Ivacaftor reduced hospitalizations in CF

Article Type
Changed
Fri, 01/18/2019 - 17:38

 

Ivacaftor, a therapy that targets the G551D CFTR gene mutation to treat cystic fibrosis, significantly reduced hospital admission rates in patients with cystic fibrosis with a variety of mutations, according to results published May 7 in Health Affairs.

The study involved 143 patients being treated with ivacaftor between February 2012 and February 2015. In 2014, the FDA expanded its approval for the use of ivacaftor by cystic fibrosis patients to include nine additional mutations, and patients with these mutations were included in this study.

copyright Zerbor/Thinkstock
The overall rate of inpatient admissions dropped by 55%, and cystic fibrosis–related admissions rates fell by 78% (P less than .0001) between the period 12 months before treatment and 12 months after the first filled prescription, wrote Lisa B. Feng and her coauthors.

Ms. Feng, who is senior director for policy and advocacy at the Cystic Fibrosis Foundation and her colleagues analyzed administrative claims data from the Truven Health Analytics Market Scan Commercial Research Database. All of the claims were for patients from the United States with employer-sponsored insurance plans. Eligibility criteria included an ICD-9 CM diagnosis of cystic fibrosis on one or more inpatient claims or two or more outpatient claims at least 30 days apart, a prescription claim for ivacaftor monotherapy, being at least 6 years of age at the time of the first filled prescription, and 12 months of continuous enrollment before and after the first filled prescription.

The “pre-ivacaftor” period was defined as the 12 months before the first filled prescription. The “post-ivacaftor” period was defined as the 12 months after the first filled prescription. For each period, the numbers and percentages of patients hospitalized were calculated, for any reason and for cystic fibrosis–related reasons. Hospitalization rates also were calculated as numbers of admissions per person-year, the authors said.

Data also were analyzed for two subcohorts: the 86 patients who started using ivacaftor between Feb. 6, 2012, and Feb. 21, 2014, under the initial Food and Drug Administration label; and the 57 patients who initiated use between Feb. 22, 2014, and Dec. 31, 2015, under the expanded FDA label, which included nine additional genetic mutations.

Of the 143 patients who had filled prescriptions for ivacaftor, 63% were aged 18 years or older. The rate of overall inpatient admissions decreased 55%, from 0.57 admissions per person-year in the pre-ivacaftor period to 0.26 admissions per person-year in the post-ivacaftor period, the investigators reported.

 

 


The declines in hospital admissions also were similar between the initial label and the expanded FDA label groups, with declines in overall admissions of 59% and 57%, respectively.

Hospital admissions related to cystic fibrosis also decreased significantly, by 78%. Admissions with principal diagnosis codes for cystic fibrosis decreased from 42 in the preprescription period, to 8 after filling the prescription. Rates per person per year decreased by 82% in patients aged 6-17 years and 80% among adults aged 18 years and older. Additionally, patients who filled at least 10 prescriptions during the study period experienced a 68% reduction in inpatient admissions, compared with 45% for those with three to nine prescriptions filled.

Ivacaftor also was associated with 60% lower per-person inpatient spending overall, with a greater proportional reduction in hospital costs for adults (68%) than for children (45%), and an absolute per-person reduction of $10,567, the authors reported.

“Treatments that target the protein defect that causes cystic fibrosis illustrate the promise of precision medicine,” the authors wrote. “To deliver the right care to the right patient, cystic fibrosis care must continue to account for other aspects unique to individuals such as environment, physiology, patients’ preferences, and lifestyle,” they concluded.

Ivacaftor (Kalydeco) is manufactured for Vertex Pharmaceuticals. No disclosures or conflicts of interest were reported.

SOURCE: Feng LB et al. Health Aff. 2018 May 8. doi: 10.1377/hlthaff.2017.1554

Publications
Topics
Sections

 

Ivacaftor, a therapy that targets the G551D CFTR gene mutation to treat cystic fibrosis, significantly reduced hospital admission rates in patients with cystic fibrosis with a variety of mutations, according to results published May 7 in Health Affairs.

The study involved 143 patients being treated with ivacaftor between February 2012 and February 2015. In 2014, the FDA expanded its approval for the use of ivacaftor by cystic fibrosis patients to include nine additional mutations, and patients with these mutations were included in this study.

copyright Zerbor/Thinkstock
The overall rate of inpatient admissions dropped by 55%, and cystic fibrosis–related admissions rates fell by 78% (P less than .0001) between the period 12 months before treatment and 12 months after the first filled prescription, wrote Lisa B. Feng and her coauthors.

Ms. Feng, who is senior director for policy and advocacy at the Cystic Fibrosis Foundation and her colleagues analyzed administrative claims data from the Truven Health Analytics Market Scan Commercial Research Database. All of the claims were for patients from the United States with employer-sponsored insurance plans. Eligibility criteria included an ICD-9 CM diagnosis of cystic fibrosis on one or more inpatient claims or two or more outpatient claims at least 30 days apart, a prescription claim for ivacaftor monotherapy, being at least 6 years of age at the time of the first filled prescription, and 12 months of continuous enrollment before and after the first filled prescription.

The “pre-ivacaftor” period was defined as the 12 months before the first filled prescription. The “post-ivacaftor” period was defined as the 12 months after the first filled prescription. For each period, the numbers and percentages of patients hospitalized were calculated, for any reason and for cystic fibrosis–related reasons. Hospitalization rates also were calculated as numbers of admissions per person-year, the authors said.

Data also were analyzed for two subcohorts: the 86 patients who started using ivacaftor between Feb. 6, 2012, and Feb. 21, 2014, under the initial Food and Drug Administration label; and the 57 patients who initiated use between Feb. 22, 2014, and Dec. 31, 2015, under the expanded FDA label, which included nine additional genetic mutations.

Of the 143 patients who had filled prescriptions for ivacaftor, 63% were aged 18 years or older. The rate of overall inpatient admissions decreased 55%, from 0.57 admissions per person-year in the pre-ivacaftor period to 0.26 admissions per person-year in the post-ivacaftor period, the investigators reported.

 

 


The declines in hospital admissions also were similar between the initial label and the expanded FDA label groups, with declines in overall admissions of 59% and 57%, respectively.

Hospital admissions related to cystic fibrosis also decreased significantly, by 78%. Admissions with principal diagnosis codes for cystic fibrosis decreased from 42 in the preprescription period, to 8 after filling the prescription. Rates per person per year decreased by 82% in patients aged 6-17 years and 80% among adults aged 18 years and older. Additionally, patients who filled at least 10 prescriptions during the study period experienced a 68% reduction in inpatient admissions, compared with 45% for those with three to nine prescriptions filled.

Ivacaftor also was associated with 60% lower per-person inpatient spending overall, with a greater proportional reduction in hospital costs for adults (68%) than for children (45%), and an absolute per-person reduction of $10,567, the authors reported.

“Treatments that target the protein defect that causes cystic fibrosis illustrate the promise of precision medicine,” the authors wrote. “To deliver the right care to the right patient, cystic fibrosis care must continue to account for other aspects unique to individuals such as environment, physiology, patients’ preferences, and lifestyle,” they concluded.

Ivacaftor (Kalydeco) is manufactured for Vertex Pharmaceuticals. No disclosures or conflicts of interest were reported.

SOURCE: Feng LB et al. Health Aff. 2018 May 8. doi: 10.1377/hlthaff.2017.1554

 

Ivacaftor, a therapy that targets the G551D CFTR gene mutation to treat cystic fibrosis, significantly reduced hospital admission rates in patients with cystic fibrosis with a variety of mutations, according to results published May 7 in Health Affairs.

The study involved 143 patients being treated with ivacaftor between February 2012 and February 2015. In 2014, the FDA expanded its approval for the use of ivacaftor by cystic fibrosis patients to include nine additional mutations, and patients with these mutations were included in this study.

copyright Zerbor/Thinkstock
The overall rate of inpatient admissions dropped by 55%, and cystic fibrosis–related admissions rates fell by 78% (P less than .0001) between the period 12 months before treatment and 12 months after the first filled prescription, wrote Lisa B. Feng and her coauthors.

Ms. Feng, who is senior director for policy and advocacy at the Cystic Fibrosis Foundation and her colleagues analyzed administrative claims data from the Truven Health Analytics Market Scan Commercial Research Database. All of the claims were for patients from the United States with employer-sponsored insurance plans. Eligibility criteria included an ICD-9 CM diagnosis of cystic fibrosis on one or more inpatient claims or two or more outpatient claims at least 30 days apart, a prescription claim for ivacaftor monotherapy, being at least 6 years of age at the time of the first filled prescription, and 12 months of continuous enrollment before and after the first filled prescription.

The “pre-ivacaftor” period was defined as the 12 months before the first filled prescription. The “post-ivacaftor” period was defined as the 12 months after the first filled prescription. For each period, the numbers and percentages of patients hospitalized were calculated, for any reason and for cystic fibrosis–related reasons. Hospitalization rates also were calculated as numbers of admissions per person-year, the authors said.

Data also were analyzed for two subcohorts: the 86 patients who started using ivacaftor between Feb. 6, 2012, and Feb. 21, 2014, under the initial Food and Drug Administration label; and the 57 patients who initiated use between Feb. 22, 2014, and Dec. 31, 2015, under the expanded FDA label, which included nine additional genetic mutations.

Of the 143 patients who had filled prescriptions for ivacaftor, 63% were aged 18 years or older. The rate of overall inpatient admissions decreased 55%, from 0.57 admissions per person-year in the pre-ivacaftor period to 0.26 admissions per person-year in the post-ivacaftor period, the investigators reported.

 

 


The declines in hospital admissions also were similar between the initial label and the expanded FDA label groups, with declines in overall admissions of 59% and 57%, respectively.

Hospital admissions related to cystic fibrosis also decreased significantly, by 78%. Admissions with principal diagnosis codes for cystic fibrosis decreased from 42 in the preprescription period, to 8 after filling the prescription. Rates per person per year decreased by 82% in patients aged 6-17 years and 80% among adults aged 18 years and older. Additionally, patients who filled at least 10 prescriptions during the study period experienced a 68% reduction in inpatient admissions, compared with 45% for those with three to nine prescriptions filled.

Ivacaftor also was associated with 60% lower per-person inpatient spending overall, with a greater proportional reduction in hospital costs for adults (68%) than for children (45%), and an absolute per-person reduction of $10,567, the authors reported.

“Treatments that target the protein defect that causes cystic fibrosis illustrate the promise of precision medicine,” the authors wrote. “To deliver the right care to the right patient, cystic fibrosis care must continue to account for other aspects unique to individuals such as environment, physiology, patients’ preferences, and lifestyle,” they concluded.

Ivacaftor (Kalydeco) is manufactured for Vertex Pharmaceuticals. No disclosures or conflicts of interest were reported.

SOURCE: Feng LB et al. Health Aff. 2018 May 8. doi: 10.1377/hlthaff.2017.1554

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM HEALTH AFFAIRS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Ivacaftor significantly reduced hospital admission rates in patients with cystic fibrosis.

Major finding: Overall rate of inpatient admissions dropped by 55% and cystic fibrosis related admissions rates by 78% (P less than .0001).

Study details: A study of 143 patients treated with ivacaftor between February 2012 and February 2015.

