shaukat, MD, MPH, GI section chief Minneapolis VAMC and professor of medicine, University of Minnesota, Minneapolis. She has no conflicts of interest.
The role of aspirin in reducing the risk of colorectal cancer is well established, although the mechanisms of actions are not entirely clear. One possible mechanism is through inhibition of the cyclooxygenase-1 (COX-1) pathway. The authors investigated the role of aspirin but also clopidogrel, another antiplatelet drug that works through inhibition of the COX-1 pathway in reducing the risk of CRC in a case-control study from Spain. CRC cases were randomly matched with cancer-free controls, and the use of aspirin and clopidogrel as a risk factor for CRC was studied. Not surprisingly, aspirin use was associated with reduced risk of CRC by 17%, However, what’s new is that the use of clopidogrel was associated with reduced risk of CRC by 20% also but use of dual therapy (aspirin plus clopidogrel) did not confer additional benefit. The results did not differ by patient age or sex. The caveat is that history of CRC screening or colonoscopy was not known for cases or controls, and many other confounders, such as diet, exercise, and other lifestyle and medication history that may account for the differences could not be easily teased apart. If confirmed by others, these data suggest an additional beneficial effect of antiplatelet agent clopidogrel in reducing risk of CRC, if taken for more than 1 year. The study opens the door to exploring mechanisms by which antiplatelet agents may reduce risk of CRC, and the potential role of other antiplatelet agents in reducing risk of CRC.
Aasma Shaukat, MD, MPH, GI section chief Minneapolis VAMC and professor of medicine, University of Minnesota, Minneapolis. She has no conflicts of interest.
The role of aspirin in reducing the risk of colorectal cancer is well established, although the mechanisms of actions are not entirely clear. One possible mechanism is through inhibition of the cyclooxygenase-1 (COX-1) pathway. The authors investigated the role of aspirin but also clopidogrel, another antiplatelet drug that works through inhibition of the COX-1 pathway in reducing the risk of CRC in a case-control study from Spain. CRC cases were randomly matched with cancer-free controls, and the use of aspirin and clopidogrel as a risk factor for CRC was studied. Not surprisingly, aspirin use was associated with reduced risk of CRC by 17%, However, what’s new is that the use of clopidogrel was associated with reduced risk of CRC by 20% also but use of dual therapy (aspirin plus clopidogrel) did not confer additional benefit. The results did not differ by patient age or sex. The caveat is that history of CRC screening or colonoscopy was not known for cases or controls, and many other confounders, such as diet, exercise, and other lifestyle and medication history that may account for the differences could not be easily teased apart. If confirmed by others, these data suggest an additional beneficial effect of antiplatelet agent clopidogrel in reducing risk of CRC, if taken for more than 1 year. The study opens the door to exploring mechanisms by which antiplatelet agents may reduce risk of CRC, and the potential role of other antiplatelet agents in reducing risk of CRC.
Aasma Shaukat, MD, MPH, GI section chief Minneapolis VAMC and professor of medicine, University of Minnesota, Minneapolis. She has no conflicts of interest.
Clopidogrel appears to reduce the risk of colorectal cancer (CRC) as much as low-dose aspirin, based on a case-control study involving more than 15,000 cases.
Source: American Gastroenterological Association
Risk of CRC was reduced by 20%-30% when clopidogrel was given alone or in combination with aspirin, reported lead author Antonio Rodríguez-Miguel of Príncipe de Asturias University Hospital in Madrid and colleagues. This finding adds support to the hypothesis that low-dose aspirin is chemoprotective primarily because of its antiplatelet properties, they noted.
“The mechanism of action of low-dose aspirin to explain its protective effect is subject to debate,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Although aspirin is a nonsteroidal anti-inflammatory drug (NSAID) and these drugs are known to prevent CRC through the inhibition of cyclooxygenase (COX)-2 in epithelial and stromal cells in the large bowel, at low doses (75-300 mg/d) aspirin has only transient effects on this isozyme, while permanently inactivating platelet COX-1 and suppressing thromboxane A2 production. The apparent lack of dose-dependence of the chemoprotective effect of aspirin, as well as the potential role of locally activated platelets in upregulating COX-2 expression in adjacent nucleated cells of the intestinal mucosa, have led [to] the postulation that low-dose aspirin could exert its chemoprotective effect via its antiplatelet action.”
Although previous studies have explored the chemoprotective potential of other antiplatelet agents, such as clopidogrel, the resultant body of evidence remains small. In 2017, for example, Avi Leader, MD, and colleagues reported that the chemoprotective effect of dual-antiplatelet therapy (DAPT) with clopidogrel and aspirin was superior to aspirin monotherapy, based on an additional 8% risk reduction. The present study aimed to build on such findings with evaluation of a Mediterranean cohort, which could reduce confounding lifestyle factors, owing to a lower rate of cardiovascular morbidity than other populations.
