User login
Patient adjustments needed for closed-loop insulin delivery
TORONTO – Closed-loop insulin delivery is expected to become the standard of care in type 1 diabetes mellitus (T1DM), but there are multiple barriers that patients need to overcome.
“Many people who are potentially going to be using closed-loop systems are enthusiastic but have unrealistic expectations of how the systems are going to perform, and there are many barriers to uptake and optimal use that we still haven’t quite figured out,” said Korey K. Hood, PhD, a professor in the departments of pediatrics and psychiatry & behavioral sciences at Stanford (Calif.) University.
In a session dedicated to all aspects of closed-loop automated insulin delivery at the Pediatric Academic Societies annual meeting, Dr. Hood offered comments on patient and family factors important to the uptake and use of closed-loop technologies. His research at Stanford is focused on understanding the psychosocial aspects of diabetes management and how these factors contribute to disease outcomes.
Closed-loop insulin delivery refers to technologies that combine automated glucose monitoring (AGM) with an algorithm to determine insulin needs and an insulin delivery device. Sometimes called an “artificial pancreas” or “bionic pancreas,” closed-loop insulin delivery is considered a significant advance in the management of T1DM, relegating daily finger sticks and nighttime hypoglycemia to things of the past.
In a recent meta-analysis of randomized clinical trials, use of any automated device added nearly 2.5 hours of time in near normoglycemia over 24 hours in patients with TIDM, compared with any other type of insulin-based treatment (BMJ. 2018. doi: 10.1136/bmj.k1310). The benefit was primarily based on better glucose control in the overnight period.
In September 2016, the Food and Drug Administration approved the MiniMed 670G Insulin Pump System (Medtronic), the first hybrid automated insulin delivery device for T1DM and the only one approved in the United States. The system is intended for subcutaneous continuous glucose monitoring (CGM) and continuous delivery of basal insulin and administration of insulin for the management of T1DM in persons 14 years of age and older.
Barriers from different perspectives
Barriers to uptake and use are common for the devices that are components of closed-loop systems. In a survey of 1,503 adults with TIDM, Dr. Hood’s group found a wide range of barriers to adoption of CGM or insulin pumps that could potentially also impact use of closed-loop systems (Diabetes Care. 2017;40:181-7). Some were nonmodifiable, like costs, but most were modifiable.
“Many people talk about the hassle of wearing devices. They don’t like having multiple devices on their bodies. They don’t always like the way that they look, and so these are things that we can have some kind of impact on and need to be paying attention to,” he said.
“The younger participants indicated a lot more barriers to using devices, and as they got older, they indicated fewer barriers. But what was also interesting is that the younger participants also indicated a lot more diabetes distress. As time went on, that was less of a factor in whether or not people were using diabetes devices,” reported Dr. Hood.
Not surprisingly, he added, was that younger participants had more favorable views of technology in general. “But they had less favorable views of diabetes technology [than older participants], so they’re really not crazy about using these devices.”
Dr. Hood’s group has also studied whether patient-reported barriers to CGM use align with what clinicians perceive to be patient-related barriers (Diabetes Sci Technol. 2017;11[3]484-92). Similar to the patients, clinicians most frequently endorsed the perception that patients dislike having the device on their body. However, other things they felt their patients worried about were the alarms on the device and the difficulty in understanding its features, neither of which patients considered a primary barrier to CGM or insulin pump adoption.
“So, we need to be cautious and mindful as we move forward that there are mismatches between the patient-reported and clinician-reported barriers,” said Dr. Hood. “Our response, often, is to teach and to provide some kind of education, when that’s not necessarily what the patient is asking for.”
Would you use it?
In 2017, a group of investigators conducted a qualitative study of 284 participants, ranging in age from 8 to 86 years, with T1DM. The researchers used structured interviews or focus groups to explore expectations, desired features, potential benefits, and perceived burdens of automated insulin delivery systems (Diabetes Care. 2017;40[11]:1453-61).
“We were interested in children, adolescents, and adults with type 1, and then also the partners of the adults and the parents of the youth,” he explained.
“The findings revealed three themes identified as pressing for the uptake of automated insulin delivery: considerations of trust and control, system features, and concerns and barriers to adoption.
“For children, the areas of most concern revolved around specific social situations. Adolescents, on the other hand, were more concerned about the physical features of the device, the wearability, the discreetness of using it, and the comfort,” said Dr. Hood.
Adults and parents were much more interested in device accuracy, safety, adaptability, and algorithm quality. “For the kids and teens, not surprisingly, this wasn’t high on their list,” he added.
A clear indication of the unrealistic expectations surrounding this technology came from a 2018 study of almost 200 family members, which found that “reducing the constant concerns about diabetes, relieving family stress, and improving overall family relationships” were the three major areas the participants hoped would be helped with automated insulin delivery (Diabetes Technol Ther. 2018;20[3]:222-8).
“If we come up with a device that does this, then I think we will have fixed everything!” Dr. Hood said, adding that it really highlights the “very high hopes and expectations” of what closed-loop systems should deliver.
Device readiness is another area researchers have studied in the run-up to closed-loop systems. “The idea that everybody’s going to be ready to start in the same way, I think, is going to set us up for some failures,” he noted, adding that, in general, parents are much more enthusiastic about this than pediatric patients.
“Individuals who had been using diabetes devices – and some had already been in closed-loop studies – They had more realistic expectations of what these systems are going to be, because they knew that it wasn’t going to be a complete fix. Whereas others with more limited experience with component devices and these systems had much higher expectations and reported a fair amount of dissatisfaction at the end of the study because it didn’t do everything that they wanted it to do.”
Waves of uptake
“Ultimately, a closed-loop system is going to be judged by whether it can increase time on target and reduce cognitive burden,” said Dr. Hood. He finished his talk with some projections about the future of closed-loop systems. “I think we’re going to probably to have different waves, or types, of closed-loop users.”
The first wave will be the group that’s already “sold” on the idea, which might encompass about 15% of patients. The second wave, which might represent about 30% of the relevant patient population, will be those who are sold on the idea and will likely use it but will have high expectations of the system’s ease of use and effectiveness and thus are highly likely to discontinue its use if those expectations are not met.
“The third wave will be those who might use a closed-loop system but might be unaware of them currently and will need a fair amount of education.” And, finally, the fourth group are unlikely to ever use closed-loop insulin delivery. “They are a group that feels burned by previous generations of systems, and I think that they may not perceive benefit,” Dr. Hood suggested.
“But all of this is to say that I do think that a tailored experience, and one that is focused on different profiles, can optimize both the uptake and the use of these systems.”
Dr. Hood reported receiving grant/research support from Dexcom and being a consultant for Lilly Innovation Center, J&J Diabetes Institute, and Bigfoot Biomedical.
TORONTO – Closed-loop insulin delivery is expected to become the standard of care in type 1 diabetes mellitus (T1DM), but there are multiple barriers that patients need to overcome.
“Many people who are potentially going to be using closed-loop systems are enthusiastic but have unrealistic expectations of how the systems are going to perform, and there are many barriers to uptake and optimal use that we still haven’t quite figured out,” said Korey K. Hood, PhD, a professor in the departments of pediatrics and psychiatry & behavioral sciences at Stanford (Calif.) University.
In a session dedicated to all aspects of closed-loop automated insulin delivery at the Pediatric Academic Societies annual meeting, Dr. Hood offered comments on patient and family factors important to the uptake and use of closed-loop technologies. His research at Stanford is focused on understanding the psychosocial aspects of diabetes management and how these factors contribute to disease outcomes.
Closed-loop insulin delivery refers to technologies that combine automated glucose monitoring (AGM) with an algorithm to determine insulin needs and an insulin delivery device. Sometimes called an “artificial pancreas” or “bionic pancreas,” closed-loop insulin delivery is considered a significant advance in the management of T1DM, relegating daily finger sticks and nighttime hypoglycemia to things of the past.
In a recent meta-analysis of randomized clinical trials, use of any automated device added nearly 2.5 hours of time in near normoglycemia over 24 hours in patients with TIDM, compared with any other type of insulin-based treatment (BMJ. 2018. doi: 10.1136/bmj.k1310). The benefit was primarily based on better glucose control in the overnight period.
In September 2016, the Food and Drug Administration approved the MiniMed 670G Insulin Pump System (Medtronic), the first hybrid automated insulin delivery device for T1DM and the only one approved in the United States. The system is intended for subcutaneous continuous glucose monitoring (CGM) and continuous delivery of basal insulin and administration of insulin for the management of T1DM in persons 14 years of age and older.
Barriers from different perspectives
Barriers to uptake and use are common for the devices that are components of closed-loop systems. In a survey of 1,503 adults with TIDM, Dr. Hood’s group found a wide range of barriers to adoption of CGM or insulin pumps that could potentially also impact use of closed-loop systems (Diabetes Care. 2017;40:181-7). Some were nonmodifiable, like costs, but most were modifiable.
“Many people talk about the hassle of wearing devices. They don’t like having multiple devices on their bodies. They don’t always like the way that they look, and so these are things that we can have some kind of impact on and need to be paying attention to,” he said.
“The younger participants indicated a lot more barriers to using devices, and as they got older, they indicated fewer barriers. But what was also interesting is that the younger participants also indicated a lot more diabetes distress. As time went on, that was less of a factor in whether or not people were using diabetes devices,” reported Dr. Hood.
Not surprisingly, he added, was that younger participants had more favorable views of technology in general. “But they had less favorable views of diabetes technology [than older participants], so they’re really not crazy about using these devices.”
Dr. Hood’s group has also studied whether patient-reported barriers to CGM use align with what clinicians perceive to be patient-related barriers (Diabetes Sci Technol. 2017;11[3]484-92). Similar to the patients, clinicians most frequently endorsed the perception that patients dislike having the device on their body. However, other things they felt their patients worried about were the alarms on the device and the difficulty in understanding its features, neither of which patients considered a primary barrier to CGM or insulin pump adoption.
“So, we need to be cautious and mindful as we move forward that there are mismatches between the patient-reported and clinician-reported barriers,” said Dr. Hood. “Our response, often, is to teach and to provide some kind of education, when that’s not necessarily what the patient is asking for.”
Would you use it?
In 2017, a group of investigators conducted a qualitative study of 284 participants, ranging in age from 8 to 86 years, with T1DM. The researchers used structured interviews or focus groups to explore expectations, desired features, potential benefits, and perceived burdens of automated insulin delivery systems (Diabetes Care. 2017;40[11]:1453-61).
