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Manufactured graft deemed safe in blood cancer patients
LISBON—Phase 1 results suggest a programmed cellular therapy is safe for use in patients with hematologic malignancies.
The therapy, ProTmune, is being developed as a next-generation allogeneic graft intended to reduce the incidence and severity of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplant (HSCT).
Three of 7 patients who received ProTmune in this trial did develop acute GVHD, and 2 patients died.
However, the remaining 5 patients were still alive and disease-free at last follow-up.
There were no serious adverse events (AEs) attributed to ProTmune. The most common AEs were nausea, vomiting, and chest pain.
These results were presented at the 44th Annual Meeting of the EBMT (abstract A401*).
The trial, known as PROTECT, is sponsored by Fate Therapeutics, the company developing ProTmune.
The phase 1 portion of PROTECT enrolled 7 adults with hematologic malignancies—1 with myelodysplastic syndrome, 3 with acute lymphoblastic leukemia, and 3 with acute myeloid leukemia.
Patients were set to undergo matched, unrelated donor HSCT and received ProTmune as the graft. ProTmune is manufactured by modulating a mobilized peripheral blood graft with 2 small molecules, FT1050 and FT4145.
The patients ranged in age from 34 to 69, and most (n=5) were female. For conditioning, patients received fludarabine/busulfan (n=1), busulfan/cyclophosphamide (n=1), fludarabine/melphalan (n=3), or cyclophosphamide/total body irradiation (n=2).
Results
The data cut-off was February 26, 2018. The median time on study was 228 days (range, 151 to 353).
None of the patients had graft failure. The median time to neutrophil engraftment was 18 days (range, 14 to 22).
Three patients had acute GVHD at day 100 after HSCT. Two patients had grade 2 skin GVHD, and 1 had grade 3 GVHD in the skin and gut.
All 3 patients responded to steroid treatment. GVHD resolved in 5 days for the patient with grade 3 GVHD. For the grade 2 patients, GVHD resolved in 7 days and 8 days, respectively.
None of the patients relapsed, but 2 died—1 of pulmonary edema and 1 of atrial fibrillation.
AEs related to ProTmune included grade 1 vomiting (n=2), grade 2 nausea (n=2), and grade 2 chest pain (n=1).
Phase 2
The phase 2 portion of PROTECT is ongoing. This is a randomized, controlled, double-blinded trial designed to assess the safety and efficacy of ProTmune in up to 60 adults with hematologic malignancies undergoing matched, unrelated donor HSCT following myeloablative conditioning.
Patients are being randomized, in a 1:1 ratio, to receive either ProTmune or a conventional, mobilized peripheral blood cell graft from a matched, unrelated donor.
The primary efficacy endpoint is the cumulative incidence of grade 2-4 acute GVHD by day 100 post-HSCT. Rates of chronic GVHD, cancer relapse, disease-free survival, and overall survival are also being assessed.
*Some data in the abstract differ from the presentation.
LISBON—Phase 1 results suggest a programmed cellular therapy is safe for use in patients with hematologic malignancies.
The therapy, ProTmune, is being developed as a next-generation allogeneic graft intended to reduce the incidence and severity of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplant (HSCT).
Three of 7 patients who received ProTmune in this trial did develop acute GVHD, and 2 patients died.
However, the remaining 5 patients were still alive and disease-free at last follow-up.
There were no serious adverse events (AEs) attributed to ProTmune. The most common AEs were nausea, vomiting, and chest pain.
These results were presented at the 44th Annual Meeting of the EBMT (abstract A401*).
The trial, known as PROTECT, is sponsored by Fate Therapeutics, the company developing ProTmune.
The phase 1 portion of PROTECT enrolled 7 adults with hematologic malignancies—1 with myelodysplastic syndrome, 3 with acute lymphoblastic leukemia, and 3 with acute myeloid leukemia.
Patients were set to undergo matched, unrelated donor HSCT and received ProTmune as the graft. ProTmune is manufactured by modulating a mobilized peripheral blood graft with 2 small molecules, FT1050 and FT4145.
The patients ranged in age from 34 to 69, and most (n=5) were female. For conditioning, patients received fludarabine/busulfan (n=1), busulfan/cyclophosphamide (n=1), fludarabine/melphalan (n=3), or cyclophosphamide/total body irradiation (n=2).
Results
The data cut-off was February 26, 2018. The median time on study was 228 days (range, 151 to 353).
None of the patients had graft failure. The median time to neutrophil engraftment was 18 days (range, 14 to 22).
Three patients had acute GVHD at day 100 after HSCT. Two patients had grade 2 skin GVHD, and 1 had grade 3 GVHD in the skin and gut.
All 3 patients responded to steroid treatment. GVHD resolved in 5 days for the patient with grade 3 GVHD. For the grade 2 patients, GVHD resolved in 7 days and 8 days, respectively.
None of the patients relapsed, but 2 died—1 of pulmonary edema and 1 of atrial fibrillation.
AEs related to ProTmune included grade 1 vomiting (n=2), grade 2 nausea (n=2), and grade 2 chest pain (n=1).
Phase 2
The phase 2 portion of PROTECT is ongoing. This is a randomized, controlled, double-blinded trial designed to assess the safety and efficacy of ProTmune in up to 60 adults with hematologic malignancies undergoing matched, unrelated donor HSCT following myeloablative conditioning.
Patients are being randomized, in a 1:1 ratio, to receive either ProTmune or a conventional, mobilized peripheral blood cell graft from a matched, unrelated donor.
The primary efficacy endpoint is the cumulative incidence of grade 2-4 acute GVHD by day 100 post-HSCT. Rates of chronic GVHD, cancer relapse, disease-free survival, and overall survival are also being assessed.
*Some data in the abstract differ from the presentation.
LISBON—Phase 1 results suggest a programmed cellular therapy is safe for use in patients with hematologic malignancies.
The therapy, ProTmune, is being developed as a next-generation allogeneic graft intended to reduce the incidence and severity of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplant (HSCT).
Three of 7 patients who received ProTmune in this trial did develop acute GVHD, and 2 patients died.
However, the remaining 5 patients were still alive and disease-free at last follow-up.
There were no serious adverse events (AEs) attributed to ProTmune. The most common AEs were nausea, vomiting, and chest pain.
These results were presented at the 44th Annual Meeting of the EBMT (abstract A401*).
The trial, known as PROTECT, is sponsored by Fate Therapeutics, the company developing ProTmune.
The phase 1 portion of PROTECT enrolled 7 adults with hematologic malignancies—1 with myelodysplastic syndrome, 3 with acute lymphoblastic leukemia, and 3 with acute myeloid leukemia.
Patients were set to undergo matched, unrelated donor HSCT and received ProTmune as the graft. ProTmune is manufactured by modulating a mobilized peripheral blood graft with 2 small molecules, FT1050 and FT4145.
The patients ranged in age from 34 to 69, and most (n=5) were female. For conditioning, patients received fludarabine/busulfan (n=1), busulfan/cyclophosphamide (n=1), fludarabine/melphalan (n=3), or cyclophosphamide/total body irradiation (n=2).
Results
The data cut-off was February 26, 2018. The median time on study was 228 days (range, 151 to 353).
None of the patients had graft failure. The median time to neutrophil engraftment was 18 days (range, 14 to 22).
Three patients had acute GVHD at day 100 after HSCT. Two patients had grade 2 skin GVHD, and 1 had grade 3 GVHD in the skin and gut.
All 3 patients responded to steroid treatment. GVHD resolved in 5 days for the patient with grade 3 GVHD. For the grade 2 patients, GVHD resolved in 7 days and 8 days, respectively.
None of the patients relapsed, but 2 died—1 of pulmonary edema and 1 of atrial fibrillation.
AEs related to ProTmune included grade 1 vomiting (n=2), grade 2 nausea (n=2), and grade 2 chest pain (n=1).
Phase 2
The phase 2 portion of PROTECT is ongoing. This is a randomized, controlled, double-blinded trial designed to assess the safety and efficacy of ProTmune in up to 60 adults with hematologic malignancies undergoing matched, unrelated donor HSCT following myeloablative conditioning.
Patients are being randomized, in a 1:1 ratio, to receive either ProTmune or a conventional, mobilized peripheral blood cell graft from a matched, unrelated donor.
The primary efficacy endpoint is the cumulative incidence of grade 2-4 acute GVHD by day 100 post-HSCT. Rates of chronic GVHD, cancer relapse, disease-free survival, and overall survival are also being assessed.
*Some data in the abstract differ from the presentation.
Severe anemia in pregnancy may double risk of death
Pregnant women with severe anemia are twice as likely as those without it to die during or shortly after pregnancy, according to research published in The Lancet Global Health.
Previous studies suggested anemia was strongly associated with death, but this was due to other clinical reasons.
For the current study, researchers took into account factors that influence the development of anemia in pregnancy (such as blood loss or malaria infection) and still found a significant association between anemia and death.
“Anemia in pregnancy is one of the most common medical problems pregnant women encounter, both in low- and high-income countries,” said study author Jahnavi Daru, MBBS, from Queen Mary University of London in the UK.
“We’ve now shown that, if a woman develops severe anemia at any point in her pregnancy or in the 7 days after delivery, she is at a higher risk of dying, making urgent treatment even more important.”
To make this discovery, Dr Daru and her colleagues analyzed World Health Organization data on 312,281 pregnancies in 29 countries* across Latin America, Africa, the Western Pacific region, the Eastern Mediterranean, and South East Asia.
There were 4687 cases of severe anemia (a blood count of less than 70 g/L) and 341 deaths in this group. Deaths were included if they occurred any time after hospital admission until the seventh day post-partum or post-discharge.
The researchers matched 4189 of the women with severe anemia to 8218 women without severe anemia and found a significantly increased risk of death among the women with anemia, both in a crude analysis and an analysis adjusted for potential confounding variables.