Disclosures: No disclosures or conflicts of interest were reported.

Source: Feng LB et al. Health Aff. 2018 May 8. doi: 10.1377/hlthaff.2017.1554.

Disqus Comments
Default
Use ProPublica

New trial to assess HIV+/HIV+ kidney transplants

Article Type
Changed
Wed, 01/02/2019 - 10:09

 

The HOPE in Action Multicenter Kidney Study, the first large-scale clinical trial to study kidney transplantations between people with HIV, has begun at clinical centers across the United States, according to an announcement by the National Institutes of Health. The study, sponsored by the National Institute of Allergy and Infectious Diseases and NIH, will assess the safety of HIV-positive donor to HIV-positive recipient kidney transplantation. This form of transplantation was made legal by the passage of the HOPE (HIV Organ Policy Equity) Act, which permits the transplantation of organs from donors with HIV into qualified HIV-positive recipients with end-stage organ failure.

London_England/Thinkstock

Outcomes to be studied in the multicenter trial will include potential transplant-related and HIV-related complications following surgery, as well as organ rejection, organ failure, and failure of previously effective HIV medications. The study is currently enrolling and is expected to include 360 participants, with an estimated completion date of Aug. 1, 2022.

“The HOPE Act of 2013 opened the door for researchers to explore a potential new source of donor organs for those living with HIV – a population with a significant and growing need for transplants. This study offers a chance to improve the health of those living with HIV, and increase the overall supply of transplantable organs,” said NIAID Director Anthony S. Fauci, MD, in the NIH news release. Transplantation of organs from HIV-positive donors to HIV-negative recipients remains illegal in the United States.

More information about the study can be found at ClinicalTrials.gov using the identifier NCT03500315. A similar trial to examine liver transplantation, the HOPE in Action Multicenter Liver Study, is expected to launch later in 2018.

Publications
Topics
Sections

 

The HOPE in Action Multicenter Kidney Study, the first large-scale clinical trial to study kidney transplantations between people with HIV, has begun at clinical centers across the United States, according to an announcement by the National Institutes of Health. The study, sponsored by the National Institute of Allergy and Infectious Diseases and NIH, will assess the safety of HIV-positive donor to HIV-positive recipient kidney transplantation. This form of transplantation was made legal by the passage of the HOPE (HIV Organ Policy Equity) Act, which permits the transplantation of organs from donors with HIV into qualified HIV-positive recipients with end-stage organ failure.

London_England/Thinkstock

Outcomes to be studied in the multicenter trial will include potential transplant-related and HIV-related complications following surgery, as well as organ rejection, organ failure, and failure of previously effective HIV medications. The study is currently enrolling and is expected to include 360 participants, with an estimated completion date of Aug. 1, 2022.

“The HOPE Act of 2013 opened the door for researchers to explore a potential new source of donor organs for those living with HIV – a population with a significant and growing need for transplants. This study offers a chance to improve the health of those living with HIV, and increase the overall supply of transplantable organs,” said NIAID Director Anthony S. Fauci, MD, in the NIH news release. Transplantation of organs from HIV-positive donors to HIV-negative recipients remains illegal in the United States.

More information about the study can be found at ClinicalTrials.gov using the identifier NCT03500315. A similar trial to examine liver transplantation, the HOPE in Action Multicenter Liver Study, is expected to launch later in 2018.

 

The HOPE in Action Multicenter Kidney Study, the first large-scale clinical trial to study kidney transplantations between people with HIV, has begun at clinical centers across the United States, according to an announcement by the National Institutes of Health. The study, sponsored by the National Institute of Allergy and Infectious Diseases and NIH, will assess the safety of HIV-positive donor to HIV-positive recipient kidney transplantation. This form of transplantation was made legal by the passage of the HOPE (HIV Organ Policy Equity) Act, which permits the transplantation of organs from donors with HIV into qualified HIV-positive recipients with end-stage organ failure.

London_England/Thinkstock

Outcomes to be studied in the multicenter trial will include potential transplant-related and HIV-related complications following surgery, as well as organ rejection, organ failure, and failure of previously effective HIV medications. The study is currently enrolling and is expected to include 360 participants, with an estimated completion date of Aug. 1, 2022.

“The HOPE Act of 2013 opened the door for researchers to explore a potential new source of donor organs for those living with HIV – a population with a significant and growing need for transplants. This study offers a chance to improve the health of those living with HIV, and increase the overall supply of transplantable organs,” said NIAID Director Anthony S. Fauci, MD, in the NIH news release. Transplantation of organs from HIV-positive donors to HIV-negative recipients remains illegal in the United States.

More information about the study can be found at ClinicalTrials.gov using the identifier NCT03500315. A similar trial to examine liver transplantation, the HOPE in Action Multicenter Liver Study, is expected to launch later in 2018.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

In PAH trials, clinical worsening risk rose with time

Article Type
Changed
Fri, 01/18/2019 - 17:38

 

Current clinical trials evaluating combination therapy for pulmonary artery hypertension (PAH) may be longer than what is needed to demonstrate treatment benefit, results of a recent meta-analysis suggest.

In PAH trials of combination therapy, the absolute risk reduction of clinical worsening beyond 6-12 months was relatively constant, according to results of the study published in the May issue of the journal Chest®.

Rawpixel/iStock/Getty Images
That finding “questions the requirement for longer-term event-driven trials beyond that duration in an orphan disease such as PAH,” wrote investigator Annie C. Lajoie, MD, of the Pulmonary Hypertension Research Group, Quebec City, and her coauthors.

The meta-analysis by Dr. Lajoie and her colleagues included 3,801 patients enrolled in one of 15 previously published randomized clinical trials. Of those trials, four were long-term, event driven studies, with a mean duration of 87 weeks, while the remainder were shorter studies with a mean duration of 15 weeks.

For the long-term, event-driven trials, the mean number needed to treat (NNT) was 17.4 at week 16, gradually decreasing to 8.8 at 52 weeks of follow-up, remaining stable after that, according to investigators.

Consistent with that finding, the mean relative risk of clinical worsening was 0.38 at 16 weeks, and similarly, 0.41 at 26 weeks, investigators reported. After that, the relative risk progressively increased to 0.54 at 52 weeks and 0.68 at 104 weeks.

Looking at all trials combined, Dr. Lajoie and her colleagues observed that longer trial duration had a positive correlation with relative risk of clinical worsening (P = .0002).

 

 


Pragmatically, these results raise the possibility that PAH combination therapy trials could be shorter in duration. Some recent event-driven studies have lasted up to 6 years, with patients on treatment for about 2 of those years, investigators noted.

“In the context of an orphan disease with limited and competing recruitment for trials and the rapidly changing treatment paradigm in PAH, the optimal duration of future trials should be revisited,” Dr. Lajoie and her colleagues wrote in a discussion of their findings.

They also cautioned that NNT, a measure of how many patient treatments are needed to prevent one additional adverse event, could be “misleading” despite its value as a simple measure of treatment impact.

Likewise, relative risk can be misleading; for example, a treatment reducing event risk from 30% to 20% represents a relative risk reduction of approximately 35%, but so does a treatment reducing event risk from 3% to 2%, the researchers noted.

 

 


“Multiple factors, in addition to the efficacy of the therapy and the comparator, may directly influence the NNT and relative risk and should be taken into account in their interpretation,” they said in their report.

Dr. Lajoie had no disclosures related to the study. Her coauthors had disclosures related to Actelion Pharmaceuticals, Bayer, and GlaxoSmithKline, among others.

SOURCE: Lajoie AC et al. Chest. 2017 May;153(5):1142-52.

Body

 

Key clinical point: A meta-analysis calls into question the need to perform pulmonary arterial hypertension (PAH) trials beyond 6 to 12 months of treatment in the future.

Major finding: The mean number needed to treat was stable at 52 weeks of follow-up and thereafter, while the mean relative risk of clinical worsening progressively increased from approximately 0.38 at week 16 to 0.68 at week 104.

Study details: A systematic review of 3,801 patients enrolled in 15 randomized clinical trials.

Disclosures: The authors reported disclosures related to Actelion Pharmaceuticals, Bayer, and GlaxoSmithKline, among other entities.

Source: Lajoie AC et al. Chest. 2017 May;153(5):1142-52.

Publications
Topics
Sections
Body

 

Key clinical point: A meta-analysis calls into question the need to perform pulmonary arterial hypertension (PAH) trials beyond 6 to 12 months of treatment in the future.

Major finding: The mean number needed to treat was stable at 52 weeks of follow-up and thereafter, while the mean relative risk of clinical worsening progressively increased from approximately 0.38 at week 16 to 0.68 at week 104.

Study details: A systematic review of 3,801 patients enrolled in 15 randomized clinical trials.

Disclosures: The authors reported disclosures related to Actelion Pharmaceuticals, Bayer, and GlaxoSmithKline, among other entities.

Source: Lajoie AC et al. Chest. 2017 May;153(5):1142-52.

Body

 

Key clinical point: A meta-analysis calls into question the need to perform pulmonary arterial hypertension (PAH) trials beyond 6 to 12 months of treatment in the future.

Major finding: The mean number needed to treat was stable at 52 weeks of follow-up and thereafter, while the mean relative risk of clinical worsening progressively increased from approximately 0.38 at week 16 to 0.68 at week 104.

Study details: A systematic review of 3,801 patients enrolled in 15 randomized clinical trials.

Disclosures: The authors reported disclosures related to Actelion Pharmaceuticals, Bayer, and GlaxoSmithKline, among other entities.

Source: Lajoie AC et al. Chest. 2017 May;153(5):1142-52.

 

Current clinical trials evaluating combination therapy for pulmonary artery hypertension (PAH) may be longer than what is needed to demonstrate treatment benefit, results of a recent meta-analysis suggest.

In PAH trials of combination therapy, the absolute risk reduction of clinical worsening beyond 6-12 months was relatively constant, according to results of the study published in the May issue of the journal Chest®.

Rawpixel/iStock/Getty Images
That finding “questions the requirement for longer-term event-driven trials beyond that duration in an orphan disease such as PAH,” wrote investigator Annie C. Lajoie, MD, of the Pulmonary Hypertension Research Group, Quebec City, and her coauthors.

The meta-analysis by Dr. Lajoie and her colleagues included 3,801 patients enrolled in one of 15 previously published randomized clinical trials. Of those trials, four were long-term, event driven studies, with a mean duration of 87 weeks, while the remainder were shorter studies with a mean duration of 15 weeks.

For the long-term, event-driven trials, the mean number needed to treat (NNT) was 17.4 at week 16, gradually decreasing to 8.8 at 52 weeks of follow-up, remaining stable after that, according to investigators.

Consistent with that finding, the mean relative risk of clinical worsening was 0.38 at 16 weeks, and similarly, 0.41 at 26 weeks, investigators reported. After that, the relative risk progressively increased to 0.54 at 52 weeks and 0.68 at 104 weeks.

Looking at all trials combined, Dr. Lajoie and her colleagues observed that longer trial duration had a positive correlation with relative risk of clinical worsening (P = .0002).

 

 


Pragmatically, these results raise the possibility that PAH combination therapy trials could be shorter in duration. Some recent event-driven studies have lasted up to 6 years, with patients on treatment for about 2 of those years, investigators noted.

