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Obtaining coverage for transgender and gender-expansive youth
Transgender and gender-expansive youth face many barriers to health care. (Gender-expansive youth are defined as “youth who do not identify with traditional gender roles but are otherwise not confined to one gender narrative or experience.”) Although some of these youth may be fortunate to have a supportive family and access to health care providers proficient in transgender health care, they still face difficulties in having their insurance cover transgender-related services. This is not an impossible task, but it is a constant struggle for many clinicians.
In this column, I will provide some tips and strategies to help clinicians get insurance companies to cover these critical services. However, keep in mind that there is no one-size-fits-all approach to obtaining insurance coverage. In addition, growing uncertainty over the repeal of the Affordable Care Act (ACA) – which was critical in lifting many of the barriers to insurance coverage for transgender individuals – will make this task challenging.
Health insurance is extraordinarily complex. There are multiple private and public plans that vary in the services they cover. This variation is state dependent. And even within states, there is additional variability. Most health insurance plans are purchased by employers, and employers have a choice of what can be covered in their health plans. So even though an insurance company may state that it covers transgender-related services, the patient’s employer may pay for a plan that doesn’t cover such services. The only way to be sure whether a patient’s insurance will cover transgender-related services or not is to contact the insurance provider directly, but with extremely busy schedules and heavy patient loads, this is easier said than done. It would be helpful to have a social worker perform this task, but even having a social worker can be a luxury for some clinics.
The ACA made it easier for transgender individuals to obtain insurance coverage. Three years ago, the U.S. Department of Health and Human Services stated that Medicare’s longstanding exclusion of “transsexual surgical procedures” was no longer valid.1 Although it did not universally ban transgender exclusion policies, it did allow individual states to do so. Thirteen states have explicit policies that ban exclusions of transgender-related services in both private insurance and in Medicaid, and an additional five states have some policies that discourage such practices.2 This allowed some insurance providers and state Medicaid plans to offer coverage of transgender-related services.
Another challenge in obtaining insurance coverage for transgender and gender-expansive youth is claims denial for sex-specific procedures. For example, if a transwoman is designated as “male” in the electronic medical record and requires a breast ultrasound, the insurance company may automatically reject this claim because this procedure is covered for bodies designated as “female.” If the patient’s insurance plan covers transgender-related services, the clinic can notify the insurance company that the patient is transgender; if the patient’s plan does not, then the clinic will need to appeal to the insurance provider. Alternatively, for clinics associated with federally-funded institutions (e.g., most hospitals), the clinician can use Condition Code 45 in the billing to override the sex mismatch, although not all hospitals have implemented this code.3
1. Patient’s identifying information. Usually the patient’s name and date of birth is sufficient. Clinicians should use the patient’s preferred name in the letter, but provide the insurance or legal name of the patient so that the insurance provider can locate the patient’s records.
2. Result of a psychosocial evaluation and diagnosis (if any). Many insurance providers are looking specifically for the gender dysphoria diagnosis.
3. The duration of the referring health professional’s relationship with the patient, which includes the type of evaluation and therapy or counseling (e.g., cognitive behavior therapy or gender coaching).
4. An explanation that the criteria (usually from the World Professional Association for Transgender Health standard of care4 or the Endocrine Society Guidelines titled Endocrine Treatment of Transsexual Persons5) for hormone therapy have been met, and a brief description of the clinical rationale for supporting the client’s request for hormone therapy.
5. A statement that informed consent has been obtained from the patient (or parental permission if the patient is younger than 18 years).
6. A statement that the referring health professional is available for coordination of care.
If the clinician fails to convince the insurance provider of the necessity of covering transgender-related services, the patient still can pay out of pocket. Some hormones can be affordable to certain patients. In the state of Pennsylvania, for example, a 10-mL vial of testosterone can cost anywhere from $60 to $80, and may generally last anywhere from 10 weeks to a year, depending on dosage. Nevertheless, these costs still may be prohibitive for many transgender youth. Many are chronically unemployed or underemployed, or struggle with homelessness.6 Some transgender youth have to the face the excruciatingly difficult choice between having something to eat for the day or living another day with gender dysphoria.
Clinicians should work very hard to make sure that their transgender and gender-expansive patients obtain the care they need. The above strategies may help navigate the complex insurance system. However, insurance policies vary by state, and anti-trans discrimination creates additional barriers to health care. Therefore, clinicians who take care of transgender youth also should advocate for policies that protect these patients from discrimination, and they should advocate for policies that expand medical coverage for this vulnerable population.
Resources
• The Human Rights Campaign keeps a list of insurance plans that cover transgender-related services, but this list is far from comprehensive.
• Healthcare.gov provides some guidance on how to obtain coverage and navigate the insurance system for transgender individuals.
• UCSF Center of Excellence for Transgender Health provides some excellent resources and guidance on obtaining insurance coverage for transgender individuals.
References
1. LGBT Health 2014;1(4):256-8.
2. Map: State Health Insurance Rules: National Center for Transgender Equality, 2016 [Available from: www.transequality.org/issues/resources/map-state-health-insurance-rules].
3. Health insurance coverage issues for transgender people in the United States: University of California, San Fransisco Center of Excellence for Transgender Health, 2017 [Available from: http://transhealth.ucsf.edu/trans?page=guidelines-insurance].
4. International Journal of Transgenderism 2012;13(4):165-232.
5. J Clin Endocrinol Metab 2009;94(9):3132-54.
6. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011.
Transgender and gender-expansive youth face many barriers to health care. (Gender-expansive youth are defined as “youth who do not identify with traditional gender roles but are otherwise not confined to one gender narrative or experience.”) Although some of these youth may be fortunate to have a supportive family and access to health care providers proficient in transgender health care, they still face difficulties in having their insurance cover transgender-related services. This is not an impossible task, but it is a constant struggle for many clinicians.
In this column, I will provide some tips and strategies to help clinicians get insurance companies to cover these critical services. However, keep in mind that there is no one-size-fits-all approach to obtaining insurance coverage. In addition, growing uncertainty over the repeal of the Affordable Care Act (ACA) – which was critical in lifting many of the barriers to insurance coverage for transgender individuals – will make this task challenging.
Health insurance is extraordinarily complex. There are multiple private and public plans that vary in the services they cover. This variation is state dependent. And even within states, there is additional variability. Most health insurance plans are purchased by employers, and employers have a choice of what can be covered in their health plans. So even though an insurance company may state that it covers transgender-related services, the patient’s employer may pay for a plan that doesn’t cover such services. The only way to be sure whether a patient’s insurance will cover transgender-related services or not is to contact the insurance provider directly, but with extremely busy schedules and heavy patient loads, this is easier said than done. It would be helpful to have a social worker perform this task, but even having a social worker can be a luxury for some clinics.
The ACA made it easier for transgender individuals to obtain insurance coverage. Three years ago, the U.S. Department of Health and Human Services stated that Medicare’s longstanding exclusion of “transsexual surgical procedures” was no longer valid.1 Although it did not universally ban transgender exclusion policies, it did allow individual states to do so. Thirteen states have explicit policies that ban exclusions of transgender-related services in both private insurance and in Medicaid, and an additional five states have some policies that discourage such practices.2 This allowed some insurance providers and state Medicaid plans to offer coverage of transgender-related services.
Another challenge in obtaining insurance coverage for transgender and gender-expansive youth is claims denial for sex-specific procedures. For example, if a transwoman is designated as “male” in the electronic medical record and requires a breast ultrasound, the insurance company may automatically reject this claim because this procedure is covered for bodies designated as “female.” If the patient’s insurance plan covers transgender-related services, the clinic can notify the insurance company that the patient is transgender; if the patient’s plan does not, then the clinic will need to appeal to the insurance provider. Alternatively, for clinics associated with federally-funded institutions (e.g., most hospitals), the clinician can use Condition Code 45 in the billing to override the sex mismatch, although not all hospitals have implemented this code.3
1. Patient’s identifying information. Usually the patient’s name and date of birth is sufficient. Clinicians should use the patient’s preferred name in the letter, but provide the insurance or legal name of the patient so that the insurance provider can locate the patient’s records.
2. Result of a psychosocial evaluation and diagnosis (if any). Many insurance providers are looking specifically for the gender dysphoria diagnosis.
3. The duration of the referring health professional’s relationship with the patient, which includes the type of evaluation and therapy or counseling (e.g., cognitive behavior therapy or gender coaching).
4. An explanation that the criteria (usually from the World Professional Association for Transgender Health standard of care4 or the Endocrine Society Guidelines titled Endocrine Treatment of Transsexual Persons5) for hormone therapy have been met, and a brief description of the clinical rationale for supporting the client’s request for hormone therapy.
5. A statement that informed consent has been obtained from the patient (or parental permission if the patient is younger than 18 years).
6. A statement that the referring health professional is available for coordination of care.
If the clinician fails to convince the insurance provider of the necessity of covering transgender-related services, the patient still can pay out of pocket. Some hormones can be affordable to certain patients. In the state of Pennsylvania, for example, a 10-mL vial of testosterone can cost anywhere from $60 to $80, and may generally last anywhere from 10 weeks to a year, depending on dosage. Nevertheless, these costs still may be prohibitive for many transgender youth. Many are chronically unemployed or underemployed, or struggle with homelessness.6 Some transgender youth have to the face the excruciatingly difficult choice between having something to eat for the day or living another day with gender dysphoria.
Clinicians should work very hard to make sure that their transgender and gender-expansive patients obtain the care they need. The above strategies may help navigate the complex insurance system. However, insurance policies vary by state, and anti-trans discrimination creates additional barriers to health care. Therefore, clinicians who take care of transgender youth also should advocate for policies that protect these patients from discrimination, and they should advocate for policies that expand medical coverage for this vulnerable population.
Resources
• The Human Rights Campaign keeps a list of insurance plans that cover transgender-related services, but this list is far from comprehensive.
• Healthcare.gov provides some guidance on how to obtain coverage and navigate the insurance system for transgender individuals.
• UCSF Center of Excellence for Transgender Health provides some excellent resources and guidance on obtaining insurance coverage for transgender individuals.
References
1. LGBT Health 2014;1(4):256-8.
2. Map: State Health Insurance Rules: National Center for Transgender Equality, 2016 [Available from: www.transequality.org/issues/resources/map-state-health-insurance-rules].