In the crude analysis, the odds ratio (OR) for death was 43.35 for women with severe anemia (P<0.0001). In the adjusted analysis, the OR was 2.36 (P<0.0001).
The researchers also conducted a propensity score analysis, matching women with severe anemia to their non-anemic counterparts 1:2. In this analysis, the OR for death was 1.86 (P<0.0001) for the women with severe anemia.
“Anemia is a readily treatable condition, but the existing approaches so far have not been able to tackle the problem,” Dr Daru pointed out. “Clinicians, policy makers, and healthcare professionals should now focus their attention on preventing anemia using a multifaceted approach, not just hoping that iron tablets will solve the problem.”
* The countries included were Afghanistan, Angola, Argentina, Brazil, Cambodia, China, Democratic Republic of the Congo, Ecuador, India, Japan, Jordan, Kenya, Lebanon, Mexico, Mongolia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Qatar, Sri Lanka, Thailand, Uganda, and Vietnam.
Pregnant women with severe anemia are twice as likely as those without it to die during or shortly after pregnancy, according to research published in The Lancet Global Health.
Previous studies suggested anemia was strongly associated with death, but this was due to other clinical reasons.
For the current study, researchers took into account factors that influence the development of anemia in pregnancy (such as blood loss or malaria infection) and still found a significant association between anemia and death.
“Anemia in pregnancy is one of the most common medical problems pregnant women encounter, both in low- and high-income countries,” said study author Jahnavi Daru, MBBS, from Queen Mary University of London in the UK.
“We’ve now shown that, if a woman develops severe anemia at any point in her pregnancy or in the 7 days after delivery, she is at a higher risk of dying, making urgent treatment even more important.”
To make this discovery, Dr Daru and her colleagues analyzed World Health Organization data on 312,281 pregnancies in 29 countries* across Latin America, Africa, the Western Pacific region, the Eastern Mediterranean, and South East Asia.
There were 4687 cases of severe anemia (a blood count of less than 70 g/L) and 341 deaths in this group. Deaths were included if they occurred any time after hospital admission until the seventh day post-partum or post-discharge.
The researchers matched 4189 of the women with severe anemia to 8218 women without severe anemia and found a significantly increased risk of death among the women with anemia, both in a crude analysis and an analysis adjusted for potential confounding variables.
In the crude analysis, the odds ratio (OR) for death was 43.35 for women with severe anemia (P<0.0001). In the adjusted analysis, the OR was 2.36 (P<0.0001).
The researchers also conducted a propensity score analysis, matching women with severe anemia to their non-anemic counterparts 1:2. In this analysis, the OR for death was 1.86 (P<0.0001) for the women with severe anemia.
“Anemia is a readily treatable condition, but the existing approaches so far have not been able to tackle the problem,” Dr Daru pointed out. “Clinicians, policy makers, and healthcare professionals should now focus their attention on preventing anemia using a multifaceted approach, not just hoping that iron tablets will solve the problem.”
* The countries included were Afghanistan, Angola, Argentina, Brazil, Cambodia, China, Democratic Republic of the Congo, Ecuador, India, Japan, Jordan, Kenya, Lebanon, Mexico, Mongolia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Qatar, Sri Lanka, Thailand, Uganda, and Vietnam.
Pregnant women with severe anemia are twice as likely as those without it to die during or shortly after pregnancy, according to research published in The Lancet Global Health.
Previous studies suggested anemia was strongly associated with death, but this was due to other clinical reasons.
For the current study, researchers took into account factors that influence the development of anemia in pregnancy (such as blood loss or malaria infection) and still found a significant association between anemia and death.
“Anemia in pregnancy is one of the most common medical problems pregnant women encounter, both in low- and high-income countries,” said study author Jahnavi Daru, MBBS, from Queen Mary University of London in the UK.
“We’ve now shown that, if a woman develops severe anemia at any point in her pregnancy or in the 7 days after delivery, she is at a higher risk of dying, making urgent treatment even more important.”
To make this discovery, Dr Daru and her colleagues analyzed World Health Organization data on 312,281 pregnancies in 29 countries* across Latin America, Africa, the Western Pacific region, the Eastern Mediterranean, and South East Asia.
There were 4687 cases of severe anemia (a blood count of less than 70 g/L) and 341 deaths in this group. Deaths were included if they occurred any time after hospital admission until the seventh day post-partum or post-discharge.
The researchers matched 4189 of the women with severe anemia to 8218 women without severe anemia and found a significantly increased risk of death among the women with anemia, both in a crude analysis and an analysis adjusted for potential confounding variables.
In the crude analysis, the odds ratio (OR) for death was 43.35 for women with severe anemia (P<0.0001). In the adjusted analysis, the OR was 2.36 (P<0.0001).
The researchers also conducted a propensity score analysis, matching women with severe anemia to their non-anemic counterparts 1:2. In this analysis, the OR for death was 1.86 (P<0.0001) for the women with severe anemia.
“Anemia is a readily treatable condition, but the existing approaches so far have not been able to tackle the problem,” Dr Daru pointed out. “Clinicians, policy makers, and healthcare professionals should now focus their attention on preventing anemia using a multifaceted approach, not just hoping that iron tablets will solve the problem.”
* The countries included were Afghanistan, Angola, Argentina, Brazil, Cambodia, China, Democratic Republic of the Congo, Ecuador, India, Japan, Jordan, Kenya, Lebanon, Mexico, Mongolia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Qatar, Sri Lanka, Thailand, Uganda, and Vietnam.
Drug receives orphan designation for CTCL
The US Food and Drug Administration (FDA) has granted orphan drug designation to TTI-621 for the treatment of cutaneous T-cell lymphoma (CTCL).
TTI-621 is designed to activate the innate immune system by blocking the activity of CD47, a protein commonly found on the surface of cancer cells.
TTI-621 is a SIRPaFc fusion protein that consists of the CD47-binding domain of human SIRPa linked to the Fc region of a human immunoglobulin.
The drug is intended to act as a soluble decoy receptor, preventing CD47 from delivering its inhibitory signal, thereby enabling the activation of macrophage anti-tumor effects by pro-phagocytic signals.
TTI-621 is under investigation in a phase 1 trial of patients with relapsed/refractory solid tumors and CTCL (NCT02890368). Results from the dose-escalation portion of this study were presented at the 2017 ASH Annual Meeting (abstract 4076*).
The dose-escalation portion had a 3+3 design. TTI-621 was first given as a single intratumoral injection at 1 mg, 3 mg, or 10 mg. Then, it was given at 10 mg on Monday, Wednesday, and Friday for 1 week. Next, it was given on the same 3-day schedule for 2 weeks.
Results were reported for 18 patients, 56% of whom were male. They had a median age of 69 (range, 32-85) and a median number of 3 prior therapies (range, 1-16), including radiation (39%).
Eleven patients had CTCL, and 10 were evaluable. Researchers said they observed “rapid decreases in circulating Sézary cells and/or the size of mycosis fungoides tumors” after treatment with TTI-621.
Nine of the 10 patients had a reduction in CAILS score from baseline, and 3 had a reduction in circulating Sézary cells.
There were no dose-limiting toxicities, so the 10 mg dose given 3 times a week for 2 weeks was considered the optimal dose schedule.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
*Data in the abstract differ from the presentation.
The US Food and Drug Administration (FDA) has granted orphan drug designation to TTI-621 for the treatment of cutaneous T-cell lymphoma (CTCL).
TTI-621 is designed to activate the innate immune system by blocking the activity of CD47, a protein commonly found on the surface of cancer cells.
TTI-621 is a SIRPaFc fusion protein that consists of the CD47-binding domain of human SIRPa linked to the Fc region of a human immunoglobulin.
The drug is intended to act as a soluble decoy receptor, preventing CD47 from delivering its inhibitory signal, thereby enabling the activation of macrophage anti-tumor effects by pro-phagocytic signals.
TTI-621 is under investigation in a phase 1 trial of patients with relapsed/refractory solid tumors and CTCL (NCT02890368). Results from the dose-escalation portion of this study were presented at the 2017 ASH Annual Meeting (abstract 4076*).
The dose-escalation portion had a 3+3 design. TTI-621 was first given as a single intratumoral injection at 1 mg, 3 mg, or 10 mg. Then, it was given at 10 mg on Monday, Wednesday, and Friday for 1 week. Next, it was given on the same 3-day schedule for 2 weeks.
Results were reported for 18 patients, 56% of whom were male. They had a median age of 69 (range, 32-85) and a median number of 3 prior therapies (range, 1-16), including radiation (39%).
Eleven patients had CTCL, and 10 were evaluable. Researchers said they observed “rapid decreases in circulating Sézary cells and/or the size of mycosis fungoides tumors” after treatment with TTI-621.
Nine of the 10 patients had a reduction in CAILS score from baseline, and 3 had a reduction in circulating Sézary cells.
There were no dose-limiting toxicities, so the 10 mg dose given 3 times a week for 2 weeks was considered the optimal dose schedule.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
*Data in the abstract differ from the presentation.
The US Food and Drug Administration (FDA) has granted orphan drug designation to TTI-621 for the treatment of cutaneous T-cell lymphoma (CTCL).
TTI-621 is designed to activate the innate immune system by blocking the activity of CD47, a protein commonly found on the surface of cancer cells.
TTI-621 is a SIRPaFc fusion protein that consists of the CD47-binding domain of human SIRPa linked to the Fc region of a human immunoglobulin.
The drug is intended to act as a soluble decoy receptor, preventing CD47 from delivering its inhibitory signal, thereby enabling the activation of macrophage anti-tumor effects by pro-phagocytic signals.
TTI-621 is under investigation in a phase 1 trial of patients with relapsed/refractory solid tumors and CTCL (NCT02890368). Results from the dose-escalation portion of this study were presented at the 2017 ASH Annual Meeting (abstract 4076*).
The dose-escalation portion had a 3+3 design. TTI-621 was first given as a single intratumoral injection at 1 mg, 3 mg, or 10 mg. Then, it was given at 10 mg on Monday, Wednesday, and Friday for 1 week. Next, it was given on the same 3-day schedule for 2 weeks.
