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New data dissect global burden of scabies
Scabies hits hardest in tropical parts of the world, and children and teens are most affected by the condition, based on data from a global epidemiological assessment.
“,” wrote Chante Karimkhani, MD, of the University of Colorado, Aurora, and her colleagues. To estimate the global impact of scabies, the researchers used the Global Burden of Disease (GBD) Study 2015, which included literature searches between 1980 and 2014 in both English and Spanish.
Overall, the prevalence of scabies worldwide was 204,151,715, and the age-standardized DALYs was 71/100,000 people. The highest DALYs in terms of world regions were reported in East Asia (136/100,000), Southeast Asia (135/100,000) the region described as Oceania (120/100,000) (which included American Samoa, Fiji, Guam, Marshall Islands, Northern Mariana Islands, Papua New Guinea, Samoa, Solomon Islands, and others), tropical Latin America (100/100,000), and South Asia (69/100,000). Scabies caused 0.21% of DALYs from all the conditions that are studied by GBD 2015 globally. The mean percent change in age-standardized DALY from 1990 to 2015 increased 22% in North America, but the age-standardized DALY still remained less than 5/100,000.
In addition, global DALYs from scabies skin infection were highest in children aged 1-4 years (116/100,000 individuals) and adolescents aged 15-19 years (102/100,000). DALYs were not significantly different between men and women across all age groups, Dr. Karimkhani and her associates reported.
“As a worldwide epidemiological assessment, GBD 2015 provides broad and frequently updated measures of scabies burden in terms of skin effects. These global data might help guide research protocols and prioritization efforts and focus scabies treatment and control measures,” the researchers said.
Of note is that these analyses do not include information about complications of scabies such as impetigo, local and systemic bacterial infections, glomerulonephritis, and rheumatic fever.
The study was funded by the Bill and Melinda Gates Foundation. The researchers had no financial conflicts to disclose.
Read the full study here: (Lancet Infect. Dis. 2017. doi: 10.1016/S1473-3099[17]30483-8).
Scabies hits hardest in tropical parts of the world, and children and teens are most affected by the condition, based on data from a global epidemiological assessment.
“,” wrote Chante Karimkhani, MD, of the University of Colorado, Aurora, and her colleagues. To estimate the global impact of scabies, the researchers used the Global Burden of Disease (GBD) Study 2015, which included literature searches between 1980 and 2014 in both English and Spanish.
Overall, the prevalence of scabies worldwide was 204,151,715, and the age-standardized DALYs was 71/100,000 people. The highest DALYs in terms of world regions were reported in East Asia (136/100,000), Southeast Asia (135/100,000) the region described as Oceania (120/100,000) (which included American Samoa, Fiji, Guam, Marshall Islands, Northern Mariana Islands, Papua New Guinea, Samoa, Solomon Islands, and others), tropical Latin America (100/100,000), and South Asia (69/100,000). Scabies caused 0.21% of DALYs from all the conditions that are studied by GBD 2015 globally. The mean percent change in age-standardized DALY from 1990 to 2015 increased 22% in North America, but the age-standardized DALY still remained less than 5/100,000.
In addition, global DALYs from scabies skin infection were highest in children aged 1-4 years (116/100,000 individuals) and adolescents aged 15-19 years (102/100,000). DALYs were not significantly different between men and women across all age groups, Dr. Karimkhani and her associates reported.
“As a worldwide epidemiological assessment, GBD 2015 provides broad and frequently updated measures of scabies burden in terms of skin effects. These global data might help guide research protocols and prioritization efforts and focus scabies treatment and control measures,” the researchers said.
Of note is that these analyses do not include information about complications of scabies such as impetigo, local and systemic bacterial infections, glomerulonephritis, and rheumatic fever.
The study was funded by the Bill and Melinda Gates Foundation. The researchers had no financial conflicts to disclose.
Read the full study here: (Lancet Infect. Dis. 2017. doi: 10.1016/S1473-3099[17]30483-8).
Scabies hits hardest in tropical parts of the world, and children and teens are most affected by the condition, based on data from a global epidemiological assessment.
“,” wrote Chante Karimkhani, MD, of the University of Colorado, Aurora, and her colleagues. To estimate the global impact of scabies, the researchers used the Global Burden of Disease (GBD) Study 2015, which included literature searches between 1980 and 2014 in both English and Spanish.
Overall, the prevalence of scabies worldwide was 204,151,715, and the age-standardized DALYs was 71/100,000 people. The highest DALYs in terms of world regions were reported in East Asia (136/100,000), Southeast Asia (135/100,000) the region described as Oceania (120/100,000) (which included American Samoa, Fiji, Guam, Marshall Islands, Northern Mariana Islands, Papua New Guinea, Samoa, Solomon Islands, and others), tropical Latin America (100/100,000), and South Asia (69/100,000). Scabies caused 0.21% of DALYs from all the conditions that are studied by GBD 2015 globally. The mean percent change in age-standardized DALY from 1990 to 2015 increased 22% in North America, but the age-standardized DALY still remained less than 5/100,000.
In addition, global DALYs from scabies skin infection were highest in children aged 1-4 years (116/100,000 individuals) and adolescents aged 15-19 years (102/100,000). DALYs were not significantly different between men and women across all age groups, Dr. Karimkhani and her associates reported.
“As a worldwide epidemiological assessment, GBD 2015 provides broad and frequently updated measures of scabies burden in terms of skin effects. These global data might help guide research protocols and prioritization efforts and focus scabies treatment and control measures,” the researchers said.
Of note is that these analyses do not include information about complications of scabies such as impetigo, local and systemic bacterial infections, glomerulonephritis, and rheumatic fever.
The study was funded by the Bill and Melinda Gates Foundation. The researchers had no financial conflicts to disclose.
Read the full study here: (Lancet Infect. Dis. 2017. doi: 10.1016/S1473-3099[17]30483-8).
FROM THE LANCET INFECTIOUS DISEASES
Behavioral approach to appropriate antimicrobial prescribing in hospitals: The DUMAS study
Clinical question: How effective is an antimicrobial stewardship approach grounded in behavioral theory and focused on preserving prescriber autonomy and participation in improving appropriateness of antimicrobial prescribing in hospitals?
Background: Antimicrobial stewardship programs aim to achieve the goal of improving antimicrobial prescribing. This leads to significant benefits, including decreased antimicrobial resistance, improved clinical outcomes (lower morbidity and mortality), and lower health care costs. Stewardship programs do not often focus on the human behavior element of the prescribing physicians. Changing antimicrobial prescribing is a complex behavioral process, and there is a known persistent resistance between prescribers and the stewardship team. In a simple sense, this resistance is generated by tension created when prescribers do not have autonomy.
Previous studies that used interventions based on behavioral theory found promising results, but none of them were in a hospital setting. Rather, most of these studies had a narrow focus of respiratory tract infections in outpatient clinics.
Setting: Seven clinical departments (two medical, three surgical, and two pediatric) in a tertiary care medical center and a general teaching hospital, both in Amsterdam. The first hospital was a 700-bed tertiary care center with salaried specialists, while the second hospital was a 550-bed general medical center with self-employed specialists.
Synopsis: During a baseline period of 16 months and an intervention period of 12 months, physicians who prescribed systemic antimicrobial drugs for any indication were included in the study. In all, 1,121 patient cases with 700 prescriptions were studied during the baseline period and 882 patient cases with 531 prescriptions were studied during the intervention period. The intervention was as follows: Prescribers were offered a free choice of how to improve their antimicrobial prescribing. They were stimulated to choose interventions with higher potential for success based on a root cause analysis of inappropriate prescribing. The study was inspired by the participatory action research paradigm, which focuses on collaboration and empowerment of the stakeholders in the change process. In this study, prescribers were given reports of root cause analysis of their prior prescribing patterns. Then, they were invited to choose and codevelop one or more interventions that were tailored and individualized to improve their own prescribing. This approach draws on the following three behavioral principles: 1) respect for the prescriber’s autonomy to avoid feelings of resistance; 2) the inclination that people have to value a product higher and feel more ownership of it if they made it themselves (the IKEA effect); 3) the tendency of people to follow up on an active and public commitment.
The primary outcome was antimicrobial appropriateness, measured with a validated appropriateness assessment instrument. One of three infectious disease specialists assessed the adult prescriptions, and one of three infectious disease/immunology pediatricians assessed the pediatric prescriptions for appropriateness. Appropriateness criteria were as follows: indication, choice of antimicrobial, dosage, route, and duration. A secondary outcome was antimicrobial consumption, reported as days of therapy per 100 admissions per month. Other outcomes were changes in specific appropriateness categories, intravenous antimicrobial consumption, consumption of specific antimicrobial subgroups, and length of hospital stay.
The mean antimicrobial appropriateness increased from 64.1% at intervention start to 77.4% at 12-month follow-up (+13.3%; relative risk, 1.17; 95% CI, 1.04-1.27), without a change in slope. Antimicrobial consumption remained the same during both study periods. Length of hospital stay did not change relative to the start of the intervention approach.
This is the first study of its kind, as a hospital antimicrobial stewardship program study grounded in behavioral science, with the key element being the free choice allowed to the prescribers, who made their own autonomous decisions about how to improve their prescribing. The authors hypothesize that the prescribers felt relatively nonthreatened by their approach since the prescribers maintained their free will to change their own behavior if so desired. The prescribers were given a free intervention choice. For example, they could have just chosen “education” as an easy out; however, the root cause analysis seemed to be an impetus for the prescribers to choose interventions that would be more effective. A prior study in a nursing home setting was unsuccessful; aside from other differences, that study used a predetermined set of interventions, thus lacking the autonomy and IKEA effect seen in this study.
Bottom line: Use of a behavioral approach that preserves prescriber autonomy resulted in an increase in antimicrobial appropriateness sustained for at least 12 months. The intervention is effective, inexpensive, and transferable to various health care settings.