“We were interested in children, adolescents, and adults with type 1, and then also the partners of the adults and the parents of the youth,” he explained.
“The findings revealed three themes identified as pressing for the uptake of automated insulin delivery: considerations of trust and control, system features, and concerns and barriers to adoption.
“For children, the areas of most concern revolved around specific social situations. Adolescents, on the other hand, were more concerned about the physical features of the device, the wearability, the discreetness of using it, and the comfort,” said Dr. Hood.
Adults and parents were much more interested in device accuracy, safety, adaptability, and algorithm quality. “For the kids and teens, not surprisingly, this wasn’t high on their list,” he added.
A clear indication of the unrealistic expectations surrounding this technology came from a 2018 study of almost 200 family members, which found that “reducing the constant concerns about diabetes, relieving family stress, and improving overall family relationships” were the three major areas the participants hoped would be helped with automated insulin delivery (Diabetes Technol Ther. 2018;20[3]:222-8).
“If we come up with a device that does this, then I think we will have fixed everything!” Dr. Hood said, adding that it really highlights the “very high hopes and expectations” of what closed-loop systems should deliver.
Device readiness is another area researchers have studied in the run-up to closed-loop systems. “The idea that everybody’s going to be ready to start in the same way, I think, is going to set us up for some failures,” he noted, adding that, in general, parents are much more enthusiastic about this than pediatric patients.
“Individuals who had been using diabetes devices – and some had already been in closed-loop studies – They had more realistic expectations of what these systems are going to be, because they knew that it wasn’t going to be a complete fix. Whereas others with more limited experience with component devices and these systems had much higher expectations and reported a fair amount of dissatisfaction at the end of the study because it didn’t do everything that they wanted it to do.”
Waves of uptake
“Ultimately, a closed-loop system is going to be judged by whether it can increase time on target and reduce cognitive burden,” said Dr. Hood. He finished his talk with some projections about the future of closed-loop systems. “I think we’re going to probably to have different waves, or types, of closed-loop users.”
The first wave will be the group that’s already “sold” on the idea, which might encompass about 15% of patients. The second wave, which might represent about 30% of the relevant patient population, will be those who are sold on the idea and will likely use it but will have high expectations of the system’s ease of use and effectiveness and thus are highly likely to discontinue its use if those expectations are not met.
“The third wave will be those who might use a closed-loop system but might be unaware of them currently and will need a fair amount of education.” And, finally, the fourth group are unlikely to ever use closed-loop insulin delivery. “They are a group that feels burned by previous generations of systems, and I think that they may not perceive benefit,” Dr. Hood suggested.
“But all of this is to say that I do think that a tailored experience, and one that is focused on different profiles, can optimize both the uptake and the use of these systems.”
Dr. Hood reported receiving grant/research support from Dexcom and being a consultant for Lilly Innovation Center, J&J Diabetes Institute, and Bigfoot Biomedical.
TORONTO – Closed-loop insulin delivery is expected to become the standard of care in type 1 diabetes mellitus (T1DM), but there are multiple barriers that patients need to overcome.
“Many people who are potentially going to be using closed-loop systems are enthusiastic but have unrealistic expectations of how the systems are going to perform, and there are many barriers to uptake and optimal use that we still haven’t quite figured out,” said Korey K. Hood, PhD, a professor in the departments of pediatrics and psychiatry & behavioral sciences at Stanford (Calif.) University.
In a session dedicated to all aspects of closed-loop automated insulin delivery at the Pediatric Academic Societies annual meeting, Dr. Hood offered comments on patient and family factors important to the uptake and use of closed-loop technologies. His research at Stanford is focused on understanding the psychosocial aspects of diabetes management and how these factors contribute to disease outcomes.
Closed-loop insulin delivery refers to technologies that combine automated glucose monitoring (AGM) with an algorithm to determine insulin needs and an insulin delivery device. Sometimes called an “artificial pancreas” or “bionic pancreas,” closed-loop insulin delivery is considered a significant advance in the management of T1DM, relegating daily finger sticks and nighttime hypoglycemia to things of the past.
In a recent meta-analysis of randomized clinical trials, use of any automated device added nearly 2.5 hours of time in near normoglycemia over 24 hours in patients with TIDM, compared with any other type of insulin-based treatment (BMJ. 2018. doi: 10.1136/bmj.k1310). The benefit was primarily based on better glucose control in the overnight period.
In September 2016, the Food and Drug Administration approved the MiniMed 670G Insulin Pump System (Medtronic), the first hybrid automated insulin delivery device for T1DM and the only one approved in the United States. The system is intended for subcutaneous continuous glucose monitoring (CGM) and continuous delivery of basal insulin and administration of insulin for the management of T1DM in persons 14 years of age and older.
Barriers from different perspectives
Barriers to uptake and use are common for the devices that are components of closed-loop systems. In a survey of 1,503 adults with TIDM, Dr. Hood’s group found a wide range of barriers to adoption of CGM or insulin pumps that could potentially also impact use of closed-loop systems (Diabetes Care. 2017;40:181-7). Some were nonmodifiable, like costs, but most were modifiable.
“Many people talk about the hassle of wearing devices. They don’t like having multiple devices on their bodies. They don’t always like the way that they look, and so these are things that we can have some kind of impact on and need to be paying attention to,” he said.
“The younger participants indicated a lot more barriers to using devices, and as they got older, they indicated fewer barriers. But what was also interesting is that the younger participants also indicated a lot more diabetes distress. As time went on, that was less of a factor in whether or not people were using diabetes devices,” reported Dr. Hood.
Not surprisingly, he added, was that younger participants had more favorable views of technology in general. “But they had less favorable views of diabetes technology [than older participants], so they’re really not crazy about using these devices.”
Dr. Hood’s group has also studied whether patient-reported barriers to CGM use align with what clinicians perceive to be patient-related barriers (Diabetes Sci Technol. 2017;11[3]484-92). Similar to the patients, clinicians most frequently endorsed the perception that patients dislike having the device on their body. However, other things they felt their patients worried about were the alarms on the device and the difficulty in understanding its features, neither of which patients considered a primary barrier to CGM or insulin pump adoption.
“So, we need to be cautious and mindful as we move forward that there are mismatches between the patient-reported and clinician-reported barriers,” said Dr. Hood. “Our response, often, is to teach and to provide some kind of education, when that’s not necessarily what the patient is asking for.”
Would you use it?
In 2017, a group of investigators conducted a qualitative study of 284 participants, ranging in age from 8 to 86 years, with T1DM. The researchers used structured interviews or focus groups to explore expectations, desired features, potential benefits, and perceived burdens of automated insulin delivery systems (Diabetes Care. 2017;40[11]:1453-61).
“We were interested in children, adolescents, and adults with type 1, and then also the partners of the adults and the parents of the youth,” he explained.
“The findings revealed three themes identified as pressing for the uptake of automated insulin delivery: considerations of trust and control, system features, and concerns and barriers to adoption.
“For children, the areas of most concern revolved around specific social situations. Adolescents, on the other hand, were more concerned about the physical features of the device, the wearability, the discreetness of using it, and the comfort,” said Dr. Hood.
Adults and parents were much more interested in device accuracy, safety, adaptability, and algorithm quality. “For the kids and teens, not surprisingly, this wasn’t high on their list,” he added.
A clear indication of the unrealistic expectations surrounding this technology came from a 2018 study of almost 200 family members, which found that “reducing the constant concerns about diabetes, relieving family stress, and improving overall family relationships” were the three major areas the participants hoped would be helped with automated insulin delivery (Diabetes Technol Ther. 2018;20[3]:222-8).
“If we come up with a device that does this, then I think we will have fixed everything!” Dr. Hood said, adding that it really highlights the “very high hopes and expectations” of what closed-loop systems should deliver.
Device readiness is another area researchers have studied in the run-up to closed-loop systems. “The idea that everybody’s going to be ready to start in the same way, I think, is going to set us up for some failures,” he noted, adding that, in general, parents are much more enthusiastic about this than pediatric patients.
“Individuals who had been using diabetes devices – and some had already been in closed-loop studies – They had more realistic expectations of what these systems are going to be, because they knew that it wasn’t going to be a complete fix. Whereas others with more limited experience with component devices and these systems had much higher expectations and reported a fair amount of dissatisfaction at the end of the study because it didn’t do everything that they wanted it to do.”
Waves of uptake
“Ultimately, a closed-loop system is going to be judged by whether it can increase time on target and reduce cognitive burden,” said Dr. Hood. He finished his talk with some projections about the future of closed-loop systems. “I think we’re going to probably to have different waves, or types, of closed-loop users.”
The first wave will be the group that’s already “sold” on the idea, which might encompass about 15% of patients. The second wave, which might represent about 30% of the relevant patient population, will be those who are sold on the idea and will likely use it but will have high expectations of the system’s ease of use and effectiveness and thus are highly likely to discontinue its use if those expectations are not met.
“The third wave will be those who might use a closed-loop system but might be unaware of them currently and will need a fair amount of education.” And, finally, the fourth group are unlikely to ever use closed-loop insulin delivery. “They are a group that feels burned by previous generations of systems, and I think that they may not perceive benefit,” Dr. Hood suggested.
“But all of this is to say that I do think that a tailored experience, and one that is focused on different profiles, can optimize both the uptake and the use of these systems.”
Dr. Hood reported receiving grant/research support from Dexcom and being a consultant for Lilly Innovation Center, J&J Diabetes Institute, and Bigfoot Biomedical.
EXPERT ANALYSIS FROM PAS 2018
Testosterone therapy tied to kidney stone risk
SAN FRANCISCO – , according to an analysis of more than 50,000 men with low testosterone.
When researchers compared hypogonadal men to age- and comorbidity-matched controls, they found a statistically significantly higher number of clinical diagnoses of a kidney stone, or of patients undergoing a kidney stone–related procedure.
The new study is the first large-scale analysis of the question in humans, according to Tyler McClintock, MD, who presented the findings at a poster session at the annual meeting of the American Urological Association. Dr. McClintock is a urology resident at Brigham and Women’s Hospital and Harvard Medical School in Boston.