3. Health insurance coverage issues for transgender people in the United States: University of California, San Fransisco Center of Excellence for Transgender Health, 2017 [Available from: http://transhealth.ucsf.edu/trans?page=guidelines-insurance].
4. International Journal of Transgenderism 2012;13(4):165-232.
5. J Clin Endocrinol Metab 2009;94(9):3132-54.
6. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011.
Transgender and gender-expansive youth face many barriers to health care. (Gender-expansive youth are defined as “youth who do not identify with traditional gender roles but are otherwise not confined to one gender narrative or experience.”) Although some of these youth may be fortunate to have a supportive family and access to health care providers proficient in transgender health care, they still face difficulties in having their insurance cover transgender-related services. This is not an impossible task, but it is a constant struggle for many clinicians.
In this column, I will provide some tips and strategies to help clinicians get insurance companies to cover these critical services. However, keep in mind that there is no one-size-fits-all approach to obtaining insurance coverage. In addition, growing uncertainty over the repeal of the Affordable Care Act (ACA) – which was critical in lifting many of the barriers to insurance coverage for transgender individuals – will make this task challenging.
Health insurance is extraordinarily complex. There are multiple private and public plans that vary in the services they cover. This variation is state dependent. And even within states, there is additional variability. Most health insurance plans are purchased by employers, and employers have a choice of what can be covered in their health plans. So even though an insurance company may state that it covers transgender-related services, the patient’s employer may pay for a plan that doesn’t cover such services. The only way to be sure whether a patient’s insurance will cover transgender-related services or not is to contact the insurance provider directly, but with extremely busy schedules and heavy patient loads, this is easier said than done. It would be helpful to have a social worker perform this task, but even having a social worker can be a luxury for some clinics.
The ACA made it easier for transgender individuals to obtain insurance coverage. Three years ago, the U.S. Department of Health and Human Services stated that Medicare’s longstanding exclusion of “transsexual surgical procedures” was no longer valid.1 Although it did not universally ban transgender exclusion policies, it did allow individual states to do so. Thirteen states have explicit policies that ban exclusions of transgender-related services in both private insurance and in Medicaid, and an additional five states have some policies that discourage such practices.2 This allowed some insurance providers and state Medicaid plans to offer coverage of transgender-related services.
Another challenge in obtaining insurance coverage for transgender and gender-expansive youth is claims denial for sex-specific procedures. For example, if a transwoman is designated as “male” in the electronic medical record and requires a breast ultrasound, the insurance company may automatically reject this claim because this procedure is covered for bodies designated as “female.” If the patient’s insurance plan covers transgender-related services, the clinic can notify the insurance company that the patient is transgender; if the patient’s plan does not, then the clinic will need to appeal to the insurance provider. Alternatively, for clinics associated with federally-funded institutions (e.g., most hospitals), the clinician can use Condition Code 45 in the billing to override the sex mismatch, although not all hospitals have implemented this code.3
1. Patient’s identifying information. Usually the patient’s name and date of birth is sufficient. Clinicians should use the patient’s preferred name in the letter, but provide the insurance or legal name of the patient so that the insurance provider can locate the patient’s records.
2. Result of a psychosocial evaluation and diagnosis (if any). Many insurance providers are looking specifically for the gender dysphoria diagnosis.
3. The duration of the referring health professional’s relationship with the patient, which includes the type of evaluation and therapy or counseling (e.g., cognitive behavior therapy or gender coaching).
4. An explanation that the criteria (usually from the World Professional Association for Transgender Health standard of care4 or the Endocrine Society Guidelines titled Endocrine Treatment of Transsexual Persons5) for hormone therapy have been met, and a brief description of the clinical rationale for supporting the client’s request for hormone therapy.
5. A statement that informed consent has been obtained from the patient (or parental permission if the patient is younger than 18 years).
6. A statement that the referring health professional is available for coordination of care.
If the clinician fails to convince the insurance provider of the necessity of covering transgender-related services, the patient still can pay out of pocket. Some hormones can be affordable to certain patients. In the state of Pennsylvania, for example, a 10-mL vial of testosterone can cost anywhere from $60 to $80, and may generally last anywhere from 10 weeks to a year, depending on dosage. Nevertheless, these costs still may be prohibitive for many transgender youth. Many are chronically unemployed or underemployed, or struggle with homelessness.6 Some transgender youth have to the face the excruciatingly difficult choice between having something to eat for the day or living another day with gender dysphoria.
Clinicians should work very hard to make sure that their transgender and gender-expansive patients obtain the care they need. The above strategies may help navigate the complex insurance system. However, insurance policies vary by state, and anti-trans discrimination creates additional barriers to health care. Therefore, clinicians who take care of transgender youth also should advocate for policies that protect these patients from discrimination, and they should advocate for policies that expand medical coverage for this vulnerable population.
Resources
• The Human Rights Campaign keeps a list of insurance plans that cover transgender-related services, but this list is far from comprehensive.
• Healthcare.gov provides some guidance on how to obtain coverage and navigate the insurance system for transgender individuals.
• UCSF Center of Excellence for Transgender Health provides some excellent resources and guidance on obtaining insurance coverage for transgender individuals.
References
1. LGBT Health 2014;1(4):256-8.
2. Map: State Health Insurance Rules: National Center for Transgender Equality, 2016 [Available from: www.transequality.org/issues/resources/map-state-health-insurance-rules].
3. Health insurance coverage issues for transgender people in the United States: University of California, San Fransisco Center of Excellence for Transgender Health, 2017 [Available from: http://transhealth.ucsf.edu/trans?page=guidelines-insurance].
4. International Journal of Transgenderism 2012;13(4):165-232.
5. J Clin Endocrinol Metab 2009;94(9):3132-54.
6. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011.
Why extended release metformin?
“TREATING POLYCYSTIC OVARY SYNDROME: START USING DUAL MEDICAL THERAPY”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2017)
Why extended release metformin?
I read with interest Dr. Barbieri’s editorial on polycystic ovary syndrome. It left me wondering: Is there a metabolic or pharmacologic reason why you give metformin XR 1,500 mg with dinner instead of 750 mg orally twice per day?
Marcelo Andreoli, MD
Vienna, Virginia
Dr. Barbieri responds
I thank Dr. Andreoli for the important clinical question about one-time or multiple dosing of metformin. To improve patient adherence with metformin treatment, I think once-daily dosing at dinner with an extended-release formulation is more convenient than twice-daily dosing with immediate-release metformin. Following ingestion of immediate- or extended-release metformin, peak metformin blood concentrations are achieved after 2 and 7 hours, respectively.1 There is some evidence that extended-release metformin has fewer gastrointestinal (GI) adverse effects than immediate-release metformin.2 In one study, the reported rates of GI adverse effects were 29% versus 39% with extended-release and immediate-release formulations, respectively.2
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Ali S, Fonseca V. Overview of metformin: special focus on metformin extended release. Expert Opin Pharmacother. 2012;13(12):1797–1805.
- Fujioka K, Pans M, Joyal S. Glycemic control in patients with type 2 diabetes mellitus switched from twice-daily immediate-release metformin to a once-daily extended-release formulation. Clin Ther. 2003;25(2):515–529.
“TREATING POLYCYSTIC OVARY SYNDROME: START USING DUAL MEDICAL THERAPY”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2017)
Why extended release metformin?
I read with interest Dr. Barbieri’s editorial on polycystic ovary syndrome. It left me wondering: Is there a metabolic or pharmacologic reason why you give metformin XR 1,500 mg with dinner instead of 750 mg orally twice per day?
Marcelo Andreoli, MD
Vienna, Virginia
Dr. Barbieri responds
I thank Dr. Andreoli for the important clinical question about one-time or multiple dosing of metformin. To improve patient adherence with metformin treatment, I think once-daily dosing at dinner with an extended-release formulation is more convenient than twice-daily dosing with immediate-release metformin. Following ingestion of immediate- or extended-release metformin, peak metformin blood concentrations are achieved after 2 and 7 hours, respectively.1 There is some evidence that extended-release metformin has fewer gastrointestinal (GI) adverse effects than immediate-release metformin.2 In one study, the reported rates of GI adverse effects were 29% versus 39% with extended-release and immediate-release formulations, respectively.2
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
“TREATING POLYCYSTIC OVARY SYNDROME: START USING DUAL MEDICAL THERAPY”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2017)
Why extended release metformin?
I read with interest Dr. Barbieri’s editorial on polycystic ovary syndrome. It left me wondering: Is there a metabolic or pharmacologic reason why you give metformin XR 1,500 mg with dinner instead of 750 mg orally twice per day?
Marcelo Andreoli, MD
Vienna, Virginia
Dr. Barbieri responds
I thank Dr. Andreoli for the important clinical question about one-time or multiple dosing of metformin. To improve patient adherence with metformin treatment, I think once-daily dosing at dinner with an extended-release formulation is more convenient than twice-daily dosing with immediate-release metformin. Following ingestion of immediate- or extended-release metformin, peak metformin blood concentrations are achieved after 2 and 7 hours, respectively.1 There is some evidence that extended-release metformin has fewer gastrointestinal (GI) adverse effects than immediate-release metformin.2 In one study, the reported rates of GI adverse effects were 29% versus 39% with extended-release and immediate-release formulations, respectively.2
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Ali S, Fonseca V. Overview of metformin: special focus on metformin extended release. Expert Opin Pharmacother. 2012;13(12):1797–1805.
- Fujioka K, Pans M, Joyal S. Glycemic control in patients with type 2 diabetes mellitus switched from twice-daily immediate-release metformin to a once-daily extended-release formulation. Clin Ther. 2003;25(2):515–529.
- Ali S, Fonseca V. Overview of metformin: special focus on metformin extended release. Expert Opin Pharmacother. 2012;13(12):1797–1805.
- Fujioka K, Pans M, Joyal S. Glycemic control in patients with type 2 diabetes mellitus switched from twice-daily immediate-release metformin to a once-daily extended-release formulation. Clin Ther. 2003;25(2):515–529.
Look for symptoms of IBS, PCOS, and PMS
“WHY ARE THERE DELAYS IN THE DIAGNOSIS OF ENDOMETRIOSIS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2017)
Look for symptoms of IBS, PCOS, and PMS
I practiced reproductive endocrinology for 40 years and saw too many patients whose endometriosis had been ignored or undertreated. I found that the initial suspicion for the disease could be discovered by looking for symptoms of 3 comorbidities: irritable bowel syndrome, polycystic ovary syndrome, and premenstrual syndrome.