Results were reported for 18 patients, 56% of whom were male. They had a median age of 69 (range, 32-85) and a median number of 3 prior therapies (range, 1-16), including radiation (39%).
Eleven patients had CTCL, and 10 were evaluable. Researchers said they observed “rapid decreases in circulating Sézary cells and/or the size of mycosis fungoides tumors” after treatment with TTI-621.
Nine of the 10 patients had a reduction in CAILS score from baseline, and 3 had a reduction in circulating Sézary cells.
There were no dose-limiting toxicities, so the 10 mg dose given 3 times a week for 2 weeks was considered the optimal dose schedule.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
*Data in the abstract differ from the presentation.
FDA approves new option in Hodgkin lymphoma treatment
The Food and Drug Administration has approved brentuximab vedotin, in combination with chemotherapy, for previously untreated adults with stage III or IV classical Hodgkin lymphoma.
The drug, which is marketed by Seattle Genetics as Adcetris, is already approved in classical Hodgkin lymphoma after relapse and after stem cell transplant when the patient is at risk of relapse or progression. The drug is also approved to treat both systemic anaplastic large cell lymphoma (ALCL) and primary cutaneous ALCL after failure on other treatments.
The modified 2-year progression-free survival in the trial was 82.1% for patients receiving brentuximab plus AVD versus 77.2% for ABVD (P = .03), a 23% relative risk reduction (N Engl J Med. 2018;378:331-44).
Common side effects of brentuximab vedotin include neutropenia, anemia, peripheral neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and pyrexia. The drug carries a boxed warning highlighting the risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy.
The Food and Drug Administration has approved brentuximab vedotin, in combination with chemotherapy, for previously untreated adults with stage III or IV classical Hodgkin lymphoma.
The drug, which is marketed by Seattle Genetics as Adcetris, is already approved in classical Hodgkin lymphoma after relapse and after stem cell transplant when the patient is at risk of relapse or progression. The drug is also approved to treat both systemic anaplastic large cell lymphoma (ALCL) and primary cutaneous ALCL after failure on other treatments.
The modified 2-year progression-free survival in the trial was 82.1% for patients receiving brentuximab plus AVD versus 77.2% for ABVD (P = .03), a 23% relative risk reduction (N Engl J Med. 2018;378:331-44).
Common side effects of brentuximab vedotin include neutropenia, anemia, peripheral neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and pyrexia. The drug carries a boxed warning highlighting the risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy.
The Food and Drug Administration has approved brentuximab vedotin, in combination with chemotherapy, for previously untreated adults with stage III or IV classical Hodgkin lymphoma.
The drug, which is marketed by Seattle Genetics as Adcetris, is already approved in classical Hodgkin lymphoma after relapse and after stem cell transplant when the patient is at risk of relapse or progression. The drug is also approved to treat both systemic anaplastic large cell lymphoma (ALCL) and primary cutaneous ALCL after failure on other treatments.
The modified 2-year progression-free survival in the trial was 82.1% for patients receiving brentuximab plus AVD versus 77.2% for ABVD (P = .03), a 23% relative risk reduction (N Engl J Med. 2018;378:331-44).
Common side effects of brentuximab vedotin include neutropenia, anemia, peripheral neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and pyrexia. The drug carries a boxed warning highlighting the risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy.
FDA wants data on role of flavored tobacco products in youth initiation
The Food and Drug Administration is seeking data on the role that flavors, including menthol, in tobacco products play in the initiation, use, and cessation of tobacco products, with an emphasis on how flavoring impacts young people.
“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” FDA Commissioner Scott Gottlieb, MD, said in statement. It is important “that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain noncombustible forms of tobacco products.”
“Youth consistently report product flavoring as a leading reason for using tobacco products,” Dr. Gottlieb noted. “In fact, there is evidence indicating that youth tobacco users who reported their first tobacco was flavored had a higher prevalence of current tobacco product use, compared to youth whose product was not flavored.”
The advance notice calls for information across a number of areas, including the role of flavors other than tobacco in tobacco products; flavors and initiation and patterns of tobacco product use, particularly among youths and young adults; and flavors and cessation, dual-use, and relapse among current and former tobacco product users.
It also is seeking comment on whether standards should be set on tobacco flavoring, including whether there should a prohibition or restriction on flavors and to which types of products these standards should apply. The notice specifically asks about menthol and its role in cigarette initiation and whether limitations on menthol could lead to use of other tobacco products.
“Because almost 90% of adult smokers started smoking by the age of 18, it’s imperative we look at new ways we can ensure that kids don’t progress from experimentation to regular use,” Commissioner Gottlieb said.
The American Heart Association called the action “long overdue.”
“We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard,” CEO Nancy Brown said in a statement. “There is already clear evidence that flavored tobacco products, including menthol, harm the public health. To make it worse, fruit- and candy-flavored e-cigarettes, cigars, and other tobacco products are highly attractive to kids and make it more likely that they will take up this addiction.”
The action comes less than a week after FDA published an advance notice seeking information comments on reducing nicotine levels in cigarettes to help combat nicotine addiction.
The advance notice will be published March 21 in the Federal Register; comments will be accepted at www.regulations.gov for 90 days.
The Food and Drug Administration is seeking data on the role that flavors, including menthol, in tobacco products play in the initiation, use, and cessation of tobacco products, with an emphasis on how flavoring impacts young people.
“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” FDA Commissioner Scott Gottlieb, MD, said in statement. It is important “that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain noncombustible forms of tobacco products.”
“Youth consistently report product flavoring as a leading reason for using tobacco products,” Dr. Gottlieb noted. “In fact, there is evidence indicating that youth tobacco users who reported their first tobacco was flavored had a higher prevalence of current tobacco product use, compared to youth whose product was not flavored.”
The advance notice calls for information across a number of areas, including the role of flavors other than tobacco in tobacco products; flavors and initiation and patterns of tobacco product use, particularly among youths and young adults; and flavors and cessation, dual-use, and relapse among current and former tobacco product users.
It also is seeking comment on whether standards should be set on tobacco flavoring, including whether there should a prohibition or restriction on flavors and to which types of products these standards should apply. The notice specifically asks about menthol and its role in cigarette initiation and whether limitations on menthol could lead to use of other tobacco products.
“Because almost 90% of adult smokers started smoking by the age of 18, it’s imperative we look at new ways we can ensure that kids don’t progress from experimentation to regular use,” Commissioner Gottlieb said.
The American Heart Association called the action “long overdue.”
“We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard,” CEO Nancy Brown said in a statement. “There is already clear evidence that flavored tobacco products, including menthol, harm the public health. To make it worse, fruit- and candy-flavored e-cigarettes, cigars, and other tobacco products are highly attractive to kids and make it more likely that they will take up this addiction.”
The action comes less than a week after FDA published an advance notice seeking information comments on reducing nicotine levels in cigarettes to help combat nicotine addiction.
The advance notice will be published March 21 in the Federal Register; comments will be accepted at www.regulations.gov for 90 days.
The Food and Drug Administration is seeking data on the role that flavors, including menthol, in tobacco products play in the initiation, use, and cessation of tobacco products, with an emphasis on how flavoring impacts young people.
“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” FDA Commissioner Scott Gottlieb, MD, said in statement. It is important “that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain noncombustible forms of tobacco products.”
“Youth consistently report product flavoring as a leading reason for using tobacco products,” Dr. Gottlieb noted. “In fact, there is evidence indicating that youth tobacco users who reported their first tobacco was flavored had a higher prevalence of current tobacco product use, compared to youth whose product was not flavored.”
The advance notice calls for information across a number of areas, including the role of flavors other than tobacco in tobacco products; flavors and initiation and patterns of tobacco product use, particularly among youths and young adults; and flavors and cessation, dual-use, and relapse among current and former tobacco product users.
It also is seeking comment on whether standards should be set on tobacco flavoring, including whether there should a prohibition or restriction on flavors and to which types of products these standards should apply. The notice specifically asks about menthol and its role in cigarette initiation and whether limitations on menthol could lead to use of other tobacco products.
“Because almost 90% of adult smokers started smoking by the age of 18, it’s imperative we look at new ways we can ensure that kids don’t progress from experimentation to regular use,” Commissioner Gottlieb said.
The American Heart Association called the action “long overdue.”
“We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard,” CEO Nancy Brown said in a statement. “There is already clear evidence that flavored tobacco products, including menthol, harm the public health. To make it worse, fruit- and candy-flavored e-cigarettes, cigars, and other tobacco products are highly attractive to kids and make it more likely that they will take up this addiction.”
The action comes less than a week after FDA published an advance notice seeking information comments on reducing nicotine levels in cigarettes to help combat nicotine addiction.
The advance notice will be published March 21 in the Federal Register; comments will be accepted at www.regulations.gov for 90 days.
Beware of polypharmacy in patients taking warfarin
SAN DIEGO – The incidence of polypharmacy among patients on warfarin therapy appears to peak at age 75, with close to 10 concurrent active prescriptions on average, results from a single-center study showed.
“Beware of polypharmacy with these patients,” Alan Jacobson, MD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “Anticoagulation tends to be a high-risk area. If you don’t treat, people have strokes. If you treat, they can have bleeds. Warfarin is the number one drug that gets older patients into the ER and admitted. We know that warfarin has a lot of drug-drug interactions.”
For example, in the ARISTOTLE trial, patients used a median of six drugs, and 26% of patients used nine or more drugs (BMJ. 2016 Jun 15;353:i2868.
In an effort to determine the average and maximum number of concurrent prescription drugs for age-dependent brackets of patients on warfarin, Dr. Jacobson and his associates reviewed the electronic pharmacy records of 1,122 warfarin patients at the VA Loma Linda Healthcare System. They excluded medications that could be obtained over the counter and calculated the average number of concurrent drugs for each of 10 age brackets: under age 50, over age 90, and eight brackets between those limits.