Dr. McClintock and his colleagues analyzed data from the Military Health System Data Repository (MDR). The MDR includes beneficiaries of the TRICARE program for service members, retirees, and their families. They looked at 26,586 men aged 40-64 years who had been diagnosed with low testosterone and who had received continuous testosterone replacement therapy between April 2006 and March 2014. The researchers compared them to 26,586 controls with low testosterone who did not receive testosterone replacement therapy.
Stone events were significantly higher in the treatment group. There were 67 extracorporeal shock wave lithotripsy procedures in the treatment group, compared with 51 among controls. Similar trends were seen with ureteroscopy with lithotripsy (75 vs. 46) and clinical diagnoses of kidney stone (1,059 vs. 794).
The researchers also broke down stone events by type of testosterone replacement therapy. A total of 5.4% of patients who received pellets (9 of 167) experienced an event (P = .27), compared with 5.1% of those who received injections (218 of 4,259; P = .004) and 3.5% of those who received it topically (655 of 18,895; P less than .0001).
At 2 years, Dr. McClintock reported that there were significantly more kidney stone events in the testosterone-treated group than in the untreated group (659 and 482, respectively; P less than .001). Two years after starting testosterone replacement therapy, significantly more of the treatment group had experienced a stone episode, compared with the matched controls during the same time period (3.9% and 3%, respectively; P less than .001).
Dr. McClintock said the study is convincing in part because it used data from TRICARE, which sets a lower testosterone level even than AUA guidelines for determining if a patient is eligible for testosterone therapy.
“It would suggest that those are the real low testosterone patients, not necessarily men who heard an ad or went to a test center,” noted Patrick Shepherd Lowry, MD, associate professor of urology at Scott & White Medical Center, Temple, Texas, who attended the presentation but was not involved in the study. “It’s preliminary, but it’s very interesting. It hasn’t been shown before.”
The Department of Defense funded the study. Dr. McClintock reported having no relevant financial disclosures.
SOURCE: McClintock T. AUA Annual Meeting. Abstract MP13-19.
SAN FRANCISCO – , according to an analysis of more than 50,000 men with low testosterone.
When researchers compared hypogonadal men to age- and comorbidity-matched controls, they found a statistically significantly higher number of clinical diagnoses of a kidney stone, or of patients undergoing a kidney stone–related procedure.
The new study is the first large-scale analysis of the question in humans, according to Tyler McClintock, MD, who presented the findings at a poster session at the annual meeting of the American Urological Association. Dr. McClintock is a urology resident at Brigham and Women’s Hospital and Harvard Medical School in Boston.
Dr. McClintock and his colleagues analyzed data from the Military Health System Data Repository (MDR). The MDR includes beneficiaries of the TRICARE program for service members, retirees, and their families. They looked at 26,586 men aged 40-64 years who had been diagnosed with low testosterone and who had received continuous testosterone replacement therapy between April 2006 and March 2014. The researchers compared them to 26,586 controls with low testosterone who did not receive testosterone replacement therapy.
Stone events were significantly higher in the treatment group. There were 67 extracorporeal shock wave lithotripsy procedures in the treatment group, compared with 51 among controls. Similar trends were seen with ureteroscopy with lithotripsy (75 vs. 46) and clinical diagnoses of kidney stone (1,059 vs. 794).
The researchers also broke down stone events by type of testosterone replacement therapy. A total of 5.4% of patients who received pellets (9 of 167) experienced an event (P = .27), compared with 5.1% of those who received injections (218 of 4,259; P = .004) and 3.5% of those who received it topically (655 of 18,895; P less than .0001).
At 2 years, Dr. McClintock reported that there were significantly more kidney stone events in the testosterone-treated group than in the untreated group (659 and 482, respectively; P less than .001). Two years after starting testosterone replacement therapy, significantly more of the treatment group had experienced a stone episode, compared with the matched controls during the same time period (3.9% and 3%, respectively; P less than .001).
Dr. McClintock said the study is convincing in part because it used data from TRICARE, which sets a lower testosterone level even than AUA guidelines for determining if a patient is eligible for testosterone therapy.
“It would suggest that those are the real low testosterone patients, not necessarily men who heard an ad or went to a test center,” noted Patrick Shepherd Lowry, MD, associate professor of urology at Scott & White Medical Center, Temple, Texas, who attended the presentation but was not involved in the study. “It’s preliminary, but it’s very interesting. It hasn’t been shown before.”
The Department of Defense funded the study. Dr. McClintock reported having no relevant financial disclosures.
SOURCE: McClintock T. AUA Annual Meeting. Abstract MP13-19.
SAN FRANCISCO – , according to an analysis of more than 50,000 men with low testosterone.
When researchers compared hypogonadal men to age- and comorbidity-matched controls, they found a statistically significantly higher number of clinical diagnoses of a kidney stone, or of patients undergoing a kidney stone–related procedure.
The new study is the first large-scale analysis of the question in humans, according to Tyler McClintock, MD, who presented the findings at a poster session at the annual meeting of the American Urological Association. Dr. McClintock is a urology resident at Brigham and Women’s Hospital and Harvard Medical School in Boston.
Dr. McClintock and his colleagues analyzed data from the Military Health System Data Repository (MDR). The MDR includes beneficiaries of the TRICARE program for service members, retirees, and their families. They looked at 26,586 men aged 40-64 years who had been diagnosed with low testosterone and who had received continuous testosterone replacement therapy between April 2006 and March 2014. The researchers compared them to 26,586 controls with low testosterone who did not receive testosterone replacement therapy.
Stone events were significantly higher in the treatment group. There were 67 extracorporeal shock wave lithotripsy procedures in the treatment group, compared with 51 among controls. Similar trends were seen with ureteroscopy with lithotripsy (75 vs. 46) and clinical diagnoses of kidney stone (1,059 vs. 794).
The researchers also broke down stone events by type of testosterone replacement therapy. A total of 5.4% of patients who received pellets (9 of 167) experienced an event (P = .27), compared with 5.1% of those who received injections (218 of 4,259; P = .004) and 3.5% of those who received it topically (655 of 18,895; P less than .0001).
At 2 years, Dr. McClintock reported that there were significantly more kidney stone events in the testosterone-treated group than in the untreated group (659 and 482, respectively; P less than .001). Two years after starting testosterone replacement therapy, significantly more of the treatment group had experienced a stone episode, compared with the matched controls during the same time period (3.9% and 3%, respectively; P less than .001).
Dr. McClintock said the study is convincing in part because it used data from TRICARE, which sets a lower testosterone level even than AUA guidelines for determining if a patient is eligible for testosterone therapy.
“It would suggest that those are the real low testosterone patients, not necessarily men who heard an ad or went to a test center,” noted Patrick Shepherd Lowry, MD, associate professor of urology at Scott & White Medical Center, Temple, Texas, who attended the presentation but was not involved in the study. “It’s preliminary, but it’s very interesting. It hasn’t been shown before.”
The Department of Defense funded the study. Dr. McClintock reported having no relevant financial disclosures.
SOURCE: McClintock T. AUA Annual Meeting. Abstract MP13-19.
REPORTING FROM THE AUA ANNUAL MEETING
Key clinical point: Kidney stone risk may be a factor when considering testosterone replacement therapy.
Major finding: In untreated men, 482 kidney stone events occurred, compared with 659 in those receiving testosterone.
Study details: A case-control analysis of 26,586 treated men and 26,586 matched controls.
Disclosures: The Department of Defense funded the study. Dr. McClintock reported having no relevant financial disclosures.
Source: McClintock T. AUA Annual Meeting. Abstract MP13-19.
Do Cardiovascular Risk Factors Contribute to Brain Atrophy in MS?
LOS ANGELES—Hypertension and heart disease may contribute to advanced central and white matter atrophy in patients with multiple sclerosis (MS) over five years, according to a study presented at the 70th Annual Meeting of the American Academy of Neurology.
The findings suggest that management of cardiovascular comorbidities in MS may improve overall long-term disease outcomes, said Dejan Jakimovski, MD, a clinical research fellow at the Buffalo Neuroimaging Analysis Center at the University at Buffalo, New York, and colleagues. 
Cardiovascular diseases and risk factors are more common in patients with MS, compared with healthy individuals, and cross-sectional studies have linked smoking, hypertension, hyperlipidemia, and heart disease to lesion burden and brain atrophy, the researchers said.
To determine the influence of cardiovascular diseases over five years in a larger number of patients with MS, Dr. Jakimovski and colleagues examined data from 194 patients with MS in a prospective study of cardiovascular, environmental, and genetic risk factors in MS (CEG-MS). Patients in the study underwent clinical evaluation and completed questionnaires about cardiovascular risk factors (ie, hypertension, hyperlipidemia, heart disease, smoking, diabetes, and obesity or overweight status). The researchers assessed T2 and T1 lesion volumes and volumes of whole brain, gray matter, white matter, cortex, and lateral ventricles using 3-T MRI. They used analysis of covariance adjusted for age, sex, and disease duration to detect significant differences between patients with and without cardiovascular risk factors.
The 194 patients with MS (73.7% female; mean age, 46.7) had an average disease duration of 13.6 years, a median baseline Expanded Disability Status Scale (EDSS) score of 2.5, and a median EDSS at follow-up of 3. Mean BMI was 27.6, 14.9% had hypertension, and 9.8% had heart disease.
At baseline, patients with hypertension had larger lateral ventricular volume, compared with patients without hypertension (66.1 mL vs 49.9 mL). Over the follow-up period, the percentage lateral ventricular volume change was significantly greater in patients with hypertension, compared with patients without hypertension (24.5% vs 14.1%). Over the follow-up period, patients with a diagnosis of heart disease had greater white matter volume loss, compared with those without heart disease (–4.2% vs –0.7%).
Hyperlipidemia, diabetes, smoking, and obesity or overweight status
—Jake Remaly
LOS ANGELES—Hypertension and heart disease may contribute to advanced central and white matter atrophy in patients with multiple sclerosis (MS) over five years, according to a study presented at the 70th Annual Meeting of the American Academy of Neurology.
The findings suggest that management of cardiovascular comorbidities in MS may improve overall long-term disease outcomes, said Dejan Jakimovski, MD, a clinical research fellow at the Buffalo Neuroimaging Analysis Center at the University at Buffalo, New York, and colleagues.
Cardiovascular diseases and risk factors are more common in patients with MS, compared with healthy individuals, and cross-sectional studies have linked smoking, hypertension, hyperlipidemia, and heart disease to lesion burden and brain atrophy, the researchers said.