Citation: Sikkens JJ, van Agtmael MA, Peters EJG, et al. Behavioral approach to appropriate antimicrobial prescribing in hospitals: The dutch unique method for antimicrobial stewardship (DUMAS) participatoryintervention study. JAMA Intern Med. Published online May 1, 2017. doi: 10.1001/jamainternmed.2017.0946.
Dr. Ramee is a hospitalist at Ochsner Health System, New Orleans.
Clinical question: How effective is an antimicrobial stewardship approach grounded in behavioral theory and focused on preserving prescriber autonomy and participation in improving appropriateness of antimicrobial prescribing in hospitals?
Background: Antimicrobial stewardship programs aim to achieve the goal of improving antimicrobial prescribing. This leads to significant benefits, including decreased antimicrobial resistance, improved clinical outcomes (lower morbidity and mortality), and lower health care costs. Stewardship programs do not often focus on the human behavior element of the prescribing physicians. Changing antimicrobial prescribing is a complex behavioral process, and there is a known persistent resistance between prescribers and the stewardship team. In a simple sense, this resistance is generated by tension created when prescribers do not have autonomy.
Previous studies that used interventions based on behavioral theory found promising results, but none of them were in a hospital setting. Rather, most of these studies had a narrow focus of respiratory tract infections in outpatient clinics.
Setting: Seven clinical departments (two medical, three surgical, and two pediatric) in a tertiary care medical center and a general teaching hospital, both in Amsterdam. The first hospital was a 700-bed tertiary care center with salaried specialists, while the second hospital was a 550-bed general medical center with self-employed specialists.
Synopsis: During a baseline period of 16 months and an intervention period of 12 months, physicians who prescribed systemic antimicrobial drugs for any indication were included in the study. In all, 1,121 patient cases with 700 prescriptions were studied during the baseline period and 882 patient cases with 531 prescriptions were studied during the intervention period. The intervention was as follows: Prescribers were offered a free choice of how to improve their antimicrobial prescribing. They were stimulated to choose interventions with higher potential for success based on a root cause analysis of inappropriate prescribing. The study was inspired by the participatory action research paradigm, which focuses on collaboration and empowerment of the stakeholders in the change process. In this study, prescribers were given reports of root cause analysis of their prior prescribing patterns. Then, they were invited to choose and codevelop one or more interventions that were tailored and individualized to improve their own prescribing. This approach draws on the following three behavioral principles: 1) respect for the prescriber’s autonomy to avoid feelings of resistance; 2) the inclination that people have to value a product higher and feel more ownership of it if they made it themselves (the IKEA effect); 3) the tendency of people to follow up on an active and public commitment.
The primary outcome was antimicrobial appropriateness, measured with a validated appropriateness assessment instrument. One of three infectious disease specialists assessed the adult prescriptions, and one of three infectious disease/immunology pediatricians assessed the pediatric prescriptions for appropriateness. Appropriateness criteria were as follows: indication, choice of antimicrobial, dosage, route, and duration. A secondary outcome was antimicrobial consumption, reported as days of therapy per 100 admissions per month. Other outcomes were changes in specific appropriateness categories, intravenous antimicrobial consumption, consumption of specific antimicrobial subgroups, and length of hospital stay.
The mean antimicrobial appropriateness increased from 64.1% at intervention start to 77.4% at 12-month follow-up (+13.3%; relative risk, 1.17; 95% CI, 1.04-1.27), without a change in slope. Antimicrobial consumption remained the same during both study periods. Length of hospital stay did not change relative to the start of the intervention approach.
This is the first study of its kind, as a hospital antimicrobial stewardship program study grounded in behavioral science, with the key element being the free choice allowed to the prescribers, who made their own autonomous decisions about how to improve their prescribing. The authors hypothesize that the prescribers felt relatively nonthreatened by their approach since the prescribers maintained their free will to change their own behavior if so desired. The prescribers were given a free intervention choice. For example, they could have just chosen “education” as an easy out; however, the root cause analysis seemed to be an impetus for the prescribers to choose interventions that would be more effective. A prior study in a nursing home setting was unsuccessful; aside from other differences, that study used a predetermined set of interventions, thus lacking the autonomy and IKEA effect seen in this study.
Bottom line: Use of a behavioral approach that preserves prescriber autonomy resulted in an increase in antimicrobial appropriateness sustained for at least 12 months. The intervention is effective, inexpensive, and transferable to various health care settings.
Citation: Sikkens JJ, van Agtmael MA, Peters EJG, et al. Behavioral approach to appropriate antimicrobial prescribing in hospitals: The dutch unique method for antimicrobial stewardship (DUMAS) participatoryintervention study. JAMA Intern Med. Published online May 1, 2017. doi: 10.1001/jamainternmed.2017.0946.
Dr. Ramee is a hospitalist at Ochsner Health System, New Orleans.
Clinical question: How effective is an antimicrobial stewardship approach grounded in behavioral theory and focused on preserving prescriber autonomy and participation in improving appropriateness of antimicrobial prescribing in hospitals?
Background: Antimicrobial stewardship programs aim to achieve the goal of improving antimicrobial prescribing. This leads to significant benefits, including decreased antimicrobial resistance, improved clinical outcomes (lower morbidity and mortality), and lower health care costs. Stewardship programs do not often focus on the human behavior element of the prescribing physicians. Changing antimicrobial prescribing is a complex behavioral process, and there is a known persistent resistance between prescribers and the stewardship team. In a simple sense, this resistance is generated by tension created when prescribers do not have autonomy.
Previous studies that used interventions based on behavioral theory found promising results, but none of them were in a hospital setting. Rather, most of these studies had a narrow focus of respiratory tract infections in outpatient clinics.
Setting: Seven clinical departments (two medical, three surgical, and two pediatric) in a tertiary care medical center and a general teaching hospital, both in Amsterdam. The first hospital was a 700-bed tertiary care center with salaried specialists, while the second hospital was a 550-bed general medical center with self-employed specialists.
Synopsis: During a baseline period of 16 months and an intervention period of 12 months, physicians who prescribed systemic antimicrobial drugs for any indication were included in the study. In all, 1,121 patient cases with 700 prescriptions were studied during the baseline period and 882 patient cases with 531 prescriptions were studied during the intervention period. The intervention was as follows: Prescribers were offered a free choice of how to improve their antimicrobial prescribing. They were stimulated to choose interventions with higher potential for success based on a root cause analysis of inappropriate prescribing. The study was inspired by the participatory action research paradigm, which focuses on collaboration and empowerment of the stakeholders in the change process. In this study, prescribers were given reports of root cause analysis of their prior prescribing patterns. Then, they were invited to choose and codevelop one or more interventions that were tailored and individualized to improve their own prescribing. This approach draws on the following three behavioral principles: 1) respect for the prescriber’s autonomy to avoid feelings of resistance; 2) the inclination that people have to value a product higher and feel more ownership of it if they made it themselves (the IKEA effect); 3) the tendency of people to follow up on an active and public commitment.
The primary outcome was antimicrobial appropriateness, measured with a validated appropriateness assessment instrument. One of three infectious disease specialists assessed the adult prescriptions, and one of three infectious disease/immunology pediatricians assessed the pediatric prescriptions for appropriateness. Appropriateness criteria were as follows: indication, choice of antimicrobial, dosage, route, and duration. A secondary outcome was antimicrobial consumption, reported as days of therapy per 100 admissions per month. Other outcomes were changes in specific appropriateness categories, intravenous antimicrobial consumption, consumption of specific antimicrobial subgroups, and length of hospital stay.
The mean antimicrobial appropriateness increased from 64.1% at intervention start to 77.4% at 12-month follow-up (+13.3%; relative risk, 1.17; 95% CI, 1.04-1.27), without a change in slope. Antimicrobial consumption remained the same during both study periods. Length of hospital stay did not change relative to the start of the intervention approach.
This is the first study of its kind, as a hospital antimicrobial stewardship program study grounded in behavioral science, with the key element being the free choice allowed to the prescribers, who made their own autonomous decisions about how to improve their prescribing. The authors hypothesize that the prescribers felt relatively nonthreatened by their approach since the prescribers maintained their free will to change their own behavior if so desired. The prescribers were given a free intervention choice. For example, they could have just chosen “education” as an easy out; however, the root cause analysis seemed to be an impetus for the prescribers to choose interventions that would be more effective. A prior study in a nursing home setting was unsuccessful; aside from other differences, that study used a predetermined set of interventions, thus lacking the autonomy and IKEA effect seen in this study.
Bottom line: Use of a behavioral approach that preserves prescriber autonomy resulted in an increase in antimicrobial appropriateness sustained for at least 12 months. The intervention is effective, inexpensive, and transferable to various health care settings.
Citation: Sikkens JJ, van Agtmael MA, Peters EJG, et al. Behavioral approach to appropriate antimicrobial prescribing in hospitals: The dutch unique method for antimicrobial stewardship (DUMAS) participatoryintervention study. JAMA Intern Med. Published online May 1, 2017. doi: 10.1001/jamainternmed.2017.0946.
Dr. Ramee is a hospitalist at Ochsner Health System, New Orleans.
FDA grants drug orphan designation to treat cGVHD
The US Food and Drug Administration (FDA) has granted orphan drug designation to KD025 for the treatment of chronic graft-versus-host disease (cGVHD).
KD025 is a Rho-associated coiled-coil kinase (ROCK) inhibitor being developed by Kadmon Holdings, Inc.
The drug is currently under investigation in a phase 2 trial of adults with steroid-dependent or steroid-refractory cGVHD and active disease.
This dose-finding study has enrolled 48 patients divided into 3 cohorts in which patients receive KD025 at 200 mg once daily, 200 mg twice daily, or 400 mg once daily. The patients were enrolled sequentially following a safety assessment of each cohort.
In July, Kadmon Holdings, Inc. released a preliminary analysis of data from the lowest-dose cohort (n=17, 200 mg once daily).
The overall response rate in this cohort was 71% (12/17). Of responders remaining on KD025 through week 24, 89% (8/9) sustained responses. Sixty-seven percent (8/12) of responders saw an improvement in symptoms, as measured by the Lee cGVHD Symptom Scale score.