The researchers reported that 9,885 prescriptions were tabulated for the study population, which translated into a per patient average of 8.8 concurrent active prescription drugs, independent of age. They observed an age-dependent increase in the number of concurrent drugs that peaked at 9.9 among patients aged 70-74 years, and tapered off in those older than age 75. One patient in the 70- to 74-year-old age group was on 28 active prescriptions.
“If you’re on 28 pills, your chance of a bleeding complication is high,” Dr. Jacobson said. “We try to be rigorous with all of our patients on education. With these patients, slow the conversation down more. Have a family member come in with them and go into more detail.”
He added that the maximum number of concurrent prescriptions for any single patient in each age bracket tended to be two to three times higher than that of the average patient.
Dr. Jacobson acknowledged certain limitations of the study, including its single-center design and relatively small sample size. There was also no comparison available as to the number of concurrent prescriptions for patients not receiving warfarin. He reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Jacobson M et al. THSNA 2018. Poster 2.
SAN DIEGO – The incidence of polypharmacy among patients on warfarin therapy appears to peak at age 75, with close to 10 concurrent active prescriptions on average, results from a single-center study showed.
“Beware of polypharmacy with these patients,” Alan Jacobson, MD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “Anticoagulation tends to be a high-risk area. If you don’t treat, people have strokes. If you treat, they can have bleeds. Warfarin is the number one drug that gets older patients into the ER and admitted. We know that warfarin has a lot of drug-drug interactions.”
For example, in the ARISTOTLE trial, patients used a median of six drugs, and 26% of patients used nine or more drugs (BMJ. 2016 Jun 15;353:i2868.
In an effort to determine the average and maximum number of concurrent prescription drugs for age-dependent brackets of patients on warfarin, Dr. Jacobson and his associates reviewed the electronic pharmacy records of 1,122 warfarin patients at the VA Loma Linda Healthcare System. They excluded medications that could be obtained over the counter and calculated the average number of concurrent drugs for each of 10 age brackets: under age 50, over age 90, and eight brackets between those limits.
The researchers reported that 9,885 prescriptions were tabulated for the study population, which translated into a per patient average of 8.8 concurrent active prescription drugs, independent of age. They observed an age-dependent increase in the number of concurrent drugs that peaked at 9.9 among patients aged 70-74 years, and tapered off in those older than age 75. One patient in the 70- to 74-year-old age group was on 28 active prescriptions.
“If you’re on 28 pills, your chance of a bleeding complication is high,” Dr. Jacobson said. “We try to be rigorous with all of our patients on education. With these patients, slow the conversation down more. Have a family member come in with them and go into more detail.”
He added that the maximum number of concurrent prescriptions for any single patient in each age bracket tended to be two to three times higher than that of the average patient.
Dr. Jacobson acknowledged certain limitations of the study, including its single-center design and relatively small sample size. There was also no comparison available as to the number of concurrent prescriptions for patients not receiving warfarin. He reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Jacobson M et al. THSNA 2018. Poster 2.
SAN DIEGO – The incidence of polypharmacy among patients on warfarin therapy appears to peak at age 75, with close to 10 concurrent active prescriptions on average, results from a single-center study showed.
“Beware of polypharmacy with these patients,” Alan Jacobson, MD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “Anticoagulation tends to be a high-risk area. If you don’t treat, people have strokes. If you treat, they can have bleeds. Warfarin is the number one drug that gets older patients into the ER and admitted. We know that warfarin has a lot of drug-drug interactions.”
For example, in the ARISTOTLE trial, patients used a median of six drugs, and 26% of patients used nine or more drugs (BMJ. 2016 Jun 15;353:i2868.
In an effort to determine the average and maximum number of concurrent prescription drugs for age-dependent brackets of patients on warfarin, Dr. Jacobson and his associates reviewed the electronic pharmacy records of 1,122 warfarin patients at the VA Loma Linda Healthcare System. They excluded medications that could be obtained over the counter and calculated the average number of concurrent drugs for each of 10 age brackets: under age 50, over age 90, and eight brackets between those limits.
The researchers reported that 9,885 prescriptions were tabulated for the study population, which translated into a per patient average of 8.8 concurrent active prescription drugs, independent of age. They observed an age-dependent increase in the number of concurrent drugs that peaked at 9.9 among patients aged 70-74 years, and tapered off in those older than age 75. One patient in the 70- to 74-year-old age group was on 28 active prescriptions.
“If you’re on 28 pills, your chance of a bleeding complication is high,” Dr. Jacobson said. “We try to be rigorous with all of our patients on education. With these patients, slow the conversation down more. Have a family member come in with them and go into more detail.”
He added that the maximum number of concurrent prescriptions for any single patient in each age bracket tended to be two to three times higher than that of the average patient.
Dr. Jacobson acknowledged certain limitations of the study, including its single-center design and relatively small sample size. There was also no comparison available as to the number of concurrent prescriptions for patients not receiving warfarin. He reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Jacobson M et al. THSNA 2018. Poster 2.
REPORTING FROM THSNA 2018
Key clinical point:
Major finding: On average, warfarin patients had 8.8 concurrent active prescription drugs.
Study details: A review of medical records from 1,122 warfarin patients.
Disclosures: Dr. Jacobson reported having no financial disclosures.
Source: Jacobson A et al. THSNA 2018. Poster 2.
Telestroke Neurologists May Have Longer Nonenhanced CT-to-CTA Times, Compared With Bedside Neurologists
LOS ANGELES—Among patients with acute ischemic stroke due to large-vessel occlusion, average time from nonenhanced CT (NECT) to CT angiogram (CTA) was significantly longer for patients evaluated at nonendovascular stroke centers by telestroke neurologists, compared with the average time for patients evaluated at endovascular stroke centers by bedside neurologists, according to research presented at the International Stroke Conference 2018.
“Importantly, it may be that the delays at facilities covered by teleneurologists are due to radiology policies and procedures.… Telestroke neurologists should work with emergency department physicians and CT personnel to ensure that patients with suspected large-vessel occlusions have a CTA performed immediately after completion of the NECT,” said Andrew W. Asimos, MD, Medical Director of the Carolina Stroke Network of Carolinas Healthcare System in Charlotte, North Carolina.
“These data suggest that steps should be taken to ensure that NECT-to-CTA times receive the same attention as door-to-needle IV t-PA times in assessing overall telestroke neurologist process performance.”
The 2015 American Heart Association/American Stroke Association stroke management guidelines strongly recommend that if endovascular therapy is considered, CTA should be included in the initial imaging evaluation. A prompt CTA can expedite the identification and transfer of patients with large-vessel occlusion for endovascular treatment, said Dr. Asimos.
Telestroke Neurologists vs Bedside Neurologists
Telestroke neurologists mainly focus on achieving quick door-to-needle IV t-PA times, rather than prompt CTA performance times, however. As a result, the researchers hypothesized that the NECT-to-CTA time interval for patients with large-vessel occlusion would be significantly longer at nonendovascular stroke centers using telestroke neurologists than at endovascular stroke centers with bedside neurologists.
To test this hypothesis, the researchers conducted a retrospective analysis. They compared the NECT–to-CTA time performance interval for consecutive patients with large-vessel occlusion who initially presented to any of 23 hospitals or freestanding emergency departments in a large healthcare system’s stroke network database and were candidates for endovascular treatment.
Over a seven-month period, researchers identified 71 cases of large-vessel occlusion in which patients initially presented to one of 21 nonendovascular stroke centers covered by telestroke neurologists and 62 cases in which patients presented to one of two endovascular stroke centers covered by bedside neurologists. After removing the outliers (ie, those NECT-to-CTA times greater than the 95th percentile for endovascular stroke center cases and greater than the 90th percentile for nonendovascular stroke center cases), researchers retained 64 cases from nonendovascular stroke centers and 59 cases from endovascular stroke centers.
In all, 48.4% of patients evaluated at nonendovascular stroke centers and 45.8% of patients evaluated at endovascular stroke centers were female.
NECT-to-CTA Times Were Longer at Nonendovascular Stroke Centers
Overall, patients evaluated at nonendovascular stroke centers had significantly longer NECT-to-CTA performance times, compared with those examined at endovascular stroke centers. The mean NECT–to-CTA time interval was 29.9 minutes for telestroke neurologists, compared with 10 minutes for bedside neurologists. It is unknown, however, what protocol limitations contributed to these longer NECT to CTA performance times at non-endovascular stroke centers, said the researchers.
“Our focus now is to ensure that a sensitive large-vessel occlusion screen is performed on all patients prior to going to CT. For patients that screen positive for a possible large-vessel occlusion, we advocate that a CTA be performed immediately after the NECT,” said
—Erica Tricarico
LOS ANGELES—Among patients with acute ischemic stroke due to large-vessel occlusion, average time from nonenhanced CT (NECT) to CT angiogram (CTA) was significantly longer for patients evaluated at nonendovascular stroke centers by telestroke neurologists, compared with the average time for patients evaluated at endovascular stroke centers by bedside neurologists, according to research presented at the International Stroke Conference 2018.
“Importantly, it may be that the delays at facilities covered by teleneurologists are due to radiology policies and procedures.… Telestroke neurologists should work with emergency department physicians and CT personnel to ensure that patients with suspected large-vessel occlusions have a CTA performed immediately after completion of the NECT,” said Andrew W. Asimos, MD, Medical Director of the Carolina Stroke Network of Carolinas Healthcare System in Charlotte, North Carolina.
“These data suggest that steps should be taken to ensure that NECT-to-CTA times receive the same attention as door-to-needle IV t-PA times in assessing overall telestroke neurologist process performance.”
The 2015 American Heart Association/American Stroke Association stroke management guidelines strongly recommend that if endovascular therapy is considered, CTA should be included in the initial imaging evaluation. A prompt CTA can expedite the identification and transfer of patients with large-vessel occlusion for endovascular treatment, said Dr. Asimos.