The nested, case-control study involved 15,491 cases of CRC and 60,000 controls who were randomly selected and frequency matched by sex, age, and year of indexing. Data were drawn from Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP), a Spanish medical record database with more than 7 million patients. Records of patients involved in the present study were screened for prescription of three antiplatelet agents: low-dose aspirin, clopidogrel, and triflusal. Additional categorization identified current users, recent users, past users, and nonusers. The effects of clopidogrel and aspirin were evaluated separately, as monotherapies, and together, as DAPT.
Demographically, the mean age of the entire study population was 68.6 years, with a slight male predominance (59%). Median follow-up was similar between cases and controls, at approximately 3 years, ranging from about 1.5 to 6 years. Cases showed higher rates of gout, alcohol abuse, acute digestive diseases, and peripheral artery disease, whereas controls were more likely to have histories involving stroke, acute myocardial infarction, chronic digestive diseases, and constipation.
Controls were more likely to be current aspirin users than patients diagnosed with CRC (12.8% vs. 12.2%), giving an associated adjusted odds ratio (AOR) of 0.83. Risk reduction became statistically apparent after 180 days of aspirin usage, with an AOR of 0.79, and more prominent in the 1- to 3-year range, with an AOR of 0.73. This chemoprotective effect faded rapidly with discontinuation.
Current clopidogrel usage led to a comparable level of risk reduction, with an AOR of 0.80. It wasn’t until a year of continuous clopidogrel monotherapy that risk reduction became statistically significant, with an AOR of 0.65, which dropped to 0.57 between years 1 and 3.
Turning to a matched comparison of aspirin or clopidogrel monotherapy versus DAPT, the investigators found similar rates of chemoprotection. Current aspirin usage of any duration offered an adjusted risk reduction of 17%, compared with 25% for clopidogrel, and 29% for DAPT. Beyond 1 year of continuous and current usage, the superiority of DAPT was called into question, as clopidogrel monotherapy offered the greatest risk reduction, at 37%, compared with 22% for aspirin, and 22% for DAPT. Risk analyses involving triflusal lacked statistical significance.
“The results of the present study are compatible with a chemoprotective effect of clopidogrel against CRC, equivalent in magnitude to the one observed for low-dose aspirin,” the investigators wrote. “This finding indirectly supports the hypothesis that the chemoprotective effect of low-dose aspirin is mediated mostly through the permanent inactivation of platelet COX-1.”
The investigators pointed out that the chemoprotective effects of antiplatelet therapy begin to appear early in treatment, independently from lifestyle factors, but risk reduction depends on current usage. Although short-term usage of either aspirin or clopidogrel was associated with an increased risk of CRC, the investigators suggested that this was more likely a perceived risk rather than an actual one. “In our view, this observation could be explained in part by a detection bias, owing to an increased risk of GI bleeding induced by antiplatelet agents that could lead to a greater number of colonoscopies, and, as a result, an early cancer diagnosis,” they wrote.
The study was funded by the Fundación Instituto Teófilo Hernando. Dr. García-Rodríguez disclosed a relationship with CEIFE, which has received funding from Bayer and AstraZeneca.
SOURCE: Rodríguez-Miguel et al. Clin Gastrenterol Hepatol. 2018 Dec 20. doi: 10.1016/j.cgh.2018.12.012.
Clopidogrel appears to reduce the risk of colorectal cancer (CRC) as much as low-dose aspirin, based on a case-control study involving more than 15,000 cases.
Source: American Gastroenterological Association
Risk of CRC was reduced by 20%-30% when clopidogrel was given alone or in combination with aspirin, reported lead author Antonio Rodríguez-Miguel of Príncipe de Asturias University Hospital in Madrid and colleagues. This finding adds support to the hypothesis that low-dose aspirin is chemoprotective primarily because of its antiplatelet properties, they noted.
“The mechanism of action of low-dose aspirin to explain its protective effect is subject to debate,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Although aspirin is a nonsteroidal anti-inflammatory drug (NSAID) and these drugs are known to prevent CRC through the inhibition of cyclooxygenase (COX)-2 in epithelial and stromal cells in the large bowel, at low doses (75-300 mg/d) aspirin has only transient effects on this isozyme, while permanently inactivating platelet COX-1 and suppressing thromboxane A2 production. The apparent lack of dose-dependence of the chemoprotective effect of aspirin, as well as the potential role of locally activated platelets in upregulating COX-2 expression in adjacent nucleated cells of the intestinal mucosa, have led [to] the postulation that low-dose aspirin could exert its chemoprotective effect via its antiplatelet action.”
Although previous studies have explored the chemoprotective potential of other antiplatelet agents, such as clopidogrel, the resultant body of evidence remains small. In 2017, for example, Avi Leader, MD, and colleagues reported that the chemoprotective effect of dual-antiplatelet therapy (DAPT) with clopidogrel and aspirin was superior to aspirin monotherapy, based on an additional 8% risk reduction. The present study aimed to build on such findings with evaluation of a Mediterranean cohort, which could reduce confounding lifestyle factors, owing to a lower rate of cardiovascular morbidity than other populations.