In addition to the 12 responders, 3 patients had stable disease and were still on KD025 through week 24. So an overall clinical benefit (response and stable disease) occurred in 88% (15/17) of patients.
Sixty-seven percent (8/12) of responders had a reduction in steroid doses, and 67% (4/6) of responders on tacrolimus had a reduction in tacrolimus doses.
There were no drug-related serious adverse events or drug-related elevations in liver function tests reported.
Kadmon Holdings, Inc. plans to present additional data from this study toward the end of this year.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved. 
The US Food and Drug Administration (FDA) has granted orphan drug designation to KD025 for the treatment of chronic graft-versus-host disease (cGVHD).
KD025 is a Rho-associated coiled-coil kinase (ROCK) inhibitor being developed by Kadmon Holdings, Inc.
The drug is currently under investigation in a phase 2 trial of adults with steroid-dependent or steroid-refractory cGVHD and active disease.
This dose-finding study has enrolled 48 patients divided into 3 cohorts in which patients receive KD025 at 200 mg once daily, 200 mg twice daily, or 400 mg once daily. The patients were enrolled sequentially following a safety assessment of each cohort.
In July, Kadmon Holdings, Inc. released a preliminary analysis of data from the lowest-dose cohort (n=17, 200 mg once daily).
The overall response rate in this cohort was 71% (12/17). Of responders remaining on KD025 through week 24, 89% (8/9) sustained responses. Sixty-seven percent (8/12) of responders saw an improvement in symptoms, as measured by the Lee cGVHD Symptom Scale score.
In addition to the 12 responders, 3 patients had stable disease and were still on KD025 through week 24. So an overall clinical benefit (response and stable disease) occurred in 88% (15/17) of patients.
Sixty-seven percent (8/12) of responders had a reduction in steroid doses, and 67% (4/6) of responders on tacrolimus had a reduction in tacrolimus doses.
There were no drug-related serious adverse events or drug-related elevations in liver function tests reported.
Kadmon Holdings, Inc. plans to present additional data from this study toward the end of this year.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation to KD025 for the treatment of chronic graft-versus-host disease (cGVHD).
KD025 is a Rho-associated coiled-coil kinase (ROCK) inhibitor being developed by Kadmon Holdings, Inc.
The drug is currently under investigation in a phase 2 trial of adults with steroid-dependent or steroid-refractory cGVHD and active disease.
This dose-finding study has enrolled 48 patients divided into 3 cohorts in which patients receive KD025 at 200 mg once daily, 200 mg twice daily, or 400 mg once daily. The patients were enrolled sequentially following a safety assessment of each cohort.
In July, Kadmon Holdings, Inc. released a preliminary analysis of data from the lowest-dose cohort (n=17, 200 mg once daily).
The overall response rate in this cohort was 71% (12/17). Of responders remaining on KD025 through week 24, 89% (8/9) sustained responses. Sixty-seven percent (8/12) of responders saw an improvement in symptoms, as measured by the Lee cGVHD Symptom Scale score.
In addition to the 12 responders, 3 patients had stable disease and were still on KD025 through week 24. So an overall clinical benefit (response and stable disease) occurred in 88% (15/17) of patients.
Sixty-seven percent (8/12) of responders had a reduction in steroid doses, and 67% (4/6) of responders on tacrolimus had a reduction in tacrolimus doses.
There were no drug-related serious adverse events or drug-related elevations in liver function tests reported.
Kadmon Holdings, Inc. plans to present additional data from this study toward the end of this year.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
Duty vs. confidentiality
Question: During an office visit, a patient confided in his primary care provider his intention to go on a shooting spree. When pressed, he admitted he owned a firearm, but did not truly intend to carry out the act. He denied having a specific target location or victim in mind. The primary care provider (PCP) opted to counsel the patient, and continued him on his antidepressant medication. The PCP did not make a referral to a psychiatrist. Several weeks later, the patient put his threat into action, shooting and injuring several innocent shoppers at a mall.
In a lawsuit against the PCP, which of the following is best?
A. It is unethical for the PCP to report this threat, because it violates the principle of confidentiality.
B. Failure to warn under the circumstances definitely makes the physician liable.
C. The PCP is liable under the Tarasoff doctrine.
D. Without a named victim, there is no one to warn.
E. Whether the PCP is liable may turn on the issue of foreseeability, and an immediate referral to a psychiatrist would have been a more prudent course of action.
Answer: E. One of the physician’s sacred promises is to maintain patient confidentiality. It is more than an unspoken contractual agreement; it’s a central component of trust, without which the doctor-patient relationship cannot exist. Indeed, Hippocrates had cautioned, “whatever in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge as reckoning that all should be kept secret.”
Thus, the recent expansive decision handed down by the Washington state Supreme Court stunned many mental health professionals.1 In Volk v. DeMeerleer, a clinic patient had confided in his psychiatrist over 9 years of therapy his suicidal and homicidal ideations. He eventually went on to kill his former girlfriend and one of her sons, and then committed suicide. The psychiatrist did not have full control of this clinic patient, nor had the patient named a specific victim. Nevertheless, the Volk court held that the doctor’s duty extended to any foreseeable harm by the patient, leaving it up to the jury to decide on the issue of foreseeability.
The court held that the psychiatrist had a “special relationship” with the victims, because he had a duty to exercise reasonable care to act, consistent with the standards of the mental health profession, in order to protect the foreseeable victims.
The court reasoned that some ability to control the patient’s conduct is sufficient for the “special relationship” and the consequent duty of care to exist, writing: “We find that absolute control is unnecessary, and the actions available to mental health professionals, even in the outpatient setting, weigh in favor of imposing a duty.” The court also noted that a psychiatrist’s obligation to protect third parties against patients’ violence would normally set aside confidentiality and yield to greater societal interests.
The vexing issue of compromising confidentiality in the name of protecting public safety had its genesis in the famous Tarasoff v. Regents of University of California case.2
In Tarasoff, the California court imposed a legal duty on a college psychologist to warn an intended victim of harm, even though that meant breaching confidentiality in a professional relationship. A jilted patient had confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, whom the patient stabbed to death 2 months later.
The court reasoned that the protection of public safety was more important than the sanctity of the doctor-patient confidentiality relationship, pointing out: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault. ... In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal.”
Following Tarasoff, it is generally accepted that there is no affirmative duty to warn where there is no readily identifiable victim. In a subsequent case, the same court explained that “the duty to warn depends upon and arises from the existence of a prior threat to a specific identifiable victim. In those instances in which the released offender poses a predictable threat of harm to a named or readily identifiable victim or group of victims who can be effectively warned of the danger, a releasing agent may well be liable for failure to warn such persons. Despite the tragic events underlying the present complaint, plaintiffs’ decedent was not a known, identifiable victim, but rather a member of a large, amorphous public group of potential targets. Under these circumstances, we hold that County had no affirmative duty to warn plaintiffs, the police, the mother of the juvenile offender, or other local parents.”3
Commentators have suggested that such post-Tarasoff cases, coupled with the advent of state statutes that codify Tarasoff, have witnessed a retreat from imposing on clinicians a duty to warn.4 By dispensing with the control and “readily identifiable victim” elements, Volk appears to contradict this perceived trend. Foreseeability may turn out to be the dispositive issue.
Some have speculated whether Volk’s expanded view will apply to other professionals such as a family practitioner or even a school counselor. Physicians who are not experienced in treating mental health patients will do well to promptly refer their unstable patients to a specialist psychiatrist.
Volk can also be read as offering judicial insight into patients who pose a health hazard by insisting on operating a vehicle against medical advice. In its 2012 Code of Medical Ethics, the American Medical Association had this to say: “In situations where clear evidence of substantial driving impairment implies a strong threat to patient and public safety, and where the physician’s advice to discontinue driving privileges is ignored, it is desirable and ethical to notify the department of motor vehicles.”5
That is now replaced in the AMA code with a broader version covering the duty to disclose: “Physicians may disclose personal health information without the specific consent of the patient ... to other third parties situated to mitigate the threat when in the physician’s judgment there is a reasonable probability that: (i) the patient will seriously harm him/herself; or (ii) the patient will inflict serious physical harm on an identifiable individual or individuals.”6
Under Volk, physicians are now more likely to forsake confidentiality in the name of public safety – even in the absence of a readily identifiable potential victim.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Volk v. DeMeerleer, 386 P.3d 254 (Wa. 2016).
2. Tarasoff v. Regents of University of California, 551 P.2d 334 (Cal. 1976).
3. Thompson v. County of Alameda, 167 Cal. Rptr. 70, 76 (1980).
4. Behav Sci Law. 2001;19(3):325-43.
5. AMA Code of Medical Ethics [2.24 (3), 2012-2013 ed].
6. AMA Code of Medical Ethics, 2017 ed. [3.2.1 Confidentiality].
Question: During an office visit, a patient confided in his primary care provider his intention to go on a shooting spree. When pressed, he admitted he owned a firearm, but did not truly intend to carry out the act. He denied having a specific target location or victim in mind. The primary care provider (PCP) opted to counsel the patient, and continued him on his antidepressant medication. The PCP did not make a referral to a psychiatrist. Several weeks later, the patient put his threat into action, shooting and injuring several innocent shoppers at a mall.
In a lawsuit against the PCP, which of the following is best?
A. It is unethical for the PCP to report this threat, because it violates the principle of confidentiality.
B. Failure to warn under the circumstances definitely makes the physician liable.
C. The PCP is liable under the Tarasoff doctrine.
D. Without a named victim, there is no one to warn.
E. Whether the PCP is liable may turn on the issue of foreseeability, and an immediate referral to a psychiatrist would have been a more prudent course of action.
Answer: E. One of the physician’s sacred promises is to maintain patient confidentiality. It is more than an unspoken contractual agreement; it’s a central component of trust, without which the doctor-patient relationship cannot exist. Indeed, Hippocrates had cautioned, “whatever in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge as reckoning that all should be kept secret.”