Telestroke Neurologists vs Bedside Neurologists
Telestroke neurologists mainly focus on achieving quick door-to-needle IV t-PA times, rather than prompt CTA performance times, however. As a result, the researchers hypothesized that the NECT-to-CTA time interval for patients with large-vessel occlusion would be significantly longer at nonendovascular stroke centers using telestroke neurologists than at endovascular stroke centers with bedside neurologists.
To test this hypothesis, the researchers conducted a retrospective analysis. They compared the NECT–to-CTA time performance interval for consecutive patients with large-vessel occlusion who initially presented to any of 23 hospitals or freestanding emergency departments in a large healthcare system’s stroke network database and were candidates for endovascular treatment.
Over a seven-month period, researchers identified 71 cases of large-vessel occlusion in which patients initially presented to one of 21 nonendovascular stroke centers covered by telestroke neurologists and 62 cases in which patients presented to one of two endovascular stroke centers covered by bedside neurologists. After removing the outliers (ie, those NECT-to-CTA times greater than the 95th percentile for endovascular stroke center cases and greater than the 90th percentile for nonendovascular stroke center cases), researchers retained 64 cases from nonendovascular stroke centers and 59 cases from endovascular stroke centers.
In all, 48.4% of patients evaluated at nonendovascular stroke centers and 45.8% of patients evaluated at endovascular stroke centers were female.
NECT-to-CTA Times Were Longer at Nonendovascular Stroke Centers
Overall, patients evaluated at nonendovascular stroke centers had significantly longer NECT-to-CTA performance times, compared with those examined at endovascular stroke centers. The mean NECT–to-CTA time interval was 29.9 minutes for telestroke neurologists, compared with 10 minutes for bedside neurologists. It is unknown, however, what protocol limitations contributed to these longer NECT to CTA performance times at non-endovascular stroke centers, said the researchers.
“Our focus now is to ensure that a sensitive large-vessel occlusion screen is performed on all patients prior to going to CT. For patients that screen positive for a possible large-vessel occlusion, we advocate that a CTA be performed immediately after the NECT,” said
—Erica Tricarico
LOS ANGELES—Among patients with acute ischemic stroke due to large-vessel occlusion, average time from nonenhanced CT (NECT) to CT angiogram (CTA) was significantly longer for patients evaluated at nonendovascular stroke centers by telestroke neurologists, compared with the average time for patients evaluated at endovascular stroke centers by bedside neurologists, according to research presented at the International Stroke Conference 2018.
“Importantly, it may be that the delays at facilities covered by teleneurologists are due to radiology policies and procedures.… Telestroke neurologists should work with emergency department physicians and CT personnel to ensure that patients with suspected large-vessel occlusions have a CTA performed immediately after completion of the NECT,” said Andrew W. Asimos, MD, Medical Director of the Carolina Stroke Network of Carolinas Healthcare System in Charlotte, North Carolina.
“These data suggest that steps should be taken to ensure that NECT-to-CTA times receive the same attention as door-to-needle IV t-PA times in assessing overall telestroke neurologist process performance.”
The 2015 American Heart Association/American Stroke Association stroke management guidelines strongly recommend that if endovascular therapy is considered, CTA should be included in the initial imaging evaluation. A prompt CTA can expedite the identification and transfer of patients with large-vessel occlusion for endovascular treatment, said Dr. Asimos.
Telestroke Neurologists vs Bedside Neurologists
Telestroke neurologists mainly focus on achieving quick door-to-needle IV t-PA times, rather than prompt CTA performance times, however. As a result, the researchers hypothesized that the NECT-to-CTA time interval for patients with large-vessel occlusion would be significantly longer at nonendovascular stroke centers using telestroke neurologists than at endovascular stroke centers with bedside neurologists.
To test this hypothesis, the researchers conducted a retrospective analysis. They compared the NECT–to-CTA time performance interval for consecutive patients with large-vessel occlusion who initially presented to any of 23 hospitals or freestanding emergency departments in a large healthcare system’s stroke network database and were candidates for endovascular treatment.
Over a seven-month period, researchers identified 71 cases of large-vessel occlusion in which patients initially presented to one of 21 nonendovascular stroke centers covered by telestroke neurologists and 62 cases in which patients presented to one of two endovascular stroke centers covered by bedside neurologists. After removing the outliers (ie, those NECT-to-CTA times greater than the 95th percentile for endovascular stroke center cases and greater than the 90th percentile for nonendovascular stroke center cases), researchers retained 64 cases from nonendovascular stroke centers and 59 cases from endovascular stroke centers.
In all, 48.4% of patients evaluated at nonendovascular stroke centers and 45.8% of patients evaluated at endovascular stroke centers were female.
NECT-to-CTA Times Were Longer at Nonendovascular Stroke Centers
Overall, patients evaluated at nonendovascular stroke centers had significantly longer NECT-to-CTA performance times, compared with those examined at endovascular stroke centers. The mean NECT–to-CTA time interval was 29.9 minutes for telestroke neurologists, compared with 10 minutes for bedside neurologists. It is unknown, however, what protocol limitations contributed to these longer NECT to CTA performance times at non-endovascular stroke centers, said the researchers.
“Our focus now is to ensure that a sensitive large-vessel occlusion screen is performed on all patients prior to going to CT. For patients that screen positive for a possible large-vessel occlusion, we advocate that a CTA be performed immediately after the NECT,” said
—Erica Tricarico
Trauma surgeon shares story of involuntary commitment, redemption
Over the last few years, I have spoken to many people about their experiences with involuntary psychiatric hospitalizations. While the stories I’ve heard are anecdotes, often from people who have reached out to me, and not randomized, controlled studies, I’ve taken the liberty of coming to a few conclusions. First, involuntary hospitalizations help people. Most people say that they left the hospital with fewer symptoms than they had when they entered. Second, many of those people, helped though they may have been, are angry about the treatment they received. An unknown percentage feel traumatized by their psychiatric treatment, and years later they dwell on a perception of injustice and injury.
It’s perplexing that this negative residue remains given that involuntary psychiatric care often helps people to escape from the torment of psychosis or from soul-crushing depressions. While many feel it should be easier to involuntarily treat psychiatric disorders, there are no groups of patients asking for easier access to involuntary care. One group, Mad in America – formed by journalist Robert Whitaker – takes the position that psychiatric medications don’t just harm people, but that psychotropic medications actually cause psychiatric disorders in people who would have fared better without them. It now offers CME activities through its conferences and website!
“In the middle of elective inpatient electroconvulsive therapy for treatment-resistant depression, he had become profoundly depressed, delirious, and hopeless. He’d lost faith in treatment and in reasons to live. He withdrew to bed and would not get up or eat. He had to be committed for his own safety. Several security guards had to forcefully remove him from his bed.”
The patient, he noted, was injected with haloperidol and placed in restraints in a seclusion room. By the third paragraph, Weinstein switches to a first-person narrative and reveals that he is that patient. He goes on to talk about the stresses of life as a trauma surgeon, and describes both classic physician burnout and severe major depression. The essay includes an element of catharsis. The author shares his painful story, with all the gore of amputating the limbs of others to the agony of feeling that those he loves might be better off without him. Post-hospitalization, Weinstein’s message is clear: He wants to help others break free from the stigma of silent shame and let them know that help is available. “You would not be reading this today were it not for the love of my wife, my children, my mother and sister, and so many others, including the guards and doctors who ‘locked me up’ against my will. They kept me from crossing into the abyss,” he writes.
The essay (N Engl J Med. 2018;378:793-5) surprised me, because I have never heard a patient who has been forcibly medicated and placed in restraints and seclusion talk about the experience with gratitude. I contacted Dr. Weinstein and asked if he would speak with me about his experiences as a committed patient back in early 2016. In fact, he said that he had only recently begun to speak of his experiences with his therapist, and he spoke openly about what he remembered of those events.
Dr. Weinstein told me his story in more detail – it was a long and tumultuous journey from the depth of depression to where he is now. “I’m in a much better place than I’ve ever been. I’ve developed tools for resilience and I’ve found joy.” His gratitude was real, and his purpose in sharing his story remains a positive and hopeful vision for others who suffer. Clearly, he was not traumatized by his treatment. I approached him with the question of what psychiatrists could learn from his experiences. The story that followed had the texture of those I was used to hearing from people who had been involuntarily treated.
Like many people I’ve spoken with, Dr. Weinstein assumed he was officially committed to the locked unit, but he did not recall a legal hearing. In fact, many of those I’ve talked with had actually signed themselves in, and Dr. Weinstein thought that was possible.
“When I wrote the New England Journal piece, it originated from a place of anger. I was voluntarily admitted to a private, self-pay psychiatric unit, and I was getting ECT. I was getting worse, not better. I was in a scary place, and I was deeply depressed. The day before, I had gone for a walk without telling the staff or following the sign-out procedure. They decided I needed to be in a locked unit, and when they told me, I was lying in bed.”
Upon hearing that he would be transferred, Dr. Weinstein became combative. He was medicated and taken to a locked unit in the hospital, placed in restraints, and put into a seclusion room.
“I’ve wondered if this could have been done another way. Maybe if they had given me a chance to process the information, perhaps I would have gone more willingly without guards carrying me through the facility. I wondered if the way the information was delivered didn’t escalate things, if it could have been done differently.” Listening to him, I wondered as well, though Dr. Weinstein was well aware that the actions of his treatment team came with the best of intentions to help him. I pointed out that the treatment team may have felt fearful when he disappeared from the unit, and as they watched him decline further, they may well have felt a bit desperate and fearful of their ability to keep him safe on an unlocked unit. None of this surprised him.
Was Dr. Weinstein open to returning to a psychiatric unit if his depression recurs?
“A few months after I left, I became even more depressed and suicidal. I didn’t go back, and I really hope I’ll never have to be in a hospital again.” Instead,. “They changed my perspective.”