To determine the influence of cardiovascular diseases over five years in a larger number of patients with MS, Dr. Jakimovski and colleagues examined data from 194 patients with MS in a prospective study of cardiovascular, environmental, and genetic risk factors in MS (CEG-MS). Patients in the study underwent clinical evaluation and completed questionnaires about cardiovascular risk factors (ie, hypertension, hyperlipidemia, heart disease, smoking, diabetes, and obesity or overweight status). The researchers assessed T2 and T1 lesion volumes and volumes of whole brain, gray matter, white matter, cortex, and lateral ventricles using 3-T MRI. They used analysis of covariance adjusted for age, sex, and disease duration to detect significant differences between patients with and without cardiovascular risk factors.
The 194 patients with MS (73.7% female; mean age, 46.7) had an average disease duration of 13.6 years, a median baseline Expanded Disability Status Scale (EDSS) score of 2.5, and a median EDSS at follow-up of 3. Mean BMI was 27.6, 14.9% had hypertension, and 9.8% had heart disease.
At baseline, patients with hypertension had larger lateral ventricular volume, compared with patients without hypertension (66.1 mL vs 49.9 mL). Over the follow-up period, the percentage lateral ventricular volume change was significantly greater in patients with hypertension, compared with patients without hypertension (24.5% vs 14.1%). Over the follow-up period, patients with a diagnosis of heart disease had greater white matter volume loss, compared with those without heart disease (–4.2% vs –0.7%).
Hyperlipidemia, diabetes, smoking, and obesity or overweight status
—Jake Remaly
LOS ANGELES—Hypertension and heart disease may contribute to advanced central and white matter atrophy in patients with multiple sclerosis (MS) over five years, according to a study presented at the 70th Annual Meeting of the American Academy of Neurology.
The findings suggest that management of cardiovascular comorbidities in MS may improve overall long-term disease outcomes, said Dejan Jakimovski, MD, a clinical research fellow at the Buffalo Neuroimaging Analysis Center at the University at Buffalo, New York, and colleagues.
Cardiovascular diseases and risk factors are more common in patients with MS, compared with healthy individuals, and cross-sectional studies have linked smoking, hypertension, hyperlipidemia, and heart disease to lesion burden and brain atrophy, the researchers said.
To determine the influence of cardiovascular diseases over five years in a larger number of patients with MS, Dr. Jakimovski and colleagues examined data from 194 patients with MS in a prospective study of cardiovascular, environmental, and genetic risk factors in MS (CEG-MS). Patients in the study underwent clinical evaluation and completed questionnaires about cardiovascular risk factors (ie, hypertension, hyperlipidemia, heart disease, smoking, diabetes, and obesity or overweight status). The researchers assessed T2 and T1 lesion volumes and volumes of whole brain, gray matter, white matter, cortex, and lateral ventricles using 3-T MRI. They used analysis of covariance adjusted for age, sex, and disease duration to detect significant differences between patients with and without cardiovascular risk factors.
The 194 patients with MS (73.7% female; mean age, 46.7) had an average disease duration of 13.6 years, a median baseline Expanded Disability Status Scale (EDSS) score of 2.5, and a median EDSS at follow-up of 3. Mean BMI was 27.6, 14.9% had hypertension, and 9.8% had heart disease.
At baseline, patients with hypertension had larger lateral ventricular volume, compared with patients without hypertension (66.1 mL vs 49.9 mL). Over the follow-up period, the percentage lateral ventricular volume change was significantly greater in patients with hypertension, compared with patients without hypertension (24.5% vs 14.1%). Over the follow-up period, patients with a diagnosis of heart disease had greater white matter volume loss, compared with those without heart disease (–4.2% vs –0.7%).
Hyperlipidemia, diabetes, smoking, and obesity or overweight status
—Jake Remaly
CAR T therapy to enter early testing in multiple myeloma
Janssen Biotech is launching a phase 1b/2 trial of an .
The trial, which was cleared by the Food and Drug Administration to begin in the second half of 2018, will evaluate the safety and efficacy of LCAR-B38M (JNJ-68284528). The CAR T therapy targets B-cell Maturation Antigen and expresses a CAR protein that is identical to a product that was developed by Legend Biotech and evaluated in a first-in-human clinical study in China.
The drug is being developed as part of a collaboration between Legend Biotech and Janssen Biotech.
Janssen Biotech is launching a phase 1b/2 trial of an .
The trial, which was cleared by the Food and Drug Administration to begin in the second half of 2018, will evaluate the safety and efficacy of LCAR-B38M (JNJ-68284528). The CAR T therapy targets B-cell Maturation Antigen and expresses a CAR protein that is identical to a product that was developed by Legend Biotech and evaluated in a first-in-human clinical study in China.
The drug is being developed as part of a collaboration between Legend Biotech and Janssen Biotech.
Janssen Biotech is launching a phase 1b/2 trial of an .
The trial, which was cleared by the Food and Drug Administration to begin in the second half of 2018, will evaluate the safety and efficacy of LCAR-B38M (JNJ-68284528). The CAR T therapy targets B-cell Maturation Antigen and expresses a CAR protein that is identical to a product that was developed by Legend Biotech and evaluated in a first-in-human clinical study in China.
The drug is being developed as part of a collaboration between Legend Biotech and Janssen Biotech.
Delays in lactate measurement ups mortality risk in sepsis patients
For patients with , findings of a retrospective study show.
Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest®.
In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.
The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.
They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.
In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.
For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.
The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.
“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.
These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.
“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.
They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.
SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.
For patients with , findings of a retrospective study show.
Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest®.
In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.
The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.
They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.
In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.
For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.
The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.
“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.
These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.
“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.
They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.
SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.
For patients with , findings of a retrospective study show.
Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest®.
In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.
The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.
They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.
In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.
For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.
The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.
“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.
These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.
“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.
They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.
SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.
FROM CHEST
Key clinical point: Sepsis patients who have timely lactate measurements have lower mortality risk.
Major finding: Odds of death increased with each hour of delay (odds ratio, 1.02).
Study details: Retrospective study of 5,762 admissions meeting Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) criteria for severe sepsis.
Disclosures: The study authors reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.
Source: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.
Practice management pearls: Advice from seasoned doctors for residents looking to start a practice
The notion that residency training falls short when it comes to preparing residents and doctors for starting their own practice is a common thread across the board, whether you’re just getting started or have been managing your own practice for years. I did a survey on LinkedIn and over 50 dermatology and plastic surgery colleagues generously provided their own personal insights and words of wisdom to help young doctors avoid common practice management problems.
I could not quote everyone, but here are some of the best tips that I received:
Choose your staff carefully – and invest in the right candidates
One of the biggest pieces of practice management advice that doctors had to offer was to hire the right employees from the beginning, even if that means spending a little more time in the hiring process. This will eliminate headaches and frustration later.
In his own practice in Palm Beach Gardens, Fla., Dr. Lickstein has chosen a stable group of staff members who are, “first and foremost, nice, compassionate, and mature,” he said. “They need to be able to relate to cosmetic and medical patients of all ages. My office manager screens them, and then we have potential candidates shadow us for at least a half-day in the office. Afterward, we seek feedback from the current staff. I also try and talk with the candidate for a while, because I’ve found that once you get them to loosen up, you can get an actual sense of how they really are.”
Along the same lines, Cincinnati plastic surgeon Alex Donath, MD, suggests incentivizing employees and giving them an active role in the hiring process. “Give everyone in the office a chance to meet new employee candidates,” he said, “as that will both give the employees a sense of involvement in the process and allow more opportunities to catch glimpses of poor interpersonal skills that could hurt your reputation.”
Many doctors stressed the importance of the interview process, detailed job descriptions, a 60-day trial period, and background checks prior to hiring. This advice goes along with the famous quote “Be slow to hire and quick to fire (in the first 60 days)” that I have seen in many business books.
Foster teamwork
Another important aspect of managing your practice is building a sense of teamwork and camaraderie among employees and other doctors. Sean Weiss, MD, a facial plastic surgeon in New Orleans, has a great team-building tip that he uses daily.
“I plan a daily morning huddle with my staff. During the huddle, we review the prior day’s performance, those patients that need following up on, and whether or not the prior day’s goals were met. We then review the patient list for the current day to identify patient needs. We look specifically for ways to improve efficiency and avoid slowing down the work flow. We also try to identify opportunities to cross-promote our offerings to increase awareness of our services. In about 10 minutes, the entire team becomes focused and ready for a productive day.”
For Lacey Elwyn, DO, making staff feel appreciated can be as simple as telling them thank you on a regular basis. “The success of a dermatology practice encompasses every staff member of the team,” Dr. Elwyn, a medical and cosmetic dermatologist in South Florida, said. “The physician should respect and value all staff members. Tell them when they are doing a great job and tell them that you appreciate them every day, but also let them know right away when something is wrong.”
Don’t forget about patient education
Janet Trowbridge, MD, PhD, who practices in Edmond, Wash., expressed a great point that not only do patients need to be educated about their medical or cosmetic concerns, but they also need to be educated about the way that health care works in general. “I would say that 50% of my time as a physician is spent educating patients not about their disease, but about how medicine works – or doesn’t work,” she said. “I am constantly amazed by how little the average person understands about how health care is delivered. I talk about copays, coinsurance, annual deductibles, and why their prescriptions are not being covered. Patients feel that the system has let them down.”
Play the dual role of doctor and businessperson
At the end of the day, if you are managing your own practice, you must be able to split your time and skill set between being a physician and being a businessperson. Having realized the importance of the business aspect of running a practice, Justin Bryant, DO, a plastic and reconstructive surgeon in Walled Lake, Mich., enrolled in a dual-degree program during medical school in order to obtain his MBA.
“That investment already has proven priceless, as I’ve helped attendings and colleagues with their practice in marketing, finance, technology, and simply in translating business terms and contracts with physicians,” he said. “Although I don’t think it’s necessary for all physicians to pursue an MBA, and it’s not the answer to every business problem in the field of medicine, when applied, it can be very powerful!”
Build and protect your online reputation
Now more than ever, it is imperative to build and protect your online reputation, as online reviews can make or break your business. For plastic surgeon Nirmal Nathan, MD, in Plantation, Fla., managing your reputation is one of the most important considerations when starting a practice. “I would tell residents to start early on reputation management,” he said. “Reviews are so important, even with patients referred by word of mouth. Good reputation management also allows you to quickly ramp up if you decide to move your practice location.”
