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Type 1 diabetes test gets FDA go-ahead
The Food and Drug Administration has announced that it is allowing marketing of a novel diagnostic test to help differentiate type 1 diabetes from other diseases by detecting zinc transporter 8 autoantibody.
The immune systems of many people with type 1 diabetes generate zinc transporter 8 autoantibody (ZnT8Ab), a substance not produced by people with type 2 diabetes or gestational diabetes.
The new enzyme-linked immunosorbent assay to detect ZnT8Ab in a patient’s blood, when used with other tests and patient clinical information, may help some patients with type 1 diabetes get more timely diagnosis and treatment, the FDA announced. The agency reviewed the test through the de novo premarket regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to a device already on the market.
The test detected ZnT8Ab in 65% of 323 patients with diagnosed type 1 diabetes and incorrectly gave a positive result in less than 2% of 246 blood samples from patients diagnosed with other kinds of diabetes, other autoimmune disorders, or other clinical conditions, according to clinical trial data reviewed by the FDA.
"Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin-producing cells," Alberto Gutierrez, Ph.D., said in an FDA statement. "This test can help patients get a timely diagnosis and help start the right treatment sooner," said Dr. Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
A negative result from the ZnT8Ab test does not rule out type 1 diabetes, and the test should not be used to monitor the stage of diabetes or a patient’s response to treatment, the FDA cautioned.
The test is manufactured by Kronus Market Development Associates, Star, Idaho.
On Twitter @sherryboschert
The Food and Drug Administration has announced that it is allowing marketing of a novel diagnostic test to help differentiate type 1 diabetes from other diseases by detecting zinc transporter 8 autoantibody.
The immune systems of many people with type 1 diabetes generate zinc transporter 8 autoantibody (ZnT8Ab), a substance not produced by people with type 2 diabetes or gestational diabetes.
The new enzyme-linked immunosorbent assay to detect ZnT8Ab in a patient’s blood, when used with other tests and patient clinical information, may help some patients with type 1 diabetes get more timely diagnosis and treatment, the FDA announced. The agency reviewed the test through the de novo premarket regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to a device already on the market.
The test detected ZnT8Ab in 65% of 323 patients with diagnosed type 1 diabetes and incorrectly gave a positive result in less than 2% of 246 blood samples from patients diagnosed with other kinds of diabetes, other autoimmune disorders, or other clinical conditions, according to clinical trial data reviewed by the FDA.
"Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin-producing cells," Alberto Gutierrez, Ph.D., said in an FDA statement. "This test can help patients get a timely diagnosis and help start the right treatment sooner," said Dr. Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
A negative result from the ZnT8Ab test does not rule out type 1 diabetes, and the test should not be used to monitor the stage of diabetes or a patient’s response to treatment, the FDA cautioned.
The test is manufactured by Kronus Market Development Associates, Star, Idaho.
On Twitter @sherryboschert
The Food and Drug Administration has announced that it is allowing marketing of a novel diagnostic test to help differentiate type 1 diabetes from other diseases by detecting zinc transporter 8 autoantibody.
The immune systems of many people with type 1 diabetes generate zinc transporter 8 autoantibody (ZnT8Ab), a substance not produced by people with type 2 diabetes or gestational diabetes.
The new enzyme-linked immunosorbent assay to detect ZnT8Ab in a patient’s blood, when used with other tests and patient clinical information, may help some patients with type 1 diabetes get more timely diagnosis and treatment, the FDA announced. The agency reviewed the test through the de novo premarket regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to a device already on the market.
The test detected ZnT8Ab in 65% of 323 patients with diagnosed type 1 diabetes and incorrectly gave a positive result in less than 2% of 246 blood samples from patients diagnosed with other kinds of diabetes, other autoimmune disorders, or other clinical conditions, according to clinical trial data reviewed by the FDA.
"Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin-producing cells," Alberto Gutierrez, Ph.D., said in an FDA statement. "This test can help patients get a timely diagnosis and help start the right treatment sooner," said Dr. Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
A negative result from the ZnT8Ab test does not rule out type 1 diabetes, and the test should not be used to monitor the stage of diabetes or a patient’s response to treatment, the FDA cautioned.
The test is manufactured by Kronus Market Development Associates, Star, Idaho.
On Twitter @sherryboschert
App use increased physical activity
People who used a smartphone pedometer app walked 22% more steps (or about half a mile) per day after 8 weeks than did people in a control group in a small, randomized, open-label study.
The 90 participants in rural western Ireland were older than 16 years and owned an Android smartphone, which they were asked to keep charged and to carry during waking hours. Investigators downloaded the app to all phones and calibrated it to each individual to record step counts accurately. All participants were given physical activity goals and information on the benefits of exercise.
In the first week, the app display was not visible while it recorded baseline activity data. Mean step counts in the first week were 5,138 steps/day in the control group and 4,365/day in the intervention group. That difference was not statistically significant, but the investigators still adjusted for it in final analyses, Dr. Liam G. Glynn and his associates reported in the British Journal of General Practice.
The intervention group was then showed the app’s features and settings and encouraged to interact with the app to help meet activity goals. The control group’s app continued to track steps without any interaction.
Among 40 people in the control group and 37 in the intervention group with follow-up data 7 weeks later, the daily counts decreased by 386 steps in the control group and increased by 1,631 steps in the intervention group (Br. J. Gen. Pract. 2014;64:e384-91).
Participants in both groups increased their walking initially, but only the intervention group maintained the increased activity, accounting for the step count difference between groups at 8 weeks, said Dr. Glynn, a general practice physician at the National University of Ireland, Galway.
The study used the Accupedo-Pro pedometer app because it included preestablished, desirable features such as automatic feedback and tracking of step counts and calories burned, visually appealing graphics of step count history, the ability to input goals, and feedback on goal achievement. The Accupedo-Pro app is available for iPhones and Android devices for $3.99. Hundreds of other activity-tracking apps of varying quality are available for free or for sale.
After researchers adjusted for factors unrelated to the study that may have increased step counts during the study period, they found that the mean daily count at baseline for the intervention group was 4,771 steps/day. The difference between the intervention and control groups by the end of 8 weeks was a mean increase of 1,029 steps/day favoring the app use, a 22% gain, compared with the intervention group’s baseline, Dr. Glynn reported.
That’s enough of a change to be clinically meaningful if it’s maintained, based on a large body of literature on exercise and health, he said. Dr. Glynn and his associates now are following app users in several European countries to monitor long-term health outcomes.
The current study was too small to show a difference in health measures such as blood pressure, weight, or body mass index. And it was too short to show whether or not apps embedded in phones can overcome one of the weak points of separate devices used solely as pedometers or activity trackers – namely, the tendency for many people to stop using them over time.
One in three people who owned a fitness tracker stopped using the device in the past year, mainly because they lost interest in tracking their activity level, according to a survey by International Data Corp.
Nonetheless, pedometers and other small hardware-based fitness trackers remain popular. Florida insurer AvMed recently announced that it will cover the cost of the Fitlinxx Pebble activity meter for Medicare Advantage members enrolled in the Walkadoo pedometer-based walking program run by MeYou Health.
Separate data suggest that, among mobile phone customers, 60% in the United States and 57% in Ireland have a smartphone, Dr. Glynn said, and that 90% of U.S. mobile phone users have their phone with them 24 hours a day. Theoretically, a smartphone pedometer app might get more use than a conventional pedometer because it doesn’t require carrying a separate piece of technology.
"This intervention is now firmly on my list (as a clinician) of options for patients to whom I am recommending increased physical activity," Dr. Glynn said in an interview.
He reported having no financial disclosures.
On Twitter @sherryboschert
People who used a smartphone pedometer app walked 22% more steps (or about half a mile) per day after 8 weeks than did people in a control group in a small, randomized, open-label study.
The 90 participants in rural western Ireland were older than 16 years and owned an Android smartphone, which they were asked to keep charged and to carry during waking hours. Investigators downloaded the app to all phones and calibrated it to each individual to record step counts accurately. All participants were given physical activity goals and information on the benefits of exercise.
In the first week, the app display was not visible while it recorded baseline activity data. Mean step counts in the first week were 5,138 steps/day in the control group and 4,365/day in the intervention group. That difference was not statistically significant, but the investigators still adjusted for it in final analyses, Dr. Liam G. Glynn and his associates reported in the British Journal of General Practice.
The intervention group was then showed the app’s features and settings and encouraged to interact with the app to help meet activity goals. The control group’s app continued to track steps without any interaction.
Among 40 people in the control group and 37 in the intervention group with follow-up data 7 weeks later, the daily counts decreased by 386 steps in the control group and increased by 1,631 steps in the intervention group (Br. J. Gen. Pract. 2014;64:e384-91).
Participants in both groups increased their walking initially, but only the intervention group maintained the increased activity, accounting for the step count difference between groups at 8 weeks, said Dr. Glynn, a general practice physician at the National University of Ireland, Galway.
The study used the Accupedo-Pro pedometer app because it included preestablished, desirable features such as automatic feedback and tracking of step counts and calories burned, visually appealing graphics of step count history, the ability to input goals, and feedback on goal achievement. The Accupedo-Pro app is available for iPhones and Android devices for $3.99. Hundreds of other activity-tracking apps of varying quality are available for free or for sale.
After researchers adjusted for factors unrelated to the study that may have increased step counts during the study period, they found that the mean daily count at baseline for the intervention group was 4,771 steps/day. The difference between the intervention and control groups by the end of 8 weeks was a mean increase of 1,029 steps/day favoring the app use, a 22% gain, compared with the intervention group’s baseline, Dr. Glynn reported.
That’s enough of a change to be clinically meaningful if it’s maintained, based on a large body of literature on exercise and health, he said. Dr. Glynn and his associates now are following app users in several European countries to monitor long-term health outcomes.
The current study was too small to show a difference in health measures such as blood pressure, weight, or body mass index. And it was too short to show whether or not apps embedded in phones can overcome one of the weak points of separate devices used solely as pedometers or activity trackers – namely, the tendency for many people to stop using them over time.
One in three people who owned a fitness tracker stopped using the device in the past year, mainly because they lost interest in tracking their activity level, according to a survey by International Data Corp.
Nonetheless, pedometers and other small hardware-based fitness trackers remain popular. Florida insurer AvMed recently announced that it will cover the cost of the Fitlinxx Pebble activity meter for Medicare Advantage members enrolled in the Walkadoo pedometer-based walking program run by MeYou Health.
Separate data suggest that, among mobile phone customers, 60% in the United States and 57% in Ireland have a smartphone, Dr. Glynn said, and that 90% of U.S. mobile phone users have their phone with them 24 hours a day. Theoretically, a smartphone pedometer app might get more use than a conventional pedometer because it doesn’t require carrying a separate piece of technology.
"This intervention is now firmly on my list (as a clinician) of options for patients to whom I am recommending increased physical activity," Dr. Glynn said in an interview.
He reported having no financial disclosures.
On Twitter @sherryboschert
People who used a smartphone pedometer app walked 22% more steps (or about half a mile) per day after 8 weeks than did people in a control group in a small, randomized, open-label study.
The 90 participants in rural western Ireland were older than 16 years and owned an Android smartphone, which they were asked to keep charged and to carry during waking hours. Investigators downloaded the app to all phones and calibrated it to each individual to record step counts accurately. All participants were given physical activity goals and information on the benefits of exercise.
In the first week, the app display was not visible while it recorded baseline activity data. Mean step counts in the first week were 5,138 steps/day in the control group and 4,365/day in the intervention group. That difference was not statistically significant, but the investigators still adjusted for it in final analyses, Dr. Liam G. Glynn and his associates reported in the British Journal of General Practice.
The intervention group was then showed the app’s features and settings and encouraged to interact with the app to help meet activity goals. The control group’s app continued to track steps without any interaction.
Among 40 people in the control group and 37 in the intervention group with follow-up data 7 weeks later, the daily counts decreased by 386 steps in the control group and increased by 1,631 steps in the intervention group (Br. J. Gen. Pract. 2014;64:e384-91).
Participants in both groups increased their walking initially, but only the intervention group maintained the increased activity, accounting for the step count difference between groups at 8 weeks, said Dr. Glynn, a general practice physician at the National University of Ireland, Galway.
The study used the Accupedo-Pro pedometer app because it included preestablished, desirable features such as automatic feedback and tracking of step counts and calories burned, visually appealing graphics of step count history, the ability to input goals, and feedback on goal achievement. The Accupedo-Pro app is available for iPhones and Android devices for $3.99. Hundreds of other activity-tracking apps of varying quality are available for free or for sale.
After researchers adjusted for factors unrelated to the study that may have increased step counts during the study period, they found that the mean daily count at baseline for the intervention group was 4,771 steps/day. The difference between the intervention and control groups by the end of 8 weeks was a mean increase of 1,029 steps/day favoring the app use, a 22% gain, compared with the intervention group’s baseline, Dr. Glynn reported.
That’s enough of a change to be clinically meaningful if it’s maintained, based on a large body of literature on exercise and health, he said. Dr. Glynn and his associates now are following app users in several European countries to monitor long-term health outcomes.