Dr. Weinstein also questions if he should have agreed to ECT. “I was better when I left the hospital, but the treatment itself was crude, and I still wonder if it affects my memory now.”
I wanted to know what psychiatrists might learn from his experiences with involuntary care. Weinstein hesitated. “It wasn’t the best experience, and I felt there had to be a better way, but I know everyone was trying to help me, and I want my overall message to be one of hope. I don’t want to complain, because I’ve ended up in a much better place, I’m back at work, enjoying my family, and I feel joy now.”
For psychiatrists, this is the best outcome from a story such as Dr. Weinstein’s. He’s much better, in a scenario where he could have just as easily have died, and he wasn’t traumatized by his care. However, he avoided returning to inpatient care at a precarious time, and he’s left asking if there weren’t a gentler way this could have transpired. These questions are easier to look at from the perspective of a Monday morning quarterback than they are to look at from the perspective of a treatment team dealing with a very sick and combative patient. Still, I hope we all continue to question patients about their experiences and ask if there might be better ways.
Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Care” (Baltimore: Johns Hopkins University Press, 2016).
Over the last few years, I have spoken to many people about their experiences with involuntary psychiatric hospitalizations. While the stories I’ve heard are anecdotes, often from people who have reached out to me, and not randomized, controlled studies, I’ve taken the liberty of coming to a few conclusions. First, involuntary hospitalizations help people. Most people say that they left the hospital with fewer symptoms than they had when they entered. Second, many of those people, helped though they may have been, are angry about the treatment they received. An unknown percentage feel traumatized by their psychiatric treatment, and years later they dwell on a perception of injustice and injury.
It’s perplexing that this negative residue remains given that involuntary psychiatric care often helps people to escape from the torment of psychosis or from soul-crushing depressions. While many feel it should be easier to involuntarily treat psychiatric disorders, there are no groups of patients asking for easier access to involuntary care. One group, Mad in America – formed by journalist Robert Whitaker – takes the position that psychiatric medications don’t just harm people, but that psychotropic medications actually cause psychiatric disorders in people who would have fared better without them. It now offers CME activities through its conferences and website!
“In the middle of elective inpatient electroconvulsive therapy for treatment-resistant depression, he had become profoundly depressed, delirious, and hopeless. He’d lost faith in treatment and in reasons to live. He withdrew to bed and would not get up or eat. He had to be committed for his own safety. Several security guards had to forcefully remove him from his bed.”
The patient, he noted, was injected with haloperidol and placed in restraints in a seclusion room. By the third paragraph, Weinstein switches to a first-person narrative and reveals that he is that patient. He goes on to talk about the stresses of life as a trauma surgeon, and describes both classic physician burnout and severe major depression. The essay includes an element of catharsis. The author shares his painful story, with all the gore of amputating the limbs of others to the agony of feeling that those he loves might be better off without him. Post-hospitalization, Weinstein’s message is clear: He wants to help others break free from the stigma of silent shame and let them know that help is available. “You would not be reading this today were it not for the love of my wife, my children, my mother and sister, and so many others, including the guards and doctors who ‘locked me up’ against my will. They kept me from crossing into the abyss,” he writes.
The essay (N Engl J Med. 2018;378:793-5) surprised me, because I have never heard a patient who has been forcibly medicated and placed in restraints and seclusion talk about the experience with gratitude. I contacted Dr. Weinstein and asked if he would speak with me about his experiences as a committed patient back in early 2016. In fact, he said that he had only recently begun to speak of his experiences with his therapist, and he spoke openly about what he remembered of those events.
Dr. Weinstein told me his story in more detail – it was a long and tumultuous journey from the depth of depression to where he is now. “I’m in a much better place than I’ve ever been. I’ve developed tools for resilience and I’ve found joy.” His gratitude was real, and his purpose in sharing his story remains a positive and hopeful vision for others who suffer. Clearly, he was not traumatized by his treatment. I approached him with the question of what psychiatrists could learn from his experiences. The story that followed had the texture of those I was used to hearing from people who had been involuntarily treated.
Like many people I’ve spoken with, Dr. Weinstein assumed he was officially committed to the locked unit, but he did not recall a legal hearing. In fact, many of those I’ve talked with had actually signed themselves in, and Dr. Weinstein thought that was possible.
“When I wrote the New England Journal piece, it originated from a place of anger. I was voluntarily admitted to a private, self-pay psychiatric unit, and I was getting ECT. I was getting worse, not better. I was in a scary place, and I was deeply depressed. The day before, I had gone for a walk without telling the staff or following the sign-out procedure. They decided I needed to be in a locked unit, and when they told me, I was lying in bed.”
Upon hearing that he would be transferred, Dr. Weinstein became combative. He was medicated and taken to a locked unit in the hospital, placed in restraints, and put into a seclusion room.
“I’ve wondered if this could have been done another way. Maybe if they had given me a chance to process the information, perhaps I would have gone more willingly without guards carrying me through the facility. I wondered if the way the information was delivered didn’t escalate things, if it could have been done differently.” Listening to him, I wondered as well, though Dr. Weinstein was well aware that the actions of his treatment team came with the best of intentions to help him. I pointed out that the treatment team may have felt fearful when he disappeared from the unit, and as they watched him decline further, they may well have felt a bit desperate and fearful of their ability to keep him safe on an unlocked unit. None of this surprised him.
Was Dr. Weinstein open to returning to a psychiatric unit if his depression recurs?
“A few months after I left, I became even more depressed and suicidal. I didn’t go back, and I really hope I’ll never have to be in a hospital again.” Instead,. “They changed my perspective.”
Dr. Weinstein also questions if he should have agreed to ECT. “I was better when I left the hospital, but the treatment itself was crude, and I still wonder if it affects my memory now.”
I wanted to know what psychiatrists might learn from his experiences with involuntary care. Weinstein hesitated. “It wasn’t the best experience, and I felt there had to be a better way, but I know everyone was trying to help me, and I want my overall message to be one of hope. I don’t want to complain, because I’ve ended up in a much better place, I’m back at work, enjoying my family, and I feel joy now.”
For psychiatrists, this is the best outcome from a story such as Dr. Weinstein’s. He’s much better, in a scenario where he could have just as easily have died, and he wasn’t traumatized by his care. However, he avoided returning to inpatient care at a precarious time, and he’s left asking if there weren’t a gentler way this could have transpired. These questions are easier to look at from the perspective of a Monday morning quarterback than they are to look at from the perspective of a treatment team dealing with a very sick and combative patient. Still, I hope we all continue to question patients about their experiences and ask if there might be better ways.
Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Care” (Baltimore: Johns Hopkins University Press, 2016).
Over the last few years, I have spoken to many people about their experiences with involuntary psychiatric hospitalizations. While the stories I’ve heard are anecdotes, often from people who have reached out to me, and not randomized, controlled studies, I’ve taken the liberty of coming to a few conclusions. First, involuntary hospitalizations help people. Most people say that they left the hospital with fewer symptoms than they had when they entered. Second, many of those people, helped though they may have been, are angry about the treatment they received. An unknown percentage feel traumatized by their psychiatric treatment, and years later they dwell on a perception of injustice and injury.
It’s perplexing that this negative residue remains given that involuntary psychiatric care often helps people to escape from the torment of psychosis or from soul-crushing depressions. While many feel it should be easier to involuntarily treat psychiatric disorders, there are no groups of patients asking for easier access to involuntary care. One group, Mad in America – formed by journalist Robert Whitaker – takes the position that psychiatric medications don’t just harm people, but that psychotropic medications actually cause psychiatric disorders in people who would have fared better without them. It now offers CME activities through its conferences and website!
“In the middle of elective inpatient electroconvulsive therapy for treatment-resistant depression, he had become profoundly depressed, delirious, and hopeless. He’d lost faith in treatment and in reasons to live. He withdrew to bed and would not get up or eat. He had to be committed for his own safety. Several security guards had to forcefully remove him from his bed.”
The patient, he noted, was injected with haloperidol and placed in restraints in a seclusion room. By the third paragraph, Weinstein switches to a first-person narrative and reveals that he is that patient. He goes on to talk about the stresses of life as a trauma surgeon, and describes both classic physician burnout and severe major depression. The essay includes an element of catharsis. The author shares his painful story, with all the gore of amputating the limbs of others to the agony of feeling that those he loves might be better off without him. Post-hospitalization, Weinstein’s message is clear: He wants to help others break free from the stigma of silent shame and let them know that help is available. “You would not be reading this today were it not for the love of my wife, my children, my mother and sister, and so many others, including the guards and doctors who ‘locked me up’ against my will. They kept me from crossing into the abyss,” he writes.
The essay (N Engl J Med. 2018;378:793-5) surprised me, because I have never heard a patient who has been forcibly medicated and placed in restraints and seclusion talk about the experience with gratitude. I contacted Dr. Weinstein and asked if he would speak with me about his experiences as a committed patient back in early 2016. In fact, he said that he had only recently begun to speak of his experiences with his therapist, and he spoke openly about what he remembered of those events.
Dr. Weinstein told me his story in more detail – it was a long and tumultuous journey from the depth of depression to where he is now. “I’m in a much better place than I’ve ever been. I’ve developed tools for resilience and I’ve found joy.” His gratitude was real, and his purpose in sharing his story remains a positive and hopeful vision for others who suffer. Clearly, he was not traumatized by his treatment. I approached him with the question of what psychiatrists could learn from his experiences. The story that followed had the texture of those I was used to hearing from people who had been involuntarily treated.
Like many people I’ve spoken with, Dr. Weinstein assumed he was officially committed to the locked unit, but he did not recall a legal hearing. In fact, many of those I’ve talked with had actually signed themselves in, and Dr. Weinstein thought that was possible.
“When I wrote the New England Journal piece, it originated from a place of anger. I was voluntarily admitted to a private, self-pay psychiatric unit, and I was getting ECT. I was getting worse, not better. I was in a scary place, and I was deeply depressed. The day before, I had gone for a walk without telling the staff or following the sign-out procedure. They decided I needed to be in a locked unit, and when they told me, I was lying in bed.”