“In the context of an orphan disease with limited and competing recruitment for trials and the rapidly changing treatment paradigm in PAH, the optimal duration of future trials should be revisited,” Dr. Lajoie and her colleagues wrote in a discussion of their findings.

They also cautioned that NNT, a measure of how many patient treatments are needed to prevent one additional adverse event, could be “misleading” despite its value as a simple measure of treatment impact.

Likewise, relative risk can be misleading; for example, a treatment reducing event risk from 30% to 20% represents a relative risk reduction of approximately 35%, but so does a treatment reducing event risk from 3% to 2%, the researchers noted.

 

 


“Multiple factors, in addition to the efficacy of the therapy and the comparator, may directly influence the NNT and relative risk and should be taken into account in their interpretation,” they said in their report.

Dr. Lajoie had no disclosures related to the study. Her coauthors had disclosures related to Actelion Pharmaceuticals, Bayer, and GlaxoSmithKline, among others.

SOURCE: Lajoie AC et al. Chest. 2017 May;153(5):1142-52.

 

Current clinical trials evaluating combination therapy for pulmonary artery hypertension (PAH) may be longer than what is needed to demonstrate treatment benefit, results of a recent meta-analysis suggest.

In PAH trials of combination therapy, the absolute risk reduction of clinical worsening beyond 6-12 months was relatively constant, according to results of the study published in the May issue of the journal Chest®.

Rawpixel/iStock/Getty Images
That finding “questions the requirement for longer-term event-driven trials beyond that duration in an orphan disease such as PAH,” wrote investigator Annie C. Lajoie, MD, of the Pulmonary Hypertension Research Group, Quebec City, and her coauthors.

The meta-analysis by Dr. Lajoie and her colleagues included 3,801 patients enrolled in one of 15 previously published randomized clinical trials. Of those trials, four were long-term, event driven studies, with a mean duration of 87 weeks, while the remainder were shorter studies with a mean duration of 15 weeks.

For the long-term, event-driven trials, the mean number needed to treat (NNT) was 17.4 at week 16, gradually decreasing to 8.8 at 52 weeks of follow-up, remaining stable after that, according to investigators.

Consistent with that finding, the mean relative risk of clinical worsening was 0.38 at 16 weeks, and similarly, 0.41 at 26 weeks, investigators reported. After that, the relative risk progressively increased to 0.54 at 52 weeks and 0.68 at 104 weeks.

Looking at all trials combined, Dr. Lajoie and her colleagues observed that longer trial duration had a positive correlation with relative risk of clinical worsening (P = .0002).

 

 


Pragmatically, these results raise the possibility that PAH combination therapy trials could be shorter in duration. Some recent event-driven studies have lasted up to 6 years, with patients on treatment for about 2 of those years, investigators noted.

“In the context of an orphan disease with limited and competing recruitment for trials and the rapidly changing treatment paradigm in PAH, the optimal duration of future trials should be revisited,” Dr. Lajoie and her colleagues wrote in a discussion of their findings.

They also cautioned that NNT, a measure of how many patient treatments are needed to prevent one additional adverse event, could be “misleading” despite its value as a simple measure of treatment impact.

Likewise, relative risk can be misleading; for example, a treatment reducing event risk from 30% to 20% represents a relative risk reduction of approximately 35%, but so does a treatment reducing event risk from 3% to 2%, the researchers noted.

 

 


“Multiple factors, in addition to the efficacy of the therapy and the comparator, may directly influence the NNT and relative risk and should be taken into account in their interpretation,” they said in their report.

Dr. Lajoie had no disclosures related to the study. Her coauthors had disclosures related to Actelion Pharmaceuticals, Bayer, and GlaxoSmithKline, among others.

SOURCE: Lajoie AC et al. Chest. 2017 May;153(5):1142-52.

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

FROM CHEST®

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

When and how to suspect asthma misdiagnosis

Article Type
Changed
Fri, 01/18/2019 - 17:38

 

If a patient’s asthma symptoms don’t fluctuate over time and in severity, it’s definitely time to entertain the possibility of diagnostic error, Kyle I. Happel, MD, said at the annual meeting of the American College of Physicians.

“Asthma is a disease whose symptoms are caused by variable airflow obstruction. It varies throughout the day, usually, and certainly by the week or by the month. I want you to think about the variability of a patient’s disease symptoms in forming your index of suspicion for this disease,” urged Dr. Happel, of the section of pulmonary, critical care, and allergy/immunology at Louisiana State University Medical Center in New Orleans.

Bruce Jancin/MDedge News
Dr. Kyle I. Happel
Lack of variability in asthma symptoms raises three possibilities: the wrong diagnosis; the presence of severe uncontrolled asthma for so long that it may have morphed into an asthma/chronic obstructive pulmonary disease overlap syndrome; or perhaps the asthma has resolved, which can occur when a patient with childhood-onset asthma moves into adulthood.

These phenomena occur often. In a Canadian multicenter study of more than 700 patients with a history of physician-diagnosed asthma within the past 5 years, current asthma was ruled out in fully 33% of them on the basis of no deterioration of asthma symptoms, no evidence of reversible airway obstruction, and no bronchial hyperresponsiveness after all asthma drugs were tapered off (JAMA. 2017 Jan 17;317[3]:269-79).

Wheezing is the most specific symptom of asthma, although it is not, in fact, terribly specific. In descending order, the next most specific symptoms are breathlessness, chest tightness, and cough.

The top seven diseases that mimic asthma symptoms are chronic obstructive pulmonary disease, rhinosinusitis, heart failure with preserved or reduced ejection fraction, gastroesophageal reflux disease, angina, anxiety, and vocal cord dysfunction syndrome.

Strike two for an asthma diagnosis is a patient’s report that albuterol doesn’t improve the symptoms. That definitely raises questions about the diagnosis.

 

 


“Most asthmatics get symptomatic relief from their disease,” Dr. Happel observed.

And, if there is no indication in the patient’s chart that the asthma diagnosis was based upon demonstration of airflow obstruction on spirometry, the diagnosis is thrown further into doubt. In the recent Canadian study, patients who didn’t undergo pulmonary function testing (PFT) to establish airflow limitation at their time of diagnosis were significantly less likely to have current asthma.

“I would strongly suggest everyone with the diagnosis of asthma get spirometry with bronchodilator testing,” Dr. Happel said. “Good-quality PFTs are critical in forming a solid diagnosis of asthma.”

In a patient who has symptoms consistent with asthma, a 200-cc and 12% or more improvement in forced expiratory volume in 1 second (FEV1) in response to bronchodilator challenge is supportive of the diagnosis. However, absence of reversible airway obstruction doesn’t exclude the possibility of asthma.
 

 

In the setting of low to-moderate clinical suspicion of asthma plus no demonstrable obstruction on spirometry, Dr. Happel recommends moving on to bronchial hyperreactivity testing via a methacholine challenge.

“The beauty of a methacholine challenge is that is has a high negative predictive value to help exclude the diagnosis of asthma, particularly in people who are having symptoms suggestive of asthma,” Dr. Happel explained. “If it takes more than 8 mg/mL of methacholine to elicit a 20% or greater decrease in FEV1, it’s probably something else. It’s not a particularly specific test, though; you can get false positives from a methacholine challenge.”
Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

If a patient’s asthma symptoms don’t fluctuate over time and in severity, it’s definitely time to entertain the possibility of diagnostic error, Kyle I. Happel, MD, said at the annual meeting of the American College of Physicians.

“Asthma is a disease whose symptoms are caused by variable airflow obstruction. It varies throughout the day, usually, and certainly by the week or by the month. I want you to think about the variability of a patient’s disease symptoms in forming your index of suspicion for this disease,” urged Dr. Happel, of the section of pulmonary, critical care, and allergy/immunology at Louisiana State University Medical Center in New Orleans.

Bruce Jancin/MDedge News
Dr. Kyle I. Happel
Lack of variability in asthma symptoms raises three possibilities: the wrong diagnosis; the presence of severe uncontrolled asthma for so long that it may have morphed into an asthma/chronic obstructive pulmonary disease overlap syndrome; or perhaps the asthma has resolved, which can occur when a patient with childhood-onset asthma moves into adulthood.

These phenomena occur often. In a Canadian multicenter study of more than 700 patients with a history of physician-diagnosed asthma within the past 5 years, current asthma was ruled out in fully 33% of them on the basis of no deterioration of asthma symptoms, no evidence of reversible airway obstruction, and no bronchial hyperresponsiveness after all asthma drugs were tapered off (JAMA. 2017 Jan 17;317[3]:269-79).

Wheezing is the most specific symptom of asthma, although it is not, in fact, terribly specific. In descending order, the next most specific symptoms are breathlessness, chest tightness, and cough.

The top seven diseases that mimic asthma symptoms are chronic obstructive pulmonary disease, rhinosinusitis, heart failure with preserved or reduced ejection fraction, gastroesophageal reflux disease, angina, anxiety, and vocal cord dysfunction syndrome.

Strike two for an asthma diagnosis is a patient’s report that albuterol doesn’t improve the symptoms. That definitely raises questions about the diagnosis.

 

 


“Most asthmatics get symptomatic relief from their disease,” Dr. Happel observed.

And, if there is no indication in the patient’s chart that the asthma diagnosis was based upon demonstration of airflow obstruction on spirometry, the diagnosis is thrown further into doubt. In the recent Canadian study, patients who didn’t undergo pulmonary function testing (PFT) to establish airflow limitation at their time of diagnosis were significantly less likely to have current asthma.

“I would strongly suggest everyone with the diagnosis of asthma get spirometry with bronchodilator testing,” Dr. Happel said. “Good-quality PFTs are critical in forming a solid diagnosis of asthma.”

In a patient who has symptoms consistent with asthma, a 200-cc and 12% or more improvement in forced expiratory volume in 1 second (FEV1) in response to bronchodilator challenge is supportive of the diagnosis. However, absence of reversible airway obstruction doesn’t exclude the possibility of asthma.
 

 

In the setting of low to-moderate clinical suspicion of asthma plus no demonstrable obstruction on spirometry, Dr. Happel recommends moving on to bronchial hyperreactivity testing via a methacholine challenge.

“The beauty of a methacholine challenge is that is has a high negative predictive value to help exclude the diagnosis of asthma, particularly in people who are having symptoms suggestive of asthma,” Dr. Happel explained. “If it takes more than 8 mg/mL of methacholine to elicit a 20% or greater decrease in FEV1, it’s probably something else. It’s not a particularly specific test, though; you can get false positives from a methacholine challenge.”

 

If a patient’s asthma symptoms don’t fluctuate over time and in severity, it’s definitely time to entertain the possibility of diagnostic error, Kyle I. Happel, MD, said at the annual meeting of the American College of Physicians.

“Asthma is a disease whose symptoms are caused by variable airflow obstruction. It varies throughout the day, usually, and certainly by the week or by the month. I want you to think about the variability of a patient’s disease symptoms in forming your index of suspicion for this disease,” urged Dr. Happel, of the section of pulmonary, critical care, and allergy/immunology at Louisiana State University Medical Center in New Orleans.

Bruce Jancin/MDedge News
Dr. Kyle I. Happel
Lack of variability in asthma symptoms raises three possibilities: the wrong diagnosis; the presence of severe uncontrolled asthma for so long that it may have morphed into an asthma/chronic obstructive pulmonary disease overlap syndrome; or perhaps the asthma has resolved, which can occur when a patient with childhood-onset asthma moves into adulthood.