Wilbur (Dub) Howard, MD
Dallas, Texas
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
“WHY ARE THERE DELAYS IN THE DIAGNOSIS OF ENDOMETRIOSIS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2017)
Look for symptoms of IBS, PCOS, and PMS
I practiced reproductive endocrinology for 40 years and saw too many patients whose endometriosis had been ignored or undertreated. I found that the initial suspicion for the disease could be discovered by looking for symptoms of 3 comorbidities: irritable bowel syndrome, polycystic ovary syndrome, and premenstrual syndrome.
Wilbur (Dub) Howard, MD
Dallas, Texas
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
“WHY ARE THERE DELAYS IN THE DIAGNOSIS OF ENDOMETRIOSIS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2017)
Look for symptoms of IBS, PCOS, and PMS
I practiced reproductive endocrinology for 40 years and saw too many patients whose endometriosis had been ignored or undertreated. I found that the initial suspicion for the disease could be discovered by looking for symptoms of 3 comorbidities: irritable bowel syndrome, polycystic ovary syndrome, and premenstrual syndrome.
Wilbur (Dub) Howard, MD
Dallas, Texas
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
The fallopian tube should have been removed
OBIANUJU SANDRA MADUEKE-LAVEAUX, MD, MPH; BETH W. RACKOW, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JANUARY 2017)
The fallopian tube should have been removed
I watched the video by Dr. Advincula and colleagues and as always was impressed with the surgical skills demonstrated. While the robot-assisted approach is quite nice, this case could have been accomplished with only three 5-mm lower abdominal port sites and traditional straight-stick laparoscopic methods. The cosmetic benefit to a 15-year-old patient of this alternative should have been considered.
More importantly, the fallopian tube separated from the rudimentary horn should have been removed. Leaving the right tube in situ exposes the patient to the possibility of a future ectopic pregnancy in that tube and provides no benefit to the patient.
David L. Zisow, MD
Baltimore, Maryland
Dr. Advincula and team respond
We appreciate Dr. Zisow’s perspective. As is known, tool selection is based on surgeon preference. Inherent to this point, a discussion about route of surgery, and any implications it would have, such as cosmesis, was had. Cosmesis was not an issue with this patient, and she was quite pleased with her cosmetic outcome.
We also discussed preoperatively, among our team and with the patient, the right fallopian tube. Although removal would have been optimal, there was concern intraoperatively of possible compromise to the ovary. Hence, a decision was made to forego removal particularly in light of the extremely rare risk of transperitoneal migration of spermatozoa weighed against the risk of compromising a perfectly healthy ovary in a 15-year-old woman.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
OBIANUJU SANDRA MADUEKE-LAVEAUX, MD, MPH; BETH W. RACKOW, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JANUARY 2017)
The fallopian tube should have been removed
I watched the video by Dr. Advincula and colleagues and as always was impressed with the surgical skills demonstrated. While the robot-assisted approach is quite nice, this case could have been accomplished with only three 5-mm lower abdominal port sites and traditional straight-stick laparoscopic methods. The cosmetic benefit to a 15-year-old patient of this alternative should have been considered.
More importantly, the fallopian tube separated from the rudimentary horn should have been removed. Leaving the right tube in situ exposes the patient to the possibility of a future ectopic pregnancy in that tube and provides no benefit to the patient.
David L. Zisow, MD
Baltimore, Maryland
Dr. Advincula and team respond
We appreciate Dr. Zisow’s perspective. As is known, tool selection is based on surgeon preference. Inherent to this point, a discussion about route of surgery, and any implications it would have, such as cosmesis, was had. Cosmesis was not an issue with this patient, and she was quite pleased with her cosmetic outcome.
We also discussed preoperatively, among our team and with the patient, the right fallopian tube. Although removal would have been optimal, there was concern intraoperatively of possible compromise to the ovary. Hence, a decision was made to forego removal particularly in light of the extremely rare risk of transperitoneal migration of spermatozoa weighed against the risk of compromising a perfectly healthy ovary in a 15-year-old woman.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
OBIANUJU SANDRA MADUEKE-LAVEAUX, MD, MPH; BETH W. RACKOW, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JANUARY 2017)
The fallopian tube should have been removed
I watched the video by Dr. Advincula and colleagues and as always was impressed with the surgical skills demonstrated. While the robot-assisted approach is quite nice, this case could have been accomplished with only three 5-mm lower abdominal port sites and traditional straight-stick laparoscopic methods. The cosmetic benefit to a 15-year-old patient of this alternative should have been considered.
More importantly, the fallopian tube separated from the rudimentary horn should have been removed. Leaving the right tube in situ exposes the patient to the possibility of a future ectopic pregnancy in that tube and provides no benefit to the patient.
David L. Zisow, MD
Baltimore, Maryland
Dr. Advincula and team respond
We appreciate Dr. Zisow’s perspective. As is known, tool selection is based on surgeon preference. Inherent to this point, a discussion about route of surgery, and any implications it would have, such as cosmesis, was had. Cosmesis was not an issue with this patient, and she was quite pleased with her cosmetic outcome.
We also discussed preoperatively, among our team and with the patient, the right fallopian tube. Although removal would have been optimal, there was concern intraoperatively of possible compromise to the ovary. Hence, a decision was made to forego removal particularly in light of the extremely rare risk of transperitoneal migration of spermatozoa weighed against the risk of compromising a perfectly healthy ovary in a 15-year-old woman.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
VIDEO: Does biologic immunogenicity matter in daily practice?
MADRID – Measuring the formation of antibodies against biologic agents has no real value in daily practice as their presence or absence does not really change how patients are likely to be treated, Johannes W.J. Bijlsma, MD, observed at the European Congress of Rheumatology.
Consider a female patient who is 59 years old, diagnosed with rheumatoid arthritis (RA) in 2014, he said. She was being treated with methotrexate at a dose of 20 mg with additional glucocorticoids, initially given at a dose of 10 mg, reduced to 5 mg after 2 years, and then stopped. The patient experiences a disease flare, however, and for various other reasons is given a tumor necrosis factor inhibitor (TNFi). She does well initially but then has another flare, so would there be any point of measuring anti-drug antibodies (ADAbs) as this point? Not really, Dr. Bijlsma suggested, as the same decision to change the biologic agent would probably result if ADAbs were detected or not.
“If I do not measure them, I decide to change the biological. If I measure them and they are present, I change the biological, and if they are absent, I still change the biological,” said Dr. Bijlsma, professor and head of the department of rheumatology and clinical immunology at University Medical Center Utrecht (the Netherlands).
Following the European League Against Rheumatism (EULAR) recommendations for biologic disease-modifying antirheumatic drug (bDMARD) use (Ann Rheum Dis. 2017;76:960-77) would then mean that the first bDMARD, in this case adalimumab (Humira), would be replaced by another biologic with a different mechanism of action or a second TNFi.
“The immune response is always there,” Dr. Bijlsma said. It does not matter what or how it is administered, introducing any foreign protein, humanized or not, will instigate some kind of immune reaction, he said. The extent to which an immune reaction is raised might vary between biologic agents, but it will be there. He cited a review paper (Rheumatology [Oxford]. 2016;55:210-20) showing that the mean estimated occurrence of ADAbs in patients with RA ranges from 0.6% with the interleukin-6-targeting agent tocilizumab (Actemra) to 30% with infliximab (Remicade).
Measuring the level of ADAbs becomes problematic when considering that different biologics will induce different levels of immune response. The level of detection also will be dependent on which of three current types of assays are used. In addition, “humanization of biological agents is not the key point in preventing anti-drug antibodies,” Dr. Bijlsma said, pointing out that the prevalence of ADAbs against adalimumab did not appear to by any lower than ADAbs against infliximab.
Preventing ADAbs can be achieved by co-administering methotrexate or alternating the treatment schedule, Dr. Bijlsma said. Treatment with methotrexate, which is usually continued when patients start a biologic, “diminishes the immune response,” he noted. Indeed, while 50% of patients who are not treated with this conventional DMARD develop ADAbs, only 14%-35% develop them while taking methotrexate, depending on the dose used.
It is likely to be more useful in clinical practice to measure individual patients’ drug trough levels than to measure ADAb levels, he suggested, with dosing continued or adjusted accordingly for each patient. Using drug trough levels to personalize adalimumab treatment has been tested (Ann Rheum Dis. 2015;74:361-8) using a theoretical algorithm based on whether patients achieve a EULAR response at 6 months. If they do achieve a EULAR response and drug trough levels are between 5 and 12 mg/L or greater than 12 mg/L, then adalimumab treatment should continue. However, if the trough levels fall below 5 mg/L, there is probably no point in continuing treatment and this TNFi should be stopped. If patients do not respond and drug testing shows a trough level above 5 mg/L, then a switch to infliximab might be advantageous, while a trough level below this threshold could indicated that a TNFi with a lower immunogenic potential such as etanercept might be a better choice.
Using drug trough levels is still very much research based right now and is not ready for clinical practice just yet, but the theory is that it could help decide if patients should continue, stop, or perhaps switch their biologic, Dr. Bijlsma said.
Dr. Bijlsma spoke about these issues in a video interview at the congress.
Dr. Bijlsma has worked with many of the pharmaceutical companies that produce biologic agents for the management of rheumatic diseases but had no specific disclosures in relation to his comments.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MADRID – Measuring the formation of antibodies against biologic agents has no real value in daily practice as their presence or absence does not really change how patients are likely to be treated, Johannes W.J. Bijlsma, MD, observed at the European Congress of Rheumatology.
Consider a female patient who is 59 years old, diagnosed with rheumatoid arthritis (RA) in 2014, he said. She was being treated with methotrexate at a dose of 20 mg with additional glucocorticoids, initially given at a dose of 10 mg, reduced to 5 mg after 2 years, and then stopped. The patient experiences a disease flare, however, and for various other reasons is given a tumor necrosis factor inhibitor (TNFi). She does well initially but then has another flare, so would there be any point of measuring anti-drug antibodies (ADAbs) as this point? Not really, Dr. Bijlsma suggested, as the same decision to change the biologic agent would probably result if ADAbs were detected or not.
“If I do not measure them, I decide to change the biological. If I measure them and they are present, I change the biological, and if they are absent, I still change the biological,” said Dr. Bijlsma, professor and head of the department of rheumatology and clinical immunology at University Medical Center Utrecht (the Netherlands).