Upon hearing that he would be transferred, Dr. Weinstein became combative. He was medicated and taken to a locked unit in the hospital, placed in restraints, and put into a seclusion room.
“I’ve wondered if this could have been done another way. Maybe if they had given me a chance to process the information, perhaps I would have gone more willingly without guards carrying me through the facility. I wondered if the way the information was delivered didn’t escalate things, if it could have been done differently.” Listening to him, I wondered as well, though Dr. Weinstein was well aware that the actions of his treatment team came with the best of intentions to help him. I pointed out that the treatment team may have felt fearful when he disappeared from the unit, and as they watched him decline further, they may well have felt a bit desperate and fearful of their ability to keep him safe on an unlocked unit. None of this surprised him.
Was Dr. Weinstein open to returning to a psychiatric unit if his depression recurs?
“A few months after I left, I became even more depressed and suicidal. I didn’t go back, and I really hope I’ll never have to be in a hospital again.” Instead,. “They changed my perspective.”
Dr. Weinstein also questions if he should have agreed to ECT. “I was better when I left the hospital, but the treatment itself was crude, and I still wonder if it affects my memory now.”
I wanted to know what psychiatrists might learn from his experiences with involuntary care. Weinstein hesitated. “It wasn’t the best experience, and I felt there had to be a better way, but I know everyone was trying to help me, and I want my overall message to be one of hope. I don’t want to complain, because I’ve ended up in a much better place, I’m back at work, enjoying my family, and I feel joy now.”
For psychiatrists, this is the best outcome from a story such as Dr. Weinstein’s. He’s much better, in a scenario where he could have just as easily have died, and he wasn’t traumatized by his care. However, he avoided returning to inpatient care at a precarious time, and he’s left asking if there weren’t a gentler way this could have transpired. These questions are easier to look at from the perspective of a Monday morning quarterback than they are to look at from the perspective of a treatment team dealing with a very sick and combative patient. Still, I hope we all continue to question patients about their experiences and ask if there might be better ways.
Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Care” (Baltimore: Johns Hopkins University Press, 2016).
Counsel children and young adults on skin cancer prevention
(USPSTF). The recommendations, published online March 20 in JAMA, advise clinicians to counsel young adults, children, and parents of young children who are aged 6 months to 24 years and have fair skin types about skin cancer prevention. Counseling for individuals aged 24 years and older should be based on a clinician’s assessment of patient risk.
The recommendations target asymptomatic individuals with no history of skin cancer who might be likely to sunburn easily, wrote David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, the corresponding author of the USPSTF recommendation statement, and his associates.
The task force found adequate (grade B) evidence to support behavioral counseling for children and young adults aged 6 months to 24 years with no notable risk of harm from this intervention. The task force gave a grade C recommendation for routine skin cancer counseling for adults older than 24 years, citing a small net benefit. In addition, the USPSTF found insufficient evidence (I statement) to evaluate the risks versus benefits of counseling adults about skin self-examination as a way to reduce skin cancer risk.
In the evidence report, lead author Nora B. Henrikson, PhD, of Kaiser Permanente Washington Health Research Institute, Seattle, and her colleagues addressed five topics: the effects of skin cancer prevention counseling on short- and long-term outcomes, the effects of primary care counseling interventions on skin cancer prevention behavior, the association between skin self-examination and skin cancer outcomes, the potential harms of counseling interventions, and the potential harms of skin self-examinations.
“Small to moderate effects of behavioral interventions on increased sun protection behaviors were observed in studies of all age groups, though overall, adult trial results were mixed and fewer studies demonstrated an intervention effect,” the researchers said.
The evidence review was limited by several factors including a focus on primary care intervention only and an exclusion of skin cancer survivors, the researchers noted. Although evidence does not show that sunburns are less frequent as a result of interventions, behavioral intervention can improve sun protection behavior, they said. However, intervention in adults “may lead to increased skin procedures without detecting additional atypical nevi or skin cancers,” they noted.
The recommendations are consistent with the draft recommendations published in 2017 and expand the recommendations from 2012 that advised counseling for individuals aged 10-24 years.
The research was funded by the Agency for Healthcare Research and Quality. The authors had no financial conflicts to disclose.
SOURCE: Grossman DC et al. JAMA. 2018;319(11):1134-42.
The term “fair skin types” as used in the USPSTF recommendations is not necessarily helpful in identifying individuals who could benefit from skin cancer prevention counseling, June K. Robinson, MD, and Nina G. Jablonski, PhD, wrote in an accompanying editorial (JAMA. 2018;319[11]:1101-2). Hair and eye color do not predict sun sensitivity, and in general, men and individuals with darker skin don’t think they are at risk for skin cancer even when they sunburn, they noted.
“The terminology that is used by investigators and then incorporated into the USPSTF evidence base needs to evolve to include all persons at risk, without disenfranchising portions of the diverse U.S. population,” they said. In addition to skin type, physicians need to evaluate a patient’s melanoma risk based on lifestyle factors, such as time spent outdoors, photosensitizing medications, and sun protection habits, they added, but primary care clinicians often lack the time to offer personalized sun protection counseling.
“It would be better to encourage people to check the UV Index daily – or consider a mobile application that automatically provides it – and plan outdoor activities, especially physical activities, to be sun safe,” they said. In addition, individuals may be more likely to manage skin cancer risk with a mix of supportive messages via social media to augment in-person counseling from a clinician; furthermore, “normative approval by friends and peers can have a strong reinforcing influence on sun safety behaviors, particularly among youth, who are at a vulnerable age for acquiring melanoma risk,” they emphasized.
Dr. Robinson is a research professor of dermatology at Northwestern University, Chicago, and is the editor of JAMA Dermatology. She is supported in part by the National Cancer Institute. Dr. Jablonski is a professor of anthropology at Pennsylvania State University, University Park. Dr. Robinson had no financial conflicts to disclose; Dr. Jablonski has served on the scientific advisory board of the L’Oreal Group.
The term “fair skin types” as used in the USPSTF recommendations is not necessarily helpful in identifying individuals who could benefit from skin cancer prevention counseling, June K. Robinson, MD, and Nina G. Jablonski, PhD, wrote in an accompanying editorial (JAMA. 2018;319[11]:1101-2). Hair and eye color do not predict sun sensitivity, and in general, men and individuals with darker skin don’t think they are at risk for skin cancer even when they sunburn, they noted.
“The terminology that is used by investigators and then incorporated into the USPSTF evidence base needs to evolve to include all persons at risk, without disenfranchising portions of the diverse U.S. population,” they said. In addition to skin type, physicians need to evaluate a patient’s melanoma risk based on lifestyle factors, such as time spent outdoors, photosensitizing medications, and sun protection habits, they added, but primary care clinicians often lack the time to offer personalized sun protection counseling.
“It would be better to encourage people to check the UV Index daily – or consider a mobile application that automatically provides it – and plan outdoor activities, especially physical activities, to be sun safe,” they said. In addition, individuals may be more likely to manage skin cancer risk with a mix of supportive messages via social media to augment in-person counseling from a clinician; furthermore, “normative approval by friends and peers can have a strong reinforcing influence on sun safety behaviors, particularly among youth, who are at a vulnerable age for acquiring melanoma risk,” they emphasized.
Dr. Robinson is a research professor of dermatology at Northwestern University, Chicago, and is the editor of JAMA Dermatology. She is supported in part by the National Cancer Institute. Dr. Jablonski is a professor of anthropology at Pennsylvania State University, University Park. Dr. Robinson had no financial conflicts to disclose; Dr. Jablonski has served on the scientific advisory board of the L’Oreal Group.
The term “fair skin types” as used in the USPSTF recommendations is not necessarily helpful in identifying individuals who could benefit from skin cancer prevention counseling, June K. Robinson, MD, and Nina G. Jablonski, PhD, wrote in an accompanying editorial (JAMA. 2018;319[11]:1101-2). Hair and eye color do not predict sun sensitivity, and in general, men and individuals with darker skin don’t think they are at risk for skin cancer even when they sunburn, they noted.
“The terminology that is used by investigators and then incorporated into the USPSTF evidence base needs to evolve to include all persons at risk, without disenfranchising portions of the diverse U.S. population,” they said. In addition to skin type, physicians need to evaluate a patient’s melanoma risk based on lifestyle factors, such as time spent outdoors, photosensitizing medications, and sun protection habits, they added, but primary care clinicians often lack the time to offer personalized sun protection counseling.
“It would be better to encourage people to check the UV Index daily – or consider a mobile application that automatically provides it – and plan outdoor activities, especially physical activities, to be sun safe,” they said. In addition, individuals may be more likely to manage skin cancer risk with a mix of supportive messages via social media to augment in-person counseling from a clinician; furthermore, “normative approval by friends and peers can have a strong reinforcing influence on sun safety behaviors, particularly among youth, who are at a vulnerable age for acquiring melanoma risk,” they emphasized.
Dr. Robinson is a research professor of dermatology at Northwestern University, Chicago, and is the editor of JAMA Dermatology. She is supported in part by the National Cancer Institute. Dr. Jablonski is a professor of anthropology at Pennsylvania State University, University Park. Dr. Robinson had no financial conflicts to disclose; Dr. Jablonski has served on the scientific advisory board of the L’Oreal Group.
(USPSTF). The recommendations, published online March 20 in JAMA, advise clinicians to counsel young adults, children, and parents of young children who are aged 6 months to 24 years and have fair skin types about skin cancer prevention. Counseling for individuals aged 24 years and older should be based on a clinician’s assessment of patient risk.
The recommendations target asymptomatic individuals with no history of skin cancer who might be likely to sunburn easily, wrote David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, the corresponding author of the USPSTF recommendation statement, and his associates.