The nested, case-control study involved 15,491 cases of CRC and 60,000 controls who were randomly selected and frequency matched by sex, age, and year of indexing. Data were drawn from Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP), a Spanish medical record database with more than 7 million patients. Records of patients involved in the present study were screened for prescription of three antiplatelet agents: low-dose aspirin, clopidogrel, and triflusal. Additional categorization identified current users, recent users, past users, and nonusers. The effects of clopidogrel and aspirin were evaluated separately, as monotherapies, and together, as DAPT.
Demographically, the mean age of the entire study population was 68.6 years, with a slight male predominance (59%). Median follow-up was similar between cases and controls, at approximately 3 years, ranging from about 1.5 to 6 years. Cases showed higher rates of gout, alcohol abuse, acute digestive diseases, and peripheral artery disease, whereas controls were more likely to have histories involving stroke, acute myocardial infarction, chronic digestive diseases, and constipation.
Controls were more likely to be current aspirin users than patients diagnosed with CRC (12.8% vs. 12.2%), giving an associated adjusted odds ratio (AOR) of 0.83. Risk reduction became statistically apparent after 180 days of aspirin usage, with an AOR of 0.79, and more prominent in the 1- to 3-year range, with an AOR of 0.73. This chemoprotective effect faded rapidly with discontinuation.
Current clopidogrel usage led to a comparable level of risk reduction, with an AOR of 0.80. It wasn’t until a year of continuous clopidogrel monotherapy that risk reduction became statistically significant, with an AOR of 0.65, which dropped to 0.57 between years 1 and 3.
Turning to a matched comparison of aspirin or clopidogrel monotherapy versus DAPT, the investigators found similar rates of chemoprotection. Current aspirin usage of any duration offered an adjusted risk reduction of 17%, compared with 25% for clopidogrel, and 29% for DAPT. Beyond 1 year of continuous and current usage, the superiority of DAPT was called into question, as clopidogrel monotherapy offered the greatest risk reduction, at 37%, compared with 22% for aspirin, and 22% for DAPT. Risk analyses involving triflusal lacked statistical significance.
“The results of the present study are compatible with a chemoprotective effect of clopidogrel against CRC, equivalent in magnitude to the one observed for low-dose aspirin,” the investigators wrote. “This finding indirectly supports the hypothesis that the chemoprotective effect of low-dose aspirin is mediated mostly through the permanent inactivation of platelet COX-1.”
The investigators pointed out that the chemoprotective effects of antiplatelet therapy begin to appear early in treatment, independently from lifestyle factors, but risk reduction depends on current usage. Although short-term usage of either aspirin or clopidogrel was associated with an increased risk of CRC, the investigators suggested that this was more likely a perceived risk rather than an actual one. “In our view, this observation could be explained in part by a detection bias, owing to an increased risk of GI bleeding induced by antiplatelet agents that could lead to a greater number of colonoscopies, and, as a result, an early cancer diagnosis,” they wrote.
The study was funded by the Fundación Instituto Teófilo Hernando. Dr. García-Rodríguez disclosed a relationship with CEIFE, which has received funding from Bayer and AstraZeneca.
SOURCE: Rodríguez-Miguel et al. Clin Gastrenterol Hepatol. 2018 Dec 20. doi: 10.1016/j.cgh.2018.12.012.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Clopidogrel usage appears to reduce the risk of colorectal cancer as much as low-dose aspirin.
Major finding: Current clopidogrel usage was associated with a 20% reduced risk of colorectal cancer (adjusted odds ratio, 0.8).
Study details: A nested case-control study involving 15,491 cases of colorectal cancer and 60,000 controls.
Disclosures: The study was funded by the Fundación Instituto Teófilo Hernando. Dr. García-Rodríguez disclosed a relationship with CEIFE, which has received funding from Bayer and AstraZeneca.
Source: Rodríguez-Miguel A et al. Clin Gastrenterol Hepatol. 2018 Dec 20. doi: 10.1016/j.cgh.2018.12.012.
No increase in UTI risk with SGLT-2 inhibitors
Sodium-glucose cotransporter 2 inhibitors do not appear to increase the risk of urinary tract infections, compared with other antidiabetic medications, new research has found.
In a paper published in Annals of Internal Medicine, researchers reported the outcomes of a population-based, propensity-matched cohort study in which the analyzed data from 235,730 individuals newly prescribed sodium-glucose cotransporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase–4 (DPP-4) inhibitors, and glucagonlike peptide–1 receptor (GLP-1) agonists.
In the first cohort, comparing SGLT-2 inhibitors with DDP-4 inhibitors, there were no significant differences between the two groups in the incidence rate of severe urinary tract infections (UTIs) (adjusted hazard ratio, 0.98; 95% confidence interval, 0.68-1.41).