Following the European League Against Rheumatism (EULAR) recommendations for biologic disease-modifying antirheumatic drug (bDMARD) use (Ann Rheum Dis. 2017;76:960-77) would then mean that the first bDMARD, in this case adalimumab (Humira), would be replaced by another biologic with a different mechanism of action or a second TNFi.
“The immune response is always there,” Dr. Bijlsma said. It does not matter what or how it is administered, introducing any foreign protein, humanized or not, will instigate some kind of immune reaction, he said. The extent to which an immune reaction is raised might vary between biologic agents, but it will be there. He cited a review paper (Rheumatology [Oxford]. 2016;55:210-20) showing that the mean estimated occurrence of ADAbs in patients with RA ranges from 0.6% with the interleukin-6-targeting agent tocilizumab (Actemra) to 30% with infliximab (Remicade).
Measuring the level of ADAbs becomes problematic when considering that different biologics will induce different levels of immune response. The level of detection also will be dependent on which of three current types of assays are used. In addition, “humanization of biological agents is not the key point in preventing anti-drug antibodies,” Dr. Bijlsma said, pointing out that the prevalence of ADAbs against adalimumab did not appear to by any lower than ADAbs against infliximab.
Preventing ADAbs can be achieved by co-administering methotrexate or alternating the treatment schedule, Dr. Bijlsma said. Treatment with methotrexate, which is usually continued when patients start a biologic, “diminishes the immune response,” he noted. Indeed, while 50% of patients who are not treated with this conventional DMARD develop ADAbs, only 14%-35% develop them while taking methotrexate, depending on the dose used.
It is likely to be more useful in clinical practice to measure individual patients’ drug trough levels than to measure ADAb levels, he suggested, with dosing continued or adjusted accordingly for each patient. Using drug trough levels to personalize adalimumab treatment has been tested (Ann Rheum Dis. 2015;74:361-8) using a theoretical algorithm based on whether patients achieve a EULAR response at 6 months. If they do achieve a EULAR response and drug trough levels are between 5 and 12 mg/L or greater than 12 mg/L, then adalimumab treatment should continue. However, if the trough levels fall below 5 mg/L, there is probably no point in continuing treatment and this TNFi should be stopped. If patients do not respond and drug testing shows a trough level above 5 mg/L, then a switch to infliximab might be advantageous, while a trough level below this threshold could indicated that a TNFi with a lower immunogenic potential such as etanercept might be a better choice.
Using drug trough levels is still very much research based right now and is not ready for clinical practice just yet, but the theory is that it could help decide if patients should continue, stop, or perhaps switch their biologic, Dr. Bijlsma said.
Dr. Bijlsma spoke about these issues in a video interview at the congress.
Dr. Bijlsma has worked with many of the pharmaceutical companies that produce biologic agents for the management of rheumatic diseases but had no specific disclosures in relation to his comments.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MADRID – Measuring the formation of antibodies against biologic agents has no real value in daily practice as their presence or absence does not really change how patients are likely to be treated, Johannes W.J. Bijlsma, MD, observed at the European Congress of Rheumatology.
Consider a female patient who is 59 years old, diagnosed with rheumatoid arthritis (RA) in 2014, he said. She was being treated with methotrexate at a dose of 20 mg with additional glucocorticoids, initially given at a dose of 10 mg, reduced to 5 mg after 2 years, and then stopped. The patient experiences a disease flare, however, and for various other reasons is given a tumor necrosis factor inhibitor (TNFi). She does well initially but then has another flare, so would there be any point of measuring anti-drug antibodies (ADAbs) as this point? Not really, Dr. Bijlsma suggested, as the same decision to change the biologic agent would probably result if ADAbs were detected or not.
“If I do not measure them, I decide to change the biological. If I measure them and they are present, I change the biological, and if they are absent, I still change the biological,” said Dr. Bijlsma, professor and head of the department of rheumatology and clinical immunology at University Medical Center Utrecht (the Netherlands).
Following the European League Against Rheumatism (EULAR) recommendations for biologic disease-modifying antirheumatic drug (bDMARD) use (Ann Rheum Dis. 2017;76:960-77) would then mean that the first bDMARD, in this case adalimumab (Humira), would be replaced by another biologic with a different mechanism of action or a second TNFi.
“The immune response is always there,” Dr. Bijlsma said. It does not matter what or how it is administered, introducing any foreign protein, humanized or not, will instigate some kind of immune reaction, he said. The extent to which an immune reaction is raised might vary between biologic agents, but it will be there. He cited a review paper (Rheumatology [Oxford]. 2016;55:210-20) showing that the mean estimated occurrence of ADAbs in patients with RA ranges from 0.6% with the interleukin-6-targeting agent tocilizumab (Actemra) to 30% with infliximab (Remicade).
Measuring the level of ADAbs becomes problematic when considering that different biologics will induce different levels of immune response. The level of detection also will be dependent on which of three current types of assays are used. In addition, “humanization of biological agents is not the key point in preventing anti-drug antibodies,” Dr. Bijlsma said, pointing out that the prevalence of ADAbs against adalimumab did not appear to by any lower than ADAbs against infliximab.
Preventing ADAbs can be achieved by co-administering methotrexate or alternating the treatment schedule, Dr. Bijlsma said. Treatment with methotrexate, which is usually continued when patients start a biologic, “diminishes the immune response,” he noted. Indeed, while 50% of patients who are not treated with this conventional DMARD develop ADAbs, only 14%-35% develop them while taking methotrexate, depending on the dose used.
It is likely to be more useful in clinical practice to measure individual patients’ drug trough levels than to measure ADAb levels, he suggested, with dosing continued or adjusted accordingly for each patient. Using drug trough levels to personalize adalimumab treatment has been tested (Ann Rheum Dis. 2015;74:361-8) using a theoretical algorithm based on whether patients achieve a EULAR response at 6 months. If they do achieve a EULAR response and drug trough levels are between 5 and 12 mg/L or greater than 12 mg/L, then adalimumab treatment should continue. However, if the trough levels fall below 5 mg/L, there is probably no point in continuing treatment and this TNFi should be stopped. If patients do not respond and drug testing shows a trough level above 5 mg/L, then a switch to infliximab might be advantageous, while a trough level below this threshold could indicated that a TNFi with a lower immunogenic potential such as etanercept might be a better choice.
Using drug trough levels is still very much research based right now and is not ready for clinical practice just yet, but the theory is that it could help decide if patients should continue, stop, or perhaps switch their biologic, Dr. Bijlsma said.
Dr. Bijlsma spoke about these issues in a video interview at the congress.
Dr. Bijlsma has worked with many of the pharmaceutical companies that produce biologic agents for the management of rheumatic diseases but had no specific disclosures in relation to his comments.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM THE EULAR 2017 CONGRESS
Hysteroscopy equipment too expensive for employed or small-group practitioners
“2017 UPDATE ON ABNORMAL UTERINE BLEEDING”
HOWARD T. SHARP, MD, AND MARISSA ADELMAN, MD (APRIL 2017)
Hysteroscopy equipment too expensive for employed or small-group practitioners
I could not agree more with Drs. Sharp and Adelman that diagnostic hysteroscopy should be performed in the office whenever possible. However, as a solo gynecologist in private practice, I could not afford or justify the cost of purchasing the equipment as well as its care and maintenance. Sometimes I was able to bring a third-party vendor to provide the equipment and a technician so that I could perform a diagnostic hysteroscopy in my office when I did an ablation with my own Thermachoice equipment and balloon system.
The hysteroscopy was bundled/required for the Current Procedural Terminology (CPT) code to work in the office. Most of these patients already had undergone an ultrasonography, endometrial biopsy, and some had an outpatient hysteroscopic dilation and curettage under general anesthesia, which did not resolve their bleeding. All of this adds to the cost and increased patient discomfort and inconvenience. Reimbursement for the office procedure was better than when performed at the hospital, and patients avoided $500 to $1,000 copays to the hospital and anesthesiologist.
When I closed my private practice and became employed by the hospital, I proposed that they purchase office hysteroscopy equipment for the other gynecologist and me to share. I continued to perform uterine ablations with my own equipment. Together we performed more than 100 outpatient diagnostic hysteroscopies per year, some with global endometrial ablation. Since there were only 2 gyns, the 2 new hysteroscopy sets they purchased sat in the closet most of the time.
I suggested they “lease” the equipment back to us on a case-by-case basis for office use since they owned and managed our practices. The hospital administration basically saw office procedures as taking away revenue from the hospital and decreasing operating room volume. The patients I treated in the office setting did well, preferred to avoid general anesthesia, and enjoyed the cost savings.
Large ObGyn groups with multiple providers and high volumes can justify the expenses of the equipment, but for those in solo practice or employed by a hospital, it may not be feasible. I sincerely hope that articles focusing on in-office hysteroscopy will open up the discussion to enable and encourage more physicians and hospital administrators to see the advantages of office-based procedures.
Steven R. Moffett, MD
Knoxville, Tennessee
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
“2017 UPDATE ON ABNORMAL UTERINE BLEEDING”
HOWARD T. SHARP, MD, AND MARISSA ADELMAN, MD (APRIL 2017)
Hysteroscopy equipment too expensive for employed or small-group practitioners
I could not agree more with Drs. Sharp and Adelman that diagnostic hysteroscopy should be performed in the office whenever possible. However, as a solo gynecologist in private practice, I could not afford or justify the cost of purchasing the equipment as well as its care and maintenance. Sometimes I was able to bring a third-party vendor to provide the equipment and a technician so that I could perform a diagnostic hysteroscopy in my office when I did an ablation with my own Thermachoice equipment and balloon system.
The hysteroscopy was bundled/required for the Current Procedural Terminology (CPT) code to work in the office. Most of these patients already had undergone an ultrasonography, endometrial biopsy, and some had an outpatient hysteroscopic dilation and curettage under general anesthesia, which did not resolve their bleeding. All of this adds to the cost and increased patient discomfort and inconvenience. Reimbursement for the office procedure was better than when performed at the hospital, and patients avoided $500 to $1,000 copays to the hospital and anesthesiologist.
When I closed my private practice and became employed by the hospital, I proposed that they purchase office hysteroscopy equipment for the other gynecologist and me to share. I continued to perform uterine ablations with my own equipment. Together we performed more than 100 outpatient diagnostic hysteroscopies per year, some with global endometrial ablation. Since there were only 2 gyns, the 2 new hysteroscopy sets they purchased sat in the closet most of the time.