A large portion of building your online reputation now as to do with what you post (and don’t post) on social media. For Haena Kim, MD, a facial plastic and reconstructive surgeon practicing in Walnut Creek, Calif., figuring out how you would like others to perceive you is the first step.
“In this day and age of social media,” she said, “it’s so hard not to feel the pressure to follow the crowd and be the loudest person out there, and it’s incredibly hard to be patient with your practice growth. It’s important to figure out how you want to present yourself and what you want patients to come away with.”
Sweat the small stuff
Seemingly small administrative and business-related tasks can quickly add up and create much larger problems if not addressed early on. Tito Vasquez, MD, who practices in Southport, Conn., summed this up with an excellent piece of advice to remember: “Sweat the small stuff now, so you don’t have to sweat over the big stuff later.”
In terms of the “small stuff” you’ll need to manage, Dr. Vasquez points to items such as learning local economics and politics, daily finances, office regulations, and documentation, investment and planning, internal and external marketing, and human resources. “While most of us would view this as mundane or at least secondary to the craft we learn,” he said, “it will actually take far greater importance to taking care of patients if you really want your business to succeed and thrive.”
Another essential aspect of business planning that may seem daunting or mundane to many doctors when first starting out is putting together the necessary training manuals to effectively run your practice. Robert Bader, MD, stressed the importance of creating manuals for the front office, back office, Material Safety Data Sheets, and Occupational Safety and Health Administration.
“This is the time, while you have some extra time, to take an active role in forming the foundation of your practice,” Dr. Bader of Deerfield Beach, Fla., said. “Set aside time every year to go over and make necessary changes to these manuals.”
Make decisions now that reflect long-term goals
When you start your practice, deciding on a location might seem like a secondary detail, but the fact of the matter is that location will ultimately play a large role in the future of your business and your life. Beverly Hills, Calif., plastic surgeon John Layke, DO, suggested “choosing where you would like to live, and then building a practice around that location. Being happy in the area you live will make a big difference,” he says. “No one will ultimately be happy making $1 million-plus per year if they are miserable living in the area. In the beginning, share office space with reputable people where you become ‘visible,’ then build the office of your dreams when you are ready.”
Summary
I was amazed at the number of responses that I received in response to this survey. It is my goal to help doctors mentor each other on these important issues so that we do not all have to recreate the wheel. Connect with me on LinkedIn if you want to participate in these surveys or if you want to see the results of them. I want to wish the residents who are graduating and going into their own practice the best of luck. My final advice is to reach out for help – it’s obvious that many people are willing to provide advice.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients,” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. She is the author of the monthly “Cosmeceutical Critique” column in Dermatology News.
The notion that residency training falls short when it comes to preparing residents and doctors for starting their own practice is a common thread across the board, whether you’re just getting started or have been managing your own practice for years. I did a survey on LinkedIn and over 50 dermatology and plastic surgery colleagues generously provided their own personal insights and words of wisdom to help young doctors avoid common practice management problems.
I could not quote everyone, but here are some of the best tips that I received:
Choose your staff carefully – and invest in the right candidates
One of the biggest pieces of practice management advice that doctors had to offer was to hire the right employees from the beginning, even if that means spending a little more time in the hiring process. This will eliminate headaches and frustration later.
In his own practice in Palm Beach Gardens, Fla., Dr. Lickstein has chosen a stable group of staff members who are, “first and foremost, nice, compassionate, and mature,” he said. “They need to be able to relate to cosmetic and medical patients of all ages. My office manager screens them, and then we have potential candidates shadow us for at least a half-day in the office. Afterward, we seek feedback from the current staff. I also try and talk with the candidate for a while, because I’ve found that once you get them to loosen up, you can get an actual sense of how they really are.”
Along the same lines, Cincinnati plastic surgeon Alex Donath, MD, suggests incentivizing employees and giving them an active role in the hiring process. “Give everyone in the office a chance to meet new employee candidates,” he said, “as that will both give the employees a sense of involvement in the process and allow more opportunities to catch glimpses of poor interpersonal skills that could hurt your reputation.”
Many doctors stressed the importance of the interview process, detailed job descriptions, a 60-day trial period, and background checks prior to hiring. This advice goes along with the famous quote “Be slow to hire and quick to fire (in the first 60 days)” that I have seen in many business books.
Foster teamwork
Another important aspect of managing your practice is building a sense of teamwork and camaraderie among employees and other doctors. Sean Weiss, MD, a facial plastic surgeon in New Orleans, has a great team-building tip that he uses daily.
“I plan a daily morning huddle with my staff. During the huddle, we review the prior day’s performance, those patients that need following up on, and whether or not the prior day’s goals were met. We then review the patient list for the current day to identify patient needs. We look specifically for ways to improve efficiency and avoid slowing down the work flow. We also try to identify opportunities to cross-promote our offerings to increase awareness of our services. In about 10 minutes, the entire team becomes focused and ready for a productive day.”
For Lacey Elwyn, DO, making staff feel appreciated can be as simple as telling them thank you on a regular basis. “The success of a dermatology practice encompasses every staff member of the team,” Dr. Elwyn, a medical and cosmetic dermatologist in South Florida, said. “The physician should respect and value all staff members. Tell them when they are doing a great job and tell them that you appreciate them every day, but also let them know right away when something is wrong.”
Don’t forget about patient education
Janet Trowbridge, MD, PhD, who practices in Edmond, Wash., expressed a great point that not only do patients need to be educated about their medical or cosmetic concerns, but they also need to be educated about the way that health care works in general. “I would say that 50% of my time as a physician is spent educating patients not about their disease, but about how medicine works – or doesn’t work,” she said. “I am constantly amazed by how little the average person understands about how health care is delivered. I talk about copays, coinsurance, annual deductibles, and why their prescriptions are not being covered. Patients feel that the system has let them down.”
Play the dual role of doctor and businessperson
At the end of the day, if you are managing your own practice, you must be able to split your time and skill set between being a physician and being a businessperson. Having realized the importance of the business aspect of running a practice, Justin Bryant, DO, a plastic and reconstructive surgeon in Walled Lake, Mich., enrolled in a dual-degree program during medical school in order to obtain his MBA.
“That investment already has proven priceless, as I’ve helped attendings and colleagues with their practice in marketing, finance, technology, and simply in translating business terms and contracts with physicians,” he said. “Although I don’t think it’s necessary for all physicians to pursue an MBA, and it’s not the answer to every business problem in the field of medicine, when applied, it can be very powerful!”
Build and protect your online reputation
Now more than ever, it is imperative to build and protect your online reputation, as online reviews can make or break your business. For plastic surgeon Nirmal Nathan, MD, in Plantation, Fla., managing your reputation is one of the most important considerations when starting a practice. “I would tell residents to start early on reputation management,” he said. “Reviews are so important, even with patients referred by word of mouth. Good reputation management also allows you to quickly ramp up if you decide to move your practice location.”
A large portion of building your online reputation now as to do with what you post (and don’t post) on social media. For Haena Kim, MD, a facial plastic and reconstructive surgeon practicing in Walnut Creek, Calif., figuring out how you would like others to perceive you is the first step.
“In this day and age of social media,” she said, “it’s so hard not to feel the pressure to follow the crowd and be the loudest person out there, and it’s incredibly hard to be patient with your practice growth. It’s important to figure out how you want to present yourself and what you want patients to come away with.”
Sweat the small stuff
Seemingly small administrative and business-related tasks can quickly add up and create much larger problems if not addressed early on. Tito Vasquez, MD, who practices in Southport, Conn., summed this up with an excellent piece of advice to remember: “Sweat the small stuff now, so you don’t have to sweat over the big stuff later.”
In terms of the “small stuff” you’ll need to manage, Dr. Vasquez points to items such as learning local economics and politics, daily finances, office regulations, and documentation, investment and planning, internal and external marketing, and human resources. “While most of us would view this as mundane or at least secondary to the craft we learn,” he said, “it will actually take far greater importance to taking care of patients if you really want your business to succeed and thrive.”
Another essential aspect of business planning that may seem daunting or mundane to many doctors when first starting out is putting together the necessary training manuals to effectively run your practice. Robert Bader, MD, stressed the importance of creating manuals for the front office, back office, Material Safety Data Sheets, and Occupational Safety and Health Administration.
“This is the time, while you have some extra time, to take an active role in forming the foundation of your practice,” Dr. Bader of Deerfield Beach, Fla., said. “Set aside time every year to go over and make necessary changes to these manuals.”
Make decisions now that reflect long-term goals
When you start your practice, deciding on a location might seem like a secondary detail, but the fact of the matter is that location will ultimately play a large role in the future of your business and your life. Beverly Hills, Calif., plastic surgeon John Layke, DO, suggested “choosing where you would like to live, and then building a practice around that location. Being happy in the area you live will make a big difference,” he says. “No one will ultimately be happy making $1 million-plus per year if they are miserable living in the area. In the beginning, share office space with reputable people where you become ‘visible,’ then build the office of your dreams when you are ready.”
Summary
I was amazed at the number of responses that I received in response to this survey. It is my goal to help doctors mentor each other on these important issues so that we do not all have to recreate the wheel. Connect with me on LinkedIn if you want to participate in these surveys or if you want to see the results of them. I want to wish the residents who are graduating and going into their own practice the best of luck. My final advice is to reach out for help – it’s obvious that many people are willing to provide advice.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients,” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. She is the author of the monthly “Cosmeceutical Critique” column in Dermatology News.
The notion that residency training falls short when it comes to preparing residents and doctors for starting their own practice is a common thread across the board, whether you’re just getting started or have been managing your own practice for years. I did a survey on LinkedIn and over 50 dermatology and plastic surgery colleagues generously provided their own personal insights and words of wisdom to help young doctors avoid common practice management problems.
I could not quote everyone, but here are some of the best tips that I received:
Choose your staff carefully – and invest in the right candidates
One of the biggest pieces of practice management advice that doctors had to offer was to hire the right employees from the beginning, even if that means spending a little more time in the hiring process. This will eliminate headaches and frustration later.
In his own practice in Palm Beach Gardens, Fla., Dr. Lickstein has chosen a stable group of staff members who are, “first and foremost, nice, compassionate, and mature,” he said. “They need to be able to relate to cosmetic and medical patients of all ages. My office manager screens them, and then we have potential candidates shadow us for at least a half-day in the office. Afterward, we seek feedback from the current staff. I also try and talk with the candidate for a while, because I’ve found that once you get them to loosen up, you can get an actual sense of how they really are.”