The current study was too small to show a difference in health measures such as blood pressure, weight, or body mass index. And it was too short to show whether or not apps embedded in phones can overcome one of the weak points of separate devices used solely as pedometers or activity trackers – namely, the tendency for many people to stop using them over time.
One in three people who owned a fitness tracker stopped using the device in the past year, mainly because they lost interest in tracking their activity level, according to a survey by International Data Corp.
Nonetheless, pedometers and other small hardware-based fitness trackers remain popular. Florida insurer AvMed recently announced that it will cover the cost of the Fitlinxx Pebble activity meter for Medicare Advantage members enrolled in the Walkadoo pedometer-based walking program run by MeYou Health.
Separate data suggest that, among mobile phone customers, 60% in the United States and 57% in Ireland have a smartphone, Dr. Glynn said, and that 90% of U.S. mobile phone users have their phone with them 24 hours a day. Theoretically, a smartphone pedometer app might get more use than a conventional pedometer because it doesn’t require carrying a separate piece of technology.
"This intervention is now firmly on my list (as a clinician) of options for patients to whom I am recommending increased physical activity," Dr. Glynn said in an interview.
He reported having no financial disclosures.
On Twitter @sherryboschert
Guideline for Overactive Bladder Adds New Treatments
Updated recommendations for the diagnosis and treatment of non-neurogenic overactive bladder incorporate two new treatments approved since 2012 – oral mirabegron and intradetrusor injection of onabotulinumtoxinA.
The 2014 update from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (AUA/SUFU) also recognizes the growing number of therapeutic options by stressing the need to take a methodical approach and give an adequate trial of individual treatments before combining them.
"As we have more and more options on the market, you don’t want to stack one on top of another," Dr. Emily Cole said in an interview.
"All of these methodologies have some side effects. What you don’t want to do is have added side effects if something is not working," said Dr. Cole, a urologist specializing in female pelvic medicine and reconstructive surgery in a group practice in San Diego.
Compared with the 2012 AUA/SUFU recommendations, the 2014 guideline on "Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults" adds the beta3-adrenoceptor agonist mirabegron (Myrbetriq, Astellas Pharma) as a first- or second-line treatment option for some patients. OnabotulinumtoxinA (Botox, Allergan) has been upgraded to a "Standard Option" among third-line treatments instead of a nonapproved, off-label therapy.
The Food and Drug Administration approved mirabegron for adults with overactive bladder in June 2012. The FDA approved onabotulinumtoxinA (Botox, Allergan) in January 2013 for adults with overactive bladder who can’t use or don’t respond adequately to anticholinergics.
Clinicians always should start with first- and second-line therapies to reduce symptoms of overactive bladder, Dr. Cole said. By the time patients come to her, they typically have failed those options, but she offers them hope with third-line treatments.
"In most cases, we can really help patients. We may not make you completely dry," she said, but "we have enough tools now that we can make marked improvements."
That’s a big change in recent years, she added. "When I started out, we had two medications that had horrible side effects," she said. Dr. Cole was not involved in creation of the AUA/SUFU guideline.
The AUA/SUFU based the 2012 guideline on 151 articles on the treatment of overactive bladder and reviewed 72 more articles on treatment for the 2014 update.
The recommendations on diagnosis have not changed since 2012 and are based on expert opinion and clinical principles due to insufficient evidence for stronger recommendations.
First-line treatments are behavioral therapies such as bladder training and bladder control strategies or pelvic floor muscle training, which may be combined with pharmacologic management, the guideline states.
Second-line treatments include oral antimuscarinic drugs or mirabegron, preferably in an extended-release formulation if available to reduce the likelihood of dry mouth from immediate-release formulations. A transdermal patch that delivers the antimuscarinic drug oxybutynin became available to adult women over the counter (without a prescription) in 2013.
If a first antimuscarinic medication doesn’t work or causes unacceptable side effects, modify the dose or offer a different antimuscarinic or beta3-adrenoceptor agonist, the guideline states. If an antimuscarinic is effective but causes constipation or dry mouth, don’t give up on that drug class without trying to manage side effects through bowel management, fluid management, modifying the dose, or trying another antimuscarinic.
Be extremely cautious in using antimuscarinics in patients with impaired gastric emptying or a history of urinary retention, and don’t use antimuscarinics in patients with narrow-angle glaucoma without approval from a treating ophthalmologist. If a patient is on other medications with anticholinergic properties, be cautious about prescribing antimuscarinics.
Patients who fail first- and second-line therapies should be evaluated by a specialist if they still desire treatment, according to the guideline.
Among third-line treatment options, sacral neuromodulation may be offered to patients with severe refractory overactive bladder or patients who are not candidates for second-line treatments and who are willing to undergo a surgical procedure. Peripheral tibial nerve stimulation is another option in carefully selected patients.
Intradetrusor injections of Botox may be appropriate for carefully selected and "thoroughly counseled" patients who failed first- and second-line treatments if they are able and willing to return for frequent postvoid residual evaluations and to perform self-catheterization if necessary.
The guideline does not recommend indwelling catheters for management of overactive bladder except as a last resort in some patients, and says that augmentation cystoplasty or urinary diversion may be considered in rare cases of severe, refractory, complicated overactive bladder.
Dr. Cole has been a speaker for Allergan, which markets Botox.
On Twitter @sherryboschert
Updated recommendations for the diagnosis and treatment of non-neurogenic overactive bladder incorporate two new treatments approved since 2012 – oral mirabegron and intradetrusor injection of onabotulinumtoxinA.
The 2014 update from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (AUA/SUFU) also recognizes the growing number of therapeutic options by stressing the need to take a methodical approach and give an adequate trial of individual treatments before combining them.
"As we have more and more options on the market, you don’t want to stack one on top of another," Dr. Emily Cole said in an interview.
"All of these methodologies have some side effects. What you don’t want to do is have added side effects if something is not working," said Dr. Cole, a urologist specializing in female pelvic medicine and reconstructive surgery in a group practice in San Diego.
Compared with the 2012 AUA/SUFU recommendations, the 2014 guideline on "Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults" adds the beta3-adrenoceptor agonist mirabegron (Myrbetriq, Astellas Pharma) as a first- or second-line treatment option for some patients. OnabotulinumtoxinA (Botox, Allergan) has been upgraded to a "Standard Option" among third-line treatments instead of a nonapproved, off-label therapy.
The Food and Drug Administration approved mirabegron for adults with overactive bladder in June 2012. The FDA approved onabotulinumtoxinA (Botox, Allergan) in January 2013 for adults with overactive bladder who can’t use or don’t respond adequately to anticholinergics.
Clinicians always should start with first- and second-line therapies to reduce symptoms of overactive bladder, Dr. Cole said. By the time patients come to her, they typically have failed those options, but she offers them hope with third-line treatments.
"In most cases, we can really help patients. We may not make you completely dry," she said, but "we have enough tools now that we can make marked improvements."
That’s a big change in recent years, she added. "When I started out, we had two medications that had horrible side effects," she said. Dr. Cole was not involved in creation of the AUA/SUFU guideline.
The AUA/SUFU based the 2012 guideline on 151 articles on the treatment of overactive bladder and reviewed 72 more articles on treatment for the 2014 update.
The recommendations on diagnosis have not changed since 2012 and are based on expert opinion and clinical principles due to insufficient evidence for stronger recommendations.
First-line treatments are behavioral therapies such as bladder training and bladder control strategies or pelvic floor muscle training, which may be combined with pharmacologic management, the guideline states.
Second-line treatments include oral antimuscarinic drugs or mirabegron, preferably in an extended-release formulation if available to reduce the likelihood of dry mouth from immediate-release formulations. A transdermal patch that delivers the antimuscarinic drug oxybutynin became available to adult women over the counter (without a prescription) in 2013.
If a first antimuscarinic medication doesn’t work or causes unacceptable side effects, modify the dose or offer a different antimuscarinic or beta3-adrenoceptor agonist, the guideline states. If an antimuscarinic is effective but causes constipation or dry mouth, don’t give up on that drug class without trying to manage side effects through bowel management, fluid management, modifying the dose, or trying another antimuscarinic.
Be extremely cautious in using antimuscarinics in patients with impaired gastric emptying or a history of urinary retention, and don’t use antimuscarinics in patients with narrow-angle glaucoma without approval from a treating ophthalmologist. If a patient is on other medications with anticholinergic properties, be cautious about prescribing antimuscarinics.
Patients who fail first- and second-line therapies should be evaluated by a specialist if they still desire treatment, according to the guideline.
Among third-line treatment options, sacral neuromodulation may be offered to patients with severe refractory overactive bladder or patients who are not candidates for second-line treatments and who are willing to undergo a surgical procedure. Peripheral tibial nerve stimulation is another option in carefully selected patients.
Intradetrusor injections of Botox may be appropriate for carefully selected and "thoroughly counseled" patients who failed first- and second-line treatments if they are able and willing to return for frequent postvoid residual evaluations and to perform self-catheterization if necessary.
The guideline does not recommend indwelling catheters for management of overactive bladder except as a last resort in some patients, and says that augmentation cystoplasty or urinary diversion may be considered in rare cases of severe, refractory, complicated overactive bladder.
Dr. Cole has been a speaker for Allergan, which markets Botox.
On Twitter @sherryboschert
Updated recommendations for the diagnosis and treatment of non-neurogenic overactive bladder incorporate two new treatments approved since 2012 – oral mirabegron and intradetrusor injection of onabotulinumtoxinA.
The 2014 update from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (AUA/SUFU) also recognizes the growing number of therapeutic options by stressing the need to take a methodical approach and give an adequate trial of individual treatments before combining them.
"As we have more and more options on the market, you don’t want to stack one on top of another," Dr. Emily Cole said in an interview.
"All of these methodologies have some side effects. What you don’t want to do is have added side effects if something is not working," said Dr. Cole, a urologist specializing in female pelvic medicine and reconstructive surgery in a group practice in San Diego.
Compared with the 2012 AUA/SUFU recommendations, the 2014 guideline on "Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults" adds the beta3-adrenoceptor agonist mirabegron (Myrbetriq, Astellas Pharma) as a first- or second-line treatment option for some patients. OnabotulinumtoxinA (Botox, Allergan) has been upgraded to a "Standard Option" among third-line treatments instead of a nonapproved, off-label therapy.
The Food and Drug Administration approved mirabegron for adults with overactive bladder in June 2012. The FDA approved onabotulinumtoxinA (Botox, Allergan) in January 2013 for adults with overactive bladder who can’t use or don’t respond adequately to anticholinergics.
Clinicians always should start with first- and second-line therapies to reduce symptoms of overactive bladder, Dr. Cole said. By the time patients come to her, they typically have failed those options, but she offers them hope with third-line treatments.
"In most cases, we can really help patients. We may not make you completely dry," she said, but "we have enough tools now that we can make marked improvements."
That’s a big change in recent years, she added. "When I started out, we had two medications that had horrible side effects," she said. Dr. Cole was not involved in creation of the AUA/SUFU guideline.
The AUA/SUFU based the 2012 guideline on 151 articles on the treatment of overactive bladder and reviewed 72 more articles on treatment for the 2014 update.
The recommendations on diagnosis have not changed since 2012 and are based on expert opinion and clinical principles due to insufficient evidence for stronger recommendations.
First-line treatments are behavioral therapies such as bladder training and bladder control strategies or pelvic floor muscle training, which may be combined with pharmacologic management, the guideline states.
Second-line treatments include oral antimuscarinic drugs or mirabegron, preferably in an extended-release formulation if available to reduce the likelihood of dry mouth from immediate-release formulations. A transdermal patch that delivers the antimuscarinic drug oxybutynin became available to adult women over the counter (without a prescription) in 2013.
If a first antimuscarinic medication doesn’t work or causes unacceptable side effects, modify the dose or offer a different antimuscarinic or beta3-adrenoceptor agonist, the guideline states. If an antimuscarinic is effective but causes constipation or dry mouth, don’t give up on that drug class without trying to manage side effects through bowel management, fluid management, modifying the dose, or trying another antimuscarinic.
Be extremely cautious in using antimuscarinics in patients with impaired gastric emptying or a history of urinary retention, and don’t use antimuscarinics in patients with narrow-angle glaucoma without approval from a treating ophthalmologist. If a patient is on other medications with anticholinergic properties, be cautious about prescribing antimuscarinics.
Patients who fail first- and second-line therapies should be evaluated by a specialist if they still desire treatment, according to the guideline.
Among third-line treatment options, sacral neuromodulation may be offered to patients with severe refractory overactive bladder or patients who are not candidates for second-line treatments and who are willing to undergo a surgical procedure. Peripheral tibial nerve stimulation is another option in carefully selected patients.
Intradetrusor injections of Botox may be appropriate for carefully selected and "thoroughly counseled" patients who failed first- and second-line treatments if they are able and willing to return for frequent postvoid residual evaluations and to perform self-catheterization if necessary.
The guideline does not recommend indwelling catheters for management of overactive bladder except as a last resort in some patients, and says that augmentation cystoplasty or urinary diversion may be considered in rare cases of severe, refractory, complicated overactive bladder.