Thus, the recent expansive decision handed down by the Washington state Supreme Court stunned many mental health professionals.1 In Volk v. DeMeerleer, a clinic patient had confided in his psychiatrist over 9 years of therapy his suicidal and homicidal ideations. He eventually went on to kill his former girlfriend and one of her sons, and then committed suicide. The psychiatrist did not have full control of this clinic patient, nor had the patient named a specific victim. Nevertheless, the Volk court held that the doctor’s duty extended to any foreseeable harm by the patient, leaving it up to the jury to decide on the issue of foreseeability.
The court held that the psychiatrist had a “special relationship” with the victims, because he had a duty to exercise reasonable care to act, consistent with the standards of the mental health profession, in order to protect the foreseeable victims.
The court reasoned that some ability to control the patient’s conduct is sufficient for the “special relationship” and the consequent duty of care to exist, writing: “We find that absolute control is unnecessary, and the actions available to mental health professionals, even in the outpatient setting, weigh in favor of imposing a duty.” The court also noted that a psychiatrist’s obligation to protect third parties against patients’ violence would normally set aside confidentiality and yield to greater societal interests.
The vexing issue of compromising confidentiality in the name of protecting public safety had its genesis in the famous Tarasoff v. Regents of University of California case.2
In Tarasoff, the California court imposed a legal duty on a college psychologist to warn an intended victim of harm, even though that meant breaching confidentiality in a professional relationship. A jilted patient had confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, whom the patient stabbed to death 2 months later.
The court reasoned that the protection of public safety was more important than the sanctity of the doctor-patient confidentiality relationship, pointing out: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault. ... In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal.”
Following Tarasoff, it is generally accepted that there is no affirmative duty to warn where there is no readily identifiable victim. In a subsequent case, the same court explained that “the duty to warn depends upon and arises from the existence of a prior threat to a specific identifiable victim. In those instances in which the released offender poses a predictable threat of harm to a named or readily identifiable victim or group of victims who can be effectively warned of the danger, a releasing agent may well be liable for failure to warn such persons. Despite the tragic events underlying the present complaint, plaintiffs’ decedent was not a known, identifiable victim, but rather a member of a large, amorphous public group of potential targets. Under these circumstances, we hold that County had no affirmative duty to warn plaintiffs, the police, the mother of the juvenile offender, or other local parents.”3
Commentators have suggested that such post-Tarasoff cases, coupled with the advent of state statutes that codify Tarasoff, have witnessed a retreat from imposing on clinicians a duty to warn.4 By dispensing with the control and “readily identifiable victim” elements, Volk appears to contradict this perceived trend. Foreseeability may turn out to be the dispositive issue.
Some have speculated whether Volk’s expanded view will apply to other professionals such as a family practitioner or even a school counselor. Physicians who are not experienced in treating mental health patients will do well to promptly refer their unstable patients to a specialist psychiatrist.
Volk can also be read as offering judicial insight into patients who pose a health hazard by insisting on operating a vehicle against medical advice. In its 2012 Code of Medical Ethics, the American Medical Association had this to say: “In situations where clear evidence of substantial driving impairment implies a strong threat to patient and public safety, and where the physician’s advice to discontinue driving privileges is ignored, it is desirable and ethical to notify the department of motor vehicles.”5
That is now replaced in the AMA code with a broader version covering the duty to disclose: “Physicians may disclose personal health information without the specific consent of the patient ... to other third parties situated to mitigate the threat when in the physician’s judgment there is a reasonable probability that: (i) the patient will seriously harm him/herself; or (ii) the patient will inflict serious physical harm on an identifiable individual or individuals.”6
Under Volk, physicians are now more likely to forsake confidentiality in the name of public safety – even in the absence of a readily identifiable potential victim.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Volk v. DeMeerleer, 386 P.3d 254 (Wa. 2016).
2. Tarasoff v. Regents of University of California, 551 P.2d 334 (Cal. 1976).
3. Thompson v. County of Alameda, 167 Cal. Rptr. 70, 76 (1980).
4. Behav Sci Law. 2001;19(3):325-43.
5. AMA Code of Medical Ethics [2.24 (3), 2012-2013 ed].
6. AMA Code of Medical Ethics, 2017 ed. [3.2.1 Confidentiality].
Question: During an office visit, a patient confided in his primary care provider his intention to go on a shooting spree. When pressed, he admitted he owned a firearm, but did not truly intend to carry out the act. He denied having a specific target location or victim in mind. The primary care provider (PCP) opted to counsel the patient, and continued him on his antidepressant medication. The PCP did not make a referral to a psychiatrist. Several weeks later, the patient put his threat into action, shooting and injuring several innocent shoppers at a mall.
In a lawsuit against the PCP, which of the following is best?
A. It is unethical for the PCP to report this threat, because it violates the principle of confidentiality.
B. Failure to warn under the circumstances definitely makes the physician liable.
C. The PCP is liable under the Tarasoff doctrine.
D. Without a named victim, there is no one to warn.
E. Whether the PCP is liable may turn on the issue of foreseeability, and an immediate referral to a psychiatrist would have been a more prudent course of action.
Answer: E. One of the physician’s sacred promises is to maintain patient confidentiality. It is more than an unspoken contractual agreement; it’s a central component of trust, without which the doctor-patient relationship cannot exist. Indeed, Hippocrates had cautioned, “whatever in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge as reckoning that all should be kept secret.”
Thus, the recent expansive decision handed down by the Washington state Supreme Court stunned many mental health professionals.1 In Volk v. DeMeerleer, a clinic patient had confided in his psychiatrist over 9 years of therapy his suicidal and homicidal ideations. He eventually went on to kill his former girlfriend and one of her sons, and then committed suicide. The psychiatrist did not have full control of this clinic patient, nor had the patient named a specific victim. Nevertheless, the Volk court held that the doctor’s duty extended to any foreseeable harm by the patient, leaving it up to the jury to decide on the issue of foreseeability.
The court held that the psychiatrist had a “special relationship” with the victims, because he had a duty to exercise reasonable care to act, consistent with the standards of the mental health profession, in order to protect the foreseeable victims.
The court reasoned that some ability to control the patient’s conduct is sufficient for the “special relationship” and the consequent duty of care to exist, writing: “We find that absolute control is unnecessary, and the actions available to mental health professionals, even in the outpatient setting, weigh in favor of imposing a duty.” The court also noted that a psychiatrist’s obligation to protect third parties against patients’ violence would normally set aside confidentiality and yield to greater societal interests.
The vexing issue of compromising confidentiality in the name of protecting public safety had its genesis in the famous Tarasoff v. Regents of University of California case.2
In Tarasoff, the California court imposed a legal duty on a college psychologist to warn an intended victim of harm, even though that meant breaching confidentiality in a professional relationship. A jilted patient had confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, whom the patient stabbed to death 2 months later.
The court reasoned that the protection of public safety was more important than the sanctity of the doctor-patient confidentiality relationship, pointing out: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault. ... In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal.”
Following Tarasoff, it is generally accepted that there is no affirmative duty to warn where there is no readily identifiable victim. In a subsequent case, the same court explained that “the duty to warn depends upon and arises from the existence of a prior threat to a specific identifiable victim. In those instances in which the released offender poses a predictable threat of harm to a named or readily identifiable victim or group of victims who can be effectively warned of the danger, a releasing agent may well be liable for failure to warn such persons. Despite the tragic events underlying the present complaint, plaintiffs’ decedent was not a known, identifiable victim, but rather a member of a large, amorphous public group of potential targets. Under these circumstances, we hold that County had no affirmative duty to warn plaintiffs, the police, the mother of the juvenile offender, or other local parents.”3
Commentators have suggested that such post-Tarasoff cases, coupled with the advent of state statutes that codify Tarasoff, have witnessed a retreat from imposing on clinicians a duty to warn.4 By dispensing with the control and “readily identifiable victim” elements, Volk appears to contradict this perceived trend. Foreseeability may turn out to be the dispositive issue.
Some have speculated whether Volk’s expanded view will apply to other professionals such as a family practitioner or even a school counselor. Physicians who are not experienced in treating mental health patients will do well to promptly refer their unstable patients to a specialist psychiatrist.
Volk can also be read as offering judicial insight into patients who pose a health hazard by insisting on operating a vehicle against medical advice. In its 2012 Code of Medical Ethics, the American Medical Association had this to say: “In situations where clear evidence of substantial driving impairment implies a strong threat to patient and public safety, and where the physician’s advice to discontinue driving privileges is ignored, it is desirable and ethical to notify the department of motor vehicles.”5
That is now replaced in the AMA code with a broader version covering the duty to disclose: “Physicians may disclose personal health information without the specific consent of the patient ... to other third parties situated to mitigate the threat when in the physician’s judgment there is a reasonable probability that: (i) the patient will seriously harm him/herself; or (ii) the patient will inflict serious physical harm on an identifiable individual or individuals.”6
Under Volk, physicians are now more likely to forsake confidentiality in the name of public safety – even in the absence of a readily identifiable potential victim.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Volk v. DeMeerleer, 386 P.3d 254 (Wa. 2016).
2. Tarasoff v. Regents of University of California, 551 P.2d 334 (Cal. 1976).
3. Thompson v. County of Alameda, 167 Cal. Rptr. 70, 76 (1980).
4. Behav Sci Law. 2001;19(3):325-43.
5. AMA Code of Medical Ethics [2.24 (3), 2012-2013 ed].
6. AMA Code of Medical Ethics, 2017 ed. [3.2.1 Confidentiality].
Baseline lab data is class specific for biologics to treat psoriasis patients
said April Armstrong, MD, of the University of Southern California, Los Angeles.
Keep class-specific considerations in mind when collecting baseline lab data to help support the success of biologics in treating psoriasis, Dr. Armstrong said at the annual Coastal Dermatology Symposium.
When clinicians consider biologics, they must balance efficacy, safety, convenience, and costs of treatment, Dr. Armstrong said.