The task force found adequate (grade B) evidence to support behavioral counseling for children and young adults aged 6 months to 24 years with no notable risk of harm from this intervention. The task force gave a grade C recommendation for routine skin cancer counseling for adults older than 24 years, citing a small net benefit. In addition, the USPSTF found insufficient evidence (I statement) to evaluate the risks versus benefits of counseling adults about skin self-examination as a way to reduce skin cancer risk.
In the evidence report, lead author Nora B. Henrikson, PhD, of Kaiser Permanente Washington Health Research Institute, Seattle, and her colleagues addressed five topics: the effects of skin cancer prevention counseling on short- and long-term outcomes, the effects of primary care counseling interventions on skin cancer prevention behavior, the association between skin self-examination and skin cancer outcomes, the potential harms of counseling interventions, and the potential harms of skin self-examinations.
“Small to moderate effects of behavioral interventions on increased sun protection behaviors were observed in studies of all age groups, though overall, adult trial results were mixed and fewer studies demonstrated an intervention effect,” the researchers said.
The evidence review was limited by several factors including a focus on primary care intervention only and an exclusion of skin cancer survivors, the researchers noted. Although evidence does not show that sunburns are less frequent as a result of interventions, behavioral intervention can improve sun protection behavior, they said. However, intervention in adults “may lead to increased skin procedures without detecting additional atypical nevi or skin cancers,” they noted.
The recommendations are consistent with the draft recommendations published in 2017 and expand the recommendations from 2012 that advised counseling for individuals aged 10-24 years.
The research was funded by the Agency for Healthcare Research and Quality. The authors had no financial conflicts to disclose.
SOURCE: Grossman DC et al. JAMA. 2018;319(11):1134-42.
(USPSTF). The recommendations, published online March 20 in JAMA, advise clinicians to counsel young adults, children, and parents of young children who are aged 6 months to 24 years and have fair skin types about skin cancer prevention. Counseling for individuals aged 24 years and older should be based on a clinician’s assessment of patient risk.
The recommendations target asymptomatic individuals with no history of skin cancer who might be likely to sunburn easily, wrote David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, the corresponding author of the USPSTF recommendation statement, and his associates.
The task force found adequate (grade B) evidence to support behavioral counseling for children and young adults aged 6 months to 24 years with no notable risk of harm from this intervention. The task force gave a grade C recommendation for routine skin cancer counseling for adults older than 24 years, citing a small net benefit. In addition, the USPSTF found insufficient evidence (I statement) to evaluate the risks versus benefits of counseling adults about skin self-examination as a way to reduce skin cancer risk.
In the evidence report, lead author Nora B. Henrikson, PhD, of Kaiser Permanente Washington Health Research Institute, Seattle, and her colleagues addressed five topics: the effects of skin cancer prevention counseling on short- and long-term outcomes, the effects of primary care counseling interventions on skin cancer prevention behavior, the association between skin self-examination and skin cancer outcomes, the potential harms of counseling interventions, and the potential harms of skin self-examinations.
“Small to moderate effects of behavioral interventions on increased sun protection behaviors were observed in studies of all age groups, though overall, adult trial results were mixed and fewer studies demonstrated an intervention effect,” the researchers said.
The evidence review was limited by several factors including a focus on primary care intervention only and an exclusion of skin cancer survivors, the researchers noted. Although evidence does not show that sunburns are less frequent as a result of interventions, behavioral intervention can improve sun protection behavior, they said. However, intervention in adults “may lead to increased skin procedures without detecting additional atypical nevi or skin cancers,” they noted.
The recommendations are consistent with the draft recommendations published in 2017 and expand the recommendations from 2012 that advised counseling for individuals aged 10-24 years.
The research was funded by the Agency for Healthcare Research and Quality. The authors had no financial conflicts to disclose.
SOURCE: Grossman DC et al. JAMA. 2018;319(11):1134-42.
FROM JAMA
Key clinical point: Moderate evidence supports behavioral counseling to help reduce skin cancer risk in children and young adults.
Major finding: One trial that included 1,356 adults showed no difference in the number of skin cancers and atypical nevi between a control group and patients who received counseling to encourage skin examination.
Study details: The evidence review included 21 trials in 27 publications for a total of 20,561 individuals.
Disclosures: The review was funded by the Agency for Healthcare Research and Quality.
Source: Grossman DC et al. JAMA. 2018;319(11):1134-42.
Full-term infant mortality: United States versus Europe
according to Neha Bairoliya, PhD, and Günther Fink, PhD.
The United States had an FTIMR of 2.19 per 1,000 full-term live births for that 3-year period, compared with a median of 1.11 for Austria, Denmark, Finland, Norway, Sweden, and Switzerland, said Dr. Bairoliya of the Harvard Center for Population and Development Studies, Cambridge, Mass., and Dr. Fink of the Swiss Tropical and Public Health Institute, Basel, Switzerland.
A classification system for individual states that rated FTIMR scores from poor (greater than or equal to 2.75) to excellent (greater than 1.25) put Connecticut, with a U.S.–low rate of 1.29 per 1,000 births, in the good (greater than or equal to1.25 to 1.75) category, so no state managed to join the excellent group of European countries, whose highest rate was 1.24, they reported in PLOS Medicine.
Missouri’s FTIMR of 3.77 per 1,000 was the highest among the 50 states. Along with Missouri, 12 other states were classified as poor, while 11 were considered fair (less than or equal to 2.25 to less than 2.75), 16 were average (less than or equal to 1.25 to less than 1.75), and 10 states earned a classification of good, the investigators said.
They used National Center for Health Statistics data for 7,431 deaths among 10,175,481 children born full term – defined as 37-42 weeks’ gestation – between Jan. 1, 2010, and Dec. 31, 2012. Data on European births came from the Euro-Peristat database.
Data for preterm births put the United States in a somewhat better light: For births from 32 to 36 weeks, mortality rates were 8.24 per 1,000 in the United States and 8.25 for the six European countries; for births at 24-27 weeks, the rates were 199 in the United States and 213 for the Euro six, Dr. Bairoliya and Dr. Fink said.
The investigators did not receive any specific funding for the study, and they said that they had no relevant conflicts of interest.
SOURCE: Bairoliya N, Fink G. PLOS Med. 2018 Mar 20;15(3):e1002531.
according to Neha Bairoliya, PhD, and Günther Fink, PhD.
The United States had an FTIMR of 2.19 per 1,000 full-term live births for that 3-year period, compared with a median of 1.11 for Austria, Denmark, Finland, Norway, Sweden, and Switzerland, said Dr. Bairoliya of the Harvard Center for Population and Development Studies, Cambridge, Mass., and Dr. Fink of the Swiss Tropical and Public Health Institute, Basel, Switzerland.
A classification system for individual states that rated FTIMR scores from poor (greater than or equal to 2.75) to excellent (greater than 1.25) put Connecticut, with a U.S.–low rate of 1.29 per 1,000 births, in the good (greater than or equal to1.25 to 1.75) category, so no state managed to join the excellent group of European countries, whose highest rate was 1.24, they reported in PLOS Medicine.
Missouri’s FTIMR of 3.77 per 1,000 was the highest among the 50 states. Along with Missouri, 12 other states were classified as poor, while 11 were considered fair (less than or equal to 2.25 to less than 2.75), 16 were average (less than or equal to 1.25 to less than 1.75), and 10 states earned a classification of good, the investigators said.
They used National Center for Health Statistics data for 7,431 deaths among 10,175,481 children born full term – defined as 37-42 weeks’ gestation – between Jan. 1, 2010, and Dec. 31, 2012. Data on European births came from the Euro-Peristat database.
Data for preterm births put the United States in a somewhat better light: For births from 32 to 36 weeks, mortality rates were 8.24 per 1,000 in the United States and 8.25 for the six European countries; for births at 24-27 weeks, the rates were 199 in the United States and 213 for the Euro six, Dr. Bairoliya and Dr. Fink said.
The investigators did not receive any specific funding for the study, and they said that they had no relevant conflicts of interest.
SOURCE: Bairoliya N, Fink G. PLOS Med. 2018 Mar 20;15(3):e1002531.
according to Neha Bairoliya, PhD, and Günther Fink, PhD.
The United States had an FTIMR of 2.19 per 1,000 full-term live births for that 3-year period, compared with a median of 1.11 for Austria, Denmark, Finland, Norway, Sweden, and Switzerland, said Dr. Bairoliya of the Harvard Center for Population and Development Studies, Cambridge, Mass., and Dr. Fink of the Swiss Tropical and Public Health Institute, Basel, Switzerland.
A classification system for individual states that rated FTIMR scores from poor (greater than or equal to 2.75) to excellent (greater than 1.25) put Connecticut, with a U.S.–low rate of 1.29 per 1,000 births, in the good (greater than or equal to1.25 to 1.75) category, so no state managed to join the excellent group of European countries, whose highest rate was 1.24, they reported in PLOS Medicine.
Missouri’s FTIMR of 3.77 per 1,000 was the highest among the 50 states. Along with Missouri, 12 other states were classified as poor, while 11 were considered fair (less than or equal to 2.25 to less than 2.75), 16 were average (less than or equal to 1.25 to less than 1.75), and 10 states earned a classification of good, the investigators said.
They used National Center for Health Statistics data for 7,431 deaths among 10,175,481 children born full term – defined as 37-42 weeks’ gestation – between Jan. 1, 2010, and Dec. 31, 2012. Data on European births came from the Euro-Peristat database.
Data for preterm births put the United States in a somewhat better light: For births from 32 to 36 weeks, mortality rates were 8.24 per 1,000 in the United States and 8.25 for the six European countries; for births at 24-27 weeks, the rates were 199 in the United States and 213 for the Euro six, Dr. Bairoliya and Dr. Fink said.
The investigators did not receive any specific funding for the study, and they said that they had no relevant conflicts of interest.
SOURCE: Bairoliya N, Fink G. PLOS Med. 2018 Mar 20;15(3):e1002531.
FROM PLOS MEDICINE