Dr. Cole has been a speaker for Allergan, which markets Botox.
On Twitter @sherryboschert
Guideline for overactive bladder adds new treatments
Updated recommendations for the diagnosis and treatment of non-neurogenic overactive bladder incorporate two new treatments approved since 2012 – oral mirabegron and intradetrusor injection of onabotulinumtoxinA.
The 2014 update from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (AUA/SUFU) also recognizes the growing number of therapeutic options by stressing the need to take a methodical approach and give an adequate trial of individual treatments before combining them.
"As we have more and more options on the market, you don’t want to stack one on top of another," Dr. Emily Cole said in an interview.
"All of these methodologies have some side effects. What you don’t want to do is have added side effects if something is not working," said Dr. Cole, a urologist specializing in female pelvic medicine and reconstructive surgery in a group practice in San Diego.
Compared with the 2012 AUA/SUFU recommendations, the 2014 guideline on "Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults" adds the beta3-adrenoceptor agonist mirabegron (Myrbetriq, Astellas Pharma) as a first- or second-line treatment option for some patients. OnabotulinumtoxinA (Botox, Allergan) has been upgraded to a "Standard Option" among third-line treatments instead of a nonapproved, off-label therapy.
The Food and Drug Administration approved mirabegron for adults with overactive bladder in June 2012. The FDA approved onabotulinumtoxinA (Botox, Allergan) in January 2013 for adults with overactive bladder who can’t use or don’t respond adequately to anticholinergics.
Clinicians always should start with first- and second-line therapies to reduce symptoms of overactive bladder, Dr. Cole said. By the time patients come to her, they typically have failed those options, but she offers them hope with third-line treatments.
"In most cases, we can really help patients. We may not make you completely dry," she said, but "we have enough tools now that we can make marked improvements."
That’s a big change in recent years, she added. "When I started out, we had two medications that had horrible side effects," she said. Dr. Cole was not involved in creation of the AUA/SUFU guideline.
The AUA/SUFU based the 2012 guideline on 151 articles on the treatment of overactive bladder and reviewed 72 more articles on treatment for the 2014 update.
The recommendations on diagnosis have not changed since 2012 and are based on expert opinion and clinical principles due to insufficient evidence for stronger recommendations.
First-line treatments are behavioral therapies such as bladder training and bladder control strategies or pelvic floor muscle training, which may be combined with pharmacologic management, the guideline states.
Second-line treatments include oral antimuscarinic drugs or mirabegron, preferably in an extended-release formulation if available to reduce the likelihood of dry mouth from immediate-release formulations. A transdermal patch that delivers the antimuscarinic drug oxybutynin became available to adult women over the counter (without a prescription) in 2013.
If a first antimuscarinic medication doesn’t work or causes unacceptable side effects, modify the dose or offer a different antimuscarinic or beta3-adrenoceptor agonist, the guideline states. If an antimuscarinic is effective but causes constipation or dry mouth, don’t give up on that drug class without trying to manage side effects through bowel management, fluid management, modifying the dose, or trying another antimuscarinic.
Be extremely cautious in using antimuscarinics in patients with impaired gastric emptying or a history of urinary retention, and don’t use antimuscarinics in patients with narrow-angle glaucoma without approval from a treating ophthalmologist. If a patient is on other medications with anticholinergic properties, be cautious about prescribing antimuscarinics.
Patients who fail first- and second-line therapies should be evaluated by a specialist if they still desire treatment, according to the guideline.
Among third-line treatment options, sacral neuromodulation may be offered to patients with severe refractory overactive bladder or patients who are not candidates for second-line treatments and who are willing to undergo a surgical procedure. Peripheral tibial nerve stimulation is another option in carefully selected patients.
Intradetrusor injections of Botox may be appropriate for carefully selected and "thoroughly counseled" patients who failed first- and second-line treatments if they are able and willing to return for frequent postvoid residual evaluations and to perform self-catheterization if necessary.
The guideline does not recommend indwelling catheters for management of overactive bladder except as a last resort in some patients, and says that augmentation cystoplasty or urinary diversion may be considered in rare cases of severe, refractory, complicated overactive bladder.
Dr. Cole has been a speaker for Allergan, which markets Botox.
On Twitter @sherryboschert
Updated recommendations for the diagnosis and treatment of non-neurogenic overactive bladder incorporate two new treatments approved since 2012 – oral mirabegron and intradetrusor injection of onabotulinumtoxinA.
The 2014 update from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (AUA/SUFU) also recognizes the growing number of therapeutic options by stressing the need to take a methodical approach and give an adequate trial of individual treatments before combining them.
"As we have more and more options on the market, you don’t want to stack one on top of another," Dr. Emily Cole said in an interview.
"All of these methodologies have some side effects. What you don’t want to do is have added side effects if something is not working," said Dr. Cole, a urologist specializing in female pelvic medicine and reconstructive surgery in a group practice in San Diego.
Compared with the 2012 AUA/SUFU recommendations, the 2014 guideline on "Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults" adds the beta3-adrenoceptor agonist mirabegron (Myrbetriq, Astellas Pharma) as a first- or second-line treatment option for some patients. OnabotulinumtoxinA (Botox, Allergan) has been upgraded to a "Standard Option" among third-line treatments instead of a nonapproved, off-label therapy.
The Food and Drug Administration approved mirabegron for adults with overactive bladder in June 2012. The FDA approved onabotulinumtoxinA (Botox, Allergan) in January 2013 for adults with overactive bladder who can’t use or don’t respond adequately to anticholinergics.
Clinicians always should start with first- and second-line therapies to reduce symptoms of overactive bladder, Dr. Cole said. By the time patients come to her, they typically have failed those options, but she offers them hope with third-line treatments.
"In most cases, we can really help patients. We may not make you completely dry," she said, but "we have enough tools now that we can make marked improvements."
That’s a big change in recent years, she added. "When I started out, we had two medications that had horrible side effects," she said. Dr. Cole was not involved in creation of the AUA/SUFU guideline.
The AUA/SUFU based the 2012 guideline on 151 articles on the treatment of overactive bladder and reviewed 72 more articles on treatment for the 2014 update.
The recommendations on diagnosis have not changed since 2012 and are based on expert opinion and clinical principles due to insufficient evidence for stronger recommendations.
First-line treatments are behavioral therapies such as bladder training and bladder control strategies or pelvic floor muscle training, which may be combined with pharmacologic management, the guideline states.
Second-line treatments include oral antimuscarinic drugs or mirabegron, preferably in an extended-release formulation if available to reduce the likelihood of dry mouth from immediate-release formulations. A transdermal patch that delivers the antimuscarinic drug oxybutynin became available to adult women over the counter (without a prescription) in 2013.
If a first antimuscarinic medication doesn’t work or causes unacceptable side effects, modify the dose or offer a different antimuscarinic or beta3-adrenoceptor agonist, the guideline states. If an antimuscarinic is effective but causes constipation or dry mouth, don’t give up on that drug class without trying to manage side effects through bowel management, fluid management, modifying the dose, or trying another antimuscarinic.
Be extremely cautious in using antimuscarinics in patients with impaired gastric emptying or a history of urinary retention, and don’t use antimuscarinics in patients with narrow-angle glaucoma without approval from a treating ophthalmologist. If a patient is on other medications with anticholinergic properties, be cautious about prescribing antimuscarinics.
Patients who fail first- and second-line therapies should be evaluated by a specialist if they still desire treatment, according to the guideline.
Among third-line treatment options, sacral neuromodulation may be offered to patients with severe refractory overactive bladder or patients who are not candidates for second-line treatments and who are willing to undergo a surgical procedure. Peripheral tibial nerve stimulation is another option in carefully selected patients.
Intradetrusor injections of Botox may be appropriate for carefully selected and "thoroughly counseled" patients who failed first- and second-line treatments if they are able and willing to return for frequent postvoid residual evaluations and to perform self-catheterization if necessary.
The guideline does not recommend indwelling catheters for management of overactive bladder except as a last resort in some patients, and says that augmentation cystoplasty or urinary diversion may be considered in rare cases of severe, refractory, complicated overactive bladder.
Dr. Cole has been a speaker for Allergan, which markets Botox.
On Twitter @sherryboschert
Updated recommendations for the diagnosis and treatment of non-neurogenic overactive bladder incorporate two new treatments approved since 2012 – oral mirabegron and intradetrusor injection of onabotulinumtoxinA.
The 2014 update from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (AUA/SUFU) also recognizes the growing number of therapeutic options by stressing the need to take a methodical approach and give an adequate trial of individual treatments before combining them.
"As we have more and more options on the market, you don’t want to stack one on top of another," Dr. Emily Cole said in an interview.
"All of these methodologies have some side effects. What you don’t want to do is have added side effects if something is not working," said Dr. Cole, a urologist specializing in female pelvic medicine and reconstructive surgery in a group practice in San Diego.
Compared with the 2012 AUA/SUFU recommendations, the 2014 guideline on "Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults" adds the beta3-adrenoceptor agonist mirabegron (Myrbetriq, Astellas Pharma) as a first- or second-line treatment option for some patients. OnabotulinumtoxinA (Botox, Allergan) has been upgraded to a "Standard Option" among third-line treatments instead of a nonapproved, off-label therapy.
The Food and Drug Administration approved mirabegron for adults with overactive bladder in June 2012. The FDA approved onabotulinumtoxinA (Botox, Allergan) in January 2013 for adults with overactive bladder who can’t use or don’t respond adequately to anticholinergics.
Clinicians always should start with first- and second-line therapies to reduce symptoms of overactive bladder, Dr. Cole said. By the time patients come to her, they typically have failed those options, but she offers them hope with third-line treatments.
"In most cases, we can really help patients. We may not make you completely dry," she said, but "we have enough tools now that we can make marked improvements."
That’s a big change in recent years, she added. "When I started out, we had two medications that had horrible side effects," she said. Dr. Cole was not involved in creation of the AUA/SUFU guideline.
The AUA/SUFU based the 2012 guideline on 151 articles on the treatment of overactive bladder and reviewed 72 more articles on treatment for the 2014 update.
The recommendations on diagnosis have not changed since 2012 and are based on expert opinion and clinical principles due to insufficient evidence for stronger recommendations.
First-line treatments are behavioral therapies such as bladder training and bladder control strategies or pelvic floor muscle training, which may be combined with pharmacologic management, the guideline states.
Second-line treatments include oral antimuscarinic drugs or mirabegron, preferably in an extended-release formulation if available to reduce the likelihood of dry mouth from immediate-release formulations. A transdermal patch that delivers the antimuscarinic drug oxybutynin became available to adult women over the counter (without a prescription) in 2013.
If a first antimuscarinic medication doesn’t work or causes unacceptable side effects, modify the dose or offer a different antimuscarinic or beta3-adrenoceptor agonist, the guideline states. If an antimuscarinic is effective but causes constipation or dry mouth, don’t give up on that drug class without trying to manage side effects through bowel management, fluid management, modifying the dose, or trying another antimuscarinic.
Be extremely cautious in using antimuscarinics in patients with impaired gastric emptying or a history of urinary retention, and don’t use antimuscarinics in patients with narrow-angle glaucoma without approval from a treating ophthalmologist. If a patient is on other medications with anticholinergic properties, be cautious about prescribing antimuscarinics.
Patients who fail first- and second-line therapies should be evaluated by a specialist if they still desire treatment, according to the guideline.
Among third-line treatment options, sacral neuromodulation may be offered to patients with severe refractory overactive bladder or patients who are not candidates for second-line treatments and who are willing to undergo a surgical procedure. Peripheral tibial nerve stimulation is another option in carefully selected patients.
Intradetrusor injections of Botox may be appropriate for carefully selected and "thoroughly counseled" patients who failed first- and second-line treatments if they are able and willing to return for frequent postvoid residual evaluations and to perform self-catheterization if necessary.
The guideline does not recommend indwelling catheters for management of overactive bladder except as a last resort in some patients, and says that augmentation cystoplasty or urinary diversion may be considered in rare cases of severe, refractory, complicated overactive bladder.
Dr. Cole has been a speaker for Allergan, which markets Botox.
On Twitter @sherryboschert
Medical consultation rates for surgical cases vary
The use of inpatient medical consultations for hospitalized surgical patients was found to vary by hospital, but consultations didn’t appear to have much of an impact on risk-adjusted 30-day mortality rates, a study found.
Rates of medical consultations varied from 50% to 91% among 91,684 patients undergoing colectomy and from 36% to 90% among 339,319 patients undergoing total hip replacements, a retrospective study found.
The variation was most dramatic for patients undergoing colectomy who did not have complications, among whom rates of inpatient medical consultation ranged from 47% to 79% between hospitals, Dr. Lena M. Chen and her associates reported. For patients undergoing colectomy who did have complications, 90%-95% received medical consultations.
Similarly, variation in the use of medical consultation for patients getting total hip replacement was wider for those without complications (36%-87%), compared with patients with complications (89%-94%).