In the second cohort, which compared patients taking GLP-1 receptor agonists with those taking SGLT-2 inhibitors, researchers saw a slightly lower incidence of severe UTIs among individuals on SGLT-2 inhibitors (HR, 0.72; 95% CI, 0.53-0.99; P = .04).
The analysis also failed to find any evidence that SGLT-2 inhibitors were associated with an increase in the risk of hospitalization or outpatient treatment for a UTI.
Chintan V. Dave, PharmD – now at Rutgers University, New Brunswick, N.J. – and colleagues from Brigham and Women’s Hospital and Harvard Medical School, Boston, wrote that the findings have significant clinical implications.
“Patients who may be good candidates to receive SGLT-2 inhibitors for diabetes control but who have a history of recurrent UTIs may be precluded from being prescribed these agents; because UTIs are highly prevalent in patients with diabetes, this could exclude a substantial number of patients from receiving an entire class of medications that has been shown to decrease risk for major cardiovascular events and death,” they wrote.
The researchers stressed that “other factors beyond risk for UTI events should be considered in decisions about whether to prescribe SGLT-2 therapy for patients with diabetes.”
The authors did note that their study was subject to the usual limitations of observational studies, such as susceptibility to confounding, and was also limited to people with health insurance.
An accompanying editorial by Kristian B. Filion, PhD, and Oriana H. Yu, MD, of McGill University, Montreal, commented that the data provided reassuring, real-world evidence on the potential safety issue of UTI risk with SGLT-2 inhibitors.
However, they also stressed that the study excluded individuals at high risk or with a history of UTIs, and that these were subgroups who required further investigation.
The study was supported by the Harvard Medical School and the National Institute on Aging. Three authors reported support from private industry outside the submitted work.
SOURCE: Dave CV et al. Ann Intern Med. 2019 Jul 29. doi: 10.7326/M18-3136.
Sodium-glucose cotransporter 2 inhibitors do not appear to increase the risk of urinary tract infections, compared with other antidiabetic medications, new research has found.
In a paper published in Annals of Internal Medicine, researchers reported the outcomes of a population-based, propensity-matched cohort study in which the analyzed data from 235,730 individuals newly prescribed sodium-glucose cotransporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase–4 (DPP-4) inhibitors, and glucagonlike peptide–1 receptor (GLP-1) agonists.
In the first cohort, comparing SGLT-2 inhibitors with DDP-4 inhibitors, there were no significant differences between the two groups in the incidence rate of severe urinary tract infections (UTIs) (adjusted hazard ratio, 0.98; 95% confidence interval, 0.68-1.41).
In the second cohort, which compared patients taking GLP-1 receptor agonists with those taking SGLT-2 inhibitors, researchers saw a slightly lower incidence of severe UTIs among individuals on SGLT-2 inhibitors (HR, 0.72; 95% CI, 0.53-0.99; P = .04).
The analysis also failed to find any evidence that SGLT-2 inhibitors were associated with an increase in the risk of hospitalization or outpatient treatment for a UTI.
Chintan V. Dave, PharmD – now at Rutgers University, New Brunswick, N.J. – and colleagues from Brigham and Women’s Hospital and Harvard Medical School, Boston, wrote that the findings have significant clinical implications.
“Patients who may be good candidates to receive SGLT-2 inhibitors for diabetes control but who have a history of recurrent UTIs may be precluded from being prescribed these agents; because UTIs are highly prevalent in patients with diabetes, this could exclude a substantial number of patients from receiving an entire class of medications that has been shown to decrease risk for major cardiovascular events and death,” they wrote.
The researchers stressed that “other factors beyond risk for UTI events should be considered in decisions about whether to prescribe SGLT-2 therapy for patients with diabetes.”
The authors did note that their study was subject to the usual limitations of observational studies, such as susceptibility to confounding, and was also limited to people with health insurance.
An accompanying editorial by Kristian B. Filion, PhD, and Oriana H. Yu, MD, of McGill University, Montreal, commented that the data provided reassuring, real-world evidence on the potential safety issue of UTI risk with SGLT-2 inhibitors.
However, they also stressed that the study excluded individuals at high risk or with a history of UTIs, and that these were subgroups who required further investigation.
The study was supported by the Harvard Medical School and the National Institute on Aging. Three authors reported support from private industry outside the submitted work.
SOURCE: Dave CV et al. Ann Intern Med. 2019 Jul 29. doi: 10.7326/M18-3136.
Sodium-glucose cotransporter 2 inhibitors do not appear to increase the risk of urinary tract infections, compared with other antidiabetic medications, new research has found.
In a paper published in Annals of Internal Medicine, researchers reported the outcomes of a population-based, propensity-matched cohort study in which the analyzed data from 235,730 individuals newly prescribed sodium-glucose cotransporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase–4 (DPP-4) inhibitors, and glucagonlike peptide–1 receptor (GLP-1) agonists.