Along the same lines, Cincinnati plastic surgeon Alex Donath, MD, suggests incentivizing employees and giving them an active role in the hiring process. “Give everyone in the office a chance to meet new employee candidates,” he said, “as that will both give the employees a sense of involvement in the process and allow more opportunities to catch glimpses of poor interpersonal skills that could hurt your reputation.”
Many doctors stressed the importance of the interview process, detailed job descriptions, a 60-day trial period, and background checks prior to hiring. This advice goes along with the famous quote “Be slow to hire and quick to fire (in the first 60 days)” that I have seen in many business books.
Foster teamwork
Another important aspect of managing your practice is building a sense of teamwork and camaraderie among employees and other doctors. Sean Weiss, MD, a facial plastic surgeon in New Orleans, has a great team-building tip that he uses daily.
“I plan a daily morning huddle with my staff. During the huddle, we review the prior day’s performance, those patients that need following up on, and whether or not the prior day’s goals were met. We then review the patient list for the current day to identify patient needs. We look specifically for ways to improve efficiency and avoid slowing down the work flow. We also try to identify opportunities to cross-promote our offerings to increase awareness of our services. In about 10 minutes, the entire team becomes focused and ready for a productive day.”
For Lacey Elwyn, DO, making staff feel appreciated can be as simple as telling them thank you on a regular basis. “The success of a dermatology practice encompasses every staff member of the team,” Dr. Elwyn, a medical and cosmetic dermatologist in South Florida, said. “The physician should respect and value all staff members. Tell them when they are doing a great job and tell them that you appreciate them every day, but also let them know right away when something is wrong.”
Don’t forget about patient education
Janet Trowbridge, MD, PhD, who practices in Edmond, Wash., expressed a great point that not only do patients need to be educated about their medical or cosmetic concerns, but they also need to be educated about the way that health care works in general. “I would say that 50% of my time as a physician is spent educating patients not about their disease, but about how medicine works – or doesn’t work,” she said. “I am constantly amazed by how little the average person understands about how health care is delivered. I talk about copays, coinsurance, annual deductibles, and why their prescriptions are not being covered. Patients feel that the system has let them down.”
Play the dual role of doctor and businessperson
At the end of the day, if you are managing your own practice, you must be able to split your time and skill set between being a physician and being a businessperson. Having realized the importance of the business aspect of running a practice, Justin Bryant, DO, a plastic and reconstructive surgeon in Walled Lake, Mich., enrolled in a dual-degree program during medical school in order to obtain his MBA.
“That investment already has proven priceless, as I’ve helped attendings and colleagues with their practice in marketing, finance, technology, and simply in translating business terms and contracts with physicians,” he said. “Although I don’t think it’s necessary for all physicians to pursue an MBA, and it’s not the answer to every business problem in the field of medicine, when applied, it can be very powerful!”
Build and protect your online reputation
Now more than ever, it is imperative to build and protect your online reputation, as online reviews can make or break your business. For plastic surgeon Nirmal Nathan, MD, in Plantation, Fla., managing your reputation is one of the most important considerations when starting a practice. “I would tell residents to start early on reputation management,” he said. “Reviews are so important, even with patients referred by word of mouth. Good reputation management also allows you to quickly ramp up if you decide to move your practice location.”
A large portion of building your online reputation now as to do with what you post (and don’t post) on social media. For Haena Kim, MD, a facial plastic and reconstructive surgeon practicing in Walnut Creek, Calif., figuring out how you would like others to perceive you is the first step.
“In this day and age of social media,” she said, “it’s so hard not to feel the pressure to follow the crowd and be the loudest person out there, and it’s incredibly hard to be patient with your practice growth. It’s important to figure out how you want to present yourself and what you want patients to come away with.”
Sweat the small stuff
Seemingly small administrative and business-related tasks can quickly add up and create much larger problems if not addressed early on. Tito Vasquez, MD, who practices in Southport, Conn., summed this up with an excellent piece of advice to remember: “Sweat the small stuff now, so you don’t have to sweat over the big stuff later.”
In terms of the “small stuff” you’ll need to manage, Dr. Vasquez points to items such as learning local economics and politics, daily finances, office regulations, and documentation, investment and planning, internal and external marketing, and human resources. “While most of us would view this as mundane or at least secondary to the craft we learn,” he said, “it will actually take far greater importance to taking care of patients if you really want your business to succeed and thrive.”
Another essential aspect of business planning that may seem daunting or mundane to many doctors when first starting out is putting together the necessary training manuals to effectively run your practice. Robert Bader, MD, stressed the importance of creating manuals for the front office, back office, Material Safety Data Sheets, and Occupational Safety and Health Administration.
“This is the time, while you have some extra time, to take an active role in forming the foundation of your practice,” Dr. Bader of Deerfield Beach, Fla., said. “Set aside time every year to go over and make necessary changes to these manuals.”
Make decisions now that reflect long-term goals
When you start your practice, deciding on a location might seem like a secondary detail, but the fact of the matter is that location will ultimately play a large role in the future of your business and your life. Beverly Hills, Calif., plastic surgeon John Layke, DO, suggested “choosing where you would like to live, and then building a practice around that location. Being happy in the area you live will make a big difference,” he says. “No one will ultimately be happy making $1 million-plus per year if they are miserable living in the area. In the beginning, share office space with reputable people where you become ‘visible,’ then build the office of your dreams when you are ready.”
Summary
I was amazed at the number of responses that I received in response to this survey. It is my goal to help doctors mentor each other on these important issues so that we do not all have to recreate the wheel. Connect with me on LinkedIn if you want to participate in these surveys or if you want to see the results of them. I want to wish the residents who are graduating and going into their own practice the best of luck. My final advice is to reach out for help – it’s obvious that many people are willing to provide advice.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients,” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. She is the author of the monthly “Cosmeceutical Critique” column in Dermatology News.
Once-weekly Glucagon-like Peptide-1 Receptor Agonists
This supplement provides an overview of the role of once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in type 2 diabetes (T2D).
Topics include:
- Burden of illness in patients with T2D
- Pharmacokinetic properties and the mode and mechanism of action of GLP-1 RAs
- Safety and clinical efficacy of GLP-1 RAs
- Implications of cardiovascular outcomes trials in T2D
This supplement provides an overview of the role of once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in type 2 diabetes (T2D).
Topics include:
- Burden of illness in patients with T2D
- Pharmacokinetic properties and the mode and mechanism of action of GLP-1 RAs
- Safety and clinical efficacy of GLP-1 RAs
- Implications of cardiovascular outcomes trials in T2D
This supplement provides an overview of the role of once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in type 2 diabetes (T2D).
Topics include:
- Burden of illness in patients with T2D
- Pharmacokinetic properties and the mode and mechanism of action of GLP-1 RAs
- Safety and clinical efficacy of GLP-1 RAs
- Implications of cardiovascular outcomes trials in T2D
Emergency contraception ... and our duty to inform
In 2013, the emergency contraception containing levonorgestrel, most commonly known as Plan B, became available for purchase without prescription or age restriction. Yet, 5 years later, many adolescents and teens remain misinformed or uninformed completely. For the scope of this article, only levonorgestrel will be discussed, acknowledging that ulipristal acetate (Ella) is also an emergency contraception by prescription.
As providers we all recognize the challenges of engaging a teen patient long enough to have a meaningful conversation on health and wellness. There are even greater challenges when it comes to discussing sexual activity and sexually transmitted diseases. So the thought of discussing prevention of unwanted pregnancy may be daunting for most of us.
This topic has many layers. First and foremost, it touches on a hotly debated topic of where life begins, and emergency contraception may be thought to cross that line. Awareness of the option of emergency contraception is thought to give a free pass to promiscuous behavior. Some just feel there is not enough research to support the safe use of these products in adolescents. As with most things, taking the time to educate ourselves on the facts usually alleviates the conflicts.
Understanding levonorgestrel mechanism of action is important in clarifying its position in the prolife debate. The International Consortium for Emergency Contraception and the International Federation of Gynecologists and Obstetrics consider that inhibition or delay of ovulation is levonorgestrel’s mechanism of action, and that it does not prevent implantation of a fertilized egg. If taken after ovulation has occurred, it is ineffective in preventing pregnancy.1,2
Levonorgestrel emergency contraception was first approved by the Food and Drug Administration in 1999 under the brand name Plan B by Teva Women’s Health, then later Next Choice (Watson Pharma) was released. Initially, it was prescribed to be taken as a 0.75-mg tab within 72 hours of unprotected intercourse and repeated in 12 hours. Further studies revealed taking a 1.5-mg tab once was just as effective with no significant increase in adverse effects and Plan B One-Step was released.3
The Catholic Health Association presented a paper clarifying that levonorgestrel is not a postfertilization contraceptive (abortifacient), hopefully preventing delay of its use in victims of sexual assault seen in Catholic health care facilities.4
Safety for this product since its release has shown no deaths or serious complications.2 The most common side effect is nausea, usually without vomiting.2 Antinausea medication given 1 hour before can be helpful but is not routinely used. The length of menstrual cycle is shorter if given early in cycle but it may be lengthened by 2 days if taken post ovulation. It is not intended for repeated use, but 11 studies showed no adverse effects when it was used repeatedly in the same ovulatory cycle, and it was shown to be safe.2
For women whose emergency contraception failed, one study of 332 pregnant women who had used levonorgestrel found no teratogenic effect or risk of birth defects.5 Although it is not contraindicated in breastfeeding mothers, it was recommended that patients discontinue breastfeeding for 8 hours post ingestion. Recognized contraindications to oral contraceptives do not apply to levonorgestrel, given the temporary and relative low exposure to the hormone.3
As for efficacy, timing is of the essence. As stated previously, if not taken before ovulation has occurred, it is ineffective. If taken within 72 hours of unprotected intercourse, one study showed levonorgestrel would prevent 85% of pregnancies that otherwise might have occurred.3 Although the package insert says it must taken within 72 hours, studies have shown protection up to 120 hours post coitus, but that efficacy declines with every hour. Body mass index also may play a role in effectiveness, but the studies have been varied and more research is required before a determination is made.2
The annual well visit is the opportune time to educate parents and teens about abstinence, sex, sexually transmitted infections, and emergency contraception. Parents need to know the statistics of teen pregnancy and rates of STIs so they can be informed and further these conversations at home. should they find themselves in this dilemma. The websites not-2-late.com and bedsider.org are excellent sources of information on emergency contraception.