I suggested they “lease” the equipment back to us on a case-by-case basis for office use since they owned and managed our practices. The hospital administration basically saw office procedures as taking away revenue from the hospital and decreasing operating room volume. The patients I treated in the office setting did well, preferred to avoid general anesthesia, and enjoyed the cost savings.
Large ObGyn groups with multiple providers and high volumes can justify the expenses of the equipment, but for those in solo practice or employed by a hospital, it may not be feasible. I sincerely hope that articles focusing on in-office hysteroscopy will open up the discussion to enable and encourage more physicians and hospital administrators to see the advantages of office-based procedures.
Steven R. Moffett, MD
Knoxville, Tennessee
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
“2017 UPDATE ON ABNORMAL UTERINE BLEEDING”
HOWARD T. SHARP, MD, AND MARISSA ADELMAN, MD (APRIL 2017)
Hysteroscopy equipment too expensive for employed or small-group practitioners
I could not agree more with Drs. Sharp and Adelman that diagnostic hysteroscopy should be performed in the office whenever possible. However, as a solo gynecologist in private practice, I could not afford or justify the cost of purchasing the equipment as well as its care and maintenance. Sometimes I was able to bring a third-party vendor to provide the equipment and a technician so that I could perform a diagnostic hysteroscopy in my office when I did an ablation with my own Thermachoice equipment and balloon system.
The hysteroscopy was bundled/required for the Current Procedural Terminology (CPT) code to work in the office. Most of these patients already had undergone an ultrasonography, endometrial biopsy, and some had an outpatient hysteroscopic dilation and curettage under general anesthesia, which did not resolve their bleeding. All of this adds to the cost and increased patient discomfort and inconvenience. Reimbursement for the office procedure was better than when performed at the hospital, and patients avoided $500 to $1,000 copays to the hospital and anesthesiologist.
When I closed my private practice and became employed by the hospital, I proposed that they purchase office hysteroscopy equipment for the other gynecologist and me to share. I continued to perform uterine ablations with my own equipment. Together we performed more than 100 outpatient diagnostic hysteroscopies per year, some with global endometrial ablation. Since there were only 2 gyns, the 2 new hysteroscopy sets they purchased sat in the closet most of the time.
I suggested they “lease” the equipment back to us on a case-by-case basis for office use since they owned and managed our practices. The hospital administration basically saw office procedures as taking away revenue from the hospital and decreasing operating room volume. The patients I treated in the office setting did well, preferred to avoid general anesthesia, and enjoyed the cost savings.
Large ObGyn groups with multiple providers and high volumes can justify the expenses of the equipment, but for those in solo practice or employed by a hospital, it may not be feasible. I sincerely hope that articles focusing on in-office hysteroscopy will open up the discussion to enable and encourage more physicians and hospital administrators to see the advantages of office-based procedures.
Steven R. Moffett, MD
Knoxville, Tennessee
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Poll: Most voters oppose House and Senate health care bills
Voters in nearly every region of the United States are opposed to the health reform bills that have been proposed in the House and Senate, according to a poll by the American Medical Association.
Surveys conducted in Alaska, Arkansas, Colorado, Nevada, Ohio, Tennessee, and West Virginia showed that voters in each state had an overall low opinion of the House-passed American Health Care Act (AHCA), according to an AMA analysis released June 27.
When asked whether the reform bill was a “good idea” or a “bad idea,” the most common response in each state was “bad idea,” ranging from 40% in Arkansas to 58% in Colorado. The majority of respondents in Alaska, Arkansas, Colorado, Nevada, and Ohio replied that the Senate should not pass the House legislation and the ACA should remain in place.
The plurality of Tennessee voters said the Senate should make major changes to the AHCA and pass it, while voters in West Virginia were split on what should happen to the AHCA.
Voters were not asked their views on the Senate’s Better Care Reconciliation Act (BCRA), but they were asked about specific provisions of the proposal.
When asked if federal funding for Medicaid expansion should be eliminated or reduced – as both the House and Senate propose – the majority of respondents in each state were opposed, ranging from 54% to 63%.
Voters in each state also strongly opposed BCRA provisions that would allow insurers to offer low-cost health plans, referred to as “skinny plans,” that would limit coverage for prescription drugs, mental health care, and other areas. When asked if low-income people should be provided with federal assistance to purchase inexpensive plans that would cover expensive illnesses, but not include preventive health care, a plurality of respondents were opposed, ranging from 43% in Arkansas to 58% in Ohio.
Respondents were supportive of the ACA’s individual mandate. When asked whether the ACA’s individual mandate should be eliminated and replaced with allowing health insurance companies to charge people 30% higher premiums for a year if they have not had continuous coverage, the majority of voters surveyed in all seven states were strongly opposed.
However, most voters were supportive of changing the Medicaid program to a federal grant program. When asked whether the government should change Medicaid from an entitlement program to a federal grant program and allow states to decide how to best use federal dollars to cover their low-income population, most voters agreed, ranging from 45% in Ohio to 52% in West Virginia.
The survey was conducted by phone in Alaska, Arkansas, Colorado, Nevada, Ohio, and Tennessee June 13-20, 2017. Samples were drawn from the voter file proportional to the statewide registered voter population. Quotas were set by specific demographics such as region, age, gender, and ethnicity based on data from the U.S. Census and the voter file to ensure a representative sample. Polling in West Virginia was conducted June 19-22, 2017.
[email protected]
On Twitter @legal_med
Voters in nearly every region of the United States are opposed to the health reform bills that have been proposed in the House and Senate, according to a poll by the American Medical Association.
Surveys conducted in Alaska, Arkansas, Colorado, Nevada, Ohio, Tennessee, and West Virginia showed that voters in each state had an overall low opinion of the House-passed American Health Care Act (AHCA), according to an AMA analysis released June 27.
When asked whether the reform bill was a “good idea” or a “bad idea,” the most common response in each state was “bad idea,” ranging from 40% in Arkansas to 58% in Colorado. The majority of respondents in Alaska, Arkansas, Colorado, Nevada, and Ohio replied that the Senate should not pass the House legislation and the ACA should remain in place.
The plurality of Tennessee voters said the Senate should make major changes to the AHCA and pass it, while voters in West Virginia were split on what should happen to the AHCA.
Voters were not asked their views on the Senate’s Better Care Reconciliation Act (BCRA), but they were asked about specific provisions of the proposal.
When asked if federal funding for Medicaid expansion should be eliminated or reduced – as both the House and Senate propose – the majority of respondents in each state were opposed, ranging from 54% to 63%.
Voters in each state also strongly opposed BCRA provisions that would allow insurers to offer low-cost health plans, referred to as “skinny plans,” that would limit coverage for prescription drugs, mental health care, and other areas. When asked if low-income people should be provided with federal assistance to purchase inexpensive plans that would cover expensive illnesses, but not include preventive health care, a plurality of respondents were opposed, ranging from 43% in Arkansas to 58% in Ohio.
Respondents were supportive of the ACA’s individual mandate. When asked whether the ACA’s individual mandate should be eliminated and replaced with allowing health insurance companies to charge people 30% higher premiums for a year if they have not had continuous coverage, the majority of voters surveyed in all seven states were strongly opposed.
However, most voters were supportive of changing the Medicaid program to a federal grant program. When asked whether the government should change Medicaid from an entitlement program to a federal grant program and allow states to decide how to best use federal dollars to cover their low-income population, most voters agreed, ranging from 45% in Ohio to 52% in West Virginia.
The survey was conducted by phone in Alaska, Arkansas, Colorado, Nevada, Ohio, and Tennessee June 13-20, 2017. Samples were drawn from the voter file proportional to the statewide registered voter population. Quotas were set by specific demographics such as region, age, gender, and ethnicity based on data from the U.S. Census and the voter file to ensure a representative sample. Polling in West Virginia was conducted June 19-22, 2017.
[email protected]
On Twitter @legal_med
Voters in nearly every region of the United States are opposed to the health reform bills that have been proposed in the House and Senate, according to a poll by the American Medical Association.
Surveys conducted in Alaska, Arkansas, Colorado, Nevada, Ohio, Tennessee, and West Virginia showed that voters in each state had an overall low opinion of the House-passed American Health Care Act (AHCA), according to an AMA analysis released June 27.
When asked whether the reform bill was a “good idea” or a “bad idea,” the most common response in each state was “bad idea,” ranging from 40% in Arkansas to 58% in Colorado. The majority of respondents in Alaska, Arkansas, Colorado, Nevada, and Ohio replied that the Senate should not pass the House legislation and the ACA should remain in place.
The plurality of Tennessee voters said the Senate should make major changes to the AHCA and pass it, while voters in West Virginia were split on what should happen to the AHCA.
Voters were not asked their views on the Senate’s Better Care Reconciliation Act (BCRA), but they were asked about specific provisions of the proposal.
When asked if federal funding for Medicaid expansion should be eliminated or reduced – as both the House and Senate propose – the majority of respondents in each state were opposed, ranging from 54% to 63%.
Voters in each state also strongly opposed BCRA provisions that would allow insurers to offer low-cost health plans, referred to as “skinny plans,” that would limit coverage for prescription drugs, mental health care, and other areas. When asked if low-income people should be provided with federal assistance to purchase inexpensive plans that would cover expensive illnesses, but not include preventive health care, a plurality of respondents were opposed, ranging from 43% in Arkansas to 58% in Ohio.
Respondents were supportive of the ACA’s individual mandate. When asked whether the ACA’s individual mandate should be eliminated and replaced with allowing health insurance companies to charge people 30% higher premiums for a year if they have not had continuous coverage, the majority of voters surveyed in all seven states were strongly opposed.
However, most voters were supportive of changing the Medicaid program to a federal grant program. When asked whether the government should change Medicaid from an entitlement program to a federal grant program and allow states to decide how to best use federal dollars to cover their low-income population, most voters agreed, ranging from 45% in Ohio to 52% in West Virginia.
The survey was conducted by phone in Alaska, Arkansas, Colorado, Nevada, Ohio, and Tennessee June 13-20, 2017. Samples were drawn from the voter file proportional to the statewide registered voter population. Quotas were set by specific demographics such as region, age, gender, and ethnicity based on data from the U.S. Census and the voter file to ensure a representative sample. Polling in West Virginia was conducted June 19-22, 2017.