In the first cohort, comparing SGLT-2 inhibitors with DDP-4 inhibitors, there were no significant differences between the two groups in the incidence rate of severe urinary tract infections (UTIs) (adjusted hazard ratio, 0.98; 95% confidence interval, 0.68-1.41).
In the second cohort, which compared patients taking GLP-1 receptor agonists with those taking SGLT-2 inhibitors, researchers saw a slightly lower incidence of severe UTIs among individuals on SGLT-2 inhibitors (HR, 0.72; 95% CI, 0.53-0.99; P = .04).
The analysis also failed to find any evidence that SGLT-2 inhibitors were associated with an increase in the risk of hospitalization or outpatient treatment for a UTI.
Chintan V. Dave, PharmD – now at Rutgers University, New Brunswick, N.J. – and colleagues from Brigham and Women’s Hospital and Harvard Medical School, Boston, wrote that the findings have significant clinical implications.
“Patients who may be good candidates to receive SGLT-2 inhibitors for diabetes control but who have a history of recurrent UTIs may be precluded from being prescribed these agents; because UTIs are highly prevalent in patients with diabetes, this could exclude a substantial number of patients from receiving an entire class of medications that has been shown to decrease risk for major cardiovascular events and death,” they wrote.
The researchers stressed that “other factors beyond risk for UTI events should be considered in decisions about whether to prescribe SGLT-2 therapy for patients with diabetes.”
The authors did note that their study was subject to the usual limitations of observational studies, such as susceptibility to confounding, and was also limited to people with health insurance.
An accompanying editorial by Kristian B. Filion, PhD, and Oriana H. Yu, MD, of McGill University, Montreal, commented that the data provided reassuring, real-world evidence on the potential safety issue of UTI risk with SGLT-2 inhibitors.
However, they also stressed that the study excluded individuals at high risk or with a history of UTIs, and that these were subgroups who required further investigation.
The study was supported by the Harvard Medical School and the National Institute on Aging. Three authors reported support from private industry outside the submitted work.
SOURCE: Dave CV et al. Ann Intern Med. 2019 Jul 29. doi: 10.7326/M18-3136.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Sodium-glucose cotransporter 2 inhibitors are not associated with a greater risk of urinary tract infections, compared with dipeptidyl peptidase-4 inhibitors or glucagonlike peptide–1 receptor agonists.
Major finding: The incidence of severe urinary tract infections is similar among patients taking sodium-glucose cotransporter 2 inhibitors, dipeptidyl peptidase–4, inhibitors or glucagonlike peptide–1 receptor agonists.
Study details: A population-based, propensity-matched cohort study in 235,730 individuals with type 2 diabetes.
Disclosures: The study was supported by the Harvard Medical School and the National Institute on Aging. Three authors reported support from private industry outside the submitted work.
Source: Dave CV et al. Ann Intern Med. 2019 Jul 29. doi: 10.7326/M18-3136.
Dr. Alexa will see you now: Is Amazon primed to come to your rescue?
Now that it’s upending the way you play music, cook, shop, hear the news, and check the weather, the friendly voice emanating from your Amazon Alexa–enabled smart speaker is poised to wriggle its way into all things health care.
Amazon has big ambitions for its devices. It thinks Alexa, the virtual assistant inside them, could help doctors diagnose mental illness, autism, concussion, and Parkinson’s disease. It even hopes Alexa will detect when you’re having a heart attack.
At present, Alexa can perform a handful of health care–related tasks: “She” can track blood glucose levels, describe symptoms, access postsurgical care instructions, monitor home prescription deliveries, and make same-day appointments at the nearest urgent care center.
Amazon has partnered with numerous health care companies, including several in California, to let consumers and employees use Alexa for health care purposes. Workers at Cigna Corp. can manage their health improvement goals and earn wellness incentives with Alexa. And Alexa helps people who use Omron Healthcare’s blood pressure monitor, HeartGuide, track their readings.
But a flood of new opportunities is emerging since Alexa won permission to use protected patient health records controlled under the U.S. privacy law known as HIPAA.
Before, Alexa had been limited to providing generic responses about medical conditions. Now that it can transmit private patient information, Amazon has extended its Alexa Skills Kit, the software development tools used to add functions. Soon, the virtual assistant will be able to send and receive individualized patient records, allowing health care companies to create services for consumers to use at home.
Amazon’s efforts in this domain are important because, with its 100 million smart devices in use worldwide, it could radically change the way consumers get health information and even treatment – and not just tech-savvy consumers. Analysts expect that 55% of U.S. households will have smart speakers by 2022.
Some of Alexa’s new skills depend on a little-understood feature of the devices: They listen to every sound around them. They have to in order to be ready to respond to a request, like “Alexa, how many tablespoons in a half-pint?” or “Put carrots on the shopping list.”