She addressed general considerations when selecting biologics for psoriasis and stressed the importance of assessing patients for tuberculosis and reviewing underlying cancer risk. Confirm that a patient has no active infections and consider whether a patient has completed all age-appropriate immunizations. Consider a complete blood count and metabolic panel for the following biologics:
- Ustekinumab: Baseline HIV or pregnancy test, and a TB evaluation at baseline as well as annual monitoring.
- Etanercept, adalimumab, infliximab: Baseline TB evaluation and screening hepatitis panel, liver function tests, and blood count, with option to add pregnancy test or HIV test. A liver function test/hepatitis panel is indicated annually, and TB should be monitored annually. Be cautious about using this class of drugs in patients with heart failure, and verify the absence of demyelinating disease in patients prior to prescribing this class of drugs.
- Guselkumab: Baseline TB evaluation, possible pregnancy or HIV tests, followed by annual TB evaluation.
- Secukinumab, ixekizumab, and brodalumab: Baseline TB evaluation, consider HIV or pregnancy tests, followed by annual TB evaluation. Be cautious about using this class of drugs in patients with ulcerative colitis or Crohn’s disease; assess and counsel for increased risk of suicidality when considering brodalumab.
Beyond the general considerations, several other factors can help maximize success with particular biologics, Dr. Armstrong said at the meeting, which is jointly presented by the University of Louisville and Global Academy for Medical Education.
The number of injections given in the first year, which range from 5 (ustekinumab) to 64 (etanercept) is an important consideration for some patients, Dr. Armstrong noted; the number of injections for the remaining biologics are guselkumab, 8; ixekizumab, 17; brodalumab and adalimumab, both 27, and secukinumab, 32. In addition, the IL-17 inhibitors carry some risk of oral candidiasis and inflammatory bowel disease.
This publication and the Global Academy for Medical Education are owned by Frontline Medical News.
Dr. Armstrong disclosed relationships with multiple companies including AbbVie, Janssen, Novartis, Lilly, Regeneron, Sanofi, Modernizing Medicine, and Valeant.
said April Armstrong, MD, of the University of Southern California, Los Angeles.
Keep class-specific considerations in mind when collecting baseline lab data to help support the success of biologics in treating psoriasis, Dr. Armstrong said at the annual Coastal Dermatology Symposium.
When clinicians consider biologics, they must balance efficacy, safety, convenience, and costs of treatment, Dr. Armstrong said.
She addressed general considerations when selecting biologics for psoriasis and stressed the importance of assessing patients for tuberculosis and reviewing underlying cancer risk. Confirm that a patient has no active infections and consider whether a patient has completed all age-appropriate immunizations. Consider a complete blood count and metabolic panel for the following biologics:
- Ustekinumab: Baseline HIV or pregnancy test, and a TB evaluation at baseline as well as annual monitoring.
- Etanercept, adalimumab, infliximab: Baseline TB evaluation and screening hepatitis panel, liver function tests, and blood count, with option to add pregnancy test or HIV test. A liver function test/hepatitis panel is indicated annually, and TB should be monitored annually. Be cautious about using this class of drugs in patients with heart failure, and verify the absence of demyelinating disease in patients prior to prescribing this class of drugs.
- Guselkumab: Baseline TB evaluation, possible pregnancy or HIV tests, followed by annual TB evaluation.
- Secukinumab, ixekizumab, and brodalumab: Baseline TB evaluation, consider HIV or pregnancy tests, followed by annual TB evaluation. Be cautious about using this class of drugs in patients with ulcerative colitis or Crohn’s disease; assess and counsel for increased risk of suicidality when considering brodalumab.
Beyond the general considerations, several other factors can help maximize success with particular biologics, Dr. Armstrong said at the meeting, which is jointly presented by the University of Louisville and Global Academy for Medical Education.
The number of injections given in the first year, which range from 5 (ustekinumab) to 64 (etanercept) is an important consideration for some patients, Dr. Armstrong noted; the number of injections for the remaining biologics are guselkumab, 8; ixekizumab, 17; brodalumab and adalimumab, both 27, and secukinumab, 32. In addition, the IL-17 inhibitors carry some risk of oral candidiasis and inflammatory bowel disease.
This publication and the Global Academy for Medical Education are owned by Frontline Medical News.
Dr. Armstrong disclosed relationships with multiple companies including AbbVie, Janssen, Novartis, Lilly, Regeneron, Sanofi, Modernizing Medicine, and Valeant.
said April Armstrong, MD, of the University of Southern California, Los Angeles.
Keep class-specific considerations in mind when collecting baseline lab data to help support the success of biologics in treating psoriasis, Dr. Armstrong said at the annual Coastal Dermatology Symposium.
When clinicians consider biologics, they must balance efficacy, safety, convenience, and costs of treatment, Dr. Armstrong said.
She addressed general considerations when selecting biologics for psoriasis and stressed the importance of assessing patients for tuberculosis and reviewing underlying cancer risk. Confirm that a patient has no active infections and consider whether a patient has completed all age-appropriate immunizations. Consider a complete blood count and metabolic panel for the following biologics:
- Ustekinumab: Baseline HIV or pregnancy test, and a TB evaluation at baseline as well as annual monitoring.
- Etanercept, adalimumab, infliximab: Baseline TB evaluation and screening hepatitis panel, liver function tests, and blood count, with option to add pregnancy test or HIV test. A liver function test/hepatitis panel is indicated annually, and TB should be monitored annually. Be cautious about using this class of drugs in patients with heart failure, and verify the absence of demyelinating disease in patients prior to prescribing this class of drugs.
- Guselkumab: Baseline TB evaluation, possible pregnancy or HIV tests, followed by annual TB evaluation.
- Secukinumab, ixekizumab, and brodalumab: Baseline TB evaluation, consider HIV or pregnancy tests, followed by annual TB evaluation. Be cautious about using this class of drugs in patients with ulcerative colitis or Crohn’s disease; assess and counsel for increased risk of suicidality when considering brodalumab.
Beyond the general considerations, several other factors can help maximize success with particular biologics, Dr. Armstrong said at the meeting, which is jointly presented by the University of Louisville and Global Academy for Medical Education.
The number of injections given in the first year, which range from 5 (ustekinumab) to 64 (etanercept) is an important consideration for some patients, Dr. Armstrong noted; the number of injections for the remaining biologics are guselkumab, 8; ixekizumab, 17; brodalumab and adalimumab, both 27, and secukinumab, 32. In addition, the IL-17 inhibitors carry some risk of oral candidiasis and inflammatory bowel disease.
This publication and the Global Academy for Medical Education are owned by Frontline Medical News.
Dr. Armstrong disclosed relationships with multiple companies including AbbVie, Janssen, Novartis, Lilly, Regeneron, Sanofi, Modernizing Medicine, and Valeant.
EXPERT ANALYSIS FROM THE COASTAL DERMATOLOGY SYMPOSIUM
Trump administration narrows contraceptive mandate
The Trump administration has issued new rules allowing more employers to opt out of the Affordable Care Act’s contraceptive mandate, a move that physician leaders say could sharply restrict women’s ability to access birth control and lead to more unplanned pregnancies.
Under two regulations, issued Oct. 6 in the Federal Register, an expanded group of employers and insurers can get out of covering contraception methods by objecting on either religious or moral grounds. The new policy will “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions,” according to the rule on moral exemptions issued by the departments of Health & Human Services, Labor, and Treasury.
The American Congress of Obstetricians and Gynecologists denounced the new rules as a move that will negatively impact the health of women and families by limiting access to essential preventive care.
“Reducing access to contraceptive coverage threatens to reverse the tremendous progress our nation has made in recent years in lowering the unintended pregnancy rate,” ACOG President Haywood L. Brown said in a statement. “Instead of fulfilling its mission ‘to enhance and protect the health and well-being of all Americans,’ HHS leaders under the current administration are focused on turning back the clock on women’s health.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of “religious employers,” which were deemed exempt. Those religious employers were, for the most part, churches and other houses of worship. After multiple complaints and legal challenges, the Obama administration later created a workaround for another group – nonprofit religious employers – to opt out of the mandate. However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016.
But the issue remained unresolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
Under the new Oct. 6 regulations, any employer or insurer can halt their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. They need not have a specific religious affiliation to do so. States would determine how companies can make these decisions.
It’s unclear how many women and employers will be impacted. In its rule on religious exemptions, HHS estimated that 109 entities will use this voluntary accommodation moving forward. The department also estimated that the expanded religious exemptions will impact the contraceptive costs of about 31,700 women of childbearing age that use the contraception coverage.
According to research by the Kaiser Family Foundation, 1 in 10 nonprofit organizations with at least 1,000 workers sought an accommodation to not provide Affordable Care Act–required contraceptive coverage to their employees in 2015, but instead allow workers to access the copay-free coverage separately. Three percent of all nonprofits with at least 10 workers sought some kind of accommodation, according to the research. For the smallest of organizations (10-199 workers), the accommodation request rate was 2%, while 5% of organizations with 200-999 workers requested an accommodation.
The American College of Physicians expressed their disappointment with the new regulation, saying that it could lead to more out-of-pocket costs for women who currently receive free contraception.
“Our concern is grounded on our long-standing policy that all Americans should have coverage for evidence-based medical services, including preventive services like contraception,” Jack Ende, MD, ACP president said in a statement. “We are concerned that allowing employers to carve out exemptions to the ACA’s requirements that health insurance plans cover evidence-based preventive services without cost sharing, including but not necessarily limited to contraception, will create substantial barriers to patients receiving appropriate medical care as recommended by their physicians.”
In a statement, national pro-life group Susan B. Anthony List declared the new rules to be a “huge victory for conscience rights and religious liberty in America,” noting that it would exempt their group as a moral objector to contraception.
agallegos@frontlinemedcom.com
On Twitter @legal_med
The Trump administration has issued new rules allowing more employers to opt out of the Affordable Care Act’s contraceptive mandate, a move that physician leaders say could sharply restrict women’s ability to access birth control and lead to more unplanned pregnancies.