These phenomena occur often. In a Canadian multicenter study of more than 700 patients with a history of physician-diagnosed asthma within the past 5 years, current asthma was ruled out in fully 33% of them on the basis of no deterioration of asthma symptoms, no evidence of reversible airway obstruction, and no bronchial hyperresponsiveness after all asthma drugs were tapered off (JAMA. 2017 Jan 17;317[3]:269-79).

Wheezing is the most specific symptom of asthma, although it is not, in fact, terribly specific. In descending order, the next most specific symptoms are breathlessness, chest tightness, and cough.

The top seven diseases that mimic asthma symptoms are chronic obstructive pulmonary disease, rhinosinusitis, heart failure with preserved or reduced ejection fraction, gastroesophageal reflux disease, angina, anxiety, and vocal cord dysfunction syndrome.

Strike two for an asthma diagnosis is a patient’s report that albuterol doesn’t improve the symptoms. That definitely raises questions about the diagnosis.

 

 


“Most asthmatics get symptomatic relief from their disease,” Dr. Happel observed.

And, if there is no indication in the patient’s chart that the asthma diagnosis was based upon demonstration of airflow obstruction on spirometry, the diagnosis is thrown further into doubt. In the recent Canadian study, patients who didn’t undergo pulmonary function testing (PFT) to establish airflow limitation at their time of diagnosis were significantly less likely to have current asthma.

“I would strongly suggest everyone with the diagnosis of asthma get spirometry with bronchodilator testing,” Dr. Happel said. “Good-quality PFTs are critical in forming a solid diagnosis of asthma.”

In a patient who has symptoms consistent with asthma, a 200-cc and 12% or more improvement in forced expiratory volume in 1 second (FEV1) in response to bronchodilator challenge is supportive of the diagnosis. However, absence of reversible airway obstruction doesn’t exclude the possibility of asthma.
 

 

In the setting of low to-moderate clinical suspicion of asthma plus no demonstrable obstruction on spirometry, Dr. Happel recommends moving on to bronchial hyperreactivity testing via a methacholine challenge.

“The beauty of a methacholine challenge is that is has a high negative predictive value to help exclude the diagnosis of asthma, particularly in people who are having symptoms suggestive of asthma,” Dr. Happel explained. “If it takes more than 8 mg/mL of methacholine to elicit a 20% or greater decrease in FEV1, it’s probably something else. It’s not a particularly specific test, though; you can get false positives from a methacholine challenge.”
Publications
Publications
Topics
Article Type
Sections
Article Source

REPORTING FROM ACP INTERNAL MEDICINE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Physician learning must evolve as industry transforms

Article Type
Changed
Fri, 09/14/2018 - 11:53
Training addresses communication challenges

 

Editor’s Note: This column was provided by the Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine. Neither SHM nor Frontline Medical Communications was involved in its production.



In medical school, students are trained on skills that will make them better future physicians, team members, and care givers. It’s a curious thing: Once we make headway into our medical careers and our days are filled with patient visits and paperwork, we rarely have the opportunity to assess our skill sets in the same way, despite the fact that new technologies and approaches to treatment have emerged since many of us attended medical school.

Dr. Eric Barna
As a hospitalist at Mount Sinai Hospital in New York, I’m part of a team that cares for moderately to severely ill patients at a major academic institution. I’m also a physician advisor, and I have the pleasure of teaching some of the youngest and brightest medical students, interns, and residents at various stages of their careers. I consider this the best part of my work, so I’m sure it comes as no surprise that I’m a firm believer in the importance of continuous learning.

That’s why I was so excited when I had the chance to participate in three standardized patient encounters training scenarios designed for me and my 22 hospitalist colleagues to improve our communication skills; this training was funded by a grant from the Doctors Company Foundation. A standardized patient encounter is essentially a live simulation in a clinical setting with trained actors.

To start the simulation, a physician is given a short prompt about the patient scenario. They may also be provided with some basic information, such as a diagnosis or a relevant imaging study, prior to entering the room. Once the testing center provides a signal, physicians are allowed to enter the room. An introduction of our role on the medical team is provided, and a discussion ensues. The actors provide relevant history, incorporate true emotional response to questioning, and display any behavioral or physical prompts that a real patient would. This allows physicians to react in real time to the needs of the patient. The use of standardized patients can also be adapted to desired testing scenarios, which might deal with issues like communication, clinical reasoning, or establishing a differential diagnosis.

Like many hospitals, we have a program in place aimed at assessing how we educate students and younger physicians. But Mount Sinai is the first hospital in New York that has established a program designed specifically to assess and address some of the unique communication challenges we face as hospitalists to improve patient care.

As hospitalists, we’ve never met patients or families before beginning conversations at critical points of care. It takes sensitivity and particular thoughtfulness to create rapport and share substantial information with a patient even without having a prior relationship.

 

 


During the training, my colleagues and I each encountered three different standardized patients in key scenarios: one at daily rounds, one upset over a missed diagnosis, and one at discharge, when the potential for errors and miscommunication is greatest. We were videotaped during the encounters for our personal review, and we received direct feedback afterward from the patient.

We discovered that we as physicians have become great at taking care of patients, but we also discovered that we don’t have enough opportunities to investigate which elements of our day-to-day communication need adjustment – or what good behaviors need reinforcing.

It was extremely helpful to be able to watch the videos and ask ourselves, “Do I use medical jargon that’s hard for the patient to understand? Do I say things that aren’t warm and welcoming to the patient?” Then, by adding in patient feedback, we learned how we performed across core domains, such as treating patients with courtesy and respect, using listening skills, and explaining complex topics in an understandable way.

Strengthening these individual communication skills is paramount to improving patient comprehension, which in turn can improve patient follow-though on discharge instructions and reduce risk of readmission. And as educators, our takeaways from the training can empower others in the health care system at large to better communicate with their patients.
 

 


Mount Sinai is proud to spearhead this innovative training effort in New York. In fact, since the initial date of the training, the three modules have expanded into a program run by the Morchand Center for Clinical Competence at the Icahn School of Medicine at Mount Sinai. So far, the Morchand Center has adapted the standardized patient methodology used for hospitalists to train 1,845 additional residents in various specialties across New York.

Nationwide, the entire medical community stands to benefit from continuous physician learning and the partnerships that facilitate it, such as the Doctors Company, which make trainings like this possible. At a time of tremendous change for health care, having a well-trained physician workforce is more important than ever before. Our patients deserve to be cared for by physicians whose knowledge evolves alongside the transformation of care delivery.

Physician learning must keep pace with our industry’s transformation. By setting the bar higher for what patients should expect on a patient communication level, we increase patient safety, raise levels of patient satisfaction, and drive quality care – no matter what the future of health care delivery looks like.

Dr. Barna is an associate residency program director for inpatient medicine in the Division of Hospital Medicine/Samuel Bronfman Department of Medicine in the Icahn School of Medicine at Mount Sinai, New York.

Publications
Topics
Sections
Training addresses communication challenges
Training addresses communication challenges

 

Editor’s Note: This column was provided by the Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine. Neither SHM nor Frontline Medical Communications was involved in its production.



In medical school, students are trained on skills that will make them better future physicians, team members, and care givers. It’s a curious thing: Once we make headway into our medical careers and our days are filled with patient visits and paperwork, we rarely have the opportunity to assess our skill sets in the same way, despite the fact that new technologies and approaches to treatment have emerged since many of us attended medical school.

Dr. Eric Barna
As a hospitalist at Mount Sinai Hospital in New York, I’m part of a team that cares for moderately to severely ill patients at a major academic institution. I’m also a physician advisor, and I have the pleasure of teaching some of the youngest and brightest medical students, interns, and residents at various stages of their careers. I consider this the best part of my work, so I’m sure it comes as no surprise that I’m a firm believer in the importance of continuous learning.

That’s why I was so excited when I had the chance to participate in three standardized patient encounters training scenarios designed for me and my 22 hospitalist colleagues to improve our communication skills; this training was funded by a grant from the Doctors Company Foundation. A standardized patient encounter is essentially a live simulation in a clinical setting with trained actors.

To start the simulation, a physician is given a short prompt about the patient scenario. They may also be provided with some basic information, such as a diagnosis or a relevant imaging study, prior to entering the room. Once the testing center provides a signal, physicians are allowed to enter the room. An introduction of our role on the medical team is provided, and a discussion ensues. The actors provide relevant history, incorporate true emotional response to questioning, and display any behavioral or physical prompts that a real patient would. This allows physicians to react in real time to the needs of the patient. The use of standardized patients can also be adapted to desired testing scenarios, which might deal with issues like communication, clinical reasoning, or establishing a differential diagnosis.

Like many hospitals, we have a program in place aimed at assessing how we educate students and younger physicians. But Mount Sinai is the first hospital in New York that has established a program designed specifically to assess and address some of the unique communication challenges we face as hospitalists to improve patient care.

As hospitalists, we’ve never met patients or families before beginning conversations at critical points of care. It takes sensitivity and particular thoughtfulness to create rapport and share substantial information with a patient even without having a prior relationship.

 

 


During the training, my colleagues and I each encountered three different standardized patients in key scenarios: one at daily rounds, one upset over a missed diagnosis, and one at discharge, when the potential for errors and miscommunication is greatest. We were videotaped during the encounters for our personal review, and we received direct feedback afterward from the patient.

We discovered that we as physicians have become great at taking care of patients, but we also discovered that we don’t have enough opportunities to investigate which elements of our day-to-day communication need adjustment – or what good behaviors need reinforcing.

It was extremely helpful to be able to watch the videos and ask ourselves, “Do I use medical jargon that’s hard for the patient to understand? Do I say things that aren’t warm and welcoming to the patient?” Then, by adding in patient feedback, we learned how we performed across core domains, such as treating patients with courtesy and respect, using listening skills, and explaining complex topics in an understandable way.

Strengthening these individual communication skills is paramount to improving patient comprehension, which in turn can improve patient follow-though on discharge instructions and reduce risk of readmission. And as educators, our takeaways from the training can empower others in the health care system at large to better communicate with their patients.
 

 


Mount Sinai is proud to spearhead this innovative training effort in New York. In fact, since the initial date of the training, the three modules have expanded into a program run by the Morchand Center for Clinical Competence at the Icahn School of Medicine at Mount Sinai. So far, the Morchand Center has adapted the standardized patient methodology used for hospitalists to train 1,845 additional residents in various specialties across New York.

Nationwide, the entire medical community stands to benefit from continuous physician learning and the partnerships that facilitate it, such as the Doctors Company, which make trainings like this possible. At a time of tremendous change for health care, having a well-trained physician workforce is more important than ever before. Our patients deserve to be cared for by physicians whose knowledge evolves alongside the transformation of care delivery.

Physician learning must keep pace with our industry’s transformation. By setting the bar higher for what patients should expect on a patient communication level, we increase patient safety, raise levels of patient satisfaction, and drive quality care – no matter what the future of health care delivery looks like.

Dr. Barna is an associate residency program director for inpatient medicine in the Division of Hospital Medicine/Samuel Bronfman Department of Medicine in the Icahn School of Medicine at Mount Sinai, New York.