Keep in mind that 10% of all unintended pregnancies occur from nonconsensual intercourse so knowing what options are available is critical. Whether you give a handout with the information or undertake a more in-depth conversation during well visits, this is vital information that can change a person’s life.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. “Emergency Contraception: Questions And Answers For Decision-Makers,” International Consortium for Emergency Contraception, 2013.
2. Clin Obstet Gynecol. 2014 Dec;57(4):741-50.
3. Pediatrics 2012;130:1174-82.
4. Health Progress. 2010 Jan-Feb. 59-61.
5. Hum Reprod. 2009 Jul;24(7):1605-11.
6. Contraception. 2016 Feb;93(2):145-52.
In 2013, the emergency contraception containing levonorgestrel, most commonly known as Plan B, became available for purchase without prescription or age restriction. Yet, 5 years later, many adolescents and teens remain misinformed or uninformed completely. For the scope of this article, only levonorgestrel will be discussed, acknowledging that ulipristal acetate (Ella) is also an emergency contraception by prescription.
As providers we all recognize the challenges of engaging a teen patient long enough to have a meaningful conversation on health and wellness. There are even greater challenges when it comes to discussing sexual activity and sexually transmitted diseases. So the thought of discussing prevention of unwanted pregnancy may be daunting for most of us.
This topic has many layers. First and foremost, it touches on a hotly debated topic of where life begins, and emergency contraception may be thought to cross that line. Awareness of the option of emergency contraception is thought to give a free pass to promiscuous behavior. Some just feel there is not enough research to support the safe use of these products in adolescents. As with most things, taking the time to educate ourselves on the facts usually alleviates the conflicts.
Understanding levonorgestrel mechanism of action is important in clarifying its position in the prolife debate. The International Consortium for Emergency Contraception and the International Federation of Gynecologists and Obstetrics consider that inhibition or delay of ovulation is levonorgestrel’s mechanism of action, and that it does not prevent implantation of a fertilized egg. If taken after ovulation has occurred, it is ineffective in preventing pregnancy.1,2
Levonorgestrel emergency contraception was first approved by the Food and Drug Administration in 1999 under the brand name Plan B by Teva Women’s Health, then later Next Choice (Watson Pharma) was released. Initially, it was prescribed to be taken as a 0.75-mg tab within 72 hours of unprotected intercourse and repeated in 12 hours. Further studies revealed taking a 1.5-mg tab once was just as effective with no significant increase in adverse effects and Plan B One-Step was released.3
The Catholic Health Association presented a paper clarifying that levonorgestrel is not a postfertilization contraceptive (abortifacient), hopefully preventing delay of its use in victims of sexual assault seen in Catholic health care facilities.4
Safety for this product since its release has shown no deaths or serious complications.2 The most common side effect is nausea, usually without vomiting.2 Antinausea medication given 1 hour before can be helpful but is not routinely used. The length of menstrual cycle is shorter if given early in cycle but it may be lengthened by 2 days if taken post ovulation. It is not intended for repeated use, but 11 studies showed no adverse effects when it was used repeatedly in the same ovulatory cycle, and it was shown to be safe.2
For women whose emergency contraception failed, one study of 332 pregnant women who had used levonorgestrel found no teratogenic effect or risk of birth defects.5 Although it is not contraindicated in breastfeeding mothers, it was recommended that patients discontinue breastfeeding for 8 hours post ingestion. Recognized contraindications to oral contraceptives do not apply to levonorgestrel, given the temporary and relative low exposure to the hormone.3
As for efficacy, timing is of the essence. As stated previously, if not taken before ovulation has occurred, it is ineffective. If taken within 72 hours of unprotected intercourse, one study showed levonorgestrel would prevent 85% of pregnancies that otherwise might have occurred.3 Although the package insert says it must taken within 72 hours, studies have shown protection up to 120 hours post coitus, but that efficacy declines with every hour. Body mass index also may play a role in effectiveness, but the studies have been varied and more research is required before a determination is made.2
The annual well visit is the opportune time to educate parents and teens about abstinence, sex, sexually transmitted infections, and emergency contraception. Parents need to know the statistics of teen pregnancy and rates of STIs so they can be informed and further these conversations at home. should they find themselves in this dilemma. The websites not-2-late.com and bedsider.org are excellent sources of information on emergency contraception.
Keep in mind that 10% of all unintended pregnancies occur from nonconsensual intercourse so knowing what options are available is critical. Whether you give a handout with the information or undertake a more in-depth conversation during well visits, this is vital information that can change a person’s life.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. “Emergency Contraception: Questions And Answers For Decision-Makers,” International Consortium for Emergency Contraception, 2013.
2. Clin Obstet Gynecol. 2014 Dec;57(4):741-50.
3. Pediatrics 2012;130:1174-82.
4. Health Progress. 2010 Jan-Feb. 59-61.
5. Hum Reprod. 2009 Jul;24(7):1605-11.
6. Contraception. 2016 Feb;93(2):145-52.
In 2013, the emergency contraception containing levonorgestrel, most commonly known as Plan B, became available for purchase without prescription or age restriction. Yet, 5 years later, many adolescents and teens remain misinformed or uninformed completely. For the scope of this article, only levonorgestrel will be discussed, acknowledging that ulipristal acetate (Ella) is also an emergency contraception by prescription.
As providers we all recognize the challenges of engaging a teen patient long enough to have a meaningful conversation on health and wellness. There are even greater challenges when it comes to discussing sexual activity and sexually transmitted diseases. So the thought of discussing prevention of unwanted pregnancy may be daunting for most of us.
This topic has many layers. First and foremost, it touches on a hotly debated topic of where life begins, and emergency contraception may be thought to cross that line. Awareness of the option of emergency contraception is thought to give a free pass to promiscuous behavior. Some just feel there is not enough research to support the safe use of these products in adolescents. As with most things, taking the time to educate ourselves on the facts usually alleviates the conflicts.
Understanding levonorgestrel mechanism of action is important in clarifying its position in the prolife debate. The International Consortium for Emergency Contraception and the International Federation of Gynecologists and Obstetrics consider that inhibition or delay of ovulation is levonorgestrel’s mechanism of action, and that it does not prevent implantation of a fertilized egg. If taken after ovulation has occurred, it is ineffective in preventing pregnancy.1,2
Levonorgestrel emergency contraception was first approved by the Food and Drug Administration in 1999 under the brand name Plan B by Teva Women’s Health, then later Next Choice (Watson Pharma) was released. Initially, it was prescribed to be taken as a 0.75-mg tab within 72 hours of unprotected intercourse and repeated in 12 hours. Further studies revealed taking a 1.5-mg tab once was just as effective with no significant increase in adverse effects and Plan B One-Step was released.3
The Catholic Health Association presented a paper clarifying that levonorgestrel is not a postfertilization contraceptive (abortifacient), hopefully preventing delay of its use in victims of sexual assault seen in Catholic health care facilities.4
Safety for this product since its release has shown no deaths or serious complications.2 The most common side effect is nausea, usually without vomiting.2 Antinausea medication given 1 hour before can be helpful but is not routinely used. The length of menstrual cycle is shorter if given early in cycle but it may be lengthened by 2 days if taken post ovulation. It is not intended for repeated use, but 11 studies showed no adverse effects when it was used repeatedly in the same ovulatory cycle, and it was shown to be safe.2
For women whose emergency contraception failed, one study of 332 pregnant women who had used levonorgestrel found no teratogenic effect or risk of birth defects.5 Although it is not contraindicated in breastfeeding mothers, it was recommended that patients discontinue breastfeeding for 8 hours post ingestion. Recognized contraindications to oral contraceptives do not apply to levonorgestrel, given the temporary and relative low exposure to the hormone.3
As for efficacy, timing is of the essence. As stated previously, if not taken before ovulation has occurred, it is ineffective. If taken within 72 hours of unprotected intercourse, one study showed levonorgestrel would prevent 85% of pregnancies that otherwise might have occurred.3 Although the package insert says it must taken within 72 hours, studies have shown protection up to 120 hours post coitus, but that efficacy declines with every hour. Body mass index also may play a role in effectiveness, but the studies have been varied and more research is required before a determination is made.2
The annual well visit is the opportune time to educate parents and teens about abstinence, sex, sexually transmitted infections, and emergency contraception. Parents need to know the statistics of teen pregnancy and rates of STIs so they can be informed and further these conversations at home. should they find themselves in this dilemma. The websites not-2-late.com and bedsider.org are excellent sources of information on emergency contraception.
Keep in mind that 10% of all unintended pregnancies occur from nonconsensual intercourse so knowing what options are available is critical. Whether you give a handout with the information or undertake a more in-depth conversation during well visits, this is vital information that can change a person’s life.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. “Emergency Contraception: Questions And Answers For Decision-Makers,” International Consortium for Emergency Contraception, 2013.
2. Clin Obstet Gynecol. 2014 Dec;57(4):741-50.
3. Pediatrics 2012;130:1174-82.
4. Health Progress. 2010 Jan-Feb. 59-61.
5. Hum Reprod. 2009 Jul;24(7):1605-11.
6. Contraception. 2016 Feb;93(2):145-52.
Psoriasis therapy with biologics not linked to increased cancer risk
Biologic treatments were not associated with an increased risk of cancer among patients with psoriasis in the medium term, in a study that analyzed data from patient registries.
“Cumulative length of exposure to biologics was not associated with the risk of developing cancers, even after controlling for the effect of age, gender, location,” as well as for previous exposure to methotrexate, cyclosporine, and phototherapy; duration of psoriasis; and comorbidities, reported Ignacio García-Doval, MD, of the Fundación Academia Española de Dermatología y Venereología, Madrid, and his associates.
The pooled adjusted odds ratio of cancer per year of biologic exposure was 1.02 (95% confidence interval, 0.92-1.13), demonstrating no significantly increased risk of cancer per cumulative year of biologic exposure for psoriasis therapy, Dr. García-Doval and his associates reported in the study, published in the British Journal of Dermatology. This was true even when broken down within the registries for comparison, and when analyzed by type of cancers, such as squamous cell carcinoma and basal cell carcinoma.