Under two regulations, issued Oct. 6 in the Federal Register, an expanded group of employers and insurers can get out of covering contraception methods by objecting on either religious or moral grounds. The new policy will “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions,” according to the rule on moral exemptions issued by the departments of Health & Human Services, Labor, and Treasury.
The American Congress of Obstetricians and Gynecologists denounced the new rules as a move that will negatively impact the health of women and families by limiting access to essential preventive care.
“Reducing access to contraceptive coverage threatens to reverse the tremendous progress our nation has made in recent years in lowering the unintended pregnancy rate,” ACOG President Haywood L. Brown said in a statement. “Instead of fulfilling its mission ‘to enhance and protect the health and well-being of all Americans,’ HHS leaders under the current administration are focused on turning back the clock on women’s health.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of “religious employers,” which were deemed exempt. Those religious employers were, for the most part, churches and other houses of worship. After multiple complaints and legal challenges, the Obama administration later created a workaround for another group – nonprofit religious employers – to opt out of the mandate. However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016.
But the issue remained unresolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
Under the new Oct. 6 regulations, any employer or insurer can halt their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. They need not have a specific religious affiliation to do so. States would determine how companies can make these decisions.
It’s unclear how many women and employers will be impacted. In its rule on religious exemptions, HHS estimated that 109 entities will use this voluntary accommodation moving forward. The department also estimated that the expanded religious exemptions will impact the contraceptive costs of about 31,700 women of childbearing age that use the contraception coverage.
According to research by the Kaiser Family Foundation, 1 in 10 nonprofit organizations with at least 1,000 workers sought an accommodation to not provide Affordable Care Act–required contraceptive coverage to their employees in 2015, but instead allow workers to access the copay-free coverage separately. Three percent of all nonprofits with at least 10 workers sought some kind of accommodation, according to the research. For the smallest of organizations (10-199 workers), the accommodation request rate was 2%, while 5% of organizations with 200-999 workers requested an accommodation.
The American College of Physicians expressed their disappointment with the new regulation, saying that it could lead to more out-of-pocket costs for women who currently receive free contraception.
“Our concern is grounded on our long-standing policy that all Americans should have coverage for evidence-based medical services, including preventive services like contraception,” Jack Ende, MD, ACP president said in a statement. “We are concerned that allowing employers to carve out exemptions to the ACA’s requirements that health insurance plans cover evidence-based preventive services without cost sharing, including but not necessarily limited to contraception, will create substantial barriers to patients receiving appropriate medical care as recommended by their physicians.”
In a statement, national pro-life group Susan B. Anthony List declared the new rules to be a “huge victory for conscience rights and religious liberty in America,” noting that it would exempt their group as a moral objector to contraception.
agallegos@frontlinemedcom.com
On Twitter @legal_med
The Trump administration has issued new rules allowing more employers to opt out of the Affordable Care Act’s contraceptive mandate, a move that physician leaders say could sharply restrict women’s ability to access birth control and lead to more unplanned pregnancies.
Under two regulations, issued Oct. 6 in the Federal Register, an expanded group of employers and insurers can get out of covering contraception methods by objecting on either religious or moral grounds. The new policy will “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions,” according to the rule on moral exemptions issued by the departments of Health & Human Services, Labor, and Treasury.
The American Congress of Obstetricians and Gynecologists denounced the new rules as a move that will negatively impact the health of women and families by limiting access to essential preventive care.
“Reducing access to contraceptive coverage threatens to reverse the tremendous progress our nation has made in recent years in lowering the unintended pregnancy rate,” ACOG President Haywood L. Brown said in a statement. “Instead of fulfilling its mission ‘to enhance and protect the health and well-being of all Americans,’ HHS leaders under the current administration are focused on turning back the clock on women’s health.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of “religious employers,” which were deemed exempt. Those religious employers were, for the most part, churches and other houses of worship. After multiple complaints and legal challenges, the Obama administration later created a workaround for another group – nonprofit religious employers – to opt out of the mandate. However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016.
But the issue remained unresolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
Under the new Oct. 6 regulations, any employer or insurer can halt their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. They need not have a specific religious affiliation to do so. States would determine how companies can make these decisions.
It’s unclear how many women and employers will be impacted. In its rule on religious exemptions, HHS estimated that 109 entities will use this voluntary accommodation moving forward. The department also estimated that the expanded religious exemptions will impact the contraceptive costs of about 31,700 women of childbearing age that use the contraception coverage.
According to research by the Kaiser Family Foundation, 1 in 10 nonprofit organizations with at least 1,000 workers sought an accommodation to not provide Affordable Care Act–required contraceptive coverage to their employees in 2015, but instead allow workers to access the copay-free coverage separately. Three percent of all nonprofits with at least 10 workers sought some kind of accommodation, according to the research. For the smallest of organizations (10-199 workers), the accommodation request rate was 2%, while 5% of organizations with 200-999 workers requested an accommodation.
The American College of Physicians expressed their disappointment with the new regulation, saying that it could lead to more out-of-pocket costs for women who currently receive free contraception.
“Our concern is grounded on our long-standing policy that all Americans should have coverage for evidence-based medical services, including preventive services like contraception,” Jack Ende, MD, ACP president said in a statement. “We are concerned that allowing employers to carve out exemptions to the ACA’s requirements that health insurance plans cover evidence-based preventive services without cost sharing, including but not necessarily limited to contraception, will create substantial barriers to patients receiving appropriate medical care as recommended by their physicians.”
In a statement, national pro-life group Susan B. Anthony List declared the new rules to be a “huge victory for conscience rights and religious liberty in America,” noting that it would exempt their group as a moral objector to contraception.
agallegos@frontlinemedcom.com
On Twitter @legal_med
New psoriasis therapies coming of age
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
FROM THE COASTAL DERMATOLOGY SYMPOSIUM
Syphilis rates reach record high
Novel models predict Parkinson’s disease motor progression
An ensemble of prediction models developed using genetic data and both baseline molecular and clinical variables from patients with Parkinson’s disease, as well as healthy controls, confirmed established predictors of the disease and identified new ones in a longitudinal cohort study.
Furthermore, the models were shown via simulated, randomized, placebo-controlled trials to have utility for clinical trial design and evaluation, as well as for clinical disease monitoring and treatment, Jeanne C. Latourelle, DSc, of GNS Healthcare, Cambridge, Mass., and her colleagues reported in Lancet Neurology.
“Understanding the causal and physiological factors that contribute to this variability in the evolution of symptoms of Parkinson’s disease is, therefore, a high priority area of Parkinson’s disease research,” they wrote (Lancet Neurol. 2017 Sep 25. doi: 10.1016/S1474-4422[17]30328-9).
The investigators developed the models by applying a Bayesian, machine-learning, multivariate predictive inference platform – known as Reverse Engineering and Forward Simulation – to data from the Parkinson’s Progression Markers Initiative (PPMI) study; they used these models to predict the annual rate of change in combined scores from the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III. The investigators tested the overall explanatory power of the models using the coefficient of determination (R2); their models also replicated novel findings from an independent clinical cohort from the Longitudinal and Biomarker Study in Parkinson’s disease (LABS-PD).
In 117 healthy age- and sex-matched controls and 312 patients with early-stage Parkinson’s disease from the PPMI study, the model ensemble showed strong performance (fivefold cross-validated Pearson R2, 41%), the investigators said.
In the 317-patient LABS-PD validation cohort, the performance of the models was reduced, but still statistically significant (R2, 9%).
Individual predictive features – including significant replication of higher baseline motor score on MDS-UPDRS, male sex, increased age, and novel Parkinson’s disease–specific epistatic interaction, which all were indicative of faster motor progression in the disease – were confirmed in the LABS-PD cohort, they said. The most useful predictive marker of motor progression was genetic variation (R2, 2.9%), the investigators said, and the cerebrospinal fluid biomarkers at baseline also significantly affected prediction of motor progression, although more modestly (R2, 0.3%).
In 5,000 trial simulations, the incorporation of predicted rates of motor progression into the final models of treatment effect reduced the variability in study outcome, which allowed for the detection of significant differences in sample sizes up to 20% smaller than in trials of drug-naive patients.
The investigators noted that the Bayesian model inference using Reverse Engineering and Forward Simulation was particularly good at predicting Parkinson’s motor progression in early disease stages, which has “immediate relevance toward enabling more effective trial recruitment and clinical disease management.”
This study was supported by grants from the Michael J. Fox Foundation for Parkinson’s Research and the National Institute of Neurological Disorders and Stroke. PPMI is funded by the Michael J. Fox Foundation for Parkinson’s Research, and it also has many industry funding partners. Dr. Latourelle and several of her coauthors are or were employees of GNS Healthcare.
The study by Latourelle and her colleagues adds substantial value to Parkinson’s disease research not only because of the findings but also because it introduces the topic of using multimodal data in disease prediction, an approach that is sure to grow in popularity, and one that is complex in its application and interpretation.
Although the discovery and replication efforts are of somewhat limited power – indicating a need for expansion of such efforts in terms of sample size and length of follow-up – the study marks a movement in the development of methods to predict disease progression and, therefore, assist clinicians, patients with Parkinson’s disease, and their family members with treatment and individualized disease management.
The methodology is promising, but fine-tuning and extension of current efforts are important because, while these endeavors are costly, they are vital for the development of disease-modifying therapies and the treatment of Parkinson’s disease.
Cornelis Blauwendraat, MD, and his colleagues are with the Laboratory of Neurogenetics at the National Institute on Aging. They declared having no competing interests. Their comments are taken from an editorial accompanying Dr. Latourelle and her colleagues’ report (Lancet Neurol. 2017 Sep 25. doi: 10.106/S1474-4422[17]30331-9).
The study by Latourelle and her colleagues adds substantial value to Parkinson’s disease research not only because of the findings but also because it introduces the topic of using multimodal data in disease prediction, an approach that is sure to grow in popularity, and one that is complex in its application and interpretation.