The results highlight the fact that there’s no consensus on when and how to best provide medical consultation for hospitalized surgical patients. "Wide variation in medical consultation use – particularly among patients without complications – suggests that understanding when medical consultations provide value will be important as hospitals seek to increase their efficiency under bundled payments," wrote Dr. Chen of the University of Michigan, Ann Arbor (JAMA Intern. Med. 2014 Aug. 4 [doi:10.1001/jamainternmed.2014.3376]).
She and her associates analyzed Medicare claims data and American Hospital Association data on patients aged 65-99 years who underwent colectomy at 930 hospitals or total hip replacement at 1,589 hospitals in 2007-2010. These are 2 of the top 10 procedures performed on Medicare patients, and total hip replacement is included in the Centers for Medicare & Medicaid Services bundled payment demonstration project, the authors noted.
At least one medical consultant saw 69% of patients undergoing colectomy and 63% of patients getting a total hip replacement. Among patients who got consultations, colectomy patients saw consultants a median of nine times, and hip replacement patients saw consultants a median of three times.
Colectomy patients most often saw general medicine consultants (50%), followed by cardiologists (28%), oncologists (25%), or gastroenterologists (22%). Among patients receiving total hip replacement, 53% had a general medicine consultation, and the most common specialist consultations were for physical medicine and rehabilitation (11%) or cardiology (8%).
Approximately a third of hip replacement patients were "comanaged" by surgeons and medical consultants, defined by records of a claim for evaluation and management by a medicine physician on at least 70% of inpatient days.
It seems logical to assume that extra care from nonsurgical physicians should improve outcomes for some surgical patients, but an exploratory analysis of the data found that risk-adjusted 30-day mortality rates were not significantly different between hospitals with the greatest or least use of medical consultations, Dr. Chen reported. The 30-day mortality rate for colectomy patients was 5% at hospitals in the lowest quintile of medical consultations and 6% at hospitals in the highest quintile. The results for total hip replacement were similar.
Greater use of medical consultation was associated with a significantly greater likelihood of having at least one postoperative complication, affecting 24% of colectomy patients at hospitals in the lowest quintile of consultations and 28% at hospitals in the highest quintile. The results for total hip replacement were similar.
The National Institute of Aging and a University of Michigan McCubed grant funded the study. Dr. Chen reported having no relevant financial disclosures. One of her coinvestigators owns stock in ArborMetrix, a company that analyzes hospital quality and cost efficiency.
On Twitter @sherryboschert
Dr. Chen’s findings that rates of medical consultation varied widely for surgical patients without complications complement a 2010 study by Dr. Gulshan Sharma and his associates that found 35% of patients hospitalized for a common surgical procedure were comanaged by medicine physicians (Arch. Intern. Med. 2010;170:363-8).
"I agree [with Dr. Chen] that understanding the ‘value’ of medical consultation is an important next step, especially in low-risk patients undergoing elective surgery," Dr. Sharma commented in an article accompanying Dr. Chen’s study (JAMA Intern. Med. 2014 Aug. 4 [doi:10.1001/jamainternmed.2014.1499]).
Comanagement may benefit patients by increasing the use of evidence-based treatments or reducing the time to surgery, postoperative complications, the need for ICU care, the length of stay, and readmission rates, among other possibilities. But there are possible downsides, too, including potential confusion among caregivers, more complicated decision making, lack of "ownership" of problems, or added costs, he noted.
Hospitals with the greatest use of medical consultation in Dr. Chen’s study had higher risk-adjusted rates of 30-day mortality and complications, compared with hospitals with the least use of medical consultation (though the difference in mortality was not statistically significant). "Is there a potential harm associated with medical consultation?" Dr. Sharma asked.
"There is no one fit for all" hospitals, he wrote. Institutional data on quality and cost should drive decisions on the routine use of medical consultation. The practice of mandating comanagement of all surgical patients "should be discouraged," Dr. Sharma said. "During preoperative evaluation, patients with comorbid conditions and those at significant risk of postoperative complications should be considered for medical comanagement."
Dr. Sharma is director of the division of pulmonary critical care and sleep medicine at the University of Texas Medical Branch, Galveston. He reported having no relevant financial disclosures.
Dr. Chen’s findings that rates of medical consultation varied widely for surgical patients without complications complement a 2010 study by Dr. Gulshan Sharma and his associates that found 35% of patients hospitalized for a common surgical procedure were comanaged by medicine physicians (Arch. Intern. Med. 2010;170:363-8).
"I agree [with Dr. Chen] that understanding the ‘value’ of medical consultation is an important next step, especially in low-risk patients undergoing elective surgery," Dr. Sharma commented in an article accompanying Dr. Chen’s study (JAMA Intern. Med. 2014 Aug. 4 [doi:10.1001/jamainternmed.2014.1499]).
Comanagement may benefit patients by increasing the use of evidence-based treatments or reducing the time to surgery, postoperative complications, the need for ICU care, the length of stay, and readmission rates, among other possibilities. But there are possible downsides, too, including potential confusion among caregivers, more complicated decision making, lack of "ownership" of problems, or added costs, he noted.
Hospitals with the greatest use of medical consultation in Dr. Chen’s study had higher risk-adjusted rates of 30-day mortality and complications, compared with hospitals with the least use of medical consultation (though the difference in mortality was not statistically significant). "Is there a potential harm associated with medical consultation?" Dr. Sharma asked.
"There is no one fit for all" hospitals, he wrote. Institutional data on quality and cost should drive decisions on the routine use of medical consultation. The practice of mandating comanagement of all surgical patients "should be discouraged," Dr. Sharma said. "During preoperative evaluation, patients with comorbid conditions and those at significant risk of postoperative complications should be considered for medical comanagement."
Dr. Sharma is director of the division of pulmonary critical care and sleep medicine at the University of Texas Medical Branch, Galveston. He reported having no relevant financial disclosures.
Dr. Chen’s findings that rates of medical consultation varied widely for surgical patients without complications complement a 2010 study by Dr. Gulshan Sharma and his associates that found 35% of patients hospitalized for a common surgical procedure were comanaged by medicine physicians (Arch. Intern. Med. 2010;170:363-8).
"I agree [with Dr. Chen] that understanding the ‘value’ of medical consultation is an important next step, especially in low-risk patients undergoing elective surgery," Dr. Sharma commented in an article accompanying Dr. Chen’s study (JAMA Intern. Med. 2014 Aug. 4 [doi:10.1001/jamainternmed.2014.1499]).
Comanagement may benefit patients by increasing the use of evidence-based treatments or reducing the time to surgery, postoperative complications, the need for ICU care, the length of stay, and readmission rates, among other possibilities. But there are possible downsides, too, including potential confusion among caregivers, more complicated decision making, lack of "ownership" of problems, or added costs, he noted.
Hospitals with the greatest use of medical consultation in Dr. Chen’s study had higher risk-adjusted rates of 30-day mortality and complications, compared with hospitals with the least use of medical consultation (though the difference in mortality was not statistically significant). "Is there a potential harm associated with medical consultation?" Dr. Sharma asked.
"There is no one fit for all" hospitals, he wrote. Institutional data on quality and cost should drive decisions on the routine use of medical consultation. The practice of mandating comanagement of all surgical patients "should be discouraged," Dr. Sharma said. "During preoperative evaluation, patients with comorbid conditions and those at significant risk of postoperative complications should be considered for medical comanagement."
Dr. Sharma is director of the division of pulmonary critical care and sleep medicine at the University of Texas Medical Branch, Galveston. He reported having no relevant financial disclosures.
The use of inpatient medical consultations for hospitalized surgical patients was found to vary by hospital, but consultations didn’t appear to have much of an impact on risk-adjusted 30-day mortality rates, a study found.
Rates of medical consultations varied from 50% to 91% among 91,684 patients undergoing colectomy and from 36% to 90% among 339,319 patients undergoing total hip replacements, a retrospective study found.
The variation was most dramatic for patients undergoing colectomy who did not have complications, among whom rates of inpatient medical consultation ranged from 47% to 79% between hospitals, Dr. Lena M. Chen and her associates reported. For patients undergoing colectomy who did have complications, 90%-95% received medical consultations.
Similarly, variation in the use of medical consultation for patients getting total hip replacement was wider for those without complications (36%-87%), compared with patients with complications (89%-94%).
The results highlight the fact that there’s no consensus on when and how to best provide medical consultation for hospitalized surgical patients. "Wide variation in medical consultation use – particularly among patients without complications – suggests that understanding when medical consultations provide value will be important as hospitals seek to increase their efficiency under bundled payments," wrote Dr. Chen of the University of Michigan, Ann Arbor (JAMA Intern. Med. 2014 Aug. 4 [doi:10.1001/jamainternmed.2014.3376]).
She and her associates analyzed Medicare claims data and American Hospital Association data on patients aged 65-99 years who underwent colectomy at 930 hospitals or total hip replacement at 1,589 hospitals in 2007-2010. These are 2 of the top 10 procedures performed on Medicare patients, and total hip replacement is included in the Centers for Medicare & Medicaid Services bundled payment demonstration project, the authors noted.
At least one medical consultant saw 69% of patients undergoing colectomy and 63% of patients getting a total hip replacement. Among patients who got consultations, colectomy patients saw consultants a median of nine times, and hip replacement patients saw consultants a median of three times.
Colectomy patients most often saw general medicine consultants (50%), followed by cardiologists (28%), oncologists (25%), or gastroenterologists (22%). Among patients receiving total hip replacement, 53% had a general medicine consultation, and the most common specialist consultations were for physical medicine and rehabilitation (11%) or cardiology (8%).
Approximately a third of hip replacement patients were "comanaged" by surgeons and medical consultants, defined by records of a claim for evaluation and management by a medicine physician on at least 70% of inpatient days.
It seems logical to assume that extra care from nonsurgical physicians should improve outcomes for some surgical patients, but an exploratory analysis of the data found that risk-adjusted 30-day mortality rates were not significantly different between hospitals with the greatest or least use of medical consultations, Dr. Chen reported. The 30-day mortality rate for colectomy patients was 5% at hospitals in the lowest quintile of medical consultations and 6% at hospitals in the highest quintile. The results for total hip replacement were similar.
Greater use of medical consultation was associated with a significantly greater likelihood of having at least one postoperative complication, affecting 24% of colectomy patients at hospitals in the lowest quintile of consultations and 28% at hospitals in the highest quintile. The results for total hip replacement were similar.
The National Institute of Aging and a University of Michigan McCubed grant funded the study. Dr. Chen reported having no relevant financial disclosures. One of her coinvestigators owns stock in ArborMetrix, a company that analyzes hospital quality and cost efficiency.
On Twitter @sherryboschert
The use of inpatient medical consultations for hospitalized surgical patients was found to vary by hospital, but consultations didn’t appear to have much of an impact on risk-adjusted 30-day mortality rates, a study found.
Rates of medical consultations varied from 50% to 91% among 91,684 patients undergoing colectomy and from 36% to 90% among 339,319 patients undergoing total hip replacements, a retrospective study found.
The variation was most dramatic for patients undergoing colectomy who did not have complications, among whom rates of inpatient medical consultation ranged from 47% to 79% between hospitals, Dr. Lena M. Chen and her associates reported. For patients undergoing colectomy who did have complications, 90%-95% received medical consultations.
Similarly, variation in the use of medical consultation for patients getting total hip replacement was wider for those without complications (36%-87%), compared with patients with complications (89%-94%).
The results highlight the fact that there’s no consensus on when and how to best provide medical consultation for hospitalized surgical patients. "Wide variation in medical consultation use – particularly among patients without complications – suggests that understanding when medical consultations provide value will be important as hospitals seek to increase their efficiency under bundled payments," wrote Dr. Chen of the University of Michigan, Ann Arbor (JAMA Intern. Med. 2014 Aug. 4 [doi:10.1001/jamainternmed.2014.3376]).
She and her associates analyzed Medicare claims data and American Hospital Association data on patients aged 65-99 years who underwent colectomy at 930 hospitals or total hip replacement at 1,589 hospitals in 2007-2010. These are 2 of the top 10 procedures performed on Medicare patients, and total hip replacement is included in the Centers for Medicare & Medicaid Services bundled payment demonstration project, the authors noted.
At least one medical consultant saw 69% of patients undergoing colectomy and 63% of patients getting a total hip replacement. Among patients who got consultations, colectomy patients saw consultants a median of nine times, and hip replacement patients saw consultants a median of three times.
Colectomy patients most often saw general medicine consultants (50%), followed by cardiologists (28%), oncologists (25%), or gastroenterologists (22%). Among patients receiving total hip replacement, 53% had a general medicine consultation, and the most common specialist consultations were for physical medicine and rehabilitation (11%) or cardiology (8%).
Approximately a third of hip replacement patients were "comanaged" by surgeons and medical consultants, defined by records of a claim for evaluation and management by a medicine physician on at least 70% of inpatient days.
It seems logical to assume that extra care from nonsurgical physicians should improve outcomes for some surgical patients, but an exploratory analysis of the data found that risk-adjusted 30-day mortality rates were not significantly different between hospitals with the greatest or least use of medical consultations, Dr. Chen reported. The 30-day mortality rate for colectomy patients was 5% at hospitals in the lowest quintile of medical consultations and 6% at hospitals in the highest quintile. The results for total hip replacement were similar.