 

Editor’s Note: This column was provided by the Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine. Neither SHM nor Frontline Medical Communications was involved in its production.



In medical school, students are trained on skills that will make them better future physicians, team members, and care givers. It’s a curious thing: Once we make headway into our medical careers and our days are filled with patient visits and paperwork, we rarely have the opportunity to assess our skill sets in the same way, despite the fact that new technologies and approaches to treatment have emerged since many of us attended medical school.

Dr. Eric Barna
As a hospitalist at Mount Sinai Hospital in New York, I’m part of a team that cares for moderately to severely ill patients at a major academic institution. I’m also a physician advisor, and I have the pleasure of teaching some of the youngest and brightest medical students, interns, and residents at various stages of their careers. I consider this the best part of my work, so I’m sure it comes as no surprise that I’m a firm believer in the importance of continuous learning.

That’s why I was so excited when I had the chance to participate in three standardized patient encounters training scenarios designed for me and my 22 hospitalist colleagues to improve our communication skills; this training was funded by a grant from the Doctors Company Foundation. A standardized patient encounter is essentially a live simulation in a clinical setting with trained actors.

To start the simulation, a physician is given a short prompt about the patient scenario. They may also be provided with some basic information, such as a diagnosis or a relevant imaging study, prior to entering the room. Once the testing center provides a signal, physicians are allowed to enter the room. An introduction of our role on the medical team is provided, and a discussion ensues. The actors provide relevant history, incorporate true emotional response to questioning, and display any behavioral or physical prompts that a real patient would. This allows physicians to react in real time to the needs of the patient. The use of standardized patients can also be adapted to desired testing scenarios, which might deal with issues like communication, clinical reasoning, or establishing a differential diagnosis.

Like many hospitals, we have a program in place aimed at assessing how we educate students and younger physicians. But Mount Sinai is the first hospital in New York that has established a program designed specifically to assess and address some of the unique communication challenges we face as hospitalists to improve patient care.

As hospitalists, we’ve never met patients or families before beginning conversations at critical points of care. It takes sensitivity and particular thoughtfulness to create rapport and share substantial information with a patient even without having a prior relationship.

 

 


During the training, my colleagues and I each encountered three different standardized patients in key scenarios: one at daily rounds, one upset over a missed diagnosis, and one at discharge, when the potential for errors and miscommunication is greatest. We were videotaped during the encounters for our personal review, and we received direct feedback afterward from the patient.

We discovered that we as physicians have become great at taking care of patients, but we also discovered that we don’t have enough opportunities to investigate which elements of our day-to-day communication need adjustment – or what good behaviors need reinforcing.

It was extremely helpful to be able to watch the videos and ask ourselves, “Do I use medical jargon that’s hard for the patient to understand? Do I say things that aren’t warm and welcoming to the patient?” Then, by adding in patient feedback, we learned how we performed across core domains, such as treating patients with courtesy and respect, using listening skills, and explaining complex topics in an understandable way.

Strengthening these individual communication skills is paramount to improving patient comprehension, which in turn can improve patient follow-though on discharge instructions and reduce risk of readmission. And as educators, our takeaways from the training can empower others in the health care system at large to better communicate with their patients.
 

 


Mount Sinai is proud to spearhead this innovative training effort in New York. In fact, since the initial date of the training, the three modules have expanded into a program run by the Morchand Center for Clinical Competence at the Icahn School of Medicine at Mount Sinai. So far, the Morchand Center has adapted the standardized patient methodology used for hospitalists to train 1,845 additional residents in various specialties across New York.

Nationwide, the entire medical community stands to benefit from continuous physician learning and the partnerships that facilitate it, such as the Doctors Company, which make trainings like this possible. At a time of tremendous change for health care, having a well-trained physician workforce is more important than ever before. Our patients deserve to be cared for by physicians whose knowledge evolves alongside the transformation of care delivery.

Physician learning must keep pace with our industry’s transformation. By setting the bar higher for what patients should expect on a patient communication level, we increase patient safety, raise levels of patient satisfaction, and drive quality care – no matter what the future of health care delivery looks like.

Dr. Barna is an associate residency program director for inpatient medicine in the Division of Hospital Medicine/Samuel Bronfman Department of Medicine in the Icahn School of Medicine at Mount Sinai, New York.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Climate change expected to impose major burden on mental health

Article Type
Changed
Mon, 05/07/2018 - 13:53

 

– Of the broad range of direct and indirect threats to public health anticipated from climate change, those involving mental health will place psychiatrists on the front lines of efforts to mitigate the impact, a member of the Climate Psychiatry Alliance said at the annual meeting of the American Psychiatric Association.

“One thing climate changes mean for us in psychiatry is more work,” reported Janet L. Lewis, MD, an assistant clinical professor of psychiatry at the University of Rochester (N.Y.).

Mental health is sensitive to climate. “Psychiatric patients can be particularly vulnerable to the medical effects of climate change,” Dr. Lewis said. “People with schizophrenia exhibit impaired thermoregulatory functioning, and many of our medications can impair the body’s normal heat regulation.”

The evidence of increased death rates among schizophrenia patients during heat waves has been attributed to this phenomenon as well as to the failure of patients with mental disorders to seek or obtain relief from heat, according to Dr. Lewis, but she noted that many studies have linked spikes in heat to increased aggression and violence. These links are true for the individual, and they affect trends in communities.

As a cause of societal stresses, such as food and water insecurity, climate change also has the very real potential of producing traumatic disruptions commensurate with disasters such as hurricanes or earthquakes. Noting that the rate of PTSD after such natural disasters typically runs at around 30%, Dr. Lewis suggested that psychiatrists might face large challenges from major upheavals induced by climate change.

However, even in the absence of catastrophic consequences, significant psychiatric morbidity may be generated by climate change in the form of “ecoanxieties” or “solastalgia,” a term coined about 10 years ago to describe psychic anxiety induced by environmental change. While many individuals continue to function normally despite fear or anxiety about climate change, Dr. Lewis said that there are many reports in the literature now show that psychoterratic illness, another term for this phenomenon, is associated with degraded or threatened environments linked to climate change.

The Climate Psychiatry Alliance is one of several professional psychiatry groups that is engaged in evaluating how psychiatry as a profession should react to climate change. The Climate Psychiatry committee of the Group for the Advancement of Psychiatry is another. Dr. Lewis, addressing the potential criticism that climate is a political issue, said that “we bring some very particular things to this 21st-century disaster … hopefully, everything I have said about the mental effects of climate change convinces you that it is not just a political problem.”

 

 


It is, however, a problem that is complex. Differentiating complex problems from complicated problems – which can be solved eventually with sufficient information – Dr. Lewis explained that complex problems are dynamic with an interplay between components that make solutions uncertain without experimentation and continual reassessment. She believes both mitigation of the problem and adaption to the inevitability of rising temperatures will be necessary.

This is relevant for psychiatrists who also must adapt to the environmental changes and develop resilience that will help them deal objectively with the mental health consequences of climate change. She noted that environmentalists recognize two traps in approaching solutions to climate change. The first is proposing overly simplistic solutions that fail to address the profound implications of climate change. The second is being rendered inactive by the overwhelming complexity of this growing problem.

Ultimately, Dr. Lewis called for psychiatrists to be proactive in dealing the mental health consequences of climate change. She noted that the APA issued a position statement in 2017, which emphasized that individuals with mental health disorders are disproportionately affected by climate change.

“We as psychiatrists know what it is to deal with complex systems, and we understand through our own work with traumatized patients how to manage patients with trauma responses and how to get empowered and engaged in the rebuilding of realistic lives,” Dr. Lewis said. She believes those skills will be important as the impact of climate change on mental health unfolds.
Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

– Of the broad range of direct and indirect threats to public health anticipated from climate change, those involving mental health will place psychiatrists on the front lines of efforts to mitigate the impact, a member of the Climate Psychiatry Alliance said at the annual meeting of the American Psychiatric Association.

“One thing climate changes mean for us in psychiatry is more work,” reported Janet L. Lewis, MD, an assistant clinical professor of psychiatry at the University of Rochester (N.Y.).

Mental health is sensitive to climate. “Psychiatric patients can be particularly vulnerable to the medical effects of climate change,” Dr. Lewis said. “People with schizophrenia exhibit impaired thermoregulatory functioning, and many of our medications can impair the body’s normal heat regulation.”

The evidence of increased death rates among schizophrenia patients during heat waves has been attributed to this phenomenon as well as to the failure of patients with mental disorders to seek or obtain relief from heat, according to Dr. Lewis, but she noted that many studies have linked spikes in heat to increased aggression and violence. These links are true for the individual, and they affect trends in communities.

As a cause of societal stresses, such as food and water insecurity, climate change also has the very real potential of producing traumatic disruptions commensurate with disasters such as hurricanes or earthquakes. Noting that the rate of PTSD after such natural disasters typically runs at around 30%, Dr. Lewis suggested that psychiatrists might face large challenges from major upheavals induced by climate change.

However, even in the absence of catastrophic consequences, significant psychiatric morbidity may be generated by climate change in the form of “ecoanxieties” or “solastalgia,” a term coined about 10 years ago to describe psychic anxiety induced by environmental change. While many individuals continue to function normally despite fear or anxiety about climate change, Dr. Lewis said that there are many reports in the literature now show that psychoterratic illness, another term for this phenomenon, is associated with degraded or threatened environments linked to climate change.

The Climate Psychiatry Alliance is one of several professional psychiatry groups that is engaged in evaluating how psychiatry as a profession should react to climate change. The Climate Psychiatry committee of the Group for the Advancement of Psychiatry is another. Dr. Lewis, addressing the potential criticism that climate is a political issue, said that “we bring some very particular things to this 21st-century disaster … hopefully, everything I have said about the mental effects of climate change convinces you that it is not just a political problem.”

 

 


It is, however, a problem that is complex. Differentiating complex problems from complicated problems – which can be solved eventually with sufficient information – Dr. Lewis explained that complex problems are dynamic with an interplay between components that make solutions uncertain without experimentation and continual reassessment. She believes both mitigation of the problem and adaption to the inevitability of rising temperatures will be necessary.

This is relevant for psychiatrists who also must adapt to the environmental changes and develop resilience that will help them deal objectively with the mental health consequences of climate change. She noted that environmentalists recognize two traps in approaching solutions to climate change. The first is proposing overly simplistic solutions that fail to address the profound implications of climate change. The second is being rendered inactive by the overwhelming complexity of this growing problem.

Ultimately, Dr. Lewis called for psychiatrists to be proactive in dealing the mental health consequences of climate change. She noted that the APA issued a position statement in 2017, which emphasized that individuals with mental health disorders are disproportionately affected by climate change.

“We as psychiatrists know what it is to deal with complex systems, and we understand through our own work with traumatized patients how to manage patients with trauma responses and how to get empowered and engaged in the rebuilding of realistic lives,” Dr. Lewis said. She believes those skills will be important as the impact of climate change on mental health unfolds.

 

– Of the broad range of direct and indirect threats to public health anticipated from climate change, those involving mental health will place psychiatrists on the front lines of efforts to mitigate the impact, a member of the Climate Psychiatry Alliance said at the annual meeting of the American Psychiatric Association.