Although the discovery and replication efforts are of somewhat limited power – indicating a need for expansion of such efforts in terms of sample size and length of follow-up – the study marks a movement in the development of methods to predict disease progression and, therefore, assist clinicians, patients with Parkinson’s disease, and their family members with treatment and individualized disease management.
The methodology is promising, but fine-tuning and extension of current efforts are important because, while these endeavors are costly, they are vital for the development of disease-modifying therapies and the treatment of Parkinson’s disease.
Cornelis Blauwendraat, MD, and his colleagues are with the Laboratory of Neurogenetics at the National Institute on Aging. They declared having no competing interests. Their comments are taken from an editorial accompanying Dr. Latourelle and her colleagues’ report (Lancet Neurol. 2017 Sep 25. doi: 10.106/S1474-4422[17]30331-9).
The study by Latourelle and her colleagues adds substantial value to Parkinson’s disease research not only because of the findings but also because it introduces the topic of using multimodal data in disease prediction, an approach that is sure to grow in popularity, and one that is complex in its application and interpretation.
Although the discovery and replication efforts are of somewhat limited power – indicating a need for expansion of such efforts in terms of sample size and length of follow-up – the study marks a movement in the development of methods to predict disease progression and, therefore, assist clinicians, patients with Parkinson’s disease, and their family members with treatment and individualized disease management.
The methodology is promising, but fine-tuning and extension of current efforts are important because, while these endeavors are costly, they are vital for the development of disease-modifying therapies and the treatment of Parkinson’s disease.
Cornelis Blauwendraat, MD, and his colleagues are with the Laboratory of Neurogenetics at the National Institute on Aging. They declared having no competing interests. Their comments are taken from an editorial accompanying Dr. Latourelle and her colleagues’ report (Lancet Neurol. 2017 Sep 25. doi: 10.106/S1474-4422[17]30331-9).
An ensemble of prediction models developed using genetic data and both baseline molecular and clinical variables from patients with Parkinson’s disease, as well as healthy controls, confirmed established predictors of the disease and identified new ones in a longitudinal cohort study.
Furthermore, the models were shown via simulated, randomized, placebo-controlled trials to have utility for clinical trial design and evaluation, as well as for clinical disease monitoring and treatment, Jeanne C. Latourelle, DSc, of GNS Healthcare, Cambridge, Mass., and her colleagues reported in Lancet Neurology.
“Understanding the causal and physiological factors that contribute to this variability in the evolution of symptoms of Parkinson’s disease is, therefore, a high priority area of Parkinson’s disease research,” they wrote (Lancet Neurol. 2017 Sep 25. doi: 10.1016/S1474-4422[17]30328-9).
The investigators developed the models by applying a Bayesian, machine-learning, multivariate predictive inference platform – known as Reverse Engineering and Forward Simulation – to data from the Parkinson’s Progression Markers Initiative (PPMI) study; they used these models to predict the annual rate of change in combined scores from the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III. The investigators tested the overall explanatory power of the models using the coefficient of determination (R2); their models also replicated novel findings from an independent clinical cohort from the Longitudinal and Biomarker Study in Parkinson’s disease (LABS-PD).
In 117 healthy age- and sex-matched controls and 312 patients with early-stage Parkinson’s disease from the PPMI study, the model ensemble showed strong performance (fivefold cross-validated Pearson R2, 41%), the investigators said.
In the 317-patient LABS-PD validation cohort, the performance of the models was reduced, but still statistically significant (R2, 9%).
Individual predictive features – including significant replication of higher baseline motor score on MDS-UPDRS, male sex, increased age, and novel Parkinson’s disease–specific epistatic interaction, which all were indicative of faster motor progression in the disease – were confirmed in the LABS-PD cohort, they said. The most useful predictive marker of motor progression was genetic variation (R2, 2.9%), the investigators said, and the cerebrospinal fluid biomarkers at baseline also significantly affected prediction of motor progression, although more modestly (R2, 0.3%).
In 5,000 trial simulations, the incorporation of predicted rates of motor progression into the final models of treatment effect reduced the variability in study outcome, which allowed for the detection of significant differences in sample sizes up to 20% smaller than in trials of drug-naive patients.
The investigators noted that the Bayesian model inference using Reverse Engineering and Forward Simulation was particularly good at predicting Parkinson’s motor progression in early disease stages, which has “immediate relevance toward enabling more effective trial recruitment and clinical disease management.”
This study was supported by grants from the Michael J. Fox Foundation for Parkinson’s Research and the National Institute of Neurological Disorders and Stroke. PPMI is funded by the Michael J. Fox Foundation for Parkinson’s Research, and it also has many industry funding partners. Dr. Latourelle and several of her coauthors are or were employees of GNS Healthcare.
An ensemble of prediction models developed using genetic data and both baseline molecular and clinical variables from patients with Parkinson’s disease, as well as healthy controls, confirmed established predictors of the disease and identified new ones in a longitudinal cohort study.
Furthermore, the models were shown via simulated, randomized, placebo-controlled trials to have utility for clinical trial design and evaluation, as well as for clinical disease monitoring and treatment, Jeanne C. Latourelle, DSc, of GNS Healthcare, Cambridge, Mass., and her colleagues reported in Lancet Neurology.
“Understanding the causal and physiological factors that contribute to this variability in the evolution of symptoms of Parkinson’s disease is, therefore, a high priority area of Parkinson’s disease research,” they wrote (Lancet Neurol. 2017 Sep 25. doi: 10.1016/S1474-4422[17]30328-9).
The investigators developed the models by applying a Bayesian, machine-learning, multivariate predictive inference platform – known as Reverse Engineering and Forward Simulation – to data from the Parkinson’s Progression Markers Initiative (PPMI) study; they used these models to predict the annual rate of change in combined scores from the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III. The investigators tested the overall explanatory power of the models using the coefficient of determination (R2); their models also replicated novel findings from an independent clinical cohort from the Longitudinal and Biomarker Study in Parkinson’s disease (LABS-PD).
In 117 healthy age- and sex-matched controls and 312 patients with early-stage Parkinson’s disease from the PPMI study, the model ensemble showed strong performance (fivefold cross-validated Pearson R2, 41%), the investigators said.
In the 317-patient LABS-PD validation cohort, the performance of the models was reduced, but still statistically significant (R2, 9%).
Individual predictive features – including significant replication of higher baseline motor score on MDS-UPDRS, male sex, increased age, and novel Parkinson’s disease–specific epistatic interaction, which all were indicative of faster motor progression in the disease – were confirmed in the LABS-PD cohort, they said. The most useful predictive marker of motor progression was genetic variation (R2, 2.9%), the investigators said, and the cerebrospinal fluid biomarkers at baseline also significantly affected prediction of motor progression, although more modestly (R2, 0.3%).
In 5,000 trial simulations, the incorporation of predicted rates of motor progression into the final models of treatment effect reduced the variability in study outcome, which allowed for the detection of significant differences in sample sizes up to 20% smaller than in trials of drug-naive patients.
The investigators noted that the Bayesian model inference using Reverse Engineering and Forward Simulation was particularly good at predicting Parkinson’s motor progression in early disease stages, which has “immediate relevance toward enabling more effective trial recruitment and clinical disease management.”
This study was supported by grants from the Michael J. Fox Foundation for Parkinson’s Research and the National Institute of Neurological Disorders and Stroke. PPMI is funded by the Michael J. Fox Foundation for Parkinson’s Research, and it also has many industry funding partners. Dr. Latourelle and several of her coauthors are or were employees of GNS Healthcare.
FROM LANCET NEUROLOGY
Key clinical point:
Major finding: The model ensemble showed strong performance (fivefold cross-validated Pearson R2, 41%) and remained significant in a validation cohort (R2, 9%).
Data source: A longitudinal cohort study of 429 patients and controls, as well as a validation cohort of 317 patients.
Disclosures: This study was supported by grants from the Michael J. Fox Foundation for Parkinson’s Research and the National Institute of Neurological Disorders and Stroke. The Parkinson’s Progression Markers Initiative is funded by the Michael J. Fox Foundation for Parkinson’s Research, and it also has many industry funding partners. Dr. Latourelle and several of her coauthors are or were employees of GNS Healthcare.
Dentist-prescribed antibiotics implicated in community-acquired C. diff
SAN DIEGO – Antibiotic prescriptions written by dentists make a substantial but largely unrecognized contribution to the risk of community-acquired Clostridium difficile (CA-CDI) infections, according to results of a public health initiative that was presented at an annual scientific meeting on infectious diseases.
When nearly 1,000 cases of CA-CDI suspected of being the result of antibiotic exposure were evaluated, it was found that 15% of the prescriptions were written by dentists, often for indications that are counter to current guidelines, reported Maria Bye, MPH, an officer in the Infectious Disease Epidemiology, Prevention, and Control Division of the Minnesota Department of Health, St. Paul.
In another finding from this study relevant to infection control, a substantial proportion of dentist-prescribed antibiotics associated with CA-CDI were not in the medical record. Rather, they were discovered in interviews conducted to isolate risk factors. “This is concerning since clinicians unaware of these exposures will not think about CA-CDI or other complications of antibiotic use, possibly delaying therapy,” Ms. Bye said.
The importance of dental antibiotic prescriptions in CA-CDI was identified in an ongoing infectious disease program managed by the Minnesota Department of Health in collaboration with the Centers for Disease Control and Prevention. In the years 2009-2015, medical records and interviews were conducted to identify risk factors in 1,626 confirmed cases of CA-CDI in five Minnesota counties. All cases were among patients without an overnight stay in a health care facility in the previous 12 weeks, which was an exclusion criterion.
After the review of medical records and patient interviews, 926 (57%) of the CA-CDI cases were deemed likely to be related to antibiotic exposure. Of these antibiotic exposures, 136 (15%) were from prescriptions written by dentists, a figure reached only when patients were interviewed. According to Ms. Bye, 34% of the antibiotics prescribed by dentists were not in the medical record.