A limitation of the study was inadequate power to detect and compare risk between individual biologics, they said. Also, “as our data describe limited follow-up and latencies, it is still possible that a risk after longer periods of exposure and latencies exists.”
Most of the authors had numerous financial disclosures related to pharmaceutical companies. Psonet was supported with funds from the European Association of Venereology and Dermatology and the Italian Drug Agency. Funding for the individual registries includes support from pharmaceutical companies.
SOURCE: García-Doval I et al. Br J Dermatol. 2018 May 3. doi: 10.1111/bjd.16715.
Biologic treatments were not associated with an increased risk of cancer among patients with psoriasis in the medium term, in a study that analyzed data from patient registries.
“Cumulative length of exposure to biologics was not associated with the risk of developing cancers, even after controlling for the effect of age, gender, location,” as well as for previous exposure to methotrexate, cyclosporine, and phototherapy; duration of psoriasis; and comorbidities, reported Ignacio García-Doval, MD, of the Fundación Academia Española de Dermatología y Venereología, Madrid, and his associates.
The pooled adjusted odds ratio of cancer per year of biologic exposure was 1.02 (95% confidence interval, 0.92-1.13), demonstrating no significantly increased risk of cancer per cumulative year of biologic exposure for psoriasis therapy, Dr. García-Doval and his associates reported in the study, published in the British Journal of Dermatology. This was true even when broken down within the registries for comparison, and when analyzed by type of cancers, such as squamous cell carcinoma and basal cell carcinoma.
A limitation of the study was inadequate power to detect and compare risk between individual biologics, they said. Also, “as our data describe limited follow-up and latencies, it is still possible that a risk after longer periods of exposure and latencies exists.”
Most of the authors had numerous financial disclosures related to pharmaceutical companies. Psonet was supported with funds from the European Association of Venereology and Dermatology and the Italian Drug Agency. Funding for the individual registries includes support from pharmaceutical companies.
SOURCE: García-Doval I et al. Br J Dermatol. 2018 May 3. doi: 10.1111/bjd.16715.
Biologic treatments were not associated with an increased risk of cancer among patients with psoriasis in the medium term, in a study that analyzed data from patient registries.
“Cumulative length of exposure to biologics was not associated with the risk of developing cancers, even after controlling for the effect of age, gender, location,” as well as for previous exposure to methotrexate, cyclosporine, and phototherapy; duration of psoriasis; and comorbidities, reported Ignacio García-Doval, MD, of the Fundación Academia Española de Dermatología y Venereología, Madrid, and his associates.
The pooled adjusted odds ratio of cancer per year of biologic exposure was 1.02 (95% confidence interval, 0.92-1.13), demonstrating no significantly increased risk of cancer per cumulative year of biologic exposure for psoriasis therapy, Dr. García-Doval and his associates reported in the study, published in the British Journal of Dermatology. This was true even when broken down within the registries for comparison, and when analyzed by type of cancers, such as squamous cell carcinoma and basal cell carcinoma.
A limitation of the study was inadequate power to detect and compare risk between individual biologics, they said. Also, “as our data describe limited follow-up and latencies, it is still possible that a risk after longer periods of exposure and latencies exists.”
Most of the authors had numerous financial disclosures related to pharmaceutical companies. Psonet was supported with funds from the European Association of Venereology and Dermatology and the Italian Drug Agency. Funding for the individual registries includes support from pharmaceutical companies.
SOURCE: García-Doval I et al. Br J Dermatol. 2018 May 3. doi: 10.1111/bjd.16715.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point:
Major finding: The pooled adjusted odds ratio of cancer per year of biologic exposure was 1.02.
Study details: Patient data were drawn from four national databases within Psonet, which included 579 cancer cases and 2,671 matched controls.
Disclosures: Most of the authors had numerous financial disclosures related to pharmaceutical companies. Psonet was supported with funds from the European Association of Venereology and Dermatology and the Italian Drug Agency. Funding for the individual registries includes support from pharmaceutical companies.
Source: García-Doval I et al. Br J Dermatol. 2018 May 3. doi: 10.1111/bjd.16715.
Uterine fibroids registry looks to provide comparative treatment data
Early findings from a uterine fibroids registry suggest more than half of enrolled women chose an alternative to hysterectomy, underscoring the need to study the efficacy of these uterine-sparing treatment options, said Elizabeth A. Stewart, MD, of the Mayo Clinic, Rochester, Minn., and her associates.
There is very little evidence on the comparative efficacy of uterine fibroid treatment options so the COMPARE-UF (Comparing Options for Management: Patient-Centered Results for Uterine Fibroids) registry was initiated for women who choose procedural therapy for symptomatic uterine fibroids. Data at the nine clinical centers – representing rural and urban populations – are being collected regarding hysterectomy, myomectomy (abdominal, hysteroscopic, vaginal, and laparoscopic/robotic), endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance–guided focused ultrasound, and therapeutic use of progestin-releasing intrauterine devices.
A total of 16% of the women were under age 35, and 40% were aged 40 years or younger. “The fact that a sizable proportion of women are under age 40 suggests that with long-term follow-up, data on reproductive outcomes can be obtained as these women seek pregnancy,” Dr. Stewart and her associates noted.
Although African American women make up only 13% of the U.S. population, they constitute 42% of enrollment in COMPARE-UF, the investigators reported in the American Journal of Obstetrics and Gynecology. African American women chose similar or greater numbers of each type of myomectomy and uterine embolization as white women chose.
The study was supported by a grant from the Agency for Healthcare Research and Quality. The registry is supported by AHRQ and the Patient-Centered Outcomes Research Institute. Dr. Stewart reported personal fees from AbbVie, Allergan, Astellas, Pharma, Bayer, Gynesonics, and Myovant Sciences. Several researchers reported grants from pharmaceutical companies outside this study, and the remainder of the investigators reported no relevant financial disclosures.
SOURCE: Stewart EA et al. Am J Obstet Gynecol. 2018 May 8. doi: 10.1016/j.ajog.2018.05.004.
Early findings from a uterine fibroids registry suggest more than half of enrolled women chose an alternative to hysterectomy, underscoring the need to study the efficacy of these uterine-sparing treatment options, said Elizabeth A. Stewart, MD, of the Mayo Clinic, Rochester, Minn., and her associates.
There is very little evidence on the comparative efficacy of uterine fibroid treatment options so the COMPARE-UF (Comparing Options for Management: Patient-Centered Results for Uterine Fibroids) registry was initiated for women who choose procedural therapy for symptomatic uterine fibroids. Data at the nine clinical centers – representing rural and urban populations – are being collected regarding hysterectomy, myomectomy (abdominal, hysteroscopic, vaginal, and laparoscopic/robotic), endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance–guided focused ultrasound, and therapeutic use of progestin-releasing intrauterine devices.
A total of 16% of the women were under age 35, and 40% were aged 40 years or younger. “The fact that a sizable proportion of women are under age 40 suggests that with long-term follow-up, data on reproductive outcomes can be obtained as these women seek pregnancy,” Dr. Stewart and her associates noted.
Although African American women make up only 13% of the U.S. population, they constitute 42% of enrollment in COMPARE-UF, the investigators reported in the American Journal of Obstetrics and Gynecology. African American women chose similar or greater numbers of each type of myomectomy and uterine embolization as white women chose.
The study was supported by a grant from the Agency for Healthcare Research and Quality. The registry is supported by AHRQ and the Patient-Centered Outcomes Research Institute. Dr. Stewart reported personal fees from AbbVie, Allergan, Astellas, Pharma, Bayer, Gynesonics, and Myovant Sciences. Several researchers reported grants from pharmaceutical companies outside this study, and the remainder of the investigators reported no relevant financial disclosures.
SOURCE: Stewart EA et al. Am J Obstet Gynecol. 2018 May 8. doi: 10.1016/j.ajog.2018.05.004.
Early findings from a uterine fibroids registry suggest more than half of enrolled women chose an alternative to hysterectomy, underscoring the need to study the efficacy of these uterine-sparing treatment options, said Elizabeth A. Stewart, MD, of the Mayo Clinic, Rochester, Minn., and her associates.
There is very little evidence on the comparative efficacy of uterine fibroid treatment options so the COMPARE-UF (Comparing Options for Management: Patient-Centered Results for Uterine Fibroids) registry was initiated for women who choose procedural therapy for symptomatic uterine fibroids. Data at the nine clinical centers – representing rural and urban populations – are being collected regarding hysterectomy, myomectomy (abdominal, hysteroscopic, vaginal, and laparoscopic/robotic), endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance–guided focused ultrasound, and therapeutic use of progestin-releasing intrauterine devices.
A total of 16% of the women were under age 35, and 40% were aged 40 years or younger. “The fact that a sizable proportion of women are under age 40 suggests that with long-term follow-up, data on reproductive outcomes can be obtained as these women seek pregnancy,” Dr. Stewart and her associates noted.
Although African American women make up only 13% of the U.S. population, they constitute 42% of enrollment in COMPARE-UF, the investigators reported in the American Journal of Obstetrics and Gynecology. African American women chose similar or greater numbers of each type of myomectomy and uterine embolization as white women chose.
The study was supported by a grant from the Agency for Healthcare Research and Quality. The registry is supported by AHRQ and the Patient-Centered Outcomes Research Institute. Dr. Stewart reported personal fees from AbbVie, Allergan, Astellas, Pharma, Bayer, Gynesonics, and Myovant Sciences. Several researchers reported grants from pharmaceutical companies outside this study, and the remainder of the investigators reported no relevant financial disclosures.
SOURCE: Stewart EA et al. Am J Obstet Gynecol. 2018 May 8. doi: 10.1016/j.ajog.2018.05.004.
FROM THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
Key clinical point:
Major finding: Of the initial 2,031 women enrolled in the registry, hysterectomy was chosen by 38%, and myomectomies were chosen by 46%.
Study details: Initial results from the COMPARE-UF registry.
Disclosures: The study was supported by a grant from the Agency for Healthcare Research and Quality. Dr. Stewart reported personal fees from AbbVie, Allergan, Astellas, Pharma, Bayer, Gynesonics, and Myovant Sciences. Several researchers reported grants from pharmaceutical companies outside this study, and the remainder of the investigators reported no relevant financial disclosures.
Source: Stewart EA et al. Am J Obstet Gynecol. 2018 May 8. doi: 10.1016/j.ajog.2018.05.004.