Greater use of medical consultation was associated with a significantly greater likelihood of having at least one postoperative complication, affecting 24% of colectomy patients at hospitals in the lowest quintile of consultations and 28% at hospitals in the highest quintile. The results for total hip replacement were similar.
The National Institute of Aging and a University of Michigan McCubed grant funded the study. Dr. Chen reported having no relevant financial disclosures. One of her coinvestigators owns stock in ArborMetrix, a company that analyzes hospital quality and cost efficiency.
On Twitter @sherryboschert
FROM JAMA INTERNAL MEDICINE
Key clinical point: In the era of bundled payments for episodes of care, consider when and how medical consultation for surgical patients is helpful.
Major finding: Use of medical consultations ranged from 50%-91% for colectomies and 36%-90% for total hip replacements.
Data source: A retrospective study of Medicare data on 431,003 older adults undergoing colectomy or total hip replacement in 2007-2010.
Disclosures: Dr. Chen reported having no financial disclosures. One of her associates owns stock in ArborMetrix, a company that analyzes hospital quality and cost efficiency.
Long-term benefits shown after gastric banding
SAN FRANCISCO – The greater benefits of laparoscopic gastric banding surgery compared with medical treatment for obese patients were maintained for up to 17 years in a study of data on 1,490 patients.
The 527 obese patients (with or without diabetes) who underwent laparoscopic banding were significantly less likely to die of cardiovascular or noncardiovascular causes and were less likely to develop new cases of type 2 diabetes or cardiovascular disease, compared with the 963 nonsurgery patients, Dr. Antonio E. Pontiroli and his associates reported at the annual scientific sessions of the American Diabetes Association.
Patients underwent laparoscopic banding surgery or were seen for a first visit for medical therapy in 1995-2001, and were followed for 11-17 years, through September 2012.
Three percent of the surgery group and 10% of the nonsurgery group died during follow-up, reported Dr. Pontiroli, chair of internal medicine at Università Degli Studi de Milano and San Paolo Hospital, Milan.
To track morbidity, the investigators analyzed records to see which patients got "exemptions" for specific diseases, an Italian government system in which development of a chronic disease exempts someone from having to pay for exams or treatments for that disease. Any exemption obtained after the first surgical or medical visit was considered a proxy of new disease.
New exemptions were granted to 25% in the surgery group and 42% in the nonsurgery group.
Subset analyses divided 385 surgery patients based on the presence or absence of diabetes, and matched the subgroups separately with 681 nonsurgery patients by sex, age, blood pressure, and body mass index.
In the matched comparisons, 3% of the surgery group and 10% of the nonsurgery group died, and exemptions were granted to 22% of the surgery group and 28% of the nonsurgery group, which were statistically significant differences in the intention-to-treat analyses.
Patients in the surgery group were 66% less likely to die than the nonsurgery patients. Patients without diabetes at the first visit were 67% less likely to die than matched nonsurgery patients, and those with diabetes at the first visit were 56% less likely to die compared with matched nonsurgery patients.
Cardiovascular disease, noncardiovascular disease, or neoplasia were significantly less likely to be the causes of death in the surgery group compared with the nonsurgery group. The surgery group recorded significantly fewer hospitalizations during follow-up (120) than the nonsurgery group (273).
New cases of cardiovascular disease (defined by exemptions) appeared in 13% of the surgery group and 22% of the nonsurgery group. In the matched subgroups, 13% who underwent surgery and 18% in the nonsurgery group developed cardiovascular disease.
Among patients without diabetes at baseline, 5% of 454 in the surgery group and 10% of 724 in the nonsurgery group developed diabetes during follow-up. In the subset analysis of matched patients without diabetes at baseline, 4% of 333 in the surgery group and 9% in the nonsurgery group developed diabetes.
The investigators plan another data assessment in 2017 to confirm these long-term findings. Similar studies are needed for other bariatric surgery techniques, he suggested.
Dr. Pontiroli reported financial associations with Sanofi, Eli Lilly, and other companies.
On Twitter @sherryboschert
This is a very interesting study. It was a long-term study, over 17 years, of patients who’d had gastric banding in Milan, looking at development of cardiovascular disease, type 2 diabetes, and death. It is reassuring that there did appear to be favorable outcomes.
There clearly are limitations to the study. The researchers only looked at banding; they didn’t look at sleeve gastrectomies or gastric bypass. The study is specifically related to banding. The comparisons with medical therapies didn’t really define the medical therapies. We’d obviously need details on what they were comparing and whether there are subgroup analyses that could be done.
Nonetheless, they did show that there’s a significant improvement in death rates, cardiovascular death, all-cause death, development of type 2 diabetes, and new cases of cardiovascular disease both in the whole population and in the matched groups. I think these are useful data that are kind of reassuring.
The other thing I would mention: Although bariatric surgery has been done for many years now, it’s really only over the last 10-15 years that the numbers of surgeries have increased hugely. It will be interesting to see the outcomes of the most current cohort over the next 10-15 years.
Dr. Thomas Barber is an associate professor and honorary consultant endocrinologist at the Warwick Medical School, Coventry, England. He gave these comments in an interview at the meeting. Dr. Barber reported having no financial disclosures.
This is a very interesting study. It was a long-term study, over 17 years, of patients who’d had gastric banding in Milan, looking at development of cardiovascular disease, type 2 diabetes, and death. It is reassuring that there did appear to be favorable outcomes.
There clearly are limitations to the study. The researchers only looked at banding; they didn’t look at sleeve gastrectomies or gastric bypass. The study is specifically related to banding. The comparisons with medical therapies didn’t really define the medical therapies. We’d obviously need details on what they were comparing and whether there are subgroup analyses that could be done.
Nonetheless, they did show that there’s a significant improvement in death rates, cardiovascular death, all-cause death, development of type 2 diabetes, and new cases of cardiovascular disease both in the whole population and in the matched groups. I think these are useful data that are kind of reassuring.
The other thing I would mention: Although bariatric surgery has been done for many years now, it’s really only over the last 10-15 years that the numbers of surgeries have increased hugely. It will be interesting to see the outcomes of the most current cohort over the next 10-15 years.
Dr. Thomas Barber is an associate professor and honorary consultant endocrinologist at the Warwick Medical School, Coventry, England. He gave these comments in an interview at the meeting. Dr. Barber reported having no financial disclosures.
This is a very interesting study. It was a long-term study, over 17 years, of patients who’d had gastric banding in Milan, looking at development of cardiovascular disease, type 2 diabetes, and death. It is reassuring that there did appear to be favorable outcomes.
There clearly are limitations to the study. The researchers only looked at banding; they didn’t look at sleeve gastrectomies or gastric bypass. The study is specifically related to banding. The comparisons with medical therapies didn’t really define the medical therapies. We’d obviously need details on what they were comparing and whether there are subgroup analyses that could be done.
Nonetheless, they did show that there’s a significant improvement in death rates, cardiovascular death, all-cause death, development of type 2 diabetes, and new cases of cardiovascular disease both in the whole population and in the matched groups. I think these are useful data that are kind of reassuring.
The other thing I would mention: Although bariatric surgery has been done for many years now, it’s really only over the last 10-15 years that the numbers of surgeries have increased hugely. It will be interesting to see the outcomes of the most current cohort over the next 10-15 years.
Dr. Thomas Barber is an associate professor and honorary consultant endocrinologist at the Warwick Medical School, Coventry, England. He gave these comments in an interview at the meeting. Dr. Barber reported having no financial disclosures.
SAN FRANCISCO – The greater benefits of laparoscopic gastric banding surgery compared with medical treatment for obese patients were maintained for up to 17 years in a study of data on 1,490 patients.
The 527 obese patients (with or without diabetes) who underwent laparoscopic banding were significantly less likely to die of cardiovascular or noncardiovascular causes and were less likely to develop new cases of type 2 diabetes or cardiovascular disease, compared with the 963 nonsurgery patients, Dr. Antonio E. Pontiroli and his associates reported at the annual scientific sessions of the American Diabetes Association.
Patients underwent laparoscopic banding surgery or were seen for a first visit for medical therapy in 1995-2001, and were followed for 11-17 years, through September 2012.
Three percent of the surgery group and 10% of the nonsurgery group died during follow-up, reported Dr. Pontiroli, chair of internal medicine at Università Degli Studi de Milano and San Paolo Hospital, Milan.
To track morbidity, the investigators analyzed records to see which patients got "exemptions" for specific diseases, an Italian government system in which development of a chronic disease exempts someone from having to pay for exams or treatments for that disease. Any exemption obtained after the first surgical or medical visit was considered a proxy of new disease.
New exemptions were granted to 25% in the surgery group and 42% in the nonsurgery group.
Subset analyses divided 385 surgery patients based on the presence or absence of diabetes, and matched the subgroups separately with 681 nonsurgery patients by sex, age, blood pressure, and body mass index.
In the matched comparisons, 3% of the surgery group and 10% of the nonsurgery group died, and exemptions were granted to 22% of the surgery group and 28% of the nonsurgery group, which were statistically significant differences in the intention-to-treat analyses.
Patients in the surgery group were 66% less likely to die than the nonsurgery patients. Patients without diabetes at the first visit were 67% less likely to die than matched nonsurgery patients, and those with diabetes at the first visit were 56% less likely to die compared with matched nonsurgery patients.
Cardiovascular disease, noncardiovascular disease, or neoplasia were significantly less likely to be the causes of death in the surgery group compared with the nonsurgery group. The surgery group recorded significantly fewer hospitalizations during follow-up (120) than the nonsurgery group (273).
New cases of cardiovascular disease (defined by exemptions) appeared in 13% of the surgery group and 22% of the nonsurgery group. In the matched subgroups, 13% who underwent surgery and 18% in the nonsurgery group developed cardiovascular disease.
Among patients without diabetes at baseline, 5% of 454 in the surgery group and 10% of 724 in the nonsurgery group developed diabetes during follow-up. In the subset analysis of matched patients without diabetes at baseline, 4% of 333 in the surgery group and 9% in the nonsurgery group developed diabetes.
The investigators plan another data assessment in 2017 to confirm these long-term findings. Similar studies are needed for other bariatric surgery techniques, he suggested.
Dr. Pontiroli reported financial associations with Sanofi, Eli Lilly, and other companies.
On Twitter @sherryboschert
SAN FRANCISCO – The greater benefits of laparoscopic gastric banding surgery compared with medical treatment for obese patients were maintained for up to 17 years in a study of data on 1,490 patients.
The 527 obese patients (with or without diabetes) who underwent laparoscopic banding were significantly less likely to die of cardiovascular or noncardiovascular causes and were less likely to develop new cases of type 2 diabetes or cardiovascular disease, compared with the 963 nonsurgery patients, Dr. Antonio E. Pontiroli and his associates reported at the annual scientific sessions of the American Diabetes Association.
Patients underwent laparoscopic banding surgery or were seen for a first visit for medical therapy in 1995-2001, and were followed for 11-17 years, through September 2012.
Three percent of the surgery group and 10% of the nonsurgery group died during follow-up, reported Dr. Pontiroli, chair of internal medicine at Università Degli Studi de Milano and San Paolo Hospital, Milan.
To track morbidity, the investigators analyzed records to see which patients got "exemptions" for specific diseases, an Italian government system in which development of a chronic disease exempts someone from having to pay for exams or treatments for that disease. Any exemption obtained after the first surgical or medical visit was considered a proxy of new disease.
New exemptions were granted to 25% in the surgery group and 42% in the nonsurgery group.
Subset analyses divided 385 surgery patients based on the presence or absence of diabetes, and matched the subgroups separately with 681 nonsurgery patients by sex, age, blood pressure, and body mass index.
In the matched comparisons, 3% of the surgery group and 10% of the nonsurgery group died, and exemptions were granted to 22% of the surgery group and 28% of the nonsurgery group, which were statistically significant differences in the intention-to-treat analyses.
Patients in the surgery group were 66% less likely to die than the nonsurgery patients. Patients without diabetes at the first visit were 67% less likely to die than matched nonsurgery patients, and those with diabetes at the first visit were 56% less likely to die compared with matched nonsurgery patients.
Cardiovascular disease, noncardiovascular disease, or neoplasia were significantly less likely to be the causes of death in the surgery group compared with the nonsurgery group. The surgery group recorded significantly fewer hospitalizations during follow-up (120) than the nonsurgery group (273).
New cases of cardiovascular disease (defined by exemptions) appeared in 13% of the surgery group and 22% of the nonsurgery group. In the matched subgroups, 13% who underwent surgery and 18% in the nonsurgery group developed cardiovascular disease.
Among patients without diabetes at baseline, 5% of 454 in the surgery group and 10% of 724 in the nonsurgery group developed diabetes during follow-up. In the subset analysis of matched patients without diabetes at baseline, 4% of 333 in the surgery group and 9% in the nonsurgery group developed diabetes.
The investigators plan another data assessment in 2017 to confirm these long-term findings. Similar studies are needed for other bariatric surgery techniques, he suggested.