“One thing climate changes mean for us in psychiatry is more work,” reported Janet L. Lewis, MD, an assistant clinical professor of psychiatry at the University of Rochester (N.Y.).

Mental health is sensitive to climate. “Psychiatric patients can be particularly vulnerable to the medical effects of climate change,” Dr. Lewis said. “People with schizophrenia exhibit impaired thermoregulatory functioning, and many of our medications can impair the body’s normal heat regulation.”

The evidence of increased death rates among schizophrenia patients during heat waves has been attributed to this phenomenon as well as to the failure of patients with mental disorders to seek or obtain relief from heat, according to Dr. Lewis, but she noted that many studies have linked spikes in heat to increased aggression and violence. These links are true for the individual, and they affect trends in communities.

As a cause of societal stresses, such as food and water insecurity, climate change also has the very real potential of producing traumatic disruptions commensurate with disasters such as hurricanes or earthquakes. Noting that the rate of PTSD after such natural disasters typically runs at around 30%, Dr. Lewis suggested that psychiatrists might face large challenges from major upheavals induced by climate change.

However, even in the absence of catastrophic consequences, significant psychiatric morbidity may be generated by climate change in the form of “ecoanxieties” or “solastalgia,” a term coined about 10 years ago to describe psychic anxiety induced by environmental change. While many individuals continue to function normally despite fear or anxiety about climate change, Dr. Lewis said that there are many reports in the literature now show that psychoterratic illness, another term for this phenomenon, is associated with degraded or threatened environments linked to climate change.

The Climate Psychiatry Alliance is one of several professional psychiatry groups that is engaged in evaluating how psychiatry as a profession should react to climate change. The Climate Psychiatry committee of the Group for the Advancement of Psychiatry is another. Dr. Lewis, addressing the potential criticism that climate is a political issue, said that “we bring some very particular things to this 21st-century disaster … hopefully, everything I have said about the mental effects of climate change convinces you that it is not just a political problem.”

 

 


It is, however, a problem that is complex. Differentiating complex problems from complicated problems – which can be solved eventually with sufficient information – Dr. Lewis explained that complex problems are dynamic with an interplay between components that make solutions uncertain without experimentation and continual reassessment. She believes both mitigation of the problem and adaption to the inevitability of rising temperatures will be necessary.

This is relevant for psychiatrists who also must adapt to the environmental changes and develop resilience that will help them deal objectively with the mental health consequences of climate change. She noted that environmentalists recognize two traps in approaching solutions to climate change. The first is proposing overly simplistic solutions that fail to address the profound implications of climate change. The second is being rendered inactive by the overwhelming complexity of this growing problem.

Ultimately, Dr. Lewis called for psychiatrists to be proactive in dealing the mental health consequences of climate change. She noted that the APA issued a position statement in 2017, which emphasized that individuals with mental health disorders are disproportionately affected by climate change.

“We as psychiatrists know what it is to deal with complex systems, and we understand through our own work with traumatized patients how to manage patients with trauma responses and how to get empowered and engaged in the rebuilding of realistic lives,” Dr. Lewis said. She believes those skills will be important as the impact of climate change on mental health unfolds.
Publications
Publications
Topics
Article Type
Sections
Article Source
EXPERT ANALYSIS FROM APA
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

VIDEO: Consider unique stressors when treating members of peacekeeping operations

Article Type
Changed
Mon, 05/07/2018 - 13:50

 

– Sustained peacekeeping operations are associated with unique psychological stressors, and understanding of these stressors on the part of both community and military psychiatrists can help make a difference at each stage of a deployment cycle, according to Elspeth Cameron Ritchie, MD.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

During a workshop at the annual meeting of the American Psychiatric Association entitled “War and Peace: Understanding the Psychological Stressors Associated with Sustained Peacekeeping Operations (PKOs),” chaired by Dr. Ritchie of the Uniformed Services University of the Health Sciences, Bethesda, Md., various dimensions of salient psychological stress were discussed, as were approaches for minimizing any resultant impact on the psychological health of peacekeepers.

In this video interview, Dr. Ritchie discussed the differences and similarities between peacekeeping operations and military operations with respect to stressors and their effects, and the risk of posttraumatic stress disorder among peacekeepers.

Although treatment for PTSD is “pretty much the same,” it is important to “tailor the treatment for the situation,” she said.

“Lay out the different options, explain them to the patient, and partner with the patient in terms of what is the best option for them,” she said.

Dr. Ritchie reported having no relevant disclosures.

SOURCE: Ritchie EC et al. APA Workshop

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

– Sustained peacekeeping operations are associated with unique psychological stressors, and understanding of these stressors on the part of both community and military psychiatrists can help make a difference at each stage of a deployment cycle, according to Elspeth Cameron Ritchie, MD.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

During a workshop at the annual meeting of the American Psychiatric Association entitled “War and Peace: Understanding the Psychological Stressors Associated with Sustained Peacekeeping Operations (PKOs),” chaired by Dr. Ritchie of the Uniformed Services University of the Health Sciences, Bethesda, Md., various dimensions of salient psychological stress were discussed, as were approaches for minimizing any resultant impact on the psychological health of peacekeepers.

In this video interview, Dr. Ritchie discussed the differences and similarities between peacekeeping operations and military operations with respect to stressors and their effects, and the risk of posttraumatic stress disorder among peacekeepers.

Although treatment for PTSD is “pretty much the same,” it is important to “tailor the treatment for the situation,” she said.

“Lay out the different options, explain them to the patient, and partner with the patient in terms of what is the best option for them,” she said.

Dr. Ritchie reported having no relevant disclosures.

SOURCE: Ritchie EC et al. APA Workshop

 

– Sustained peacekeeping operations are associated with unique psychological stressors, and understanding of these stressors on the part of both community and military psychiatrists can help make a difference at each stage of a deployment cycle, according to Elspeth Cameron Ritchie, MD.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

During a workshop at the annual meeting of the American Psychiatric Association entitled “War and Peace: Understanding the Psychological Stressors Associated with Sustained Peacekeeping Operations (PKOs),” chaired by Dr. Ritchie of the Uniformed Services University of the Health Sciences, Bethesda, Md., various dimensions of salient psychological stress were discussed, as were approaches for minimizing any resultant impact on the psychological health of peacekeepers.

In this video interview, Dr. Ritchie discussed the differences and similarities between peacekeeping operations and military operations with respect to stressors and their effects, and the risk of posttraumatic stress disorder among peacekeepers.

Although treatment for PTSD is “pretty much the same,” it is important to “tailor the treatment for the situation,” she said.

“Lay out the different options, explain them to the patient, and partner with the patient in terms of what is the best option for them,” she said.

Dr. Ritchie reported having no relevant disclosures.

SOURCE: Ritchie EC et al. APA Workshop

Publications
Publications
Topics
Article Type
Sections
Article Source
REPORTING FROM APA
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Experts explore issues, controversies around medical marijuana use

Article Type
Changed
Thu, 09/20/2018 - 15:11

 

I live and work in Maryland, where medical marijuana dispensaries are just beginning to open. So far, my patients have been content to smoke illegal marijuana, even after my admonishments. Last week, however, a patient who suffers from chronic pain told me that one of her doctors suggested she try medical marijuana. What did I think? The patient is in her 70s, and she has not tolerated opiates. She lives an active life, and she drives. I didn’t know what to think and was left to tell her that I had no experience and would not object if she wanted to try it. The timing was right for “Issues and Controversies Around Marijuana Use: What’s the Buzz?” at the American Psychiatric Association’s annual meeting in New York this week.

Dr. Godfrey Pearlson
The symposium was chaired by Godfrey Pearlson, MD, director of the Olin Neuropsychiatry Research Center, New Haven, Conn., and five speakers gave a comprehensive overview of the research on different aspects of cannabis use. Let me share the take-home message that each speaker made.

William Iacono, PhD, a professor of psychiatry at the University of Minnesota, Minneapolis, started with a session called “Does Adolescent Marijuana Use Cause Cognitive Decline?” Dr. Iacono and all the speakers who followed him pointed out how difficult it is to research these issues. The research is largely retrospective, and the questions are complex. The degree of use is determined by self-report, and there are questions about acute versus chronic use, whether cognitive decline is temporary or permanent, whether the age of initiating drug use is important, and finally, which tests are used to measure cognitive abilities. Dr. Iacono noted that results are inconsistent and mentioned a large population study done in Dunedin, New Zealand, which measured a decrease in verbal IQ and vocabulary measures at age 38 years if the user began smoking cannabis as an adolescent. Dr. Iacono’s twin studies showed that marijuana users scored lower on these measures in childhood, well before they began smoking, and poor academic performance predisposes to marijuana use.

“Adolescents who use cannabis are not the same as those who don’t,” Dr. Iacono said, “and heavy or daily use does not cause cognitive decline in those who begin smoking as adults.”

Dr. Pearlson introduced the second speaker by saying, “It’s easier to get funding to show the ill effects of cannabis than to show medicinal effects.” Sue Sisley, MD, director of Midtown Roots, a medical marijuana dispensary in Phoenix, conducts cannabis trials for the treatment of PTSD in veterans and noted that she has had a long and difficult road with marijuana research, and hers is the only controlled trial on cannabis for PTSD. When her Schedule I license was approved by the Food and Drug Administration, she was able to receive marijuana from the National Institute on Drug Abuse that was grown by the University of Mississippi in Oxford – the only federal growing facility. The marijuana was delivered by FedEx, and the drug was the consistency of talcum powder. It was a challenge to find a lab that could verify the components of the test drug, and when she did, she found the tetrahydrocannabinol content was considerably lower than marijuana sold on the black market. Also, the product contained both mold and lead. “As a physician, how do you hand out mold weed to our veterans?”

Her trials are still in progress, and more veterans are needed. Anecdotally, she says, a decrease has been seen in the use of both opiates and Viagra by the research subjects.

Michael Stevens, PhD, adjunct professor of psychiatry at Yale University, New Haven, Conn., discussed the risk of motor vehicle accidents in marijuana smokers and the logistical issues enforcement poses for law enforcement officials. “There is evidence that marijuana increases the risk for accidents.” Dr. Stevens went on to say that the elevated risk is notably less than that associated with the use of alcohol or stimulants. Studying the effects of marijuana on driving is difficult, as driving simulators do not necessarily reflect on-road experiences, and cognitive testing does not always translate into impairment. “We can’t give marijuana to teens and test them, and you can’t tell people who smoke every day that you’ll check in with them in a few years and check their driving records.”

 

 


In terms of law enforcement issues, roadside sobriety tests have not been validated for marijuana use, and plasma levels of the drug drop within minutes of use. “The alcohol model works well with alcohol, but cannabis is not alcohol.”

Deborah Hasin, PhD, professor of epidemiology (psychiatry) at Columbia University, New York, talked about trends of cannabis use in the United States. “Looking at states before and after legalization, we see that there is an increase in both cannabis use and cannabis disorders in adults.” Adolescents, however, are not smoking more, and rates have not increased in states where marijuana has been legalized for medical or recreational use. “Kids are just not socializing; they are in their bedrooms with their smartphones. Depression is increasing in teens, but substance abuse is not.”