[email protected]
On Twitter @legal_med
Everything We Say and Do: Take time to leave a good impression
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I say “thank you” to each patient at the close of the clinical encounter and ask if there is something I can do for him or her before leaving the room.
Why I do it
The beginning and the end of a medical visit each have a significant impact on how patients view their overall experience with the physician. Devoting energy and thought to these critical moments during the patient-physician interaction is simple and rewarding, and helps leave patients with a good impression.
How I do it
At the close of each patient visit, whether in the emergency department with a new admission or during daily rounds, I incorporate a “thank you” prior to leaving the room.
For example, I thank the patient for going over the details of her history with me; I know she has repeated the same information several times already. I thank the patient who brought in a detailed home medication list that made medication reconciliation a breeze for this organization. If I discussed a sensitive or difficult topic with the patient, such as substance use, I thank the patient for being honest. Another option is to thank the patient for trusting me with his care during the hospitalization. My favorite “thank you,” and one that will work in any situation, is to thank a patient for his or her patience. Whether it is waiting for a procedure, waiting to eat, or waiting for the green light to go home, our patients’ patience is tremendous and absolutely deserves to be recognized.
After saying “thank you,” I close with a simple but powerful question: “Is there something I can do for you before I leave? I have time.” Perhaps I can assist with a refill of ice chips, help find the call button, or relay a message to the bedside nurse. Whatever the task may be, offering to help before departing humanizes the interaction between physician and patient and is sure to be appreciated and remembered. Furthermore, taking a pause in the hectic pace of the day to show patients that we care can give busy hospitalists a moment to recharge before moving on to the next item on the to-do list. Any way you look at it, thanking our patients and offering to help is time well spent.
Dr. Sebasky is assistant clinical professor at the University of California, San Diego.
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I say “thank you” to each patient at the close of the clinical encounter and ask if there is something I can do for him or her before leaving the room.
Why I do it
The beginning and the end of a medical visit each have a significant impact on how patients view their overall experience with the physician. Devoting energy and thought to these critical moments during the patient-physician interaction is simple and rewarding, and helps leave patients with a good impression.
How I do it
At the close of each patient visit, whether in the emergency department with a new admission or during daily rounds, I incorporate a “thank you” prior to leaving the room.
For example, I thank the patient for going over the details of her history with me; I know she has repeated the same information several times already. I thank the patient who brought in a detailed home medication list that made medication reconciliation a breeze for this organization. If I discussed a sensitive or difficult topic with the patient, such as substance use, I thank the patient for being honest. Another option is to thank the patient for trusting me with his care during the hospitalization. My favorite “thank you,” and one that will work in any situation, is to thank a patient for his or her patience. Whether it is waiting for a procedure, waiting to eat, or waiting for the green light to go home, our patients’ patience is tremendous and absolutely deserves to be recognized.
After saying “thank you,” I close with a simple but powerful question: “Is there something I can do for you before I leave? I have time.” Perhaps I can assist with a refill of ice chips, help find the call button, or relay a message to the bedside nurse. Whatever the task may be, offering to help before departing humanizes the interaction between physician and patient and is sure to be appreciated and remembered. Furthermore, taking a pause in the hectic pace of the day to show patients that we care can give busy hospitalists a moment to recharge before moving on to the next item on the to-do list. Any way you look at it, thanking our patients and offering to help is time well spent.
Dr. Sebasky is assistant clinical professor at the University of California, San Diego.
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I say “thank you” to each patient at the close of the clinical encounter and ask if there is something I can do for him or her before leaving the room.
Why I do it
The beginning and the end of a medical visit each have a significant impact on how patients view their overall experience with the physician. Devoting energy and thought to these critical moments during the patient-physician interaction is simple and rewarding, and helps leave patients with a good impression.
How I do it
At the close of each patient visit, whether in the emergency department with a new admission or during daily rounds, I incorporate a “thank you” prior to leaving the room.
For example, I thank the patient for going over the details of her history with me; I know she has repeated the same information several times already. I thank the patient who brought in a detailed home medication list that made medication reconciliation a breeze for this organization. If I discussed a sensitive or difficult topic with the patient, such as substance use, I thank the patient for being honest. Another option is to thank the patient for trusting me with his care during the hospitalization. My favorite “thank you,” and one that will work in any situation, is to thank a patient for his or her patience. Whether it is waiting for a procedure, waiting to eat, or waiting for the green light to go home, our patients’ patience is tremendous and absolutely deserves to be recognized.
After saying “thank you,” I close with a simple but powerful question: “Is there something I can do for you before I leave? I have time.” Perhaps I can assist with a refill of ice chips, help find the call button, or relay a message to the bedside nurse. Whatever the task may be, offering to help before departing humanizes the interaction between physician and patient and is sure to be appreciated and remembered. Furthermore, taking a pause in the hectic pace of the day to show patients that we care can give busy hospitalists a moment to recharge before moving on to the next item on the to-do list. Any way you look at it, thanking our patients and offering to help is time well spent.
Dr. Sebasky is assistant clinical professor at the University of California, San Diego.
Less is more in PET-negative, advanced HL
MADRID—Patients with advanced Hodgkin lymphoma (HL) who are PET-negative after initial treatment with 2 cycles of eBEACOPP* should only receive 2 additional cycles of the therapy, new research suggests.
In the HD18 trial, PET-2-negative patients who received 4 cycles of eBEACOPP had non-inferior progression-free survival (PFS) and significantly better overall survival (OS) than PET-2-negative patients who received 6 or 8 cycles of the treatment.
Patients who received 4 cycles also had less severe toxicity and fewer second neoplasms than patients who received more cycles of eBEACOPP.
“When balancing efficacy and safety, results compare favorably with any other published treatment strategy so far,” said Peter Borchmann, MD, of University Hospital of Cologne in Germany.
“That’s why we recommend treatment with PET-2-guided eBEACOPP for patients with newly diagnosed, advanced-stage Hodgkin lymphoma.”
Dr Borchmann presented results from HD18 at the 22nd Congress of the European Hematology Association (EHA) as abstract S150.
Patients and treatment
Dr Borchmann and his colleagues set out to determine if they could decrease the number of eBEACOPP cycles in patients with negative PET-2 without compromising treatment efficacy.
From May 2008 to July 2014, the researchers recruited 2101 patients with newly diagnosed, advanced-stage HL.
Patients who were PET-negative after 2 cycles of eBEACOPP (n=1005) were initially randomized to receive 6 additional cycles of eBEACOPP or 2 additional cycles—a total of 8 cycles or 4 cycles, respectively. The protocol was later amended (in June 2011), and the total number of cycles in the standard therapy arm was reduced to 6.
There were 504 patients in the standard therapy arm—288 who received 8 cycles of eBEACOPP and 216 who received 6 cycles. There were 501 patients who received 4 cycles of eBEACOPP.
Sixteen patients in the standard therapy arm and 17 in the 4-cycle arm also received radiotherapy.
The median age was 32 (range, 18-60) in the standard therapy arm and 33 (range, 18-60) in the 4-cycle arm. Sixty-three percent and 62% of patients, respectively, were male.
Eight percent of patients in both arms had Ann Arbor stage IIB disease. Fifty-seven percent in the standard therapy arm and 55% in the 4-cycle arm had stage IIIA/B. And 35% and 36%, respectively, had stage IVA/B disease.
Thirty-five percent of patients in both arms had an IPS stage of 0-1. Fifty-one percent in the standard therapy arm and 52% in the 4-cycle arm had an IPS stage of 2-3. And 14% in both arms had an IPS stage of 4-7.
The median duration of therapy was 173 days (range, 41-266) for patients randomized to receive 8 cycles of eBEACOPP, 129 days (range, 35-178) in patients randomized to receive 6 cycles, and 85 days (range, 42-133) in patients randomized to receive 4 cycles.
One patient in the 6-cycle group received more than 6 cycles, and 6 patients in the 4-cycle arm received more than 4 cycles.
PFS and OS
The median follow-up was 55 months. The estimated 3-year PFS was 92.3% in the standard therapy arm and 94.8% in the 4-cycle arm. The estimated 5-year PFS was 91.2% and 91.8%, respectively. The hazard ratio was 0.88.
“[Based on these data,] we can conclude that 4 cycles are as effective as 6 or 8 cycles,” Dr Borchmann said.
The estimated 3-year OS was 95.9% in the standard therapy arm and 98.7% in the 4-cycle arm. The estimated 5-year OS was 95.4% and 97.6%, respectively. The hazard ratio was 0.36 (P=0.006).
Toxicity and second neoplasms
Grade 3/4 organ toxicity occurred in 22% of patients in the 8-cycle group, 13% in the 6-cycle group, and 8% in the 4-cycle group. Grade 4 anemia, thrombocytopenia, or infection occurred in 59%, 53%, and 38%, respectively.
Treatment-related morbidity occurred in 66% of patients in the 8-cycle group, 61% in the 6-cycle group, and 41% in the 4-cycle group.
Eighteen patients in the standard therapy arm had second neoplasms—8 with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), 5 with non-Hodgkin lymphoma (NHL), and 5 with solid tumors.
Thirteen patients in the 4-cycle arm had second neoplasms—2 with AML/MDS, 8 with NHL, and 3 with solid tumors.
Causes of death
The cause of death was HL for 0.6% of patients (n=3) in the standard therapy arm and for 0.8% of patients (n=4) in the 4-cycle arm.
The cause of death was second malignancy for 2.2% of patients (n=11) in the standard therapy arm. Five patients died of AML, 3 of NHL, and 3 of solid tumor malignancies.
One patient (0.2%) in the 4-cycle arm died as a result of a second malignancy, which was AML.
Toxicity related to study treatment was the cause of death for 1.2% (n=6) of patients in the standard therapy arm. Five of the patients died of infection, and the sixth died of ischemic stroke.
None of the patients in the 4-cycle arm died of toxicity related to study treatment.
Other causes of death included toxicity of salvage treatment (0.4%, n=2 in both arms), other disease (0.2%, n=1 in both arms), accident (1 patient [0.2%] in the 4-cycle arm), and unknown cause (2 patients [0.4%] in the standard arm).
“[With 4 cycles of therapy,] we had a significant and very relevant reduction of severe, acute hematological and non-hematological toxicities, and this was accompanied by a relevant reduction of mortality for other reasons than HL,” Dr Borchmann said. “And we’ve almost eliminated HL as a cause of death in this trial.” 