Dr. Pontiroli reported financial associations with Sanofi, Eli Lilly, and other companies.
On Twitter @sherryboschert
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Gastric banding produced significant benefits in 17 years of follow-up.
Major finding: Obese patients treated with gastric banding were 66% less likely to die, compared with those who received medical therapy.
Data source: An intent-to-treat analysis of data on 1,490 obese patients treated at four Italian centers.
Disclosures: Dr. Pontiroli reported financial associations with Sanofi, Eli Lilly, and other companies.
Texting intervention helped smokers quit
Text-messaging programs on phones seem to help smokers quit. The jury’s still out on smartphone apps for smoking cessation when used by patients, but they may help nurses improve screening, several separate studies suggest.
The interactive text-messaging program Text2Quit helped U.S. smokers quit and stay off cigarettes in a 6-month randomized, controlled trial in 503 adults who smoked at least five cigarettes a day, owned a cell phone with an unlimited service plan for short text messaging, and had expressed an interest in quitting cigarettes. Participants already were avid texters, sending or receiving an average of 29 text messages per day before they enrolled in the study.
At the 6-month follow-up, 20% of 241 people in the Text2Quit group said they had not smoked in the prior 7 days, compared with 10% of 262 people in the control group, reported Lorien C. Abroms, Sc.D., and her associates.
Laboratory analyses of saliva from 54 members of the intervention group and 32 in the control group showed that nearly a quarter of participants had lied about quitting. Text2Quit still was effective, however, with biochemically confirmed abstinence from smoking in 11% of the intervention group and 5% of the control group (Am. J. Prev. Med. 2014 June 5 [doi: 10.1016/j.amepre.2014.04.010]). Those biochemical quit rates are similar to rates reported in studies of other text-messaging programs for smoking cessation or of telephone quit-line counseling, she said.
The results support a meta-analysis of five studies that found mobile phone–based interventions (predominantly text messaging) for smoking cessation increased 6-month quit rates (Cochrane Database Syst. Rev. 2012;11:CD006611 [doi: 10.1002/14651858]). Most U.S. studies, however, have been small, uncontrolled pilot trials with shorter follow-up and no biochemical verification of quit rates, Dr. Abroms said.
Text2Quit costs $30 for a 4-month subscription unless you have a code from a sponsoring organization. When U.S. smokers call the national quit-line number (1-800-QUIT-NOW), residents of some states get offered Text2Quit. More than 50,000 smokers have enrolled since the program became available in 2011, reported Dr. Abroms of George Washington University, Washington. Other text-messaging programs are available, such as the free SmokefreeTXT program from the National Cancer Institute’s smokefree.gov site.
People randomized to the control group in Dr. Abroms’ trial initially were given a link to smokefree.gov, but after the launch of SmokefreeTXT in 2011, new control group members instead were given a link to the National Cancer Institute’s "Clearing the Air" guidebook on quitting smoking.
Text2Quit consists of automated, bidirectional text messages, with extra support from e-mails and a web portal. The texts prompt users to track their smoking and report on their cravings and smoking status, with the messages to participants tailored by the reasons for quitting, money saved, and use of medications for smoking cessation. The frequency of texts peaked around the smoker’s chosen quit date, with five texts on that date, approximately two per day in the following week, three per week in the next 2 months, and less than one per week after that.
Considering that an estimated 75% of adults around the world have access to cell phones, text-messaging interventions potentially could puff up the number of quitters, she suggested.
Smartphones aren’t yet as ubiquitous but, still, an estimated 11 million U.S. smokers own a smartphone, Dr. Abroms wrote in a separate study of apps for smoking cessation. We don’t yet know if any of the 400 smoking cessation apps that were available in 2012 work, but her analysis of 98 of the most popular smoking cessation apps found that they seldom include information and strategies that have been proven to help smokers quit.
She and her associates rated 47 apps for iPhones and 51 for Android phones on a 42-point scale, with a top score indicating adherence to the U.S. Public Health Service’s Clinical Practice Guidelines for Treating Tobacco Use and Dependence. The average score was 13. No apps recommended calling a quit line, for example. Only 4% recommended using medications approved for smoking cessation. Only 19% offered practical counseling or advice on how to quit or stay quit (Am. J. Prev. Med. 2013;45:732-36).
On the other hand, it’s possible that national guidelines that were developed for clinical settings don’t apply to mobile apps. If the apps somehow are effective, their reach could magnify any impact, Dr. Abroms suggested. Approximately 779,400 English-language apps for smoking cessation were downloaded per month for Android phones alone during the study period. (The iTunes App Store does not provide numbers for downloads.) That’s more than the approximately 100,000 calls per month to the national quit line in the same time period and 200,000 unique visitors per month to a leading website for smoking cessation, she reported.
"Text messaging programs for smoking cessation have a reasonably good evidence base," according to Dr. Abroms. "The evidence for smartphone apps is still in its early stages. I would not recommend them as a stand-alone intervention, though many with tracking elements may be useful as part of a comprehensive program. Apps that include games could be good as a distraction from smoking."
A separate study found that an experimental "decision support system" app, created for use by nurses on smartphones and tablets, improved rates of screening and counseling for tobacco use by prompting nurses to screen for tobacco use and offered guideline-based treatment recommendations, reported Kenrick Cato, Ph.D. of Columbia University, New York, and his associates.
The 185 registered nurses who were enrolled in advanced practice degree programs handled 14,115 clinic visits, in which they asked patients about smoking status in 84% of visits and offered cessation counseling to 90% of those who expressed a willingness to stop smoking (Oncol. Nurs. Forum 2014;41:145-52).
That compares favorably with federal U.S. data suggesting that tobacco screening happens in approximately 60% of clinic visits, and fewer than 20% of patients get counseling on quitting, Dr. Cato said in a prepared statement released by the university. The federal Healthy People 2020 program aims for tobacco screening in 69% of office visits and counseling rates of 21%, he said.
If further development of the app confirms that it’s useful, it could light a fire under tobacco screening.
Dr. Abroms designed Text2Quit and receives royalties from sales. Dr. Cato reported having no financial disclosures.
On Twitter @sherryboschert
Text-messaging programs on phones seem to help smokers quit. The jury’s still out on smartphone apps for smoking cessation when used by patients, but they may help nurses improve screening, several separate studies suggest.
The interactive text-messaging program Text2Quit helped U.S. smokers quit and stay off cigarettes in a 6-month randomized, controlled trial in 503 adults who smoked at least five cigarettes a day, owned a cell phone with an unlimited service plan for short text messaging, and had expressed an interest in quitting cigarettes. Participants already were avid texters, sending or receiving an average of 29 text messages per day before they enrolled in the study.
At the 6-month follow-up, 20% of 241 people in the Text2Quit group said they had not smoked in the prior 7 days, compared with 10% of 262 people in the control group, reported Lorien C. Abroms, Sc.D., and her associates.
Laboratory analyses of saliva from 54 members of the intervention group and 32 in the control group showed that nearly a quarter of participants had lied about quitting. Text2Quit still was effective, however, with biochemically confirmed abstinence from smoking in 11% of the intervention group and 5% of the control group (Am. J. Prev. Med. 2014 June 5 [doi: 10.1016/j.amepre.2014.04.010]). Those biochemical quit rates are similar to rates reported in studies of other text-messaging programs for smoking cessation or of telephone quit-line counseling, she said.
The results support a meta-analysis of five studies that found mobile phone–based interventions (predominantly text messaging) for smoking cessation increased 6-month quit rates (Cochrane Database Syst. Rev. 2012;11:CD006611 [doi: 10.1002/14651858]). Most U.S. studies, however, have been small, uncontrolled pilot trials with shorter follow-up and no biochemical verification of quit rates, Dr. Abroms said.
Text2Quit costs $30 for a 4-month subscription unless you have a code from a sponsoring organization. When U.S. smokers call the national quit-line number (1-800-QUIT-NOW), residents of some states get offered Text2Quit. More than 50,000 smokers have enrolled since the program became available in 2011, reported Dr. Abroms of George Washington University, Washington. Other text-messaging programs are available, such as the free SmokefreeTXT program from the National Cancer Institute’s smokefree.gov site.
People randomized to the control group in Dr. Abroms’ trial initially were given a link to smokefree.gov, but after the launch of SmokefreeTXT in 2011, new control group members instead were given a link to the National Cancer Institute’s "Clearing the Air" guidebook on quitting smoking.
Text2Quit consists of automated, bidirectional text messages, with extra support from e-mails and a web portal. The texts prompt users to track their smoking and report on their cravings and smoking status, with the messages to participants tailored by the reasons for quitting, money saved, and use of medications for smoking cessation. The frequency of texts peaked around the smoker’s chosen quit date, with five texts on that date, approximately two per day in the following week, three per week in the next 2 months, and less than one per week after that.
Considering that an estimated 75% of adults around the world have access to cell phones, text-messaging interventions potentially could puff up the number of quitters, she suggested.
Smartphones aren’t yet as ubiquitous but, still, an estimated 11 million U.S. smokers own a smartphone, Dr. Abroms wrote in a separate study of apps for smoking cessation. We don’t yet know if any of the 400 smoking cessation apps that were available in 2012 work, but her analysis of 98 of the most popular smoking cessation apps found that they seldom include information and strategies that have been proven to help smokers quit.
She and her associates rated 47 apps for iPhones and 51 for Android phones on a 42-point scale, with a top score indicating adherence to the U.S. Public Health Service’s Clinical Practice Guidelines for Treating Tobacco Use and Dependence. The average score was 13. No apps recommended calling a quit line, for example. Only 4% recommended using medications approved for smoking cessation. Only 19% offered practical counseling or advice on how to quit or stay quit (Am. J. Prev. Med. 2013;45:732-36).
On the other hand, it’s possible that national guidelines that were developed for clinical settings don’t apply to mobile apps. If the apps somehow are effective, their reach could magnify any impact, Dr. Abroms suggested. Approximately 779,400 English-language apps for smoking cessation were downloaded per month for Android phones alone during the study period. (The iTunes App Store does not provide numbers for downloads.) That’s more than the approximately 100,000 calls per month to the national quit line in the same time period and 200,000 unique visitors per month to a leading website for smoking cessation, she reported.
"Text messaging programs for smoking cessation have a reasonably good evidence base," according to Dr. Abroms. "The evidence for smartphone apps is still in its early stages. I would not recommend them as a stand-alone intervention, though many with tracking elements may be useful as part of a comprehensive program. Apps that include games could be good as a distraction from smoking."
A separate study found that an experimental "decision support system" app, created for use by nurses on smartphones and tablets, improved rates of screening and counseling for tobacco use by prompting nurses to screen for tobacco use and offered guideline-based treatment recommendations, reported Kenrick Cato, Ph.D. of Columbia University, New York, and his associates.
The 185 registered nurses who were enrolled in advanced practice degree programs handled 14,115 clinic visits, in which they asked patients about smoking status in 84% of visits and offered cessation counseling to 90% of those who expressed a willingness to stop smoking (Oncol. Nurs. Forum 2014;41:145-52).
That compares favorably with federal U.S. data suggesting that tobacco screening happens in approximately 60% of clinic visits, and fewer than 20% of patients get counseling on quitting, Dr. Cato said in a prepared statement released by the university. The federal Healthy People 2020 program aims for tobacco screening in 69% of office visits and counseling rates of 21%, he said.
If further development of the app confirms that it’s useful, it could light a fire under tobacco screening.
Dr. Abroms designed Text2Quit and receives royalties from sales. Dr. Cato reported having no financial disclosures.
On Twitter @sherryboschert
Text-messaging programs on phones seem to help smokers quit. The jury’s still out on smartphone apps for smoking cessation when used by patients, but they may help nurses improve screening, several separate studies suggest.
The interactive text-messaging program Text2Quit helped U.S. smokers quit and stay off cigarettes in a 6-month randomized, controlled trial in 503 adults who smoked at least five cigarettes a day, owned a cell phone with an unlimited service plan for short text messaging, and had expressed an interest in quitting cigarettes. Participants already were avid texters, sending or receiving an average of 29 text messages per day before they enrolled in the study.
At the 6-month follow-up, 20% of 241 people in the Text2Quit group said they had not smoked in the prior 7 days, compared with 10% of 262 people in the control group, reported Lorien C. Abroms, Sc.D., and her associates.
Laboratory analyses of saliva from 54 members of the intervention group and 32 in the control group showed that nearly a quarter of participants had lied about quitting. Text2Quit still was effective, however, with biochemically confirmed abstinence from smoking in 11% of the intervention group and 5% of the control group (Am. J. Prev. Med. 2014 June 5 [doi: 10.1016/j.amepre.2014.04.010]). Those biochemical quit rates are similar to rates reported in studies of other text-messaging programs for smoking cessation or of telephone quit-line counseling, she said.
The results support a meta-analysis of five studies that found mobile phone–based interventions (predominantly text messaging) for smoking cessation increased 6-month quit rates (Cochrane Database Syst. Rev. 2012;11:CD006611 [doi: 10.1002/14651858]). Most U.S. studies, however, have been small, uncontrolled pilot trials with shorter follow-up and no biochemical verification of quit rates, Dr. Abroms said.