The last speaker was Deepak Cyril D’Souza, MD, a professor of psychiatry at Yale University, who talked about cannabis and psychosis. He defined three distinct relationships: acute transient psychosis that resolves fairly quickly, acute persistent psychosis that takes days or weeks to resolve, and psychotic reactions that are associated with recurrent psychotic symptoms. Studies suggest that those who have a psychotic reaction to marijuana are at elevated risk of being diagnosed with schizophrenia later, and that timing of exposure to marijuana may be important.

Dr. Dinah Miller
In patients with psychotic disorders who are actively being treated with antipsychotics, Dr. D’Souza found that giving tetrahydrocannabinol intravenously increases the symptoms of schizophrenia, even if the patient has the perception that marijuana is helpful. “There was a mismatch between what the patient reported and what we observed.”
 

 


With regard to the important question of whether marijuana causes schizophrenia, Dr. D’Souza noted that “it’s neither a necessary nor sufficient component, but it does appear it hastens psychosis in schizophrenia and earlier symptoms are associated with a worse prognosis.”

I’ll see what happens with my patient. A Canadian physician in the audience noted that he has treated thousands of patients, and most find medical marijuana to be helpful. In our country, marijuana continues to be a controversial topic with strong opinions about its usefulness and a conversation that is limited by our lack of research.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016). She practices in Baltimore.

Publications
Topics
Sections

 

I live and work in Maryland, where medical marijuana dispensaries are just beginning to open. So far, my patients have been content to smoke illegal marijuana, even after my admonishments. Last week, however, a patient who suffers from chronic pain told me that one of her doctors suggested she try medical marijuana. What did I think? The patient is in her 70s, and she has not tolerated opiates. She lives an active life, and she drives. I didn’t know what to think and was left to tell her that I had no experience and would not object if she wanted to try it. The timing was right for “Issues and Controversies Around Marijuana Use: What’s the Buzz?” at the American Psychiatric Association’s annual meeting in New York this week.

Dr. Godfrey Pearlson
The symposium was chaired by Godfrey Pearlson, MD, director of the Olin Neuropsychiatry Research Center, New Haven, Conn., and five speakers gave a comprehensive overview of the research on different aspects of cannabis use. Let me share the take-home message that each speaker made.

William Iacono, PhD, a professor of psychiatry at the University of Minnesota, Minneapolis, started with a session called “Does Adolescent Marijuana Use Cause Cognitive Decline?” Dr. Iacono and all the speakers who followed him pointed out how difficult it is to research these issues. The research is largely retrospective, and the questions are complex. The degree of use is determined by self-report, and there are questions about acute versus chronic use, whether cognitive decline is temporary or permanent, whether the age of initiating drug use is important, and finally, which tests are used to measure cognitive abilities. Dr. Iacono noted that results are inconsistent and mentioned a large population study done in Dunedin, New Zealand, which measured a decrease in verbal IQ and vocabulary measures at age 38 years if the user began smoking cannabis as an adolescent. Dr. Iacono’s twin studies showed that marijuana users scored lower on these measures in childhood, well before they began smoking, and poor academic performance predisposes to marijuana use.

“Adolescents who use cannabis are not the same as those who don’t,” Dr. Iacono said, “and heavy or daily use does not cause cognitive decline in those who begin smoking as adults.”

Dr. Pearlson introduced the second speaker by saying, “It’s easier to get funding to show the ill effects of cannabis than to show medicinal effects.” Sue Sisley, MD, director of Midtown Roots, a medical marijuana dispensary in Phoenix, conducts cannabis trials for the treatment of PTSD in veterans and noted that she has had a long and difficult road with marijuana research, and hers is the only controlled trial on cannabis for PTSD. When her Schedule I license was approved by the Food and Drug Administration, she was able to receive marijuana from the National Institute on Drug Abuse that was grown by the University of Mississippi in Oxford – the only federal growing facility. The marijuana was delivered by FedEx, and the drug was the consistency of talcum powder. It was a challenge to find a lab that could verify the components of the test drug, and when she did, she found the tetrahydrocannabinol content was considerably lower than marijuana sold on the black market. Also, the product contained both mold and lead. “As a physician, how do you hand out mold weed to our veterans?”

Her trials are still in progress, and more veterans are needed. Anecdotally, she says, a decrease has been seen in the use of both opiates and Viagra by the research subjects.

Michael Stevens, PhD, adjunct professor of psychiatry at Yale University, New Haven, Conn., discussed the risk of motor vehicle accidents in marijuana smokers and the logistical issues enforcement poses for law enforcement officials. “There is evidence that marijuana increases the risk for accidents.” Dr. Stevens went on to say that the elevated risk is notably less than that associated with the use of alcohol or stimulants. Studying the effects of marijuana on driving is difficult, as driving simulators do not necessarily reflect on-road experiences, and cognitive testing does not always translate into impairment. “We can’t give marijuana to teens and test them, and you can’t tell people who smoke every day that you’ll check in with them in a few years and check their driving records.”

 

 


In terms of law enforcement issues, roadside sobriety tests have not been validated for marijuana use, and plasma levels of the drug drop within minutes of use. “The alcohol model works well with alcohol, but cannabis is not alcohol.”

Deborah Hasin, PhD, professor of epidemiology (psychiatry) at Columbia University, New York, talked about trends of cannabis use in the United States. “Looking at states before and after legalization, we see that there is an increase in both cannabis use and cannabis disorders in adults.” Adolescents, however, are not smoking more, and rates have not increased in states where marijuana has been legalized for medical or recreational use. “Kids are just not socializing; they are in their bedrooms with their smartphones. Depression is increasing in teens, but substance abuse is not.”

The last speaker was Deepak Cyril D’Souza, MD, a professor of psychiatry at Yale University, who talked about cannabis and psychosis. He defined three distinct relationships: acute transient psychosis that resolves fairly quickly, acute persistent psychosis that takes days or weeks to resolve, and psychotic reactions that are associated with recurrent psychotic symptoms. Studies suggest that those who have a psychotic reaction to marijuana are at elevated risk of being diagnosed with schizophrenia later, and that timing of exposure to marijuana may be important.

Dr. Dinah Miller
In patients with psychotic disorders who are actively being treated with antipsychotics, Dr. D’Souza found that giving tetrahydrocannabinol intravenously increases the symptoms of schizophrenia, even if the patient has the perception that marijuana is helpful. “There was a mismatch between what the patient reported and what we observed.”
 

 


With regard to the important question of whether marijuana causes schizophrenia, Dr. D’Souza noted that “it’s neither a necessary nor sufficient component, but it does appear it hastens psychosis in schizophrenia and earlier symptoms are associated with a worse prognosis.”

I’ll see what happens with my patient. A Canadian physician in the audience noted that he has treated thousands of patients, and most find medical marijuana to be helpful. In our country, marijuana continues to be a controversial topic with strong opinions about its usefulness and a conversation that is limited by our lack of research.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016). She practices in Baltimore.

 

I live and work in Maryland, where medical marijuana dispensaries are just beginning to open. So far, my patients have been content to smoke illegal marijuana, even after my admonishments. Last week, however, a patient who suffers from chronic pain told me that one of her doctors suggested she try medical marijuana. What did I think? The patient is in her 70s, and she has not tolerated opiates. She lives an active life, and she drives. I didn’t know what to think and was left to tell her that I had no experience and would not object if she wanted to try it. The timing was right for “Issues and Controversies Around Marijuana Use: What’s the Buzz?” at the American Psychiatric Association’s annual meeting in New York this week.

Dr. Godfrey Pearlson
The symposium was chaired by Godfrey Pearlson, MD, director of the Olin Neuropsychiatry Research Center, New Haven, Conn., and five speakers gave a comprehensive overview of the research on different aspects of cannabis use. Let me share the take-home message that each speaker made.

William Iacono, PhD, a professor of psychiatry at the University of Minnesota, Minneapolis, started with a session called “Does Adolescent Marijuana Use Cause Cognitive Decline?” Dr. Iacono and all the speakers who followed him pointed out how difficult it is to research these issues. The research is largely retrospective, and the questions are complex. The degree of use is determined by self-report, and there are questions about acute versus chronic use, whether cognitive decline is temporary or permanent, whether the age of initiating drug use is important, and finally, which tests are used to measure cognitive abilities. Dr. Iacono noted that results are inconsistent and mentioned a large population study done in Dunedin, New Zealand, which measured a decrease in verbal IQ and vocabulary measures at age 38 years if the user began smoking cannabis as an adolescent. Dr. Iacono’s twin studies showed that marijuana users scored lower on these measures in childhood, well before they began smoking, and poor academic performance predisposes to marijuana use.

“Adolescents who use cannabis are not the same as those who don’t,” Dr. Iacono said, “and heavy or daily use does not cause cognitive decline in those who begin smoking as adults.”

Dr. Pearlson introduced the second speaker by saying, “It’s easier to get funding to show the ill effects of cannabis than to show medicinal effects.” Sue Sisley, MD, director of Midtown Roots, a medical marijuana dispensary in Phoenix, conducts cannabis trials for the treatment of PTSD in veterans and noted that she has had a long and difficult road with marijuana research, and hers is the only controlled trial on cannabis for PTSD. When her Schedule I license was approved by the Food and Drug Administration, she was able to receive marijuana from the National Institute on Drug Abuse that was grown by the University of Mississippi in Oxford – the only federal growing facility. The marijuana was delivered by FedEx, and the drug was the consistency of talcum powder. It was a challenge to find a lab that could verify the components of the test drug, and when she did, she found the tetrahydrocannabinol content was considerably lower than marijuana sold on the black market. Also, the product contained both mold and lead. “As a physician, how do you hand out mold weed to our veterans?”

Her trials are still in progress, and more veterans are needed. Anecdotally, she says, a decrease has been seen in the use of both opiates and Viagra by the research subjects.

Michael Stevens, PhD, adjunct professor of psychiatry at Yale University, New Haven, Conn., discussed the risk of motor vehicle accidents in marijuana smokers and the logistical issues enforcement poses for law enforcement officials. “There is evidence that marijuana increases the risk for accidents.” Dr. Stevens went on to say that the elevated risk is notably less than that associated with the use of alcohol or stimulants. Studying the effects of marijuana on driving is difficult, as driving simulators do not necessarily reflect on-road experiences, and cognitive testing does not always translate into impairment. “We can’t give marijuana to teens and test them, and you can’t tell people who smoke every day that you’ll check in with them in a few years and check their driving records.”

 

 


In terms of law enforcement issues, roadside sobriety tests have not been validated for marijuana use, and plasma levels of the drug drop within minutes of use. “The alcohol model works well with alcohol, but cannabis is not alcohol.”

Deborah Hasin, PhD, professor of epidemiology (psychiatry) at Columbia University, New York, talked about trends of cannabis use in the United States. “Looking at states before and after legalization, we see that there is an increase in both cannabis use and cannabis disorders in adults.” Adolescents, however, are not smoking more, and rates have not increased in states where marijuana has been legalized for medical or recreational use. “Kids are just not socializing; they are in their bedrooms with their smartphones. Depression is increasing in teens, but substance abuse is not.”

The last speaker was Deepak Cyril D’Souza, MD, a professor of psychiatry at Yale University, who talked about cannabis and psychosis. He defined three distinct relationships: acute transient psychosis that resolves fairly quickly, acute persistent psychosis that takes days or weeks to resolve, and psychotic reactions that are associated with recurrent psychotic symptoms. Studies suggest that those who have a psychotic reaction to marijuana are at elevated risk of being diagnosed with schizophrenia later, and that timing of exposure to marijuana may be important.