University of Washington researchers recently published a study in which they taught Alexa and two other devices – an iPhone 5s and a Samsung Galaxy S4 – to listen for so-called agonal breathing, the distinct gasping sounds that are an early-warning sign in about half of all cardiac arrests. These devices correctly identified agonal breathing in 97% of instances, while registering a false positive only 0.2% of the time.
Earlier research had shown that a machine learning system could recognize cardiac arrest during 911 emergency calls more accurately and far faster than human dispatchers could.
Amazon, which declined to comment for this article, holds a patent on an acoustic technology that recognizes and could act on significant audio interruptions. Combined with patented technology from the University of Washington that differentiates coughs and sneezes from other background noises, for example, Alexa could discern when someone is ill and suggest solutions.
Because Amazon also holds patents on monitoring blood flow and heart rate through an Alexa-enabled camera, Alexa could send vitals to a doctor’s office before you head to your appointment and continue to monitor your condition after you get home.
“It opens possibilities to deliver care at a distance,” said Sandhya Pruthi, MD, lead investigator for several breast cancer prevention trials at the Mayo Clinic, which has been on the front lines of using voice assistants in health care. “Think about people living in small towns who aren’t always getting access to care and knowing when to get health care,” she said. “Could this be an opportunity, if someone had symptoms, to say, ‘It’s time for this to get checked out’?”
A growing number of clinics, hospitals, home health care providers and insurers have begun experimenting with products using Alexa:
- Livongo, a Mountain View, Calif.–based startup focused on managing chronic diseases, sells an Alexa-connected blood glucose monitor that can help diabetes patients track their condition.
- Home health care provider Libertana Home Health, based in Sherman Oaks, Calif., created an Alexa skill that lets elderly or frail residents connect with caregivers, sets up reminders about medications, reports their weight and blood pressure, and schedules appointments.
- Cedars-Sinai Medical Center in Los Angeles put Amazon devices loaded with a plug-in called Aiva into more than 100 rooms to connect patients with staff and to provide hands-free television controls. Unlike a static call button, the voice-controlled device can tell nurses why a patient needs help and can then tell the patient the status of their request.
- Boston Children’s Hospital, which offered the first Alexa health care software with an educational tool called Kids MD, now uses Alexa to share postsurgical recovery data between a patient’s home and the hospital.
Many medical technology companies are tantalized by the possibilities offered by Alexa and similar technologies for an aging population. A wearable device could transmit information about falls or an uneven gait. Alexa could potentially combat loneliness. It is learning how to make conversation.
“Alexa can couple a practical interaction around health care with an interaction that can engage the patient, even delight the patient,” said elder care advocate Laurie M. Orlov.
It and other voice assistants also might help bring some relief to doctors and other medical practitioners who commonly complain that entering medical information into EHRs is too time consuming and detracts from effective interactions with patients.
This technology could work in the background to take notes on doctor-patient meetings, even suggesting possible treatments. Several startup companies are working on such applications.
One such company is Suki, based in Redwood City, Calif., which bills itself as “Alexa for doctors.” Its artificial intelligence software listens in on interactions between doctors and patients to write up medical notes automatically.
Amazon devices will need to excel at conversational artificial intelligence, capable of relating an earlier phrase to a subsequent one, if it is to remain dominant in homes.
In a 2018 interview on Amazon’s corporate blog, Rohit Prasad, a company vice president who is head scientist for Amazon Alexa, described Alexa’s anticipated evolution using “federated learning” that lets algorithms make themselves smarter by incorporating input from a wide variety of sources.
“With these advances, we will see Alexa become more contextually aware in how she recognizes, understands and responds to requests from users,” Prasad said.
This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Now that it’s upending the way you play music, cook, shop, hear the news, and check the weather, the friendly voice emanating from your Amazon Alexa–enabled smart speaker is poised to wriggle its way into all things health care.
Amazon has big ambitions for its devices. It thinks Alexa, the virtual assistant inside them, could help doctors diagnose mental illness, autism, concussion, and Parkinson’s disease. It even hopes Alexa will detect when you’re having a heart attack.
At present, Alexa can perform a handful of health care–related tasks: “She” can track blood glucose levels, describe symptoms, access postsurgical care instructions, monitor home prescription deliveries, and make same-day appointments at the nearest urgent care center.
Amazon has partnered with numerous health care companies, including several in California, to let consumers and employees use Alexa for health care purposes. Workers at Cigna Corp. can manage their health improvement goals and earn wellness incentives with Alexa. And Alexa helps people who use Omron Healthcare’s blood pressure monitor, HeartGuide, track their readings.
But a flood of new opportunities is emerging since Alexa won permission to use protected patient health records controlled under the U.S. privacy law known as HIPAA.
Before, Alexa had been limited to providing generic responses about medical conditions. Now that it can transmit private patient information, Amazon has extended its Alexa Skills Kit, the software development tools used to add functions. Soon, the virtual assistant will be able to send and receive individualized patient records, allowing health care companies to create services for consumers to use at home.
Amazon’s efforts in this domain are important because, with its 100 million smart devices in use worldwide, it could radically change the way consumers get health information and even treatment – and not just tech-savvy consumers. Analysts expect that 55% of U.S. households will have smart speakers by 2022.
Some of Alexa’s new skills depend on a little-understood feature of the devices: They listen to every sound around them. They have to in order to be ready to respond to a request, like “Alexa, how many tablespoons in a half-pint?” or “Put carrots on the shopping list.”
University of Washington researchers recently published a study in which they taught Alexa and two other devices – an iPhone 5s and a Samsung Galaxy S4 – to listen for so-called agonal breathing, the distinct gasping sounds that are an early-warning sign in about half of all cardiac arrests. These devices correctly identified agonal breathing in 97% of instances, while registering a false positive only 0.2% of the time.
Earlier research had shown that a machine learning system could recognize cardiac arrest during 911 emergency calls more accurately and far faster than human dispatchers could.
Amazon, which declined to comment for this article, holds a patent on an acoustic technology that recognizes and could act on significant audio interruptions. Combined with patented technology from the University of Washington that differentiates coughs and sneezes from other background noises, for example, Alexa could discern when someone is ill and suggest solutions.
Because Amazon also holds patents on monitoring blood flow and heart rate through an Alexa-enabled camera, Alexa could send vitals to a doctor’s office before you head to your appointment and continue to monitor your condition after you get home.
“It opens possibilities to deliver care at a distance,” said Sandhya Pruthi, MD, lead investigator for several breast cancer prevention trials at the Mayo Clinic, which has been on the front lines of using voice assistants in health care. “Think about people living in small towns who aren’t always getting access to care and knowing when to get health care,” she said. “Could this be an opportunity, if someone had symptoms, to say, ‘It’s time for this to get checked out’?”
A growing number of clinics, hospitals, home health care providers and insurers have begun experimenting with products using Alexa:
- Livongo, a Mountain View, Calif.–based startup focused on managing chronic diseases, sells an Alexa-connected blood glucose monitor that can help diabetes patients track their condition.
- Home health care provider Libertana Home Health, based in Sherman Oaks, Calif., created an Alexa skill that lets elderly or frail residents connect with caregivers, sets up reminders about medications, reports their weight and blood pressure, and schedules appointments.
- Cedars-Sinai Medical Center in Los Angeles put Amazon devices loaded with a plug-in called Aiva into more than 100 rooms to connect patients with staff and to provide hands-free television controls. Unlike a static call button, the voice-controlled device can tell nurses why a patient needs help and can then tell the patient the status of their request.
- Boston Children’s Hospital, which offered the first Alexa health care software with an educational tool called Kids MD, now uses Alexa to share postsurgical recovery data between a patient’s home and the hospital.
Many medical technology companies are tantalized by the possibilities offered by Alexa and similar technologies for an aging population. A wearable device could transmit information about falls or an uneven gait. Alexa could potentially combat loneliness. It is learning how to make conversation.
“Alexa can couple a practical interaction around health care with an interaction that can engage the patient, even delight the patient,” said elder care advocate Laurie M. Orlov.
It and other voice assistants also might help bring some relief to doctors and other medical practitioners who commonly complain that entering medical information into EHRs is too time consuming and detracts from effective interactions with patients.
This technology could work in the background to take notes on doctor-patient meetings, even suggesting possible treatments. Several startup companies are working on such applications.
One such company is Suki, based in Redwood City, Calif., which bills itself as “Alexa for doctors.” Its artificial intelligence software listens in on interactions between doctors and patients to write up medical notes automatically.
Amazon devices will need to excel at conversational artificial intelligence, capable of relating an earlier phrase to a subsequent one, if it is to remain dominant in homes.
In a 2018 interview on Amazon’s corporate blog, Rohit Prasad, a company vice president who is head scientist for Amazon Alexa, described Alexa’s anticipated evolution using “federated learning” that lets algorithms make themselves smarter by incorporating input from a wide variety of sources.
“With these advances, we will see Alexa become more contextually aware in how she recognizes, understands and responds to requests from users,” Prasad said.
This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Now that it’s upending the way you play music, cook, shop, hear the news, and check the weather, the friendly voice emanating from your Amazon Alexa–enabled smart speaker is poised to wriggle its way into all things health care.
Amazon has big ambitions for its devices. It thinks Alexa, the virtual assistant inside them, could help doctors diagnose mental illness, autism, concussion, and Parkinson’s disease. It even hopes Alexa will detect when you’re having a heart attack.
At present, Alexa can perform a handful of health care–related tasks: “She” can track blood glucose levels, describe symptoms, access postsurgical care instructions, monitor home prescription deliveries, and make same-day appointments at the nearest urgent care center.