Text2Quit costs $30 for a 4-month subscription unless you have a code from a sponsoring organization. When U.S. smokers call the national quit-line number (1-800-QUIT-NOW), residents of some states get offered Text2Quit. More than 50,000 smokers have enrolled since the program became available in 2011, reported Dr. Abroms of George Washington University, Washington. Other text-messaging programs are available, such as the free SmokefreeTXT program from the National Cancer Institute’s smokefree.gov site.
People randomized to the control group in Dr. Abroms’ trial initially were given a link to smokefree.gov, but after the launch of SmokefreeTXT in 2011, new control group members instead were given a link to the National Cancer Institute’s "Clearing the Air" guidebook on quitting smoking.
Text2Quit consists of automated, bidirectional text messages, with extra support from e-mails and a web portal. The texts prompt users to track their smoking and report on their cravings and smoking status, with the messages to participants tailored by the reasons for quitting, money saved, and use of medications for smoking cessation. The frequency of texts peaked around the smoker’s chosen quit date, with five texts on that date, approximately two per day in the following week, three per week in the next 2 months, and less than one per week after that.
Considering that an estimated 75% of adults around the world have access to cell phones, text-messaging interventions potentially could puff up the number of quitters, she suggested.
Smartphones aren’t yet as ubiquitous but, still, an estimated 11 million U.S. smokers own a smartphone, Dr. Abroms wrote in a separate study of apps for smoking cessation. We don’t yet know if any of the 400 smoking cessation apps that were available in 2012 work, but her analysis of 98 of the most popular smoking cessation apps found that they seldom include information and strategies that have been proven to help smokers quit.
She and her associates rated 47 apps for iPhones and 51 for Android phones on a 42-point scale, with a top score indicating adherence to the U.S. Public Health Service’s Clinical Practice Guidelines for Treating Tobacco Use and Dependence. The average score was 13. No apps recommended calling a quit line, for example. Only 4% recommended using medications approved for smoking cessation. Only 19% offered practical counseling or advice on how to quit or stay quit (Am. J. Prev. Med. 2013;45:732-36).
On the other hand, it’s possible that national guidelines that were developed for clinical settings don’t apply to mobile apps. If the apps somehow are effective, their reach could magnify any impact, Dr. Abroms suggested. Approximately 779,400 English-language apps for smoking cessation were downloaded per month for Android phones alone during the study period. (The iTunes App Store does not provide numbers for downloads.) That’s more than the approximately 100,000 calls per month to the national quit line in the same time period and 200,000 unique visitors per month to a leading website for smoking cessation, she reported.
"Text messaging programs for smoking cessation have a reasonably good evidence base," according to Dr. Abroms. "The evidence for smartphone apps is still in its early stages. I would not recommend them as a stand-alone intervention, though many with tracking elements may be useful as part of a comprehensive program. Apps that include games could be good as a distraction from smoking."
A separate study found that an experimental "decision support system" app, created for use by nurses on smartphones and tablets, improved rates of screening and counseling for tobacco use by prompting nurses to screen for tobacco use and offered guideline-based treatment recommendations, reported Kenrick Cato, Ph.D. of Columbia University, New York, and his associates.
The 185 registered nurses who were enrolled in advanced practice degree programs handled 14,115 clinic visits, in which they asked patients about smoking status in 84% of visits and offered cessation counseling to 90% of those who expressed a willingness to stop smoking (Oncol. Nurs. Forum 2014;41:145-52).
That compares favorably with federal U.S. data suggesting that tobacco screening happens in approximately 60% of clinic visits, and fewer than 20% of patients get counseling on quitting, Dr. Cato said in a prepared statement released by the university. The federal Healthy People 2020 program aims for tobacco screening in 69% of office visits and counseling rates of 21%, he said.
If further development of the app confirms that it’s useful, it could light a fire under tobacco screening.
Dr. Abroms designed Text2Quit and receives royalties from sales. Dr. Cato reported having no financial disclosures.
On Twitter @sherryboschert
Pharmacist-led clinic helps improve diabetes outcomes
SAN FRANCISCO – Hemoglobin A1c levels fell by 2.4% in veterans with diabetes whose primary care physicians referred them to a 6-month pharmacist-led intense management clinic, compared with a 0.2% drop in similar patients who did not attend the clinic.
That translates to a $9,104 reduction in estimated 3-year medical costs for each patient seen in the clinic and a $1,803 drop in costs in the comparison group, reported Candis M. Morello, Pharm.D. The changes in HbA1c and costs in the intervention group were significant, compared with the nonclinic group.
After factoring in the $61,992 cost of the pharmacist over 3 years, $7.81 would be saved for every $1 spent on the program, said Dr. Morello of the University of California, San Diego, and director of the diabetes intense medical management clinic in the Veterans Affairs San Diego Healthcare System.
The clinic is a collaborative practice between an endocrinologist and a doctor of pharmacy who also is a certified diabetes educator and has full prescribing privileges. The pharmacist spends 4 hours/week in the clinic and 3 hours/week on phone follow-up calls to manage 60 patients per year who have HbA1c levels of at least 8%, high comorbidity, and complex medication regimens.
Patients are referred by primary care providers for the 6-month "tune-up" clinic involving three to five hour-long, one-on-one visits between the patient and the pharmacist. After that, patients return to their primary care providers but can make follow-up phone calls to the clinic.
The tune-up focuses on finding the best combination of medications for the individual patient, education on medication adherence, simplifying the drug regimen to fit around the patient’s schedule, and setting personalized goals.
The study compared clinic patients with a random sample of patients treated by primary care providers in the same time period. Initial HbA1c levels were 10.5% in the clinic group and 9.3% in the comparison group, Dr. Morello and her associates reported at the annual scientific session of the American Diabetes Association.
They used a published regression model applied to retrospective chart data to estimate the 3-year costs of medical care (Diabetes Care 1997;20:1847-53). Based on baseline health status (largely driven by HbA1c levels), estimated costs per patient were $42,032 in the clinic group and $37,065 in the comparison group. Assuming that HbA1c changes were maintained 3 years later, estimated costs of care were $32,928 in the clinic group and $35,262 in the comparison group.
For 60 patients seen per year in the clinic, that amounts to a cumulative potential $546,240 savings from reduced costs, for a benefit-to-cost ratio of $8.81 and a return on investment of $7.81, she said.
If mean HbA1c levels rise by 1% over 3 years, the estimated medical cost avoided would be $6,412 per patient in the clinic group, still better than results in the comparison group, a secondary analysis found. That adds up to $384,720 in costs avoided over 3 years, for a benefit-to-cost ratio of $6.21 and a $5.21 return on investment after factoring in the cost of the pharmacist.
"I’m pretty sure that spending a little bit of money on the front end saves money on the back end," Dr. Morello said.
She reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Hemoglobin A1c levels fell by 2.4% in veterans with diabetes whose primary care physicians referred them to a 6-month pharmacist-led intense management clinic, compared with a 0.2% drop in similar patients who did not attend the clinic.
That translates to a $9,104 reduction in estimated 3-year medical costs for each patient seen in the clinic and a $1,803 drop in costs in the comparison group, reported Candis M. Morello, Pharm.D. The changes in HbA1c and costs in the intervention group were significant, compared with the nonclinic group.
After factoring in the $61,992 cost of the pharmacist over 3 years, $7.81 would be saved for every $1 spent on the program, said Dr. Morello of the University of California, San Diego, and director of the diabetes intense medical management clinic in the Veterans Affairs San Diego Healthcare System.
The clinic is a collaborative practice between an endocrinologist and a doctor of pharmacy who also is a certified diabetes educator and has full prescribing privileges. The pharmacist spends 4 hours/week in the clinic and 3 hours/week on phone follow-up calls to manage 60 patients per year who have HbA1c levels of at least 8%, high comorbidity, and complex medication regimens.
Patients are referred by primary care providers for the 6-month "tune-up" clinic involving three to five hour-long, one-on-one visits between the patient and the pharmacist. After that, patients return to their primary care providers but can make follow-up phone calls to the clinic.
The tune-up focuses on finding the best combination of medications for the individual patient, education on medication adherence, simplifying the drug regimen to fit around the patient’s schedule, and setting personalized goals.
The study compared clinic patients with a random sample of patients treated by primary care providers in the same time period. Initial HbA1c levels were 10.5% in the clinic group and 9.3% in the comparison group, Dr. Morello and her associates reported at the annual scientific session of the American Diabetes Association.
They used a published regression model applied to retrospective chart data to estimate the 3-year costs of medical care (Diabetes Care 1997;20:1847-53). Based on baseline health status (largely driven by HbA1c levels), estimated costs per patient were $42,032 in the clinic group and $37,065 in the comparison group. Assuming that HbA1c changes were maintained 3 years later, estimated costs of care were $32,928 in the clinic group and $35,262 in the comparison group.
For 60 patients seen per year in the clinic, that amounts to a cumulative potential $546,240 savings from reduced costs, for a benefit-to-cost ratio of $8.81 and a return on investment of $7.81, she said.
If mean HbA1c levels rise by 1% over 3 years, the estimated medical cost avoided would be $6,412 per patient in the clinic group, still better than results in the comparison group, a secondary analysis found. That adds up to $384,720 in costs avoided over 3 years, for a benefit-to-cost ratio of $6.21 and a $5.21 return on investment after factoring in the cost of the pharmacist.
"I’m pretty sure that spending a little bit of money on the front end saves money on the back end," Dr. Morello said.
She reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Hemoglobin A1c levels fell by 2.4% in veterans with diabetes whose primary care physicians referred them to a 6-month pharmacist-led intense management clinic, compared with a 0.2% drop in similar patients who did not attend the clinic.
That translates to a $9,104 reduction in estimated 3-year medical costs for each patient seen in the clinic and a $1,803 drop in costs in the comparison group, reported Candis M. Morello, Pharm.D. The changes in HbA1c and costs in the intervention group were significant, compared with the nonclinic group.
After factoring in the $61,992 cost of the pharmacist over 3 years, $7.81 would be saved for every $1 spent on the program, said Dr. Morello of the University of California, San Diego, and director of the diabetes intense medical management clinic in the Veterans Affairs San Diego Healthcare System.
The clinic is a collaborative practice between an endocrinologist and a doctor of pharmacy who also is a certified diabetes educator and has full prescribing privileges. The pharmacist spends 4 hours/week in the clinic and 3 hours/week on phone follow-up calls to manage 60 patients per year who have HbA1c levels of at least 8%, high comorbidity, and complex medication regimens.
Patients are referred by primary care providers for the 6-month "tune-up" clinic involving three to five hour-long, one-on-one visits between the patient and the pharmacist. After that, patients return to their primary care providers but can make follow-up phone calls to the clinic.
The tune-up focuses on finding the best combination of medications for the individual patient, education on medication adherence, simplifying the drug regimen to fit around the patient’s schedule, and setting personalized goals.
The study compared clinic patients with a random sample of patients treated by primary care providers in the same time period. Initial HbA1c levels were 10.5% in the clinic group and 9.3% in the comparison group, Dr. Morello and her associates reported at the annual scientific session of the American Diabetes Association.
They used a published regression model applied to retrospective chart data to estimate the 3-year costs of medical care (Diabetes Care 1997;20:1847-53). Based on baseline health status (largely driven by HbA1c levels), estimated costs per patient were $42,032 in the clinic group and $37,065 in the comparison group. Assuming that HbA1c changes were maintained 3 years later, estimated costs of care were $32,928 in the clinic group and $35,262 in the comparison group.
For 60 patients seen per year in the clinic, that amounts to a cumulative potential $546,240 savings from reduced costs, for a benefit-to-cost ratio of $8.81 and a return on investment of $7.81, she said.
If mean HbA1c levels rise by 1% over 3 years, the estimated medical cost avoided would be $6,412 per patient in the clinic group, still better than results in the comparison group, a secondary analysis found. That adds up to $384,720 in costs avoided over 3 years, for a benefit-to-cost ratio of $6.21 and a $5.21 return on investment after factoring in the cost of the pharmacist.
"I’m pretty sure that spending a little bit of money on the front end saves money on the back end," Dr. Morello said.
She reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ADA ANNUAL SCIENTIFIC SESSION
Key clinical point: A 6-month pharmacist-led diabetes clinic lowered HbA1c levels and reduced estimated costs.
Major finding: HbA1c levels fell by 2.4% in the intervention group and 0.2% in the comparison group.
Data source: A retrospective comparison of data on 85 patients in the intervention group and 51 patients seen in primary care clinics.
Disclosures: Dr. Morello reported having no financial disclosures.
Olodaterol LABA approved for some COPD patients
The Food and Drug Administration approved olodaterol inhalation spray to treat airflow obstruction in patients with chronic obstructive pulmonary disease.
The drug (Striverdi Respimat, by Boehringer Ingelheim Pharmaceuticals) can be used once daily over a long period of time but should not be used as a rescue therapy to treat sudden breathing problems or in patients with acutely deteriorating chronic obstructive pulmonary disease (COPD), according to an FDA statement.