*dose-escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone
MADRID—Patients with advanced Hodgkin lymphoma (HL) who are PET-negative after initial treatment with 2 cycles of eBEACOPP* should only receive 2 additional cycles of the therapy, new research suggests.
In the HD18 trial, PET-2-negative patients who received 4 cycles of eBEACOPP had non-inferior progression-free survival (PFS) and significantly better overall survival (OS) than PET-2-negative patients who received 6 or 8 cycles of the treatment.
Patients who received 4 cycles also had less severe toxicity and fewer second neoplasms than patients who received more cycles of eBEACOPP.
“When balancing efficacy and safety, results compare favorably with any other published treatment strategy so far,” said Peter Borchmann, MD, of University Hospital of Cologne in Germany.
“That’s why we recommend treatment with PET-2-guided eBEACOPP for patients with newly diagnosed, advanced-stage Hodgkin lymphoma.”
Dr Borchmann presented results from HD18 at the 22nd Congress of the European Hematology Association (EHA) as abstract S150.
Patients and treatment
Dr Borchmann and his colleagues set out to determine if they could decrease the number of eBEACOPP cycles in patients with negative PET-2 without compromising treatment efficacy.
From May 2008 to July 2014, the researchers recruited 2101 patients with newly diagnosed, advanced-stage HL.
Patients who were PET-negative after 2 cycles of eBEACOPP (n=1005) were initially randomized to receive 6 additional cycles of eBEACOPP or 2 additional cycles—a total of 8 cycles or 4 cycles, respectively. The protocol was later amended (in June 2011), and the total number of cycles in the standard therapy arm was reduced to 6.
There were 504 patients in the standard therapy arm—288 who received 8 cycles of eBEACOPP and 216 who received 6 cycles. There were 501 patients who received 4 cycles of eBEACOPP.
Sixteen patients in the standard therapy arm and 17 in the 4-cycle arm also received radiotherapy.
The median age was 32 (range, 18-60) in the standard therapy arm and 33 (range, 18-60) in the 4-cycle arm. Sixty-three percent and 62% of patients, respectively, were male.
Eight percent of patients in both arms had Ann Arbor stage IIB disease. Fifty-seven percent in the standard therapy arm and 55% in the 4-cycle arm had stage IIIA/B. And 35% and 36%, respectively, had stage IVA/B disease.
Thirty-five percent of patients in both arms had an IPS stage of 0-1. Fifty-one percent in the standard therapy arm and 52% in the 4-cycle arm had an IPS stage of 2-3. And 14% in both arms had an IPS stage of 4-7.
The median duration of therapy was 173 days (range, 41-266) for patients randomized to receive 8 cycles of eBEACOPP, 129 days (range, 35-178) in patients randomized to receive 6 cycles, and 85 days (range, 42-133) in patients randomized to receive 4 cycles.
One patient in the 6-cycle group received more than 6 cycles, and 6 patients in the 4-cycle arm received more than 4 cycles.
PFS and OS
The median follow-up was 55 months. The estimated 3-year PFS was 92.3% in the standard therapy arm and 94.8% in the 4-cycle arm. The estimated 5-year PFS was 91.2% and 91.8%, respectively. The hazard ratio was 0.88.
“[Based on these data,] we can conclude that 4 cycles are as effective as 6 or 8 cycles,” Dr Borchmann said.
The estimated 3-year OS was 95.9% in the standard therapy arm and 98.7% in the 4-cycle arm. The estimated 5-year OS was 95.4% and 97.6%, respectively. The hazard ratio was 0.36 (P=0.006).
Toxicity and second neoplasms
Grade 3/4 organ toxicity occurred in 22% of patients in the 8-cycle group, 13% in the 6-cycle group, and 8% in the 4-cycle group. Grade 4 anemia, thrombocytopenia, or infection occurred in 59%, 53%, and 38%, respectively.
Treatment-related morbidity occurred in 66% of patients in the 8-cycle group, 61% in the 6-cycle group, and 41% in the 4-cycle group.
Eighteen patients in the standard therapy arm had second neoplasms—8 with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), 5 with non-Hodgkin lymphoma (NHL), and 5 with solid tumors.
Thirteen patients in the 4-cycle arm had second neoplasms—2 with AML/MDS, 8 with NHL, and 3 with solid tumors.
Causes of death
The cause of death was HL for 0.6% of patients (n=3) in the standard therapy arm and for 0.8% of patients (n=4) in the 4-cycle arm.
The cause of death was second malignancy for 2.2% of patients (n=11) in the standard therapy arm. Five patients died of AML, 3 of NHL, and 3 of solid tumor malignancies.
One patient (0.2%) in the 4-cycle arm died as a result of a second malignancy, which was AML.
Toxicity related to study treatment was the cause of death for 1.2% (n=6) of patients in the standard therapy arm. Five of the patients died of infection, and the sixth died of ischemic stroke.
None of the patients in the 4-cycle arm died of toxicity related to study treatment.
Other causes of death included toxicity of salvage treatment (0.4%, n=2 in both arms), other disease (0.2%, n=1 in both arms), accident (1 patient [0.2%] in the 4-cycle arm), and unknown cause (2 patients [0.4%] in the standard arm).
“[With 4 cycles of therapy,] we had a significant and very relevant reduction of severe, acute hematological and non-hematological toxicities, and this was accompanied by a relevant reduction of mortality for other reasons than HL,” Dr Borchmann said. “And we’ve almost eliminated HL as a cause of death in this trial.”
*dose-escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone
MADRID—Patients with advanced Hodgkin lymphoma (HL) who are PET-negative after initial treatment with 2 cycles of eBEACOPP* should only receive 2 additional cycles of the therapy, new research suggests.
In the HD18 trial, PET-2-negative patients who received 4 cycles of eBEACOPP had non-inferior progression-free survival (PFS) and significantly better overall survival (OS) than PET-2-negative patients who received 6 or 8 cycles of the treatment.
Patients who received 4 cycles also had less severe toxicity and fewer second neoplasms than patients who received more cycles of eBEACOPP.
“When balancing efficacy and safety, results compare favorably with any other published treatment strategy so far,” said Peter Borchmann, MD, of University Hospital of Cologne in Germany.
“That’s why we recommend treatment with PET-2-guided eBEACOPP for patients with newly diagnosed, advanced-stage Hodgkin lymphoma.”
Dr Borchmann presented results from HD18 at the 22nd Congress of the European Hematology Association (EHA) as abstract S150.
Patients and treatment
Dr Borchmann and his colleagues set out to determine if they could decrease the number of eBEACOPP cycles in patients with negative PET-2 without compromising treatment efficacy.
From May 2008 to July 2014, the researchers recruited 2101 patients with newly diagnosed, advanced-stage HL.
Patients who were PET-negative after 2 cycles of eBEACOPP (n=1005) were initially randomized to receive 6 additional cycles of eBEACOPP or 2 additional cycles—a total of 8 cycles or 4 cycles, respectively. The protocol was later amended (in June 2011), and the total number of cycles in the standard therapy arm was reduced to 6.
There were 504 patients in the standard therapy arm—288 who received 8 cycles of eBEACOPP and 216 who received 6 cycles. There were 501 patients who received 4 cycles of eBEACOPP.
Sixteen patients in the standard therapy arm and 17 in the 4-cycle arm also received radiotherapy.
The median age was 32 (range, 18-60) in the standard therapy arm and 33 (range, 18-60) in the 4-cycle arm. Sixty-three percent and 62% of patients, respectively, were male.
Eight percent of patients in both arms had Ann Arbor stage IIB disease. Fifty-seven percent in the standard therapy arm and 55% in the 4-cycle arm had stage IIIA/B. And 35% and 36%, respectively, had stage IVA/B disease.
Thirty-five percent of patients in both arms had an IPS stage of 0-1. Fifty-one percent in the standard therapy arm and 52% in the 4-cycle arm had an IPS stage of 2-3. And 14% in both arms had an IPS stage of 4-7.
The median duration of therapy was 173 days (range, 41-266) for patients randomized to receive 8 cycles of eBEACOPP, 129 days (range, 35-178) in patients randomized to receive 6 cycles, and 85 days (range, 42-133) in patients randomized to receive 4 cycles.
One patient in the 6-cycle group received more than 6 cycles, and 6 patients in the 4-cycle arm received more than 4 cycles.
PFS and OS
The median follow-up was 55 months. The estimated 3-year PFS was 92.3% in the standard therapy arm and 94.8% in the 4-cycle arm. The estimated 5-year PFS was 91.2% and 91.8%, respectively. The hazard ratio was 0.88.
“[Based on these data,] we can conclude that 4 cycles are as effective as 6 or 8 cycles,” Dr Borchmann said.
The estimated 3-year OS was 95.9% in the standard therapy arm and 98.7% in the 4-cycle arm. The estimated 5-year OS was 95.4% and 97.6%, respectively. The hazard ratio was 0.36 (P=0.006).
Toxicity and second neoplasms
Grade 3/4 organ toxicity occurred in 22% of patients in the 8-cycle group, 13% in the 6-cycle group, and 8% in the 4-cycle group. Grade 4 anemia, thrombocytopenia, or infection occurred in 59%, 53%, and 38%, respectively.
Treatment-related morbidity occurred in 66% of patients in the 8-cycle group, 61% in the 6-cycle group, and 41% in the 4-cycle group.
Eighteen patients in the standard therapy arm had second neoplasms—8 with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), 5 with non-Hodgkin lymphoma (NHL), and 5 with solid tumors.
Thirteen patients in the 4-cycle arm had second neoplasms—2 with AML/MDS, 8 with NHL, and 3 with solid tumors.
Causes of death
The cause of death was HL for 0.6% of patients (n=3) in the standard therapy arm and for 0.8% of patients (n=4) in the 4-cycle arm.
The cause of death was second malignancy for 2.2% of patients (n=11) in the standard therapy arm. Five patients died of AML, 3 of NHL, and 3 of solid tumor malignancies.
One patient (0.2%) in the 4-cycle arm died as a result of a second malignancy, which was AML.
Toxicity related to study treatment was the cause of death for 1.2% (n=6) of patients in the standard therapy arm. Five of the patients died of infection, and the sixth died of ischemic stroke.
None of the patients in the 4-cycle arm died of toxicity related to study treatment.