There were also notable differences in antibiotic exposures stemming from dentist prescriptions relative to prescriptions from other sources. Perhaps most significantly, dental-related antibiotic prescriptions were far more likely to be for clindamycin (50% vs. 10%; P less than .001), which is commonly associated with increased risk of C. difficile, according to Ms. Bye. Fluoroquinolones (6% vs. 19%; P less than .001) and cephalosporins (7% vs. 30%; P less than .001) were significantly less likely to be prescribed by dentists. Patients who developed CA-CDI associated with antibiotics prescribed by dentists were also significantly older than were those receiving antibiotics from another source (mean age 57 years vs. 45 years; P less than .001).
For the first years of this analysis, information on the indication for dentist-prescribed antibiotics was not collected, but these data were collected beginning in 2015. In the data collected so far, a substantial proportion of prescriptions were written for prophylaxis against systemic infections, including prevention of endocarditis or infection of prosthetic joints. However, few of these prescriptions were indicated.
“The American Dental Association stated that antibiotic prophylaxis is not generally recommended in patients with prosthetic joints,” said Ms. Bye, noting that this is consistent with similar statements issued by the American Academy of Orthopedic Surgery. In 2007, the American Heart Association narrowed its recommendations for prophylactic antibiotics to patients at the highest risk of adverse consequences from endocarditis.
Of the four patients who received prophylactic antibiotics from their dentists for a cardiovascular or orthopedic indication, only one met current criteria, Ms. Bye reported.
The contribution of antibiotic exposures from dentist prescriptions to CA-CDI should not be surprising, according to Ms. Bye. In the United States, dentists prescribe 10% of all outpatient antibiotics. Although there are many valid indications for these prescriptions, Ms. Bye cited a survey that found that the proportion of dentists familiar with current guidelines and the risks of adverse events produced by antibiotics, including CA-CDI, is less than 50%.
“Dentists need to be included in antibiotic stewardship programs,” she advised. This will include educating dentists about the indications for antibiotic prophylaxis for medical conditions. She also suggested that clinicians should routinely ask patients about whether they have received antibiotics from a dentist so that this information gets into the medical record.
The event was the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
SAN DIEGO – Antibiotic prescriptions written by dentists make a substantial but largely unrecognized contribution to the risk of community-acquired Clostridium difficile (CA-CDI) infections, according to results of a public health initiative that was presented at an annual scientific meeting on infectious diseases.
When nearly 1,000 cases of CA-CDI suspected of being the result of antibiotic exposure were evaluated, it was found that 15% of the prescriptions were written by dentists, often for indications that are counter to current guidelines, reported Maria Bye, MPH, an officer in the Infectious Disease Epidemiology, Prevention, and Control Division of the Minnesota Department of Health, St. Paul.
In another finding from this study relevant to infection control, a substantial proportion of dentist-prescribed antibiotics associated with CA-CDI were not in the medical record. Rather, they were discovered in interviews conducted to isolate risk factors. “This is concerning since clinicians unaware of these exposures will not think about CA-CDI or other complications of antibiotic use, possibly delaying therapy,” Ms. Bye said.
The importance of dental antibiotic prescriptions in CA-CDI was identified in an ongoing infectious disease program managed by the Minnesota Department of Health in collaboration with the Centers for Disease Control and Prevention. In the years 2009-2015, medical records and interviews were conducted to identify risk factors in 1,626 confirmed cases of CA-CDI in five Minnesota counties. All cases were among patients without an overnight stay in a health care facility in the previous 12 weeks, which was an exclusion criterion.
After the review of medical records and patient interviews, 926 (57%) of the CA-CDI cases were deemed likely to be related to antibiotic exposure. Of these antibiotic exposures, 136 (15%) were from prescriptions written by dentists, a figure reached only when patients were interviewed. According to Ms. Bye, 34% of the antibiotics prescribed by dentists were not in the medical record.
There were also notable differences in antibiotic exposures stemming from dentist prescriptions relative to prescriptions from other sources. Perhaps most significantly, dental-related antibiotic prescriptions were far more likely to be for clindamycin (50% vs. 10%; P less than .001), which is commonly associated with increased risk of C. difficile, according to Ms. Bye. Fluoroquinolones (6% vs. 19%; P less than .001) and cephalosporins (7% vs. 30%; P less than .001) were significantly less likely to be prescribed by dentists. Patients who developed CA-CDI associated with antibiotics prescribed by dentists were also significantly older than were those receiving antibiotics from another source (mean age 57 years vs. 45 years; P less than .001).
For the first years of this analysis, information on the indication for dentist-prescribed antibiotics was not collected, but these data were collected beginning in 2015. In the data collected so far, a substantial proportion of prescriptions were written for prophylaxis against systemic infections, including prevention of endocarditis or infection of prosthetic joints. However, few of these prescriptions were indicated.
“The American Dental Association stated that antibiotic prophylaxis is not generally recommended in patients with prosthetic joints,” said Ms. Bye, noting that this is consistent with similar statements issued by the American Academy of Orthopedic Surgery. In 2007, the American Heart Association narrowed its recommendations for prophylactic antibiotics to patients at the highest risk of adverse consequences from endocarditis.
Of the four patients who received prophylactic antibiotics from their dentists for a cardiovascular or orthopedic indication, only one met current criteria, Ms. Bye reported.
The contribution of antibiotic exposures from dentist prescriptions to CA-CDI should not be surprising, according to Ms. Bye. In the United States, dentists prescribe 10% of all outpatient antibiotics. Although there are many valid indications for these prescriptions, Ms. Bye cited a survey that found that the proportion of dentists familiar with current guidelines and the risks of adverse events produced by antibiotics, including CA-CDI, is less than 50%.
“Dentists need to be included in antibiotic stewardship programs,” she advised. This will include educating dentists about the indications for antibiotic prophylaxis for medical conditions. She also suggested that clinicians should routinely ask patients about whether they have received antibiotics from a dentist so that this information gets into the medical record.
The event was the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
SAN DIEGO – Antibiotic prescriptions written by dentists make a substantial but largely unrecognized contribution to the risk of community-acquired Clostridium difficile (CA-CDI) infections, according to results of a public health initiative that was presented at an annual scientific meeting on infectious diseases.
When nearly 1,000 cases of CA-CDI suspected of being the result of antibiotic exposure were evaluated, it was found that 15% of the prescriptions were written by dentists, often for indications that are counter to current guidelines, reported Maria Bye, MPH, an officer in the Infectious Disease Epidemiology, Prevention, and Control Division of the Minnesota Department of Health, St. Paul.
In another finding from this study relevant to infection control, a substantial proportion of dentist-prescribed antibiotics associated with CA-CDI were not in the medical record. Rather, they were discovered in interviews conducted to isolate risk factors. “This is concerning since clinicians unaware of these exposures will not think about CA-CDI or other complications of antibiotic use, possibly delaying therapy,” Ms. Bye said.
The importance of dental antibiotic prescriptions in CA-CDI was identified in an ongoing infectious disease program managed by the Minnesota Department of Health in collaboration with the Centers for Disease Control and Prevention. In the years 2009-2015, medical records and interviews were conducted to identify risk factors in 1,626 confirmed cases of CA-CDI in five Minnesota counties. All cases were among patients without an overnight stay in a health care facility in the previous 12 weeks, which was an exclusion criterion.
After the review of medical records and patient interviews, 926 (57%) of the CA-CDI cases were deemed likely to be related to antibiotic exposure. Of these antibiotic exposures, 136 (15%) were from prescriptions written by dentists, a figure reached only when patients were interviewed. According to Ms. Bye, 34% of the antibiotics prescribed by dentists were not in the medical record.
There were also notable differences in antibiotic exposures stemming from dentist prescriptions relative to prescriptions from other sources. Perhaps most significantly, dental-related antibiotic prescriptions were far more likely to be for clindamycin (50% vs. 10%; P less than .001), which is commonly associated with increased risk of C. difficile, according to Ms. Bye. Fluoroquinolones (6% vs. 19%; P less than .001) and cephalosporins (7% vs. 30%; P less than .001) were significantly less likely to be prescribed by dentists. Patients who developed CA-CDI associated with antibiotics prescribed by dentists were also significantly older than were those receiving antibiotics from another source (mean age 57 years vs. 45 years; P less than .001).
For the first years of this analysis, information on the indication for dentist-prescribed antibiotics was not collected, but these data were collected beginning in 2015. In the data collected so far, a substantial proportion of prescriptions were written for prophylaxis against systemic infections, including prevention of endocarditis or infection of prosthetic joints. However, few of these prescriptions were indicated.
“The American Dental Association stated that antibiotic prophylaxis is not generally recommended in patients with prosthetic joints,” said Ms. Bye, noting that this is consistent with similar statements issued by the American Academy of Orthopedic Surgery. In 2007, the American Heart Association narrowed its recommendations for prophylactic antibiotics to patients at the highest risk of adverse consequences from endocarditis.
Of the four patients who received prophylactic antibiotics from their dentists for a cardiovascular or orthopedic indication, only one met current criteria, Ms. Bye reported.
The contribution of antibiotic exposures from dentist prescriptions to CA-CDI should not be surprising, according to Ms. Bye. In the United States, dentists prescribe 10% of all outpatient antibiotics. Although there are many valid indications for these prescriptions, Ms. Bye cited a survey that found that the proportion of dentists familiar with current guidelines and the risks of adverse events produced by antibiotics, including CA-CDI, is less than 50%.
“Dentists need to be included in antibiotic stewardship programs,” she advised. This will include educating dentists about the indications for antibiotic prophylaxis for medical conditions. She also suggested that clinicians should routinely ask patients about whether they have received antibiotics from a dentist so that this information gets into the medical record.
The event was the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
AT ID WEEK 2017
Key clinical point: A public health initiative tracking community-acquired Clostridium difficile infections suggests dental antibiotic prescribing is a significant source.
Major finding: When traced, 15% of the antibiotics related to community-acquired C. difficile infections were from a dentist prescription.
Data source: Population-based surveillance study.
Disclosures: Ms. Bye reported that she has no financial relationships relevant to this topic.