"This new long-term maintenance medication provides an additional treatment option for the millions of Americans who suffer with COPD," Dr. Curtis Rosebraugh of the FDA said in the statement.
Olodaterol is a long-acting beta-adrenergic agonist (LABA) that relaxes muscles around the lungs’ airways and helps them stay relaxed to prevent symptoms. In controlled, 48-week clinical trials in 3,104 patients with diagnosed COPD, investigators found improved lung function in those on olodaterol, compared with placebo.
The FDA’s approval included a boxed warning that LABA medications increase the risk of asthma-related death. Olodaterol is not approved to treat asthma, and the safety and effectiveness of the drug in people with asthma have not been established.
Serious side effects from olodaterol can include narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects. The most common side effects reported in clinical trials are runny nose, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and arthralgia.
On Twitter @sherryboschert
The Food and Drug Administration approved olodaterol inhalation spray to treat airflow obstruction in patients with chronic obstructive pulmonary disease.
The drug (Striverdi Respimat, by Boehringer Ingelheim Pharmaceuticals) can be used once daily over a long period of time but should not be used as a rescue therapy to treat sudden breathing problems or in patients with acutely deteriorating chronic obstructive pulmonary disease (COPD), according to an FDA statement.
"This new long-term maintenance medication provides an additional treatment option for the millions of Americans who suffer with COPD," Dr. Curtis Rosebraugh of the FDA said in the statement.
Olodaterol is a long-acting beta-adrenergic agonist (LABA) that relaxes muscles around the lungs’ airways and helps them stay relaxed to prevent symptoms. In controlled, 48-week clinical trials in 3,104 patients with diagnosed COPD, investigators found improved lung function in those on olodaterol, compared with placebo.
The FDA’s approval included a boxed warning that LABA medications increase the risk of asthma-related death. Olodaterol is not approved to treat asthma, and the safety and effectiveness of the drug in people with asthma have not been established.
Serious side effects from olodaterol can include narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects. The most common side effects reported in clinical trials are runny nose, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and arthralgia.
On Twitter @sherryboschert
The Food and Drug Administration approved olodaterol inhalation spray to treat airflow obstruction in patients with chronic obstructive pulmonary disease.
The drug (Striverdi Respimat, by Boehringer Ingelheim Pharmaceuticals) can be used once daily over a long period of time but should not be used as a rescue therapy to treat sudden breathing problems or in patients with acutely deteriorating chronic obstructive pulmonary disease (COPD), according to an FDA statement.
"This new long-term maintenance medication provides an additional treatment option for the millions of Americans who suffer with COPD," Dr. Curtis Rosebraugh of the FDA said in the statement.
Olodaterol is a long-acting beta-adrenergic agonist (LABA) that relaxes muscles around the lungs’ airways and helps them stay relaxed to prevent symptoms. In controlled, 48-week clinical trials in 3,104 patients with diagnosed COPD, investigators found improved lung function in those on olodaterol, compared with placebo.
The FDA’s approval included a boxed warning that LABA medications increase the risk of asthma-related death. Olodaterol is not approved to treat asthma, and the safety and effectiveness of the drug in people with asthma have not been established.
Serious side effects from olodaterol can include narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects. The most common side effects reported in clinical trials are runny nose, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and arthralgia.
On Twitter @sherryboschert
Guideline adjusts perioperative cardiac care in noncardiac surgery
A new clinical practice guideline on cardiovascular evaluation and management of patients undergoing noncardiac surgery adds some clarity around the controversial issue of beta-blocker therapy and updates other aspects of care.
If a patient on beta-blocker medication needs noncardiac surgery, continue the beta-blocker, because there is no evidence of harm from doing so; but you risk doing harm if the drug is stopped, according to the new guideline from the American College of Cardiology (ACC) and the American Heart Association (AHA).
Surgeons will be happy to hear that, said Dr. Lee A. Fleisher, the chair of the guideline-writing committee, because that conforms to one of the Surgical Care Improvement Project’s National Measures.
For patients at elevated risk of a cardiovascular event during noncardiac surgery who are not already on beta-blocker therapy, however, the new guideline steps back from the organization’s 2009 position that beta-blockers not be started, and says instead that it’s not unreasonable to start the drug, with a caveat. Be very cautious and start the drug early enough before surgery that you can titrate it to avoid causing hypotension or a low heart rate.
"Make sure that you’re giving the right amount and monitoring their blood pressure and heart rate," Dr. Fleisher, chair of the guideline writing committee, said in an interview. "Really think once, twice, and thrice about starting a protocol," added Dr. Fleisher, the Robert D. Dripps Professor of Anesthesiology and Critical Care at the University of Pennsylvania, Philadelphia.
The ACC and AHA commissioned a committee to review the evidence for and against beta-blockers in patients undergoing noncardiac surgery. A separate writing committee then considered the evidence review committee’s report, reviewed the literature on other aspects of perioperative care for noncardiac surgery, and compiled a 102-page guideline with a 59-page executive summary.
The "2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery" will be published online on the ACC and AHA websites.
Dr. Fleisher described other highlights of the new guideline pertinent to cardiologists, primary care physicians, or surgeons. For the first time, palliative care has been added as an option that may come out of the preoperative evaluation, he said. Patient categories of high risk and intermediate risk have been lumped together as having "elevated" risk for simplicity’s sake because recommendations for the two separate categories were so similar.
The guideline now endorses two tools to choose from for preoperative risk assessments: the Revised Cardiac Risk Index (RCRI), and the National Surgical Quality Improvement Project risk calculator. "There have been a lot of comments that [the NSQIP] is a very useful tool to have shared decision-making conversations with patients," he said.
Another change applies to patients who receive second- or third-generation coronary stents. Instead of a wait of a year after stent implantation to perform noncardiac surgery, a 6-month wait may be reasonable if the risks of delaying noncardiac surgery outweigh the risks of interrupting dual-antiplatelet therapy for the noncardiac surgery.
In addition, the guideline incorporates findings from the recent POISE-2 study to say that aspirin can be stopped and clonidine is not useful in patients without stents undergoing noncardiac surgery (N. Engl. J. Med. 2014;370:1494-503).
A new statement in the guideline about troponin says to check troponin in high-risk patients with signs or symptoms of trouble but not to include troponin in routine screening.
The recommendations on beta-blockers, however, address the most controversial topic in the guideline, Dr. Fleisher said. "There is a lot of confusing evidence" on the use of beta-blockers, "so we’ve tried to clarify as much as we can."
The ACC and AHA funded the work of the committees. Dr. Fleisher reported having no financial disclosures.
On Twitter @sherryboschert
A new clinical practice guideline on cardiovascular evaluation and management of patients undergoing noncardiac surgery adds some clarity around the controversial issue of beta-blocker therapy and updates other aspects of care.
If a patient on beta-blocker medication needs noncardiac surgery, continue the beta-blocker, because there is no evidence of harm from doing so; but you risk doing harm if the drug is stopped, according to the new guideline from the American College of Cardiology (ACC) and the American Heart Association (AHA).
Surgeons will be happy to hear that, said Dr. Lee A. Fleisher, the chair of the guideline-writing committee, because that conforms to one of the Surgical Care Improvement Project’s National Measures.
For patients at elevated risk of a cardiovascular event during noncardiac surgery who are not already on beta-blocker therapy, however, the new guideline steps back from the organization’s 2009 position that beta-blockers not be started, and says instead that it’s not unreasonable to start the drug, with a caveat. Be very cautious and start the drug early enough before surgery that you can titrate it to avoid causing hypotension or a low heart rate.
"Make sure that you’re giving the right amount and monitoring their blood pressure and heart rate," Dr. Fleisher, chair of the guideline writing committee, said in an interview. "Really think once, twice, and thrice about starting a protocol," added Dr. Fleisher, the Robert D. Dripps Professor of Anesthesiology and Critical Care at the University of Pennsylvania, Philadelphia.
The ACC and AHA commissioned a committee to review the evidence for and against beta-blockers in patients undergoing noncardiac surgery. A separate writing committee then considered the evidence review committee’s report, reviewed the literature on other aspects of perioperative care for noncardiac surgery, and compiled a 102-page guideline with a 59-page executive summary.
The "2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery" will be published online on the ACC and AHA websites.
Dr. Fleisher described other highlights of the new guideline pertinent to cardiologists, primary care physicians, or surgeons. For the first time, palliative care has been added as an option that may come out of the preoperative evaluation, he said. Patient categories of high risk and intermediate risk have been lumped together as having "elevated" risk for simplicity’s sake because recommendations for the two separate categories were so similar.
The guideline now endorses two tools to choose from for preoperative risk assessments: the Revised Cardiac Risk Index (RCRI), and the National Surgical Quality Improvement Project risk calculator. "There have been a lot of comments that [the NSQIP] is a very useful tool to have shared decision-making conversations with patients," he said.
Another change applies to patients who receive second- or third-generation coronary stents. Instead of a wait of a year after stent implantation to perform noncardiac surgery, a 6-month wait may be reasonable if the risks of delaying noncardiac surgery outweigh the risks of interrupting dual-antiplatelet therapy for the noncardiac surgery.
In addition, the guideline incorporates findings from the recent POISE-2 study to say that aspirin can be stopped and clonidine is not useful in patients without stents undergoing noncardiac surgery (N. Engl. J. Med. 2014;370:1494-503).
A new statement in the guideline about troponin says to check troponin in high-risk patients with signs or symptoms of trouble but not to include troponin in routine screening.
The recommendations on beta-blockers, however, address the most controversial topic in the guideline, Dr. Fleisher said. "There is a lot of confusing evidence" on the use of beta-blockers, "so we’ve tried to clarify as much as we can."
The ACC and AHA funded the work of the committees. Dr. Fleisher reported having no financial disclosures.
On Twitter @sherryboschert
A new clinical practice guideline on cardiovascular evaluation and management of patients undergoing noncardiac surgery adds some clarity around the controversial issue of beta-blocker therapy and updates other aspects of care.
If a patient on beta-blocker medication needs noncardiac surgery, continue the beta-blocker, because there is no evidence of harm from doing so; but you risk doing harm if the drug is stopped, according to the new guideline from the American College of Cardiology (ACC) and the American Heart Association (AHA).
Surgeons will be happy to hear that, said Dr. Lee A. Fleisher, the chair of the guideline-writing committee, because that conforms to one of the Surgical Care Improvement Project’s National Measures.
For patients at elevated risk of a cardiovascular event during noncardiac surgery who are not already on beta-blocker therapy, however, the new guideline steps back from the organization’s 2009 position that beta-blockers not be started, and says instead that it’s not unreasonable to start the drug, with a caveat. Be very cautious and start the drug early enough before surgery that you can titrate it to avoid causing hypotension or a low heart rate.
"Make sure that you’re giving the right amount and monitoring their blood pressure and heart rate," Dr. Fleisher, chair of the guideline writing committee, said in an interview. "Really think once, twice, and thrice about starting a protocol," added Dr. Fleisher, the Robert D. Dripps Professor of Anesthesiology and Critical Care at the University of Pennsylvania, Philadelphia.
The ACC and AHA commissioned a committee to review the evidence for and against beta-blockers in patients undergoing noncardiac surgery. A separate writing committee then considered the evidence review committee’s report, reviewed the literature on other aspects of perioperative care for noncardiac surgery, and compiled a 102-page guideline with a 59-page executive summary.
The "2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery" will be published online on the ACC and AHA websites.
Dr. Fleisher described other highlights of the new guideline pertinent to cardiologists, primary care physicians, or surgeons. For the first time, palliative care has been added as an option that may come out of the preoperative evaluation, he said. Patient categories of high risk and intermediate risk have been lumped together as having "elevated" risk for simplicity’s sake because recommendations for the two separate categories were so similar.
The guideline now endorses two tools to choose from for preoperative risk assessments: the Revised Cardiac Risk Index (RCRI), and the National Surgical Quality Improvement Project risk calculator. "There have been a lot of comments that [the NSQIP] is a very useful tool to have shared decision-making conversations with patients," he said.
Another change applies to patients who receive second- or third-generation coronary stents. Instead of a wait of a year after stent implantation to perform noncardiac surgery, a 6-month wait may be reasonable if the risks of delaying noncardiac surgery outweigh the risks of interrupting dual-antiplatelet therapy for the noncardiac surgery.
In addition, the guideline incorporates findings from the recent POISE-2 study to say that aspirin can be stopped and clonidine is not useful in patients without stents undergoing noncardiac surgery (N. Engl. J. Med. 2014;370:1494-503).
A new statement in the guideline about troponin says to check troponin in high-risk patients with signs or symptoms of trouble but not to include troponin in routine screening.
The recommendations on beta-blockers, however, address the most controversial topic in the guideline, Dr. Fleisher said. "There is a lot of confusing evidence" on the use of beta-blockers, "so we’ve tried to clarify as much as we can."
The ACC and AHA funded the work of the committees. Dr. Fleisher reported having no financial disclosures.
On Twitter @sherryboschert