Amazon has partnered with numerous health care companies, including several in California, to let consumers and employees use Alexa for health care purposes. Workers at Cigna Corp. can manage their health improvement goals and earn wellness incentives with Alexa. And Alexa helps people who use Omron Healthcare’s blood pressure monitor, HeartGuide, track their readings.
But a flood of new opportunities is emerging since Alexa won permission to use protected patient health records controlled under the U.S. privacy law known as HIPAA.
Before, Alexa had been limited to providing generic responses about medical conditions. Now that it can transmit private patient information, Amazon has extended its Alexa Skills Kit, the software development tools used to add functions. Soon, the virtual assistant will be able to send and receive individualized patient records, allowing health care companies to create services for consumers to use at home.
Amazon’s efforts in this domain are important because, with its 100 million smart devices in use worldwide, it could radically change the way consumers get health information and even treatment – and not just tech-savvy consumers. Analysts expect that 55% of U.S. households will have smart speakers by 2022.
Some of Alexa’s new skills depend on a little-understood feature of the devices: They listen to every sound around them. They have to in order to be ready to respond to a request, like “Alexa, how many tablespoons in a half-pint?” or “Put carrots on the shopping list.”
University of Washington researchers recently published a study in which they taught Alexa and two other devices – an iPhone 5s and a Samsung Galaxy S4 – to listen for so-called agonal breathing, the distinct gasping sounds that are an early-warning sign in about half of all cardiac arrests. These devices correctly identified agonal breathing in 97% of instances, while registering a false positive only 0.2% of the time.
Earlier research had shown that a machine learning system could recognize cardiac arrest during 911 emergency calls more accurately and far faster than human dispatchers could.
Amazon, which declined to comment for this article, holds a patent on an acoustic technology that recognizes and could act on significant audio interruptions. Combined with patented technology from the University of Washington that differentiates coughs and sneezes from other background noises, for example, Alexa could discern when someone is ill and suggest solutions.
Because Amazon also holds patents on monitoring blood flow and heart rate through an Alexa-enabled camera, Alexa could send vitals to a doctor’s office before you head to your appointment and continue to monitor your condition after you get home.
“It opens possibilities to deliver care at a distance,” said Sandhya Pruthi, MD, lead investigator for several breast cancer prevention trials at the Mayo Clinic, which has been on the front lines of using voice assistants in health care. “Think about people living in small towns who aren’t always getting access to care and knowing when to get health care,” she said. “Could this be an opportunity, if someone had symptoms, to say, ‘It’s time for this to get checked out’?”
A growing number of clinics, hospitals, home health care providers and insurers have begun experimenting with products using Alexa:
- Livongo, a Mountain View, Calif.–based startup focused on managing chronic diseases, sells an Alexa-connected blood glucose monitor that can help diabetes patients track their condition.
- Home health care provider Libertana Home Health, based in Sherman Oaks, Calif., created an Alexa skill that lets elderly or frail residents connect with caregivers, sets up reminders about medications, reports their weight and blood pressure, and schedules appointments.
- Cedars-Sinai Medical Center in Los Angeles put Amazon devices loaded with a plug-in called Aiva into more than 100 rooms to connect patients with staff and to provide hands-free television controls. Unlike a static call button, the voice-controlled device can tell nurses why a patient needs help and can then tell the patient the status of their request.
- Boston Children’s Hospital, which offered the first Alexa health care software with an educational tool called Kids MD, now uses Alexa to share postsurgical recovery data between a patient’s home and the hospital.
Many medical technology companies are tantalized by the possibilities offered by Alexa and similar technologies for an aging population. A wearable device could transmit information about falls or an uneven gait. Alexa could potentially combat loneliness. It is learning how to make conversation.
“Alexa can couple a practical interaction around health care with an interaction that can engage the patient, even delight the patient,” said elder care advocate Laurie M. Orlov.
It and other voice assistants also might help bring some relief to doctors and other medical practitioners who commonly complain that entering medical information into EHRs is too time consuming and detracts from effective interactions with patients.
This technology could work in the background to take notes on doctor-patient meetings, even suggesting possible treatments. Several startup companies are working on such applications.
One such company is Suki, based in Redwood City, Calif., which bills itself as “Alexa for doctors.” Its artificial intelligence software listens in on interactions between doctors and patients to write up medical notes automatically.
Amazon devices will need to excel at conversational artificial intelligence, capable of relating an earlier phrase to a subsequent one, if it is to remain dominant in homes.
In a 2018 interview on Amazon’s corporate blog, Rohit Prasad, a company vice president who is head scientist for Amazon Alexa, described Alexa’s anticipated evolution using “federated learning” that lets algorithms make themselves smarter by incorporating input from a wide variety of sources.
“With these advances, we will see Alexa become more contextually aware in how she recognizes, understands and responds to requests from users,” Prasad said.
This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.