Other causes of death included toxicity of salvage treatment (0.4%, n=2 in both arms), other disease (0.2%, n=1 in both arms), accident (1 patient [0.2%] in the 4-cycle arm), and unknown cause (2 patients [0.4%] in the standard arm).
“[With 4 cycles of therapy,] we had a significant and very relevant reduction of severe, acute hematological and non-hematological toxicities, and this was accompanied by a relevant reduction of mortality for other reasons than HL,” Dr Borchmann said. “And we’ve almost eliminated HL as a cause of death in this trial.”
*dose-escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone
CSF p-Tau predicts neurocognitive sequelae in survivors of childhood cancer
A small retrospective study of survivors of childhood acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL) has found that phosphorylated Tau (p-Tau) in patients’ cerebrospinal fluid (CSF) is a predictor of late neurocognitive consequences.
Investigators compared intellectual performance, memory, and executive functioning between survivors and control subjects and observed that CSF levels of p-Tau during treatment and total intrathecal methotrexate dose negatively correlated with intellectual performance.
They suggest that identifying at-risk children early “could inspire interventions to prevent or remediate chemotherapy-induced cognitive sequelae.”
The investigators enrolled 31 nonirradiated adults, 27 who had had ALL and 4 NHL. They compared the survivors to 35 age-matched controls.
All study participants were a mean age of 21.5 years (range, 16.1–29.8). The mean age of the survivors at diagnosis was 6.4 years.
"Our team collected samples of brain fluid during the cancer treatment,” Rudi D’Hooge, PhD, of KU Leuven in Belgium, said. “We analyzed the p-Tau levels to measure the damage to the brain cells."
Investigators assessed intelligence, memory, and executive function using Wechsler Adult Intelligence Scale (WAIS IV), Rey Auditory Verbal Learning Test (AVLT), and Amsterdam Neuropsychological Tasks (ANT), respectively.
Statistical analysis included two-sided, one-way analysis of covariance (ANCOVA) with survivor group vs control group as an independent factor. Parental socioeconomic status was a covariate.
Dr D’Hooge and colleagues published their findings in JNCI, the Journal of the National Cancer Institute.
Findings
Investigators found that survivors had statistically significant lower total intelligence (P=0.001), verbal intelligence (P=0.02), and performance intelligence (P=0.007) quotients than controls.
They also found a negative correlation between CSF p-Tau, but not CSF Tau, levels and total intelligence (P=0.02), verbal intelligence (P=0.001), and performance intelligence (P=0.04) quotients.
Only performance intelligence was negatively correlated with total intrathecal methotrexate (P=0.007).
And because total intrathecal methotrexate dose and CSF p-Tau were not significantly correlated (P=0.29), the investigators believe intervening factors increase CSF p-Tau independently from methotrexate dose.
Results of subset tests revealed that cognitive flexibility (set-shifting and working memory), and processing speed were affected (P<0.05).
However, long-term memory, focused and sustained attention, and inhibition appeared unaffected (P>0.05).
The investigators believe these differences in vulnerability of cognitive functions parallel patient age at time of development.
For example, long-term memory, focused and sustained attention, and inhibition develop before children reach 6 years, the mean age at which the survivor cohort was diagnosed.
But set-shifting, working memory, and processing speed mature during adolescence, after the patients were diagnosed and treated.
Limitations of the study, according to the investigators, include its retrospective and cross-sectional design, the relatively small sample size, and the lack of pretreatment neurocognitive data.
Nevertheless, they believe the study should encourage the use of the CSF biomarker, intrathecal methotrexate dose, and age at therapy initiation in neurotoxicity assessments to identify children at risk for long-term sequelae.
"If we systematically measure these p-Tau levels in the future," Iris Elens, MD, also of KU Leuven, said, "we can offer specific help to children with high values. With early coaching aimed at the most relevant functions we can prevent problems that would otherwise manifest 10 to 15 years after the treatment."
The Olivia Hendrickx Research Fund supported the study.
A small retrospective study of survivors of childhood acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL) has found that phosphorylated Tau (p-Tau) in patients’ cerebrospinal fluid (CSF) is a predictor of late neurocognitive consequences.
Investigators compared intellectual performance, memory, and executive functioning between survivors and control subjects and observed that CSF levels of p-Tau during treatment and total intrathecal methotrexate dose negatively correlated with intellectual performance.
They suggest that identifying at-risk children early “could inspire interventions to prevent or remediate chemotherapy-induced cognitive sequelae.”
The investigators enrolled 31 nonirradiated adults, 27 who had had ALL and 4 NHL. They compared the survivors to 35 age-matched controls.
All study participants were a mean age of 21.5 years (range, 16.1–29.8). The mean age of the survivors at diagnosis was 6.4 years.
"Our team collected samples of brain fluid during the cancer treatment,” Rudi D’Hooge, PhD, of KU Leuven in Belgium, said. “We analyzed the p-Tau levels to measure the damage to the brain cells."
Investigators assessed intelligence, memory, and executive function using Wechsler Adult Intelligence Scale (WAIS IV), Rey Auditory Verbal Learning Test (AVLT), and Amsterdam Neuropsychological Tasks (ANT), respectively.
Statistical analysis included two-sided, one-way analysis of covariance (ANCOVA) with survivor group vs control group as an independent factor. Parental socioeconomic status was a covariate.
Dr D’Hooge and colleagues published their findings in JNCI, the Journal of the National Cancer Institute.
Findings
Investigators found that survivors had statistically significant lower total intelligence (P=0.001), verbal intelligence (P=0.02), and performance intelligence (P=0.007) quotients than controls.
They also found a negative correlation between CSF p-Tau, but not CSF Tau, levels and total intelligence (P=0.02), verbal intelligence (P=0.001), and performance intelligence (P=0.04) quotients.
Only performance intelligence was negatively correlated with total intrathecal methotrexate (P=0.007).
And because total intrathecal methotrexate dose and CSF p-Tau were not significantly correlated (P=0.29), the investigators believe intervening factors increase CSF p-Tau independently from methotrexate dose.
Results of subset tests revealed that cognitive flexibility (set-shifting and working memory), and processing speed were affected (P<0.05).
However, long-term memory, focused and sustained attention, and inhibition appeared unaffected (P>0.05).
The investigators believe these differences in vulnerability of cognitive functions parallel patient age at time of development.
For example, long-term memory, focused and sustained attention, and inhibition develop before children reach 6 years, the mean age at which the survivor cohort was diagnosed.
But set-shifting, working memory, and processing speed mature during adolescence, after the patients were diagnosed and treated.
Limitations of the study, according to the investigators, include its retrospective and cross-sectional design, the relatively small sample size, and the lack of pretreatment neurocognitive data.
Nevertheless, they believe the study should encourage the use of the CSF biomarker, intrathecal methotrexate dose, and age at therapy initiation in neurotoxicity assessments to identify children at risk for long-term sequelae.
"If we systematically measure these p-Tau levels in the future," Iris Elens, MD, also of KU Leuven, said, "we can offer specific help to children with high values. With early coaching aimed at the most relevant functions we can prevent problems that would otherwise manifest 10 to 15 years after the treatment."
The Olivia Hendrickx Research Fund supported the study.
A small retrospective study of survivors of childhood acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL) has found that phosphorylated Tau (p-Tau) in patients’ cerebrospinal fluid (CSF) is a predictor of late neurocognitive consequences.
Investigators compared intellectual performance, memory, and executive functioning between survivors and control subjects and observed that CSF levels of p-Tau during treatment and total intrathecal methotrexate dose negatively correlated with intellectual performance.
They suggest that identifying at-risk children early “could inspire interventions to prevent or remediate chemotherapy-induced cognitive sequelae.”
The investigators enrolled 31 nonirradiated adults, 27 who had had ALL and 4 NHL. They compared the survivors to 35 age-matched controls.
All study participants were a mean age of 21.5 years (range, 16.1–29.8). The mean age of the survivors at diagnosis was 6.4 years.
"Our team collected samples of brain fluid during the cancer treatment,” Rudi D’Hooge, PhD, of KU Leuven in Belgium, said. “We analyzed the p-Tau levels to measure the damage to the brain cells."
Investigators assessed intelligence, memory, and executive function using Wechsler Adult Intelligence Scale (WAIS IV), Rey Auditory Verbal Learning Test (AVLT), and Amsterdam Neuropsychological Tasks (ANT), respectively.
Statistical analysis included two-sided, one-way analysis of covariance (ANCOVA) with survivor group vs control group as an independent factor. Parental socioeconomic status was a covariate.
Dr D’Hooge and colleagues published their findings in JNCI, the Journal of the National Cancer Institute.
Findings
Investigators found that survivors had statistically significant lower total intelligence (P=0.001), verbal intelligence (P=0.02), and performance intelligence (P=0.007) quotients than controls.
They also found a negative correlation between CSF p-Tau, but not CSF Tau, levels and total intelligence (P=0.02), verbal intelligence (P=0.001), and performance intelligence (P=0.04) quotients.
Only performance intelligence was negatively correlated with total intrathecal methotrexate (P=0.007).
And because total intrathecal methotrexate dose and CSF p-Tau were not significantly correlated (P=0.29), the investigators believe intervening factors increase CSF p-Tau independently from methotrexate dose.
Results of subset tests revealed that cognitive flexibility (set-shifting and working memory), and processing speed were affected (P<0.05).
However, long-term memory, focused and sustained attention, and inhibition appeared unaffected (P>0.05).
The investigators believe these differences in vulnerability of cognitive functions parallel patient age at time of development.
For example, long-term memory, focused and sustained attention, and inhibition develop before children reach 6 years, the mean age at which the survivor cohort was diagnosed.
But set-shifting, working memory, and processing speed mature during adolescence, after the patients were diagnosed and treated.
Limitations of the study, according to the investigators, include its retrospective and cross-sectional design, the relatively small sample size, and the lack of pretreatment neurocognitive data.
Nevertheless, they believe the study should encourage the use of the CSF biomarker, intrathecal methotrexate dose, and age at therapy initiation in neurotoxicity assessments to identify children at risk for long-term sequelae.
"If we systematically measure these p-Tau levels in the future," Iris Elens, MD, also of KU Leuven, said, "we can offer specific help to children with high values. With early coaching aimed at the most relevant functions we can prevent problems that would otherwise manifest 10 to 15 years after the treatment."
The Olivia Hendrickx Research Fund supported the study.