Dr. Dinah Miller
In patients with psychotic disorders who are actively being treated with antipsychotics, Dr. D’Souza found that giving tetrahydrocannabinol intravenously increases the symptoms of schizophrenia, even if the patient has the perception that marijuana is helpful. “There was a mismatch between what the patient reported and what we observed.”
 

 


With regard to the important question of whether marijuana causes schizophrenia, Dr. D’Souza noted that “it’s neither a necessary nor sufficient component, but it does appear it hastens psychosis in schizophrenia and earlier symptoms are associated with a worse prognosis.”

I’ll see what happens with my patient. A Canadian physician in the audience noted that he has treated thousands of patients, and most find medical marijuana to be helpful. In our country, marijuana continues to be a controversial topic with strong opinions about its usefulness and a conversation that is limited by our lack of research.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016). She practices in Baltimore.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Off-label prescribing of SGAs in children varies by diagnosis

Article Type
Changed
Fri, 01/18/2019 - 17:38

 

– On-label prescribing of second-generation antipsychotics in hospitalized pediatric patients with bipolar disorder and schizophrenia was greater than off-label prescribing, but not for patients with autism spectrum disorder, results from a single-center study showed.

“There is an increasing trend for using second-generation antipsychotics (SGAs) in children,” lead study author Debra V. McQuade, MD, PhD, said in an interview in advance of the Pediatric Academic Societies meeting. “This trend has already been widely acknowledged as concerning, due to the relatively high adverse event burden associated with them. Also, and perhaps more concerning, the great majority of these prescriptions are prescribed as ‘off-label’ (without Food and Drug Administration approval or indication). This is true in all settings, whether outpatient or inpatient. And, this off-label use is really high – usually reported as 60%-95% of all SGA prescriptions to children. We wanted to understand more about this practice of off-label prescribing of SGAs to children – to understand what drives it, to see if there were any organizing principles that might help to better explain it.”

A child is shown in a hospital bed, along with an IV drip
©drpnncpp/thinkstockphotos.com
Dr. McQuade, of the division of pediatric psychiatry and behavioral health at the University of Utah, Salt Lake City, and her associates retrospectively reviewed data for 86 inpatients hospitalized at Primary Children’s Hospital Wasatch Canyons Behavioral Health Campus, also in Salt Lake City, in 2015 with a diagnosis of autism spectrum disorder, bipolar disorder, or schizophrenia, and who were prescribed an SGA. The medications were identified as on-label (full psychiatric indication for children and adolescents) or off-label (no full psychiatric indication for children and adolescents) based upon the patients’ diagnoses and age. Next, the researchers calculated the frequency and percentage of on-label and off-label prescriptions overall and for the three diagnostic groups.

Dr. McQuade and her associates found that for the three diagnostic groups overall, on-label prescribing of SGAs was greater than off-label prescribing (65% vs. 35%, respectively; P less than .001). Prescriptions for patients with bipolar disorder and schizophrenia followed this pattern, with on-label and off-label prescribing rates of 73% vs. 27%, for bipolar disorder, and 85% vs. 14% for schizophrenia. However, this prescription pattern was reversed for patients with autism spectrum disorder (35% vs. 64%; P less than .001), a finding that the researchers did not expect.

Dr. Debra V. McQuade
“Although we entertained several hypotheses about why this might be so, the reasons for this remain unclear,” Dr. McQuade said. “Our study was not designed to explain this question directly, and our post hoc review of available data did not reveal any meaningful patterns. This is left as an open question for further research.”

She said that while off-label prescribing of SGAs to pediatric patients remains widespread and is a concerning trend, the study findings suggested that prescribers “do select and prescribe SGAs in ways that are directly or indirectly influenced by FDA guidelines, mitigating risk to their pediatric patients.” Dr. McQuade acknowledged certain weaknesses of the study, including the fact that it was limited to one hospital setting and by the small number of prescribers who contributed to the overall pool of data.

She reported having no relevant financial disclosures.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

– On-label prescribing of second-generation antipsychotics in hospitalized pediatric patients with bipolar disorder and schizophrenia was greater than off-label prescribing, but not for patients with autism spectrum disorder, results from a single-center study showed.

“There is an increasing trend for using second-generation antipsychotics (SGAs) in children,” lead study author Debra V. McQuade, MD, PhD, said in an interview in advance of the Pediatric Academic Societies meeting. “This trend has already been widely acknowledged as concerning, due to the relatively high adverse event burden associated with them. Also, and perhaps more concerning, the great majority of these prescriptions are prescribed as ‘off-label’ (without Food and Drug Administration approval or indication). This is true in all settings, whether outpatient or inpatient. And, this off-label use is really high – usually reported as 60%-95% of all SGA prescriptions to children. We wanted to understand more about this practice of off-label prescribing of SGAs to children – to understand what drives it, to see if there were any organizing principles that might help to better explain it.”

A child is shown in a hospital bed, along with an IV drip
©drpnncpp/thinkstockphotos.com
Dr. McQuade, of the division of pediatric psychiatry and behavioral health at the University of Utah, Salt Lake City, and her associates retrospectively reviewed data for 86 inpatients hospitalized at Primary Children’s Hospital Wasatch Canyons Behavioral Health Campus, also in Salt Lake City, in 2015 with a diagnosis of autism spectrum disorder, bipolar disorder, or schizophrenia, and who were prescribed an SGA. The medications were identified as on-label (full psychiatric indication for children and adolescents) or off-label (no full psychiatric indication for children and adolescents) based upon the patients’ diagnoses and age. Next, the researchers calculated the frequency and percentage of on-label and off-label prescriptions overall and for the three diagnostic groups.

Dr. McQuade and her associates found that for the three diagnostic groups overall, on-label prescribing of SGAs was greater than off-label prescribing (65% vs. 35%, respectively; P less than .001). Prescriptions for patients with bipolar disorder and schizophrenia followed this pattern, with on-label and off-label prescribing rates of 73% vs. 27%, for bipolar disorder, and 85% vs. 14% for schizophrenia. However, this prescription pattern was reversed for patients with autism spectrum disorder (35% vs. 64%; P less than .001), a finding that the researchers did not expect.

Dr. Debra V. McQuade
“Although we entertained several hypotheses about why this might be so, the reasons for this remain unclear,” Dr. McQuade said. “Our study was not designed to explain this question directly, and our post hoc review of available data did not reveal any meaningful patterns. This is left as an open question for further research.”

She said that while off-label prescribing of SGAs to pediatric patients remains widespread and is a concerning trend, the study findings suggested that prescribers “do select and prescribe SGAs in ways that are directly or indirectly influenced by FDA guidelines, mitigating risk to their pediatric patients.” Dr. McQuade acknowledged certain weaknesses of the study, including the fact that it was limited to one hospital setting and by the small number of prescribers who contributed to the overall pool of data.

She reported having no relevant financial disclosures.

 

– On-label prescribing of second-generation antipsychotics in hospitalized pediatric patients with bipolar disorder and schizophrenia was greater than off-label prescribing, but not for patients with autism spectrum disorder, results from a single-center study showed.

“There is an increasing trend for using second-generation antipsychotics (SGAs) in children,” lead study author Debra V. McQuade, MD, PhD, said in an interview in advance of the Pediatric Academic Societies meeting. “This trend has already been widely acknowledged as concerning, due to the relatively high adverse event burden associated with them. Also, and perhaps more concerning, the great majority of these prescriptions are prescribed as ‘off-label’ (without Food and Drug Administration approval or indication). This is true in all settings, whether outpatient or inpatient. And, this off-label use is really high – usually reported as 60%-95% of all SGA prescriptions to children. We wanted to understand more about this practice of off-label prescribing of SGAs to children – to understand what drives it, to see if there were any organizing principles that might help to better explain it.”

A child is shown in a hospital bed, along with an IV drip
©drpnncpp/thinkstockphotos.com
Dr. McQuade, of the division of pediatric psychiatry and behavioral health at the University of Utah, Salt Lake City, and her associates retrospectively reviewed data for 86 inpatients hospitalized at Primary Children’s Hospital Wasatch Canyons Behavioral Health Campus, also in Salt Lake City, in 2015 with a diagnosis of autism spectrum disorder, bipolar disorder, or schizophrenia, and who were prescribed an SGA. The medications were identified as on-label (full psychiatric indication for children and adolescents) or off-label (no full psychiatric indication for children and adolescents) based upon the patients’ diagnoses and age. Next, the researchers calculated the frequency and percentage of on-label and off-label prescriptions overall and for the three diagnostic groups.

Dr. McQuade and her associates found that for the three diagnostic groups overall, on-label prescribing of SGAs was greater than off-label prescribing (65% vs. 35%, respectively; P less than .001). Prescriptions for patients with bipolar disorder and schizophrenia followed this pattern, with on-label and off-label prescribing rates of 73% vs. 27%, for bipolar disorder, and 85% vs. 14% for schizophrenia. However, this prescription pattern was reversed for patients with autism spectrum disorder (35% vs. 64%; P less than .001), a finding that the researchers did not expect.

Dr. Debra V. McQuade
“Although we entertained several hypotheses about why this might be so, the reasons for this remain unclear,” Dr. McQuade said. “Our study was not designed to explain this question directly, and our post hoc review of available data did not reveal any meaningful patterns. This is left as an open question for further research.”

She said that while off-label prescribing of SGAs to pediatric patients remains widespread and is a concerning trend, the study findings suggested that prescribers “do select and prescribe SGAs in ways that are directly or indirectly influenced by FDA guidelines, mitigating risk to their pediatric patients.” Dr. McQuade acknowledged certain weaknesses of the study, including the fact that it was limited to one hospital setting and by the small number of prescribers who contributed to the overall pool of data.

She reported having no relevant financial disclosures.

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source
REPORTING FROM PAS 2018
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Off-label prescribing of second-generation antipsychotics varies by diagnosis.

Major finding: Overall, on-label prescribing of SGAs was greater than off-label prescribing (65% vs. 35%, respectively; P less than .001), but this prescription pattern did not hold true for patients with autism spectrum disorder.

Study details: A retrospective review of 86 hospitalized pediatric inpatients with a diagnosis of autism spectrum disorder, bipolar disorder, or schizophrenia.

Disclosures: Dr. McQuade reported having no financial disclosures.

Disqus Comments
Default
Use ProPublica

Celiac disease: Can biopsy be avoided?

Article Type
Changed
Thu, 06/28/2018 - 20:40

– It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.

“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.

Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.

In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.

Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.

Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.

“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.

 

 


The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).

Andrew D. Bowser/MDedge News
Dr. Joseph A. Murray

“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”

However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.

Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.

AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.  

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

– It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.

“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.

Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.

In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.

Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.

Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.

“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.

 

 


The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).

Andrew D. Bowser/MDedge News
Dr. Joseph A. Murray

“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”

However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.

Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.

AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.  

– It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.

“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.

Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.

In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.

Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.

Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.

“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.

 

 


The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).

Andrew D. Bowser/MDedge News
Dr. Joseph A. Murray

“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”

However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.

Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.

AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.  

Publications
Publications
Topics
Article Type
Sections
Article Source
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica