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Thoracic Oncology & Chest Imaging Network
Lung Cancer Section
What is comprehensive biomarker testing and who should order it? For non–small cell lung cancer, comprehensive biomarker testing is generally defined as testing eligible patients for all biomarkers that direct the use of FDA-approved therapies (Mileham KF, et al. Cancer Med. 2022;11[2]:530. What comprises comprehensive testing has changed over time and will likely continue to change as advances in biomarkers, therapies, and indications for their use continue to evolve. There are also some potential benefits to testing biomarkers without FDA-approved therapies, such as assessing eligibility for treatment as part of a clinical trial or for identifying treatment options that gain FDA-approval in the future. As for who should be responsible for biomarker test ordering, this remains unclear and variable between institutions and practices (Fox AH, et al. Chest. 2021;160[6]:2293). All subspecialties involved, including pulmonology, pathology, interventional radiology, surgery, and oncology, have the potential for knowledge gaps surrounding biomarker testing (Gregg JP, et al. Transl Lung Cancer Res. 2019;8[3]:286; Smeltzer MP, et al. J Thorac Oncol. 2020;15[9]:1434). Those obtaining diagnostic tissue, including pulmonologists, surgeons, and interventional radiologists may not appreciate the downstream use of each biomarker but are in the place to order testing as soon as the time of biopsy. Pathologists may be unaware of clinical aspects to the patient’s case, such as the suspected clinical stage of disease. Oncologists arguably have the best chance of having the expertise to order testing but, ideally, biomarker results would be available by the time a patient meets with an oncologist to discuss treatment options. There is no perfect solution to this question at present, but if you are involved with the diagnosis of lung cancer, you should collaborate with your multidisciplinary team to streamline testing and strategize how to best serve patients.
Adam Fox, MD
Section Fellow-in-Training
Lung Cancer Section
What is comprehensive biomarker testing and who should order it? For non–small cell lung cancer, comprehensive biomarker testing is generally defined as testing eligible patients for all biomarkers that direct the use of FDA-approved therapies (Mileham KF, et al. Cancer Med. 2022;11[2]:530. What comprises comprehensive testing has changed over time and will likely continue to change as advances in biomarkers, therapies, and indications for their use continue to evolve. There are also some potential benefits to testing biomarkers without FDA-approved therapies, such as assessing eligibility for treatment as part of a clinical trial or for identifying treatment options that gain FDA-approval in the future. As for who should be responsible for biomarker test ordering, this remains unclear and variable between institutions and practices (Fox AH, et al. Chest. 2021;160[6]:2293). All subspecialties involved, including pulmonology, pathology, interventional radiology, surgery, and oncology, have the potential for knowledge gaps surrounding biomarker testing (Gregg JP, et al. Transl Lung Cancer Res. 2019;8[3]:286; Smeltzer MP, et al. J Thorac Oncol. 2020;15[9]:1434). Those obtaining diagnostic tissue, including pulmonologists, surgeons, and interventional radiologists may not appreciate the downstream use of each biomarker but are in the place to order testing as soon as the time of biopsy. Pathologists may be unaware of clinical aspects to the patient’s case, such as the suspected clinical stage of disease. Oncologists arguably have the best chance of having the expertise to order testing but, ideally, biomarker results would be available by the time a patient meets with an oncologist to discuss treatment options. There is no perfect solution to this question at present, but if you are involved with the diagnosis of lung cancer, you should collaborate with your multidisciplinary team to streamline testing and strategize how to best serve patients.
Adam Fox, MD
Section Fellow-in-Training
Lung Cancer Section
What is comprehensive biomarker testing and who should order it? For non–small cell lung cancer, comprehensive biomarker testing is generally defined as testing eligible patients for all biomarkers that direct the use of FDA-approved therapies (Mileham KF, et al. Cancer Med. 2022;11[2]:530. What comprises comprehensive testing has changed over time and will likely continue to change as advances in biomarkers, therapies, and indications for their use continue to evolve. There are also some potential benefits to testing biomarkers without FDA-approved therapies, such as assessing eligibility for treatment as part of a clinical trial or for identifying treatment options that gain FDA-approval in the future. As for who should be responsible for biomarker test ordering, this remains unclear and variable between institutions and practices (Fox AH, et al. Chest. 2021;160[6]:2293). All subspecialties involved, including pulmonology, pathology, interventional radiology, surgery, and oncology, have the potential for knowledge gaps surrounding biomarker testing (Gregg JP, et al. Transl Lung Cancer Res. 2019;8[3]:286; Smeltzer MP, et al. J Thorac Oncol. 2020;15[9]:1434). Those obtaining diagnostic tissue, including pulmonologists, surgeons, and interventional radiologists may not appreciate the downstream use of each biomarker but are in the place to order testing as soon as the time of biopsy. Pathologists may be unaware of clinical aspects to the patient’s case, such as the suspected clinical stage of disease. Oncologists arguably have the best chance of having the expertise to order testing but, ideally, biomarker results would be available by the time a patient meets with an oncologist to discuss treatment options. There is no perfect solution to this question at present, but if you are involved with the diagnosis of lung cancer, you should collaborate with your multidisciplinary team to streamline testing and strategize how to best serve patients.
Adam Fox, MD
Section Fellow-in-Training
Chest Infections & Disaster Response Network
Chest Infections Section
An evolving diagnostic tool: Microbial cell-free DNA
The diagnosis of the microbial etiology of pneumonia remains a significant challenge with <50% yield of blood and sputum cultures in most studies. More reliable samples, like bronchoalveolar lavage, require invasive procedures. Undifferentiated pneumonia hampers antimicrobial stewardship and increases the risk of suboptimal treatment. New diagnostic tools that detect degraded microbial DNA in plasma, known as microbial cell-free DNA (cfDNA), may offer improved diagnostic yield. Through metagenomic next-generation approaches, these tools sequence DNA fragments to identify viral, bacterial, and fungal sequences.
Earlier studies of cfDNA in pneumonia have been mixed, correctly identifying the pathogen in 55% to 86% of cases – though notably cfDNA was superior to PCR and cultures and provided early detection of VAP in some cases (Farnaes L, et al. Diagn Microbiol Infect Dis. 2019;94:188; Langelier C, et al. Am J Respir Crit Care Med. 2020;201:491). However, a recent study of cfDNA in severe complicated pediatric pneumonia had promising results with significant clinical impact. cfDNA provided an accurate microbial diagnosis in 89% of cases, with it being the only positive study in 70% of cases. Further, cfDNA narrowed the antimicrobial regimen in 81% of cases (Dworsky ZD, et al. Hosp Pediatr. 2022;12:377).
The use of cfDNA is still in its infancy. Limitations, such as a lack of validated thresholds to differentiate colonization vs infection are noted given its detection sensitivity. Its utility, including ideal timing and patient population, needs further investigation. However, diagnostic cfDNA may soon provide earlier and less invasive microbial diagnostics in patients with chest infections and beyond.
Gregory Wigger, MD
Section Fellow-in-Training
Chest Infections Section
An evolving diagnostic tool: Microbial cell-free DNA
The diagnosis of the microbial etiology of pneumonia remains a significant challenge with <50% yield of blood and sputum cultures in most studies. More reliable samples, like bronchoalveolar lavage, require invasive procedures. Undifferentiated pneumonia hampers antimicrobial stewardship and increases the risk of suboptimal treatment. New diagnostic tools that detect degraded microbial DNA in plasma, known as microbial cell-free DNA (cfDNA), may offer improved diagnostic yield. Through metagenomic next-generation approaches, these tools sequence DNA fragments to identify viral, bacterial, and fungal sequences.
Earlier studies of cfDNA in pneumonia have been mixed, correctly identifying the pathogen in 55% to 86% of cases – though notably cfDNA was superior to PCR and cultures and provided early detection of VAP in some cases (Farnaes L, et al. Diagn Microbiol Infect Dis. 2019;94:188; Langelier C, et al. Am J Respir Crit Care Med. 2020;201:491). However, a recent study of cfDNA in severe complicated pediatric pneumonia had promising results with significant clinical impact. cfDNA provided an accurate microbial diagnosis in 89% of cases, with it being the only positive study in 70% of cases. Further, cfDNA narrowed the antimicrobial regimen in 81% of cases (Dworsky ZD, et al. Hosp Pediatr. 2022;12:377).
The use of cfDNA is still in its infancy. Limitations, such as a lack of validated thresholds to differentiate colonization vs infection are noted given its detection sensitivity. Its utility, including ideal timing and patient population, needs further investigation. However, diagnostic cfDNA may soon provide earlier and less invasive microbial diagnostics in patients with chest infections and beyond.
Gregory Wigger, MD
Section Fellow-in-Training
Chest Infections Section
An evolving diagnostic tool: Microbial cell-free DNA
The diagnosis of the microbial etiology of pneumonia remains a significant challenge with <50% yield of blood and sputum cultures in most studies. More reliable samples, like bronchoalveolar lavage, require invasive procedures. Undifferentiated pneumonia hampers antimicrobial stewardship and increases the risk of suboptimal treatment. New diagnostic tools that detect degraded microbial DNA in plasma, known as microbial cell-free DNA (cfDNA), may offer improved diagnostic yield. Through metagenomic next-generation approaches, these tools sequence DNA fragments to identify viral, bacterial, and fungal sequences.
Earlier studies of cfDNA in pneumonia have been mixed, correctly identifying the pathogen in 55% to 86% of cases – though notably cfDNA was superior to PCR and cultures and provided early detection of VAP in some cases (Farnaes L, et al. Diagn Microbiol Infect Dis. 2019;94:188; Langelier C, et al. Am J Respir Crit Care Med. 2020;201:491). However, a recent study of cfDNA in severe complicated pediatric pneumonia had promising results with significant clinical impact. cfDNA provided an accurate microbial diagnosis in 89% of cases, with it being the only positive study in 70% of cases. Further, cfDNA narrowed the antimicrobial regimen in 81% of cases (Dworsky ZD, et al. Hosp Pediatr. 2022;12:377).
The use of cfDNA is still in its infancy. Limitations, such as a lack of validated thresholds to differentiate colonization vs infection are noted given its detection sensitivity. Its utility, including ideal timing and patient population, needs further investigation. However, diagnostic cfDNA may soon provide earlier and less invasive microbial diagnostics in patients with chest infections and beyond.
Gregory Wigger, MD
Section Fellow-in-Training
Employers’ self-funded health plans can leave rheumatology patients vulnerable
Health care costs are skyrocketing for everyone! For employers, the cost of health insurance is second only to their payroll expense. Per person spending in employer plans grew by 22% between 2015 and 2019. This outpaced inflation and economic growth. Affording health insurance for business owners has become more and more difficult, bordering on desperation for some. Consequently, they are looking for ways to be more efficient in their health care spending. One way is through self-funding their employees’ health care costs. This means that the employer directly pays for the care of their employees. While it has always been thought this was just for very large employers, it is becoming more common with smaller businesses. There is more flexibility and oversight with self-funded plans, and the employer can dictate exactly what benefits are covered within the bounds of the law. While this can make it easier to exclude certain therapies and even institute site-of-care restrictions, it also can make the employer vulnerable to health insurance companies, pharmacy benefit managers (PBMs), and third-party administrators (TPAs) that promise large discounts in plan and drug spending at the expense of their employees’ health.
Recently enacted state laws often don’t apply
Because employers who self-fund the health care for their employees are increasingly desperate to save money, they will often agree to plans that are less expensive but offer suboptimal care, particularly for patients with chronic diseases requiring expensive medicines. Many employers are not fully informed of the ramifications of these policies, so the Coalition of State Rheumatology Organizations is creating an educational employer tool kit that not only highlights the importance of disease control for their employees with rheumatic conditions but also outlines the pitfalls and misinformation that may be given to them by the insurance companies, PBMs, and other third parties that administer their health plan.
Policies that sacrifice patient care of course are not exclusive to certain self-funded health plans. The CSRO’s Payer Issue Response Team (PIRT) receives complaints daily from rheumatologists around the country regarding both the Employee Retirement Income Security Act and non-ERISA health plan policies that are harmful to their patients. Our PIRT team assesses these complaints and researches solutions that can include writing letters to the health insurance companies, employers, and departments of insurance, as well as applying enacted state legislation that overrides some of the detrimental policies. (Utilization management legislation, which has passed in many states, can be easily found on CSRO’s map tool.) These state laws can help patients with everything from harmful step therapy and nonmedical switching policies to accumulator adjustment programs denying application of copay card value to their deductibles. Unfortunately, these laws do not apply to most self-funded employer health plans, which are preempted by ERISA. Consequently, those employees are not protected from harmful changes in formularies and other policies.
Forced ‘white bagging’ in self-funded plans
Mandated “white bagging” has become a favorite for health plans covered by large insurance companies, which say that the practice is less expensive than what the physician would charge for the medication. White bagging takes away the ability of the physician to “buy and bill” infusibles that are given in their office. While some rheumatologists may accept this, there are many who do not accept infusible medications coming from another source. Often the health plan will tell the rheumatologist they must accept the white bagging or transfer the patient to another rheumatologist who will. Clearly, many health plans and TPAs do not understand the bonds that are created over the years between rheumatologists and their patients. Ironically, the price of the white-bagged medication charged to the employer has been shown often to be higher than what the physician would have charged.
Some TPAs also convince employers to carve out specialty medications from their policy entirely, leaving the employee uninsured for these meds. These TPAs then attempt to obtain the medications from the manufacturers, foundations, compounding pharmacies, and even other countries for free or highly discounted prices. Even if obtained at no cost, the TPA will charge the employer a percentage of the list price or fee for obtaining it. On the surface, this may seem like a good idea, but there are a number of issues with this, including some that are legally suspect. First of all, uninsuring employees for certain medications to take advantage of patient assistance programs from manufacturers and foundations could be viewed as perfectly legal and perfectly unethical. The legality of this practice is questionable when these companies pretend to be the patient when applying for the assistance or present compounded medication as coming from the manufacturer, or if the TPA obtains the medication from outside the country. Additionally, many employers end up paying 20% of the list price of a medication for a service that physicians provide at no cost for uninsured patients.
Educating employers
CSRO’s employer tool kit hopes to educate employers with self-funded health plans about the pitfalls of some of these policies and offers suggestions on how to best navigate these issues for employees with rheumatic diseases. We are hoping to launch this tool kit to small to medium business groups in the near future.
Advocacy is more than just contacting health insurers and those who make our laws and regulations. Although that is important, reaching out to those who employ our patients can be integral to ensuring they get the best care.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Health care costs are skyrocketing for everyone! For employers, the cost of health insurance is second only to their payroll expense. Per person spending in employer plans grew by 22% between 2015 and 2019. This outpaced inflation and economic growth. Affording health insurance for business owners has become more and more difficult, bordering on desperation for some. Consequently, they are looking for ways to be more efficient in their health care spending. One way is through self-funding their employees’ health care costs. This means that the employer directly pays for the care of their employees. While it has always been thought this was just for very large employers, it is becoming more common with smaller businesses. There is more flexibility and oversight with self-funded plans, and the employer can dictate exactly what benefits are covered within the bounds of the law. While this can make it easier to exclude certain therapies and even institute site-of-care restrictions, it also can make the employer vulnerable to health insurance companies, pharmacy benefit managers (PBMs), and third-party administrators (TPAs) that promise large discounts in plan and drug spending at the expense of their employees’ health.
Recently enacted state laws often don’t apply
Because employers who self-fund the health care for their employees are increasingly desperate to save money, they will often agree to plans that are less expensive but offer suboptimal care, particularly for patients with chronic diseases requiring expensive medicines. Many employers are not fully informed of the ramifications of these policies, so the Coalition of State Rheumatology Organizations is creating an educational employer tool kit that not only highlights the importance of disease control for their employees with rheumatic conditions but also outlines the pitfalls and misinformation that may be given to them by the insurance companies, PBMs, and other third parties that administer their health plan.
Policies that sacrifice patient care of course are not exclusive to certain self-funded health plans. The CSRO’s Payer Issue Response Team (PIRT) receives complaints daily from rheumatologists around the country regarding both the Employee Retirement Income Security Act and non-ERISA health plan policies that are harmful to their patients. Our PIRT team assesses these complaints and researches solutions that can include writing letters to the health insurance companies, employers, and departments of insurance, as well as applying enacted state legislation that overrides some of the detrimental policies. (Utilization management legislation, which has passed in many states, can be easily found on CSRO’s map tool.) These state laws can help patients with everything from harmful step therapy and nonmedical switching policies to accumulator adjustment programs denying application of copay card value to their deductibles. Unfortunately, these laws do not apply to most self-funded employer health plans, which are preempted by ERISA. Consequently, those employees are not protected from harmful changes in formularies and other policies.
Forced ‘white bagging’ in self-funded plans
Mandated “white bagging” has become a favorite for health plans covered by large insurance companies, which say that the practice is less expensive than what the physician would charge for the medication. White bagging takes away the ability of the physician to “buy and bill” infusibles that are given in their office. While some rheumatologists may accept this, there are many who do not accept infusible medications coming from another source. Often the health plan will tell the rheumatologist they must accept the white bagging or transfer the patient to another rheumatologist who will. Clearly, many health plans and TPAs do not understand the bonds that are created over the years between rheumatologists and their patients. Ironically, the price of the white-bagged medication charged to the employer has been shown often to be higher than what the physician would have charged.
Some TPAs also convince employers to carve out specialty medications from their policy entirely, leaving the employee uninsured for these meds. These TPAs then attempt to obtain the medications from the manufacturers, foundations, compounding pharmacies, and even other countries for free or highly discounted prices. Even if obtained at no cost, the TPA will charge the employer a percentage of the list price or fee for obtaining it. On the surface, this may seem like a good idea, but there are a number of issues with this, including some that are legally suspect. First of all, uninsuring employees for certain medications to take advantage of patient assistance programs from manufacturers and foundations could be viewed as perfectly legal and perfectly unethical. The legality of this practice is questionable when these companies pretend to be the patient when applying for the assistance or present compounded medication as coming from the manufacturer, or if the TPA obtains the medication from outside the country. Additionally, many employers end up paying 20% of the list price of a medication for a service that physicians provide at no cost for uninsured patients.
Educating employers
CSRO’s employer tool kit hopes to educate employers with self-funded health plans about the pitfalls of some of these policies and offers suggestions on how to best navigate these issues for employees with rheumatic diseases. We are hoping to launch this tool kit to small to medium business groups in the near future.
Advocacy is more than just contacting health insurers and those who make our laws and regulations. Although that is important, reaching out to those who employ our patients can be integral to ensuring they get the best care.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Health care costs are skyrocketing for everyone! For employers, the cost of health insurance is second only to their payroll expense. Per person spending in employer plans grew by 22% between 2015 and 2019. This outpaced inflation and economic growth. Affording health insurance for business owners has become more and more difficult, bordering on desperation for some. Consequently, they are looking for ways to be more efficient in their health care spending. One way is through self-funding their employees’ health care costs. This means that the employer directly pays for the care of their employees. While it has always been thought this was just for very large employers, it is becoming more common with smaller businesses. There is more flexibility and oversight with self-funded plans, and the employer can dictate exactly what benefits are covered within the bounds of the law. While this can make it easier to exclude certain therapies and even institute site-of-care restrictions, it also can make the employer vulnerable to health insurance companies, pharmacy benefit managers (PBMs), and third-party administrators (TPAs) that promise large discounts in plan and drug spending at the expense of their employees’ health.
Recently enacted state laws often don’t apply
Because employers who self-fund the health care for their employees are increasingly desperate to save money, they will often agree to plans that are less expensive but offer suboptimal care, particularly for patients with chronic diseases requiring expensive medicines. Many employers are not fully informed of the ramifications of these policies, so the Coalition of State Rheumatology Organizations is creating an educational employer tool kit that not only highlights the importance of disease control for their employees with rheumatic conditions but also outlines the pitfalls and misinformation that may be given to them by the insurance companies, PBMs, and other third parties that administer their health plan.
Policies that sacrifice patient care of course are not exclusive to certain self-funded health plans. The CSRO’s Payer Issue Response Team (PIRT) receives complaints daily from rheumatologists around the country regarding both the Employee Retirement Income Security Act and non-ERISA health plan policies that are harmful to their patients. Our PIRT team assesses these complaints and researches solutions that can include writing letters to the health insurance companies, employers, and departments of insurance, as well as applying enacted state legislation that overrides some of the detrimental policies. (Utilization management legislation, which has passed in many states, can be easily found on CSRO’s map tool.) These state laws can help patients with everything from harmful step therapy and nonmedical switching policies to accumulator adjustment programs denying application of copay card value to their deductibles. Unfortunately, these laws do not apply to most self-funded employer health plans, which are preempted by ERISA. Consequently, those employees are not protected from harmful changes in formularies and other policies.
Forced ‘white bagging’ in self-funded plans
Mandated “white bagging” has become a favorite for health plans covered by large insurance companies, which say that the practice is less expensive than what the physician would charge for the medication. White bagging takes away the ability of the physician to “buy and bill” infusibles that are given in their office. While some rheumatologists may accept this, there are many who do not accept infusible medications coming from another source. Often the health plan will tell the rheumatologist they must accept the white bagging or transfer the patient to another rheumatologist who will. Clearly, many health plans and TPAs do not understand the bonds that are created over the years between rheumatologists and their patients. Ironically, the price of the white-bagged medication charged to the employer has been shown often to be higher than what the physician would have charged.
Some TPAs also convince employers to carve out specialty medications from their policy entirely, leaving the employee uninsured for these meds. These TPAs then attempt to obtain the medications from the manufacturers, foundations, compounding pharmacies, and even other countries for free or highly discounted prices. Even if obtained at no cost, the TPA will charge the employer a percentage of the list price or fee for obtaining it. On the surface, this may seem like a good idea, but there are a number of issues with this, including some that are legally suspect. First of all, uninsuring employees for certain medications to take advantage of patient assistance programs from manufacturers and foundations could be viewed as perfectly legal and perfectly unethical. The legality of this practice is questionable when these companies pretend to be the patient when applying for the assistance or present compounded medication as coming from the manufacturer, or if the TPA obtains the medication from outside the country. Additionally, many employers end up paying 20% of the list price of a medication for a service that physicians provide at no cost for uninsured patients.
Educating employers
CSRO’s employer tool kit hopes to educate employers with self-funded health plans about the pitfalls of some of these policies and offers suggestions on how to best navigate these issues for employees with rheumatic diseases. We are hoping to launch this tool kit to small to medium business groups in the near future.
Advocacy is more than just contacting health insurers and those who make our laws and regulations. Although that is important, reaching out to those who employ our patients can be integral to ensuring they get the best care.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Online yoga program improves physical function in OA
Although pain did not significantly improve in the yoga group, participants only completed about two-thirds of the recommended sessions, suggesting that more benefit may be possible with greater adherence, wrote lead author Kim L. Bennell, PhD, of the University of Melbourne, and colleagues in the Annals of Internal Medicine.
“To date, an online yoga program specifically for people with knee osteoarthritis has not been investigated,” the investigators said. “The need for such evidence-based packaged online exercise programs is highlighted in the 2020 U.S. National Public Health Agenda for Osteoarthritis.”
Methods and results
The trial involved 212 adults aged 45 years or older with symptomatic knee osteoarthritis. All patients had access to online educational materials about managing osteoarthritis.
Half of the participants were randomized into the 12-week online yoga program. This self-directed, unsupervised course consisted of 12 prerecorded 30-minute instructional yoga sessions, each with a unique sequence of poses to be completed three times in one week before moving on to the next class the following week. After 12 weeks, these participants could choose to continue doing yoga via the online program for 12 additional weeks, if desired.
The primary outcomes were knee pain and physical function, gauged by a 10-point numerical rating scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. Adherence was defined as completion of at least 2 yoga sessions within the preceding week.
At the 12-week mark, the yoga group did not show any significant improvement in knee pain (–0.6; 95% confidence interval, –1.2 to 0.1), but they did achieve a mean 4-point reduction in WOMAC, suggesting significant improvement in knee function (–4.0; 95% CI, –6.8 to –1.3). Of note, however, this improvement was not enough to meet the threshold for minimal clinically important difference. At 24 weeks, the yoga group no longer showed significant improvement in knee function versus baseline.
“I don’t think a longer program would necessarily reduce knee pain, as benefits from a whole range of different types of exercise for knee osteoarthritis generally can show benefits within 8 weeks,” Dr. Bennell said in an interview.
Still, she noted that the average outcome in the trial may not represent what is possible if a patient commits to a regular yoga routine.
“I think it relates more to adherence [than duration], and I think benefits for knee pain would have been seen if a greater number of people had fully adhered to the program three times a week,” she said.
At 12 weeks, 68.8% of those in the yoga group were adherent, while just 28.4% were still adherent at week 24 after the optional extension period.
“As this was a self-directed program, adherence might be expected to be less than that of a supervised program,” Dr. Bennell noted.
Referring to unpublished data, Dr. Bennell said a sensitivity analysis showed that participants in the yoga group who completed yoga at least twice a week did show greater improvements in function and pain than those who did yoga less than twice per week.
“So it does suggest that adherence is important, as we might expect,” she said.
Another tool in the OA toolbox
Nick Trasolini, MD, of Wake Forest University School of Medicine, Winston-Salem, N.C., described the benefits in the trial as “modest” and noted that the improvement in function did not meet the threshold for minimal clinically important difference.
“Nevertheless,” he said in a written comment, “the [yoga] program was safe and associated with high participant satisfaction [mean satisfaction, 8 out of 10]. While this may not be the ‘silver bullet,’ it is another tool that we can offer to sufficiently motivated patients seeking non-operative solutions for knee osteoarthritis.”
Unfortunately, these tools remain “fraught with challenges,” Dr. Trasolini added.
“While multiple injection options are available (including corticosteroid, hyaluronic acid viscosupplementation, and biologic injections), the benefits of these injections can be short-lived,” he said. “This is frustrating to patients and physicians alike. Physical therapy is beneficial for knee osteoarthritis when deconditioning has led to decreased knee, hip, and core stability. However, physical therapy can be time consuming, painful, and cost prohibitive.”
In the present study, participants in the yoga group were somewhat willing (mean willingness, 5 out of 10) to pay for their 12-week yoga program. They reported that they would pay approximately $80 U.S. dollars for chance to do it all again.
The study was supported by grants from the National Health and Medical Research Council Program and the Centres of Research Excellence. The investigators disclosed additional relationships with Pfizer, Lilly, TLCBio, and others. Dr. Trasolini disclosed no relevant conflicts of interest.
Although pain did not significantly improve in the yoga group, participants only completed about two-thirds of the recommended sessions, suggesting that more benefit may be possible with greater adherence, wrote lead author Kim L. Bennell, PhD, of the University of Melbourne, and colleagues in the Annals of Internal Medicine.
“To date, an online yoga program specifically for people with knee osteoarthritis has not been investigated,” the investigators said. “The need for such evidence-based packaged online exercise programs is highlighted in the 2020 U.S. National Public Health Agenda for Osteoarthritis.”
Methods and results
The trial involved 212 adults aged 45 years or older with symptomatic knee osteoarthritis. All patients had access to online educational materials about managing osteoarthritis.
Half of the participants were randomized into the 12-week online yoga program. This self-directed, unsupervised course consisted of 12 prerecorded 30-minute instructional yoga sessions, each with a unique sequence of poses to be completed three times in one week before moving on to the next class the following week. After 12 weeks, these participants could choose to continue doing yoga via the online program for 12 additional weeks, if desired.
The primary outcomes were knee pain and physical function, gauged by a 10-point numerical rating scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. Adherence was defined as completion of at least 2 yoga sessions within the preceding week.
At the 12-week mark, the yoga group did not show any significant improvement in knee pain (–0.6; 95% confidence interval, –1.2 to 0.1), but they did achieve a mean 4-point reduction in WOMAC, suggesting significant improvement in knee function (–4.0; 95% CI, –6.8 to –1.3). Of note, however, this improvement was not enough to meet the threshold for minimal clinically important difference. At 24 weeks, the yoga group no longer showed significant improvement in knee function versus baseline.
“I don’t think a longer program would necessarily reduce knee pain, as benefits from a whole range of different types of exercise for knee osteoarthritis generally can show benefits within 8 weeks,” Dr. Bennell said in an interview.
Still, she noted that the average outcome in the trial may not represent what is possible if a patient commits to a regular yoga routine.
“I think it relates more to adherence [than duration], and I think benefits for knee pain would have been seen if a greater number of people had fully adhered to the program three times a week,” she said.
At 12 weeks, 68.8% of those in the yoga group were adherent, while just 28.4% were still adherent at week 24 after the optional extension period.
“As this was a self-directed program, adherence might be expected to be less than that of a supervised program,” Dr. Bennell noted.
Referring to unpublished data, Dr. Bennell said a sensitivity analysis showed that participants in the yoga group who completed yoga at least twice a week did show greater improvements in function and pain than those who did yoga less than twice per week.
“So it does suggest that adherence is important, as we might expect,” she said.
Another tool in the OA toolbox
Nick Trasolini, MD, of Wake Forest University School of Medicine, Winston-Salem, N.C., described the benefits in the trial as “modest” and noted that the improvement in function did not meet the threshold for minimal clinically important difference.
“Nevertheless,” he said in a written comment, “the [yoga] program was safe and associated with high participant satisfaction [mean satisfaction, 8 out of 10]. While this may not be the ‘silver bullet,’ it is another tool that we can offer to sufficiently motivated patients seeking non-operative solutions for knee osteoarthritis.”
Unfortunately, these tools remain “fraught with challenges,” Dr. Trasolini added.
“While multiple injection options are available (including corticosteroid, hyaluronic acid viscosupplementation, and biologic injections), the benefits of these injections can be short-lived,” he said. “This is frustrating to patients and physicians alike. Physical therapy is beneficial for knee osteoarthritis when deconditioning has led to decreased knee, hip, and core stability. However, physical therapy can be time consuming, painful, and cost prohibitive.”
In the present study, participants in the yoga group were somewhat willing (mean willingness, 5 out of 10) to pay for their 12-week yoga program. They reported that they would pay approximately $80 U.S. dollars for chance to do it all again.
The study was supported by grants from the National Health and Medical Research Council Program and the Centres of Research Excellence. The investigators disclosed additional relationships with Pfizer, Lilly, TLCBio, and others. Dr. Trasolini disclosed no relevant conflicts of interest.
Although pain did not significantly improve in the yoga group, participants only completed about two-thirds of the recommended sessions, suggesting that more benefit may be possible with greater adherence, wrote lead author Kim L. Bennell, PhD, of the University of Melbourne, and colleagues in the Annals of Internal Medicine.
“To date, an online yoga program specifically for people with knee osteoarthritis has not been investigated,” the investigators said. “The need for such evidence-based packaged online exercise programs is highlighted in the 2020 U.S. National Public Health Agenda for Osteoarthritis.”
Methods and results
The trial involved 212 adults aged 45 years or older with symptomatic knee osteoarthritis. All patients had access to online educational materials about managing osteoarthritis.
Half of the participants were randomized into the 12-week online yoga program. This self-directed, unsupervised course consisted of 12 prerecorded 30-minute instructional yoga sessions, each with a unique sequence of poses to be completed three times in one week before moving on to the next class the following week. After 12 weeks, these participants could choose to continue doing yoga via the online program for 12 additional weeks, if desired.
The primary outcomes were knee pain and physical function, gauged by a 10-point numerical rating scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. Adherence was defined as completion of at least 2 yoga sessions within the preceding week.
At the 12-week mark, the yoga group did not show any significant improvement in knee pain (–0.6; 95% confidence interval, –1.2 to 0.1), but they did achieve a mean 4-point reduction in WOMAC, suggesting significant improvement in knee function (–4.0; 95% CI, –6.8 to –1.3). Of note, however, this improvement was not enough to meet the threshold for minimal clinically important difference. At 24 weeks, the yoga group no longer showed significant improvement in knee function versus baseline.
“I don’t think a longer program would necessarily reduce knee pain, as benefits from a whole range of different types of exercise for knee osteoarthritis generally can show benefits within 8 weeks,” Dr. Bennell said in an interview.
Still, she noted that the average outcome in the trial may not represent what is possible if a patient commits to a regular yoga routine.
“I think it relates more to adherence [than duration], and I think benefits for knee pain would have been seen if a greater number of people had fully adhered to the program three times a week,” she said.
At 12 weeks, 68.8% of those in the yoga group were adherent, while just 28.4% were still adherent at week 24 after the optional extension period.
“As this was a self-directed program, adherence might be expected to be less than that of a supervised program,” Dr. Bennell noted.
Referring to unpublished data, Dr. Bennell said a sensitivity analysis showed that participants in the yoga group who completed yoga at least twice a week did show greater improvements in function and pain than those who did yoga less than twice per week.
“So it does suggest that adherence is important, as we might expect,” she said.
Another tool in the OA toolbox
Nick Trasolini, MD, of Wake Forest University School of Medicine, Winston-Salem, N.C., described the benefits in the trial as “modest” and noted that the improvement in function did not meet the threshold for minimal clinically important difference.
“Nevertheless,” he said in a written comment, “the [yoga] program was safe and associated with high participant satisfaction [mean satisfaction, 8 out of 10]. While this may not be the ‘silver bullet,’ it is another tool that we can offer to sufficiently motivated patients seeking non-operative solutions for knee osteoarthritis.”
Unfortunately, these tools remain “fraught with challenges,” Dr. Trasolini added.
“While multiple injection options are available (including corticosteroid, hyaluronic acid viscosupplementation, and biologic injections), the benefits of these injections can be short-lived,” he said. “This is frustrating to patients and physicians alike. Physical therapy is beneficial for knee osteoarthritis when deconditioning has led to decreased knee, hip, and core stability. However, physical therapy can be time consuming, painful, and cost prohibitive.”
In the present study, participants in the yoga group were somewhat willing (mean willingness, 5 out of 10) to pay for their 12-week yoga program. They reported that they would pay approximately $80 U.S. dollars for chance to do it all again.
The study was supported by grants from the National Health and Medical Research Council Program and the Centres of Research Excellence. The investigators disclosed additional relationships with Pfizer, Lilly, TLCBio, and others. Dr. Trasolini disclosed no relevant conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
Is acetaminophen really safer than NSAIDs in heart disease?
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM HYPERTENSION 2022
Me, my spouse, and COVID
Managing family conflict and cohesion
I watched you in the garage, with your wipes and your mask, your gloves and bottles of sprays and potions. I admired your fealty to CNN’s Dr. Sanjay Gupta as he demonstrated the proper technique for disinfecting groceries. I watched sterile protocol being broken and quietly closed the garage door.
I listened to your descriptions of the agility of the virus with each exhalation of breath, and how far the virus could travel with a tailwind and in cold dry air. I listen as closely and with the same intention as I listen to my yoga teacher’s explication of the benefits of attention to the breath.
Relatives and friends came prepared to be entertained outdoors. Even masked, you eschewed the world. Your version of science clashes with my laissez-faire attitude. We blow up as a couple. Then we settle down and learn how to cope with the stress, as a team, together.
The COVID factor
In the first few months of any stressor, family and couple functioning must reorganize to manage well.
During lockdown, social scientists accessed an eager public ready to participate in their studies. With nowhere to go, many people, especially women, completed online COVID surveys. Community-based tools such as the Centers for Disease Control and Prevention’s Social Vulnerability Index identified populations of high social vulnerability (as caused by external stresses on human health, such as unemployment, overcrowding, presence of an individual with caregiving needs, and low educational attainment). It is assumed that such populations will experience more stress and have more difficulty coping and adjusting.
In a study by a team at the University of Miami, social vulnerability was associated with more disrupted family functioning, except when households with children (n = 2,666) were compared to households without children (n = 1,456).1 What allowed these families with children to enjoy better functioning?
Looking more closely at the Miami study, what can we find? It is a large survey study (n = 4,122), disseminated through professional networks and social media via purchased Facebook and Instagram ads. Data were logged in REDCap, and participants had the option of taking the survey in English or Spanish. Most participants were female (93.5%), 55.7% responded in English, and 44.3% in Spanish. There were few differences between the women who had and did not have children, in terms of their age, employment status, and education level. The number of children in the household did not affect the results.
This study used a new tool called the COVID-19 Household Environment Scale. This tool has 25 items measuring individual and household characteristics, and associated COVID-19 stressors. This tool also includes two family functioning measures: conflict and cohesion, asking the respondent to reflect on the change in “conflict” or “togetherness,” as it relates to household experiences and activities, compared with the period before social distancing.
The surprising finding was that even though households with children reported more conflict than before the start of the pandemic, they also reported more cohesion. This syncs with my experience. My niece and nephew found that having their teenage children at home brought them closer as a family, cut down on some of the extracurricular activities they did not support, and generally “slowed the world down.”
However, in a study in Germany, survey respondents (n = 1,042) noted that having children up to 17 years old was associated with decreases in satisfaction with family life, although this was not related to changes in family demands. The study assessed changes over 6 months and underscores the fact that perceptions of family demands and family well-being are independent of each other.2
These findings also resonate with prior research that measured burden and reward in couples. High burden is not associated with low reward; these two constructs are independent of each other.3
What about couples?
It is no surprise that poor relationships begat poor coping. In an online Belgian survey of 1,491 cohabiting couples during the shutdown, both men and women felt significantly more stress than before, because they felt restricted in their relationship.4
However, only women reported significantly more stress during the lockdown than before, because of relationship conflicts, such as feeling neglected by their partner. These feelings had predated lockdown.
In another lockdown online survey of 782 U.S. adults (89.8% White, 84.5% female), cohabitating intimate partners reported that there were higher thoughts of separation if the participants were younger, or if there was higher verbal aggression, higher relationship invalidation, and lower relationship satisfaction. Higher relationship satisfaction was reported when there was lower money stress, higher sexual fulfillment, lower relationship invalidation, and higher perceived fairness of relationship power. High relationship satisfaction was also reported where there were no children in the home.5
It should be noted that none of these relationship variables was measured in the Miami study discussed above, and this study did not measure perceived conflict or perceived cohesion, so we know less about these aspects of the family unit.
What about teens?
The COVID-19 lockdown had a positive effect on the dynamics in some families, according to a naturalistic study of adolescents (n = 155) who completed surveys at two time periods (initial and 8 weeks).6
These adolescents reported a reduction in perceived psychological control by their mothers, and no change in autonomy support. The changes did not vary according to gender or the mother’s employment situation. The decrease in psychological control was greater with higher initial levels of satisfaction with the mother, and lower levels of the teens disobeying their parents.
What about hospital settings?
The worst of the COVID experience was in the hospital. The pain was displayed on the faces of the staff as they labored to figure out how to care for the dying patients who had no contact with their families. Hospitals, out of fear of contamination and viral dissemination, excluded visitors. In those early days of uncertainty, the stress among staff, patients, and family members was high.
In response to family members feeling disconnected from the health care team and the psychological and moral distress of the staff, Nadine J. Kaslow and colleagues revised policies and procedures at Emory University, Atlanta, facilities to reprioritize patient- and family-centered care.7
The guiding principles focus on providing safe yet compassionate and ethical care, balancing community health and the mitigation of viral transmission, while appreciating family members as essential partners in care; fostering communication between patients and their families; and promoting interactions and decision-making among health care providers, patients, and families.
COVID continues to intrude in many of our lives. Many people are mourning family members and friends who died after contracting the disease. Many people choose to ignore their risk and live their lives as before. Many people, like my spouse and me, continue to debate the merits of venturing into public spaces. Personally, COVID has given me time to read many more books than I could ever have imagined and allowed my spouse to explore the delicate nuances of cooking.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Chavez JV et al. Assessing the impact of COVID-19 social distancing and social vulnerability on family functioning in an international sample of households with and without children. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 233-48. doi: 10.1037/cfp0000166.
2. Rudolph CW, Zacher H. Family demands and satisfaction with family life during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 249-59. doi: 10.1037/cfp0000170.
3. Heru AM et al. Family functioning in the caregivers of patients with dementia. Int J Geriatr Psychiatry. 2004 Jun;19(6):533-7. doi: 10.1002/gps.1119.
4. Schokkenbroek JM et al. Partners in lockdown: Relationship stress in men and women during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 149-57. doi: 10.1037/cfp0000172.
5. Eubanks Fleming CJ, Franzese AT. Should I stay or should I go? Evaluating intimate relationship outcomes during the 2020 pandemic shutdown. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 158-67. doi: 10.1037/cfp0000169.
6. Bacikova-Sleskova M,et al. Did perceived parenting in adolescence change as a result of the COVID-19 lockdown? A natural experiment. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 271-80. doi: 10.1037/cfp0000167.
7. Kaslow NJ et al. A roadmap for patient- and family-centered care during the pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 223-32. doi: 10.1037/cfp0000176.
Managing family conflict and cohesion
Managing family conflict and cohesion
I watched you in the garage, with your wipes and your mask, your gloves and bottles of sprays and potions. I admired your fealty to CNN’s Dr. Sanjay Gupta as he demonstrated the proper technique for disinfecting groceries. I watched sterile protocol being broken and quietly closed the garage door.
I listened to your descriptions of the agility of the virus with each exhalation of breath, and how far the virus could travel with a tailwind and in cold dry air. I listen as closely and with the same intention as I listen to my yoga teacher’s explication of the benefits of attention to the breath.
Relatives and friends came prepared to be entertained outdoors. Even masked, you eschewed the world. Your version of science clashes with my laissez-faire attitude. We blow up as a couple. Then we settle down and learn how to cope with the stress, as a team, together.
The COVID factor
In the first few months of any stressor, family and couple functioning must reorganize to manage well.
During lockdown, social scientists accessed an eager public ready to participate in their studies. With nowhere to go, many people, especially women, completed online COVID surveys. Community-based tools such as the Centers for Disease Control and Prevention’s Social Vulnerability Index identified populations of high social vulnerability (as caused by external stresses on human health, such as unemployment, overcrowding, presence of an individual with caregiving needs, and low educational attainment). It is assumed that such populations will experience more stress and have more difficulty coping and adjusting.
In a study by a team at the University of Miami, social vulnerability was associated with more disrupted family functioning, except when households with children (n = 2,666) were compared to households without children (n = 1,456).1 What allowed these families with children to enjoy better functioning?
Looking more closely at the Miami study, what can we find? It is a large survey study (n = 4,122), disseminated through professional networks and social media via purchased Facebook and Instagram ads. Data were logged in REDCap, and participants had the option of taking the survey in English or Spanish. Most participants were female (93.5%), 55.7% responded in English, and 44.3% in Spanish. There were few differences between the women who had and did not have children, in terms of their age, employment status, and education level. The number of children in the household did not affect the results.
This study used a new tool called the COVID-19 Household Environment Scale. This tool has 25 items measuring individual and household characteristics, and associated COVID-19 stressors. This tool also includes two family functioning measures: conflict and cohesion, asking the respondent to reflect on the change in “conflict” or “togetherness,” as it relates to household experiences and activities, compared with the period before social distancing.
The surprising finding was that even though households with children reported more conflict than before the start of the pandemic, they also reported more cohesion. This syncs with my experience. My niece and nephew found that having their teenage children at home brought them closer as a family, cut down on some of the extracurricular activities they did not support, and generally “slowed the world down.”
However, in a study in Germany, survey respondents (n = 1,042) noted that having children up to 17 years old was associated with decreases in satisfaction with family life, although this was not related to changes in family demands. The study assessed changes over 6 months and underscores the fact that perceptions of family demands and family well-being are independent of each other.2
These findings also resonate with prior research that measured burden and reward in couples. High burden is not associated with low reward; these two constructs are independent of each other.3
What about couples?
It is no surprise that poor relationships begat poor coping. In an online Belgian survey of 1,491 cohabiting couples during the shutdown, both men and women felt significantly more stress than before, because they felt restricted in their relationship.4
However, only women reported significantly more stress during the lockdown than before, because of relationship conflicts, such as feeling neglected by their partner. These feelings had predated lockdown.
In another lockdown online survey of 782 U.S. adults (89.8% White, 84.5% female), cohabitating intimate partners reported that there were higher thoughts of separation if the participants were younger, or if there was higher verbal aggression, higher relationship invalidation, and lower relationship satisfaction. Higher relationship satisfaction was reported when there was lower money stress, higher sexual fulfillment, lower relationship invalidation, and higher perceived fairness of relationship power. High relationship satisfaction was also reported where there were no children in the home.5
It should be noted that none of these relationship variables was measured in the Miami study discussed above, and this study did not measure perceived conflict or perceived cohesion, so we know less about these aspects of the family unit.
What about teens?
The COVID-19 lockdown had a positive effect on the dynamics in some families, according to a naturalistic study of adolescents (n = 155) who completed surveys at two time periods (initial and 8 weeks).6
These adolescents reported a reduction in perceived psychological control by their mothers, and no change in autonomy support. The changes did not vary according to gender or the mother’s employment situation. The decrease in psychological control was greater with higher initial levels of satisfaction with the mother, and lower levels of the teens disobeying their parents.
What about hospital settings?
The worst of the COVID experience was in the hospital. The pain was displayed on the faces of the staff as they labored to figure out how to care for the dying patients who had no contact with their families. Hospitals, out of fear of contamination and viral dissemination, excluded visitors. In those early days of uncertainty, the stress among staff, patients, and family members was high.
In response to family members feeling disconnected from the health care team and the psychological and moral distress of the staff, Nadine J. Kaslow and colleagues revised policies and procedures at Emory University, Atlanta, facilities to reprioritize patient- and family-centered care.7
The guiding principles focus on providing safe yet compassionate and ethical care, balancing community health and the mitigation of viral transmission, while appreciating family members as essential partners in care; fostering communication between patients and their families; and promoting interactions and decision-making among health care providers, patients, and families.
COVID continues to intrude in many of our lives. Many people are mourning family members and friends who died after contracting the disease. Many people choose to ignore their risk and live their lives as before. Many people, like my spouse and me, continue to debate the merits of venturing into public spaces. Personally, COVID has given me time to read many more books than I could ever have imagined and allowed my spouse to explore the delicate nuances of cooking.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Chavez JV et al. Assessing the impact of COVID-19 social distancing and social vulnerability on family functioning in an international sample of households with and without children. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 233-48. doi: 10.1037/cfp0000166.
2. Rudolph CW, Zacher H. Family demands and satisfaction with family life during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 249-59. doi: 10.1037/cfp0000170.
3. Heru AM et al. Family functioning in the caregivers of patients with dementia. Int J Geriatr Psychiatry. 2004 Jun;19(6):533-7. doi: 10.1002/gps.1119.
4. Schokkenbroek JM et al. Partners in lockdown: Relationship stress in men and women during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 149-57. doi: 10.1037/cfp0000172.
5. Eubanks Fleming CJ, Franzese AT. Should I stay or should I go? Evaluating intimate relationship outcomes during the 2020 pandemic shutdown. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 158-67. doi: 10.1037/cfp0000169.
6. Bacikova-Sleskova M,et al. Did perceived parenting in adolescence change as a result of the COVID-19 lockdown? A natural experiment. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 271-80. doi: 10.1037/cfp0000167.
7. Kaslow NJ et al. A roadmap for patient- and family-centered care during the pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 223-32. doi: 10.1037/cfp0000176.
I watched you in the garage, with your wipes and your mask, your gloves and bottles of sprays and potions. I admired your fealty to CNN’s Dr. Sanjay Gupta as he demonstrated the proper technique for disinfecting groceries. I watched sterile protocol being broken and quietly closed the garage door.
I listened to your descriptions of the agility of the virus with each exhalation of breath, and how far the virus could travel with a tailwind and in cold dry air. I listen as closely and with the same intention as I listen to my yoga teacher’s explication of the benefits of attention to the breath.
Relatives and friends came prepared to be entertained outdoors. Even masked, you eschewed the world. Your version of science clashes with my laissez-faire attitude. We blow up as a couple. Then we settle down and learn how to cope with the stress, as a team, together.
The COVID factor
In the first few months of any stressor, family and couple functioning must reorganize to manage well.
During lockdown, social scientists accessed an eager public ready to participate in their studies. With nowhere to go, many people, especially women, completed online COVID surveys. Community-based tools such as the Centers for Disease Control and Prevention’s Social Vulnerability Index identified populations of high social vulnerability (as caused by external stresses on human health, such as unemployment, overcrowding, presence of an individual with caregiving needs, and low educational attainment). It is assumed that such populations will experience more stress and have more difficulty coping and adjusting.
In a study by a team at the University of Miami, social vulnerability was associated with more disrupted family functioning, except when households with children (n = 2,666) were compared to households without children (n = 1,456).1 What allowed these families with children to enjoy better functioning?
Looking more closely at the Miami study, what can we find? It is a large survey study (n = 4,122), disseminated through professional networks and social media via purchased Facebook and Instagram ads. Data were logged in REDCap, and participants had the option of taking the survey in English or Spanish. Most participants were female (93.5%), 55.7% responded in English, and 44.3% in Spanish. There were few differences between the women who had and did not have children, in terms of their age, employment status, and education level. The number of children in the household did not affect the results.
This study used a new tool called the COVID-19 Household Environment Scale. This tool has 25 items measuring individual and household characteristics, and associated COVID-19 stressors. This tool also includes two family functioning measures: conflict and cohesion, asking the respondent to reflect on the change in “conflict” or “togetherness,” as it relates to household experiences and activities, compared with the period before social distancing.
The surprising finding was that even though households with children reported more conflict than before the start of the pandemic, they also reported more cohesion. This syncs with my experience. My niece and nephew found that having their teenage children at home brought them closer as a family, cut down on some of the extracurricular activities they did not support, and generally “slowed the world down.”
However, in a study in Germany, survey respondents (n = 1,042) noted that having children up to 17 years old was associated with decreases in satisfaction with family life, although this was not related to changes in family demands. The study assessed changes over 6 months and underscores the fact that perceptions of family demands and family well-being are independent of each other.2
These findings also resonate with prior research that measured burden and reward in couples. High burden is not associated with low reward; these two constructs are independent of each other.3
What about couples?
It is no surprise that poor relationships begat poor coping. In an online Belgian survey of 1,491 cohabiting couples during the shutdown, both men and women felt significantly more stress than before, because they felt restricted in their relationship.4
However, only women reported significantly more stress during the lockdown than before, because of relationship conflicts, such as feeling neglected by their partner. These feelings had predated lockdown.
In another lockdown online survey of 782 U.S. adults (89.8% White, 84.5% female), cohabitating intimate partners reported that there were higher thoughts of separation if the participants were younger, or if there was higher verbal aggression, higher relationship invalidation, and lower relationship satisfaction. Higher relationship satisfaction was reported when there was lower money stress, higher sexual fulfillment, lower relationship invalidation, and higher perceived fairness of relationship power. High relationship satisfaction was also reported where there were no children in the home.5
It should be noted that none of these relationship variables was measured in the Miami study discussed above, and this study did not measure perceived conflict or perceived cohesion, so we know less about these aspects of the family unit.
What about teens?
The COVID-19 lockdown had a positive effect on the dynamics in some families, according to a naturalistic study of adolescents (n = 155) who completed surveys at two time periods (initial and 8 weeks).6
These adolescents reported a reduction in perceived psychological control by their mothers, and no change in autonomy support. The changes did not vary according to gender or the mother’s employment situation. The decrease in psychological control was greater with higher initial levels of satisfaction with the mother, and lower levels of the teens disobeying their parents.
What about hospital settings?
The worst of the COVID experience was in the hospital. The pain was displayed on the faces of the staff as they labored to figure out how to care for the dying patients who had no contact with their families. Hospitals, out of fear of contamination and viral dissemination, excluded visitors. In those early days of uncertainty, the stress among staff, patients, and family members was high.
In response to family members feeling disconnected from the health care team and the psychological and moral distress of the staff, Nadine J. Kaslow and colleagues revised policies and procedures at Emory University, Atlanta, facilities to reprioritize patient- and family-centered care.7
The guiding principles focus on providing safe yet compassionate and ethical care, balancing community health and the mitigation of viral transmission, while appreciating family members as essential partners in care; fostering communication between patients and their families; and promoting interactions and decision-making among health care providers, patients, and families.
COVID continues to intrude in many of our lives. Many people are mourning family members and friends who died after contracting the disease. Many people choose to ignore their risk and live their lives as before. Many people, like my spouse and me, continue to debate the merits of venturing into public spaces. Personally, COVID has given me time to read many more books than I could ever have imagined and allowed my spouse to explore the delicate nuances of cooking.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Chavez JV et al. Assessing the impact of COVID-19 social distancing and social vulnerability on family functioning in an international sample of households with and without children. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 233-48. doi: 10.1037/cfp0000166.
2. Rudolph CW, Zacher H. Family demands and satisfaction with family life during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 249-59. doi: 10.1037/cfp0000170.
3. Heru AM et al. Family functioning in the caregivers of patients with dementia. Int J Geriatr Psychiatry. 2004 Jun;19(6):533-7. doi: 10.1002/gps.1119.
4. Schokkenbroek JM et al. Partners in lockdown: Relationship stress in men and women during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 149-57. doi: 10.1037/cfp0000172.
5. Eubanks Fleming CJ, Franzese AT. Should I stay or should I go? Evaluating intimate relationship outcomes during the 2020 pandemic shutdown. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 158-67. doi: 10.1037/cfp0000169.
6. Bacikova-Sleskova M,et al. Did perceived parenting in adolescence change as a result of the COVID-19 lockdown? A natural experiment. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 271-80. doi: 10.1037/cfp0000167.
7. Kaslow NJ et al. A roadmap for patient- and family-centered care during the pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 223-32. doi: 10.1037/cfp0000176.
ObGyn: A leader in academic medicine, with progress still to be made in diversity
The nation’s population is quickly diversifying, making racial/ethnic disparities in health care outcomes even more apparent. Minority and non-English-speaking populations have grown and may become a majority in the next generation.1 A proposed strategy to reduce disparities in health care is to recruit more practitioners who better reflect the patient populations.2 Improved access to care with racial concordance between physicians and patients has been reported.3
Being increasingly aware of access-to-care data, more patients are advocating and asking for physicians of color to be their providers.4 Despite progress (ie, more women entering the medical profession), the proportion of physicians who are underrepresented in medicine (URiM—eg, Black, Hispanic, and Native American) still lags US population demographics.3
Why diversity in medicine matters
In addition to improving access to care, diversity in medicine offers other benefits. Working within diverse learning environments has demonstrated educational advantages.5,6 Medical students and residents from diverse backgrounds are less likely to report depression symptoms, regardless of their race. Diversity may accelerate advancements in health care as well, since it is well-established that diverse teams outperform nondiverse teams when it comes to innovation and productivity.7 Finally, as a profession committed to equity, advocacy, and justice, physicians are positioned to lead the way toward racial equity.
Overall, racial and gender diversity in all clinical specialties is improving, but not at the same pace. While the diversity of US medical students and residents by sex and race/ethnicity is greater than among faculty, change in racial diversity has been slow for all 3 groups.8 During the past 40 years the number of full-time faculty has increased 6-fold for females and more than tripled for males.8 However, this rise has not favored URiM faculty, because their proportion is still underrepresented relative to their group in the general population. Clinical departments that are making the most progress in recruiting URiM residents and faculty are often primary or preventive care specialties rather than surgical or service or hospital-based specialties.8,9 ObGyn has consistently had a proportion of URiM residents (18%) that is highest in the surgical specialties and comparable to family medicine and pediatrics.10
When examining physician workforce diversity, it is important to “drill down” to individual specialties to obtain a clearer understanding of trends. The continued need for increased resident and faculty diversity prompted us to examine ObGyn departments. The most recent nationwide data were gathered about full-time faculty from the 2021 AAMC Faculty Roster, residents from the 2021 Accreditation Counsel for Graduate Medical Education (ACGME) Data Resource Book, medical student matriculants from 2021 AAMC, and US adult women (defined arbitrarily as 15 years or older) from the 2019 American Community Survey.11-13
Increase in female faculty and residents
The expanding numbers of faculty and residents over a 40-year period (from 1973 to 2012) led to more women and underrepresented minorities in ObGyn than in other major clinical departments.14,15 Women now constitute two-thirds of all ObGyn faculty and are more likely to be junior rather than senior faculty.9 When looking at junior faculty, a higher proportion of junior faculty who are URiM are female. While more junior faculty and residents are female, male faculty are also racially and ethnically diverse.9
- ObGyn is a leader in racial/ethnic diversity in academic medicine.
- The rapid rise of faculty numbers in the past has not favored underrepresented faculty.
- The rise in ObGyn faculty and residents, who were predominantly female, has contributed to greater racial/ethnic diversity.
- Improved patient outcomes with racial concordance between physicians and patients have been reported.
- More patients are advocating and asking for physicians of color to be their clinicians.
- Racial/ethnic diversity of junior faculty and residents is similar to medical students.
- The most underrepresented group is Hispanic, due in part to its rapid growth in the US population.
Continue to: Growth of URiM physicians in ObGyn...
Growth of URiM physicians in ObGyn
The distribution of racial/ethnic groups in 2021 were compared between senior and junior ObGyn faculty and residents with the US adult female population.9 As shown in the FIGURE, the proportion of ObGyn faculty who are White approximates the White US adult female population. The most rapidly growing racial/ethnic group in the US population is Hispanic. Although Hispanic is the best represented ethnicity among junior faculty, the proportions of Hispanics among faculty and residents lag well behind the US population. The proportion of ObGyn faculty who are Black has consistently been less than in the US adult female population. ObGyns who are Asian constitute higher proportions of faculty and residents than in the US adult female population. This finding about Asians is consistent across all clinical specialties.7
Recruiting URiM students into ObGyn is important. Racial and ethnic representation in surgical and nonsurgical residency programs has not substantially improved in the past decade and continues to lag the changing demographics of the US population.10 More students than residents and faculty are Hispanic, which represents a much-needed opportunity for recruitment. By contrast, junior ObGyn faculty are more likely to be Black than residents and students. Native Americans constitute less than 1% of all faculty, residents, students, and US adult females.9 Lastly, race/ethnicity being self-reported as “other” or “unknown” is most common among students and residents, which perhaps represents greater diversity.
Looking back
Increasing diversity in medicine and in ObGyn has not happened by accident. Transformational change requires rectifying any factors that detrimentally affect the racial/ethnic diversity of our medical students, residents, and faculty. For example, biases inherent in key residency application metrics are being recognized, and use of holistic review is increasing. Change is also accelerated by an explicit and public commitment from national organizations. In 2009, the Liaison Committee of Medical Education (LCME) mandated that medical schools engage in practices that focus on recruitment and retention of a diverse workforce. Increases in Black and Hispanic medical students were noted after implementation of this new mandate.16 The ACGME followed suit with similar guidelines in 2019.10
Diversity is one of the foundational strengths of the ObGyn specialty. Important aspects of the specialty are built upon the contributions of women of color, some voluntary and some not. One example is the knowledge of gynecology that was gained through the involuntary and nonanesthetized surgeries performed on
Moving forward
Advancing diversity in ObGyn offers advantages: better representation of patient populations, improving public health by better access to care, enhancing learning in medical education, building more comprehensive research agendas, and driving institutional excellence. While progress has been made, significant work is still to be done. We must continue to critically examine the role of biases and structural racism that are embedded in evaluating medical students, screening of residency applicants, and selecting and retaining faculty. In future work, we should explore the hypothesis that continued change in racial/ethnic diversity of faculty will only occur once more URiM students, especially the growing number of Hispanics, are admitted into medical schools and recruited for residency positions. We should also examine whether further diversity improves patient outcomes.
It is encouraging to realize that ObGyn departments are leaders in racial/ethnic diversity at US medical schools. It is also critical that the specialty commits to the progress that still needs to be made, including increasing diversity among faculty and institutional leadership. To maintain diversity that mirrors the US adult female population, the specialty of ObGyn will require active surveillance and continued recruitment of Black and, especially Hispanic, faculty and residents.19 The national strategies aimed at building medical student and residency diversity are beginning to yield results. For those gains to help faculty diversity, institutional and departmental leaders will need to implement best practices for recruiting, retaining, and advancing URiM faculty.19 Those practices would include making workforce diversity an explicit priority, building diverse applicant pools, and establishing infrastructure and mentorship to advance URiM faculty to senior leadership positions.20
In conclusion
Building a physician workforce that is more representative of the US population should aid in addressing inequalities in health and health care. Significant strides have been made in racial/ethnic diversity in ObGyn. This has resulted in a specialty that is among the most diverse in academic medicine. At the same time, there is more work to be done. For example, the specialty is far from reaching racial equity for Hispanic physicians. Also, continued efforts are necessary to advance URiM faculty to leadership positions. The legacy of racial/ethnic diversity in ObGyn did not happen by accident and will not be maintained without intention. ●
- Hummes KR, Jones NA, Ramierez RR. United States Census: overview of race and Hispanic origin: 2010. http//www. census.gov/prod/cen2010/briefs/c2010br-02.pdf. Accessed May 22, 2022.
- Xierali IM, Castillo-Page L, Zhang K, et al. AM last page: the urgency of physician workforce diversity. Acad Med. 2014;89:1192.
- Association of American Medical College. Diversity in the physician workforce. Facts & figures 2014. http://www .aamcdiversityfactsandfigures.org. Accessed April 9, 2022.
- Marrast LM, Zallman L, Woolhandler S, et al. Minority physicians’ role in the care of underserved patients: Diversifying the physician workforce may be key in addressing health disparities. JAMA Int Med. 2014;174:289-291.
- Amalba A, Abantanga FA, Scherpbier AJ, et al. Community-based education: The influence of role modeling on career choice and practice location. Med Teac. 2017;39:174-180.
- Umbach PD. The contribution of faculty of color to undergraduate education. Res High Educ. 2006;47:317-345.
- Gonzalo JD, Chuang CH, Glod SA, et al. General internists as change agents: opportunities and barriers to leadership in health systems and medical education transformation. J Gen Intern Med. 2020;35:1865-1869.
- Xierali IM, Fair MA, Nivet MA. Faculty diversity in U.S. medical schools: Progress and gaps coexist. AAMC Analysis in Brief. 2016;16. https://www.aamc.org/system/files/reports/1/decem ber2016facultydiversityinu.s.medicalschoolsprogressandga ps.pdf. Accessed May 4, 2022.
- Rayburn WF, Xierali IM, McDade WA. Racial-ethnic diversity of obstetrics and gynecology faculty at medical schools in the United States. Am J Obstet Gynecol. 2022;S00029378(22)00106-5. doi: 10.1016/j.ajog.2022.02.007.
- Hucko L, Al-khersan H, Lopez Dominguez J, et al. Racial and ethnic diversity of U.S. residency programs, 2011-2019. N Engl J Med. 2022;386:22-23.
- Accreditation Council for Graduate Medical Education. Data Resource Book Academic Year 2020-2021. https://www.acgme.org/globalassets/pfassets /publicationsbooks/2020-2021_acgme_databook _document.pdf. Accessed October 24, 2021
- United States Census Bureau. The 2019 American Community Survey 5-Year Public Use Microdata Sample (PUMS) Files.
- Accreditation Council for Graduate Medical Education. Data Resource Book Academic Year 2020-2021. https://www.acgme .org/globalassets/pfassets/publicationsbooks/2020-2021 _acgme_databook_document.pdf. Accessed October 24, 2021.
- Rayburn WF, Liu CQ, Elwell EC, et al. Diversity of physician faculty in obstetrics and gynecology. J Reprod Med. 2016;61:22-26.
- Xierali IM, Nivet MA, Rayburn WF. Full-time faculty in clinical and basic science departments by sex and underrepresented in medicine status: A 40-year review. Acad Med. 2021;96: 568-575.
- Boatright DH, Samuels EA, Cramer LJ, et al. Association between the Liaison Committee on Medical Education’s Diversity Standards and Changes in percentage of medical student sex, race, and ethnicity. JAMA. 2018;320:2267-2269.
- United States National Library of Medicine. Changing the face of medicine.
- https://cfmedicine.nlm.nih.gov/physicians/biography_82. html. Accessed May 5, 2022.
- Christmas M. #SayHerName: Should obstetrics and gynecology reckon with the legacy of JM Sims? Reprod Sci. 2021;28:3282-3284.
- Morgan HK, Winkel AF, Bands E, et al. Promoting diversity, equity, and inclusion in the selection of obstetrician-gynecologists. Obstet Gynecol. 2021;138:272-277.
- Peek ME, Kim KE, Johnson JK, et al. “URM candidates are encouraged to apply”: a national study to identify effective strategies to enhance racial and ethnic faculty diversity in academic departments of medicine. Acad Med. 2013;88:405-412.
The nation’s population is quickly diversifying, making racial/ethnic disparities in health care outcomes even more apparent. Minority and non-English-speaking populations have grown and may become a majority in the next generation.1 A proposed strategy to reduce disparities in health care is to recruit more practitioners who better reflect the patient populations.2 Improved access to care with racial concordance between physicians and patients has been reported.3
Being increasingly aware of access-to-care data, more patients are advocating and asking for physicians of color to be their providers.4 Despite progress (ie, more women entering the medical profession), the proportion of physicians who are underrepresented in medicine (URiM—eg, Black, Hispanic, and Native American) still lags US population demographics.3
Why diversity in medicine matters
In addition to improving access to care, diversity in medicine offers other benefits. Working within diverse learning environments has demonstrated educational advantages.5,6 Medical students and residents from diverse backgrounds are less likely to report depression symptoms, regardless of their race. Diversity may accelerate advancements in health care as well, since it is well-established that diverse teams outperform nondiverse teams when it comes to innovation and productivity.7 Finally, as a profession committed to equity, advocacy, and justice, physicians are positioned to lead the way toward racial equity.
Overall, racial and gender diversity in all clinical specialties is improving, but not at the same pace. While the diversity of US medical students and residents by sex and race/ethnicity is greater than among faculty, change in racial diversity has been slow for all 3 groups.8 During the past 40 years the number of full-time faculty has increased 6-fold for females and more than tripled for males.8 However, this rise has not favored URiM faculty, because their proportion is still underrepresented relative to their group in the general population. Clinical departments that are making the most progress in recruiting URiM residents and faculty are often primary or preventive care specialties rather than surgical or service or hospital-based specialties.8,9 ObGyn has consistently had a proportion of URiM residents (18%) that is highest in the surgical specialties and comparable to family medicine and pediatrics.10
When examining physician workforce diversity, it is important to “drill down” to individual specialties to obtain a clearer understanding of trends. The continued need for increased resident and faculty diversity prompted us to examine ObGyn departments. The most recent nationwide data were gathered about full-time faculty from the 2021 AAMC Faculty Roster, residents from the 2021 Accreditation Counsel for Graduate Medical Education (ACGME) Data Resource Book, medical student matriculants from 2021 AAMC, and US adult women (defined arbitrarily as 15 years or older) from the 2019 American Community Survey.11-13
Increase in female faculty and residents
The expanding numbers of faculty and residents over a 40-year period (from 1973 to 2012) led to more women and underrepresented minorities in ObGyn than in other major clinical departments.14,15 Women now constitute two-thirds of all ObGyn faculty and are more likely to be junior rather than senior faculty.9 When looking at junior faculty, a higher proportion of junior faculty who are URiM are female. While more junior faculty and residents are female, male faculty are also racially and ethnically diverse.9
- ObGyn is a leader in racial/ethnic diversity in academic medicine.
- The rapid rise of faculty numbers in the past has not favored underrepresented faculty.
- The rise in ObGyn faculty and residents, who were predominantly female, has contributed to greater racial/ethnic diversity.
- Improved patient outcomes with racial concordance between physicians and patients have been reported.
- More patients are advocating and asking for physicians of color to be their clinicians.
- Racial/ethnic diversity of junior faculty and residents is similar to medical students.
- The most underrepresented group is Hispanic, due in part to its rapid growth in the US population.
Continue to: Growth of URiM physicians in ObGyn...
Growth of URiM physicians in ObGyn
The distribution of racial/ethnic groups in 2021 were compared between senior and junior ObGyn faculty and residents with the US adult female population.9 As shown in the FIGURE, the proportion of ObGyn faculty who are White approximates the White US adult female population. The most rapidly growing racial/ethnic group in the US population is Hispanic. Although Hispanic is the best represented ethnicity among junior faculty, the proportions of Hispanics among faculty and residents lag well behind the US population. The proportion of ObGyn faculty who are Black has consistently been less than in the US adult female population. ObGyns who are Asian constitute higher proportions of faculty and residents than in the US adult female population. This finding about Asians is consistent across all clinical specialties.7
Recruiting URiM students into ObGyn is important. Racial and ethnic representation in surgical and nonsurgical residency programs has not substantially improved in the past decade and continues to lag the changing demographics of the US population.10 More students than residents and faculty are Hispanic, which represents a much-needed opportunity for recruitment. By contrast, junior ObGyn faculty are more likely to be Black than residents and students. Native Americans constitute less than 1% of all faculty, residents, students, and US adult females.9 Lastly, race/ethnicity being self-reported as “other” or “unknown” is most common among students and residents, which perhaps represents greater diversity.
Looking back
Increasing diversity in medicine and in ObGyn has not happened by accident. Transformational change requires rectifying any factors that detrimentally affect the racial/ethnic diversity of our medical students, residents, and faculty. For example, biases inherent in key residency application metrics are being recognized, and use of holistic review is increasing. Change is also accelerated by an explicit and public commitment from national organizations. In 2009, the Liaison Committee of Medical Education (LCME) mandated that medical schools engage in practices that focus on recruitment and retention of a diverse workforce. Increases in Black and Hispanic medical students were noted after implementation of this new mandate.16 The ACGME followed suit with similar guidelines in 2019.10
Diversity is one of the foundational strengths of the ObGyn specialty. Important aspects of the specialty are built upon the contributions of women of color, some voluntary and some not. One example is the knowledge of gynecology that was gained through the involuntary and nonanesthetized surgeries performed on
Moving forward
Advancing diversity in ObGyn offers advantages: better representation of patient populations, improving public health by better access to care, enhancing learning in medical education, building more comprehensive research agendas, and driving institutional excellence. While progress has been made, significant work is still to be done. We must continue to critically examine the role of biases and structural racism that are embedded in evaluating medical students, screening of residency applicants, and selecting and retaining faculty. In future work, we should explore the hypothesis that continued change in racial/ethnic diversity of faculty will only occur once more URiM students, especially the growing number of Hispanics, are admitted into medical schools and recruited for residency positions. We should also examine whether further diversity improves patient outcomes.
It is encouraging to realize that ObGyn departments are leaders in racial/ethnic diversity at US medical schools. It is also critical that the specialty commits to the progress that still needs to be made, including increasing diversity among faculty and institutional leadership. To maintain diversity that mirrors the US adult female population, the specialty of ObGyn will require active surveillance and continued recruitment of Black and, especially Hispanic, faculty and residents.19 The national strategies aimed at building medical student and residency diversity are beginning to yield results. For those gains to help faculty diversity, institutional and departmental leaders will need to implement best practices for recruiting, retaining, and advancing URiM faculty.19 Those practices would include making workforce diversity an explicit priority, building diverse applicant pools, and establishing infrastructure and mentorship to advance URiM faculty to senior leadership positions.20
In conclusion
Building a physician workforce that is more representative of the US population should aid in addressing inequalities in health and health care. Significant strides have been made in racial/ethnic diversity in ObGyn. This has resulted in a specialty that is among the most diverse in academic medicine. At the same time, there is more work to be done. For example, the specialty is far from reaching racial equity for Hispanic physicians. Also, continued efforts are necessary to advance URiM faculty to leadership positions. The legacy of racial/ethnic diversity in ObGyn did not happen by accident and will not be maintained without intention. ●
The nation’s population is quickly diversifying, making racial/ethnic disparities in health care outcomes even more apparent. Minority and non-English-speaking populations have grown and may become a majority in the next generation.1 A proposed strategy to reduce disparities in health care is to recruit more practitioners who better reflect the patient populations.2 Improved access to care with racial concordance between physicians and patients has been reported.3
Being increasingly aware of access-to-care data, more patients are advocating and asking for physicians of color to be their providers.4 Despite progress (ie, more women entering the medical profession), the proportion of physicians who are underrepresented in medicine (URiM—eg, Black, Hispanic, and Native American) still lags US population demographics.3
Why diversity in medicine matters
In addition to improving access to care, diversity in medicine offers other benefits. Working within diverse learning environments has demonstrated educational advantages.5,6 Medical students and residents from diverse backgrounds are less likely to report depression symptoms, regardless of their race. Diversity may accelerate advancements in health care as well, since it is well-established that diverse teams outperform nondiverse teams when it comes to innovation and productivity.7 Finally, as a profession committed to equity, advocacy, and justice, physicians are positioned to lead the way toward racial equity.
Overall, racial and gender diversity in all clinical specialties is improving, but not at the same pace. While the diversity of US medical students and residents by sex and race/ethnicity is greater than among faculty, change in racial diversity has been slow for all 3 groups.8 During the past 40 years the number of full-time faculty has increased 6-fold for females and more than tripled for males.8 However, this rise has not favored URiM faculty, because their proportion is still underrepresented relative to their group in the general population. Clinical departments that are making the most progress in recruiting URiM residents and faculty are often primary or preventive care specialties rather than surgical or service or hospital-based specialties.8,9 ObGyn has consistently had a proportion of URiM residents (18%) that is highest in the surgical specialties and comparable to family medicine and pediatrics.10
When examining physician workforce diversity, it is important to “drill down” to individual specialties to obtain a clearer understanding of trends. The continued need for increased resident and faculty diversity prompted us to examine ObGyn departments. The most recent nationwide data were gathered about full-time faculty from the 2021 AAMC Faculty Roster, residents from the 2021 Accreditation Counsel for Graduate Medical Education (ACGME) Data Resource Book, medical student matriculants from 2021 AAMC, and US adult women (defined arbitrarily as 15 years or older) from the 2019 American Community Survey.11-13
Increase in female faculty and residents
The expanding numbers of faculty and residents over a 40-year period (from 1973 to 2012) led to more women and underrepresented minorities in ObGyn than in other major clinical departments.14,15 Women now constitute two-thirds of all ObGyn faculty and are more likely to be junior rather than senior faculty.9 When looking at junior faculty, a higher proportion of junior faculty who are URiM are female. While more junior faculty and residents are female, male faculty are also racially and ethnically diverse.9
- ObGyn is a leader in racial/ethnic diversity in academic medicine.
- The rapid rise of faculty numbers in the past has not favored underrepresented faculty.
- The rise in ObGyn faculty and residents, who were predominantly female, has contributed to greater racial/ethnic diversity.
- Improved patient outcomes with racial concordance between physicians and patients have been reported.
- More patients are advocating and asking for physicians of color to be their clinicians.
- Racial/ethnic diversity of junior faculty and residents is similar to medical students.
- The most underrepresented group is Hispanic, due in part to its rapid growth in the US population.
Continue to: Growth of URiM physicians in ObGyn...
Growth of URiM physicians in ObGyn
The distribution of racial/ethnic groups in 2021 were compared between senior and junior ObGyn faculty and residents with the US adult female population.9 As shown in the FIGURE, the proportion of ObGyn faculty who are White approximates the White US adult female population. The most rapidly growing racial/ethnic group in the US population is Hispanic. Although Hispanic is the best represented ethnicity among junior faculty, the proportions of Hispanics among faculty and residents lag well behind the US population. The proportion of ObGyn faculty who are Black has consistently been less than in the US adult female population. ObGyns who are Asian constitute higher proportions of faculty and residents than in the US adult female population. This finding about Asians is consistent across all clinical specialties.7
Recruiting URiM students into ObGyn is important. Racial and ethnic representation in surgical and nonsurgical residency programs has not substantially improved in the past decade and continues to lag the changing demographics of the US population.10 More students than residents and faculty are Hispanic, which represents a much-needed opportunity for recruitment. By contrast, junior ObGyn faculty are more likely to be Black than residents and students. Native Americans constitute less than 1% of all faculty, residents, students, and US adult females.9 Lastly, race/ethnicity being self-reported as “other” or “unknown” is most common among students and residents, which perhaps represents greater diversity.
Looking back
Increasing diversity in medicine and in ObGyn has not happened by accident. Transformational change requires rectifying any factors that detrimentally affect the racial/ethnic diversity of our medical students, residents, and faculty. For example, biases inherent in key residency application metrics are being recognized, and use of holistic review is increasing. Change is also accelerated by an explicit and public commitment from national organizations. In 2009, the Liaison Committee of Medical Education (LCME) mandated that medical schools engage in practices that focus on recruitment and retention of a diverse workforce. Increases in Black and Hispanic medical students were noted after implementation of this new mandate.16 The ACGME followed suit with similar guidelines in 2019.10
Diversity is one of the foundational strengths of the ObGyn specialty. Important aspects of the specialty are built upon the contributions of women of color, some voluntary and some not. One example is the knowledge of gynecology that was gained through the involuntary and nonanesthetized surgeries performed on
Moving forward
Advancing diversity in ObGyn offers advantages: better representation of patient populations, improving public health by better access to care, enhancing learning in medical education, building more comprehensive research agendas, and driving institutional excellence. While progress has been made, significant work is still to be done. We must continue to critically examine the role of biases and structural racism that are embedded in evaluating medical students, screening of residency applicants, and selecting and retaining faculty. In future work, we should explore the hypothesis that continued change in racial/ethnic diversity of faculty will only occur once more URiM students, especially the growing number of Hispanics, are admitted into medical schools and recruited for residency positions. We should also examine whether further diversity improves patient outcomes.
It is encouraging to realize that ObGyn departments are leaders in racial/ethnic diversity at US medical schools. It is also critical that the specialty commits to the progress that still needs to be made, including increasing diversity among faculty and institutional leadership. To maintain diversity that mirrors the US adult female population, the specialty of ObGyn will require active surveillance and continued recruitment of Black and, especially Hispanic, faculty and residents.19 The national strategies aimed at building medical student and residency diversity are beginning to yield results. For those gains to help faculty diversity, institutional and departmental leaders will need to implement best practices for recruiting, retaining, and advancing URiM faculty.19 Those practices would include making workforce diversity an explicit priority, building diverse applicant pools, and establishing infrastructure and mentorship to advance URiM faculty to senior leadership positions.20
In conclusion
Building a physician workforce that is more representative of the US population should aid in addressing inequalities in health and health care. Significant strides have been made in racial/ethnic diversity in ObGyn. This has resulted in a specialty that is among the most diverse in academic medicine. At the same time, there is more work to be done. For example, the specialty is far from reaching racial equity for Hispanic physicians. Also, continued efforts are necessary to advance URiM faculty to leadership positions. The legacy of racial/ethnic diversity in ObGyn did not happen by accident and will not be maintained without intention. ●
- Hummes KR, Jones NA, Ramierez RR. United States Census: overview of race and Hispanic origin: 2010. http//www. census.gov/prod/cen2010/briefs/c2010br-02.pdf. Accessed May 22, 2022.
- Xierali IM, Castillo-Page L, Zhang K, et al. AM last page: the urgency of physician workforce diversity. Acad Med. 2014;89:1192.
- Association of American Medical College. Diversity in the physician workforce. Facts & figures 2014. http://www .aamcdiversityfactsandfigures.org. Accessed April 9, 2022.
- Marrast LM, Zallman L, Woolhandler S, et al. Minority physicians’ role in the care of underserved patients: Diversifying the physician workforce may be key in addressing health disparities. JAMA Int Med. 2014;174:289-291.
- Amalba A, Abantanga FA, Scherpbier AJ, et al. Community-based education: The influence of role modeling on career choice and practice location. Med Teac. 2017;39:174-180.
- Umbach PD. The contribution of faculty of color to undergraduate education. Res High Educ. 2006;47:317-345.
- Gonzalo JD, Chuang CH, Glod SA, et al. General internists as change agents: opportunities and barriers to leadership in health systems and medical education transformation. J Gen Intern Med. 2020;35:1865-1869.
- Xierali IM, Fair MA, Nivet MA. Faculty diversity in U.S. medical schools: Progress and gaps coexist. AAMC Analysis in Brief. 2016;16. https://www.aamc.org/system/files/reports/1/decem ber2016facultydiversityinu.s.medicalschoolsprogressandga ps.pdf. Accessed May 4, 2022.
- Rayburn WF, Xierali IM, McDade WA. Racial-ethnic diversity of obstetrics and gynecology faculty at medical schools in the United States. Am J Obstet Gynecol. 2022;S00029378(22)00106-5. doi: 10.1016/j.ajog.2022.02.007.
- Hucko L, Al-khersan H, Lopez Dominguez J, et al. Racial and ethnic diversity of U.S. residency programs, 2011-2019. N Engl J Med. 2022;386:22-23.
- Accreditation Council for Graduate Medical Education. Data Resource Book Academic Year 2020-2021. https://www.acgme.org/globalassets/pfassets /publicationsbooks/2020-2021_acgme_databook _document.pdf. Accessed October 24, 2021
- United States Census Bureau. The 2019 American Community Survey 5-Year Public Use Microdata Sample (PUMS) Files.
- Accreditation Council for Graduate Medical Education. Data Resource Book Academic Year 2020-2021. https://www.acgme .org/globalassets/pfassets/publicationsbooks/2020-2021 _acgme_databook_document.pdf. Accessed October 24, 2021.
- Rayburn WF, Liu CQ, Elwell EC, et al. Diversity of physician faculty in obstetrics and gynecology. J Reprod Med. 2016;61:22-26.
- Xierali IM, Nivet MA, Rayburn WF. Full-time faculty in clinical and basic science departments by sex and underrepresented in medicine status: A 40-year review. Acad Med. 2021;96: 568-575.
- Boatright DH, Samuels EA, Cramer LJ, et al. Association between the Liaison Committee on Medical Education’s Diversity Standards and Changes in percentage of medical student sex, race, and ethnicity. JAMA. 2018;320:2267-2269.
- United States National Library of Medicine. Changing the face of medicine.
- https://cfmedicine.nlm.nih.gov/physicians/biography_82. html. Accessed May 5, 2022.
- Christmas M. #SayHerName: Should obstetrics and gynecology reckon with the legacy of JM Sims? Reprod Sci. 2021;28:3282-3284.
- Morgan HK, Winkel AF, Bands E, et al. Promoting diversity, equity, and inclusion in the selection of obstetrician-gynecologists. Obstet Gynecol. 2021;138:272-277.
- Peek ME, Kim KE, Johnson JK, et al. “URM candidates are encouraged to apply”: a national study to identify effective strategies to enhance racial and ethnic faculty diversity in academic departments of medicine. Acad Med. 2013;88:405-412.
- Hummes KR, Jones NA, Ramierez RR. United States Census: overview of race and Hispanic origin: 2010. http//www. census.gov/prod/cen2010/briefs/c2010br-02.pdf. Accessed May 22, 2022.
- Xierali IM, Castillo-Page L, Zhang K, et al. AM last page: the urgency of physician workforce diversity. Acad Med. 2014;89:1192.
- Association of American Medical College. Diversity in the physician workforce. Facts & figures 2014. http://www .aamcdiversityfactsandfigures.org. Accessed April 9, 2022.
- Marrast LM, Zallman L, Woolhandler S, et al. Minority physicians’ role in the care of underserved patients: Diversifying the physician workforce may be key in addressing health disparities. JAMA Int Med. 2014;174:289-291.
- Amalba A, Abantanga FA, Scherpbier AJ, et al. Community-based education: The influence of role modeling on career choice and practice location. Med Teac. 2017;39:174-180.
- Umbach PD. The contribution of faculty of color to undergraduate education. Res High Educ. 2006;47:317-345.
- Gonzalo JD, Chuang CH, Glod SA, et al. General internists as change agents: opportunities and barriers to leadership in health systems and medical education transformation. J Gen Intern Med. 2020;35:1865-1869.
- Xierali IM, Fair MA, Nivet MA. Faculty diversity in U.S. medical schools: Progress and gaps coexist. AAMC Analysis in Brief. 2016;16. https://www.aamc.org/system/files/reports/1/decem ber2016facultydiversityinu.s.medicalschoolsprogressandga ps.pdf. Accessed May 4, 2022.
- Rayburn WF, Xierali IM, McDade WA. Racial-ethnic diversity of obstetrics and gynecology faculty at medical schools in the United States. Am J Obstet Gynecol. 2022;S00029378(22)00106-5. doi: 10.1016/j.ajog.2022.02.007.
- Hucko L, Al-khersan H, Lopez Dominguez J, et al. Racial and ethnic diversity of U.S. residency programs, 2011-2019. N Engl J Med. 2022;386:22-23.
- Accreditation Council for Graduate Medical Education. Data Resource Book Academic Year 2020-2021. https://www.acgme.org/globalassets/pfassets /publicationsbooks/2020-2021_acgme_databook _document.pdf. Accessed October 24, 2021
- United States Census Bureau. The 2019 American Community Survey 5-Year Public Use Microdata Sample (PUMS) Files.
- Accreditation Council for Graduate Medical Education. Data Resource Book Academic Year 2020-2021. https://www.acgme .org/globalassets/pfassets/publicationsbooks/2020-2021 _acgme_databook_document.pdf. Accessed October 24, 2021.
- Rayburn WF, Liu CQ, Elwell EC, et al. Diversity of physician faculty in obstetrics and gynecology. J Reprod Med. 2016;61:22-26.
- Xierali IM, Nivet MA, Rayburn WF. Full-time faculty in clinical and basic science departments by sex and underrepresented in medicine status: A 40-year review. Acad Med. 2021;96: 568-575.
- Boatright DH, Samuels EA, Cramer LJ, et al. Association between the Liaison Committee on Medical Education’s Diversity Standards and Changes in percentage of medical student sex, race, and ethnicity. JAMA. 2018;320:2267-2269.
- United States National Library of Medicine. Changing the face of medicine.
- https://cfmedicine.nlm.nih.gov/physicians/biography_82. html. Accessed May 5, 2022.
- Christmas M. #SayHerName: Should obstetrics and gynecology reckon with the legacy of JM Sims? Reprod Sci. 2021;28:3282-3284.
- Morgan HK, Winkel AF, Bands E, et al. Promoting diversity, equity, and inclusion in the selection of obstetrician-gynecologists. Obstet Gynecol. 2021;138:272-277.
- Peek ME, Kim KE, Johnson JK, et al. “URM candidates are encouraged to apply”: a national study to identify effective strategies to enhance racial and ethnic faculty diversity in academic departments of medicine. Acad Med. 2013;88:405-412.
Real-world efficacy and safety of anti-CGRP drugs in drug-resistant chronic migraine
Key clinical point: This real-world analysis confirms the benefits of anticalcitonin gene-related peptide (anti-CGRP) drugs, erenumab, galcanezumab, and fremanezumab, in drug-resistant chronic migraine; however, intensified erenumab regimen showed limited benefits.
Major finding: At week 12, all patients treated with erenumab (P < .001), galcanezumab (P < .001), or fremanezumab (P = .028) achieved a significant reduction in mean monthly migraine headache days, with treatment-associated toxicity being higher with erenumab vs galcanezumab and fremanezumab (P = .04). An intensified erenumab regimen demonstrated similar efficacy but with more severe grade 3/4 toxicity (140 vs 70 mg: 14.8% vs 0%; P = .038).
Study details: This was a retrospective study including 104 patients with drug-resistant chronic migraine who had failed >3 conventional migraine preventive treatments and received erenumab, galcanezumab, or fremanezumab.
Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest.
Source: Cantarelli L et al. Efficacy and safety of erenumab, galcanezumab, and fremanezumab in the treatment of drug-resistant chronic migraine: Experience in real clinical practice. Ann Pharmacother. 2022 (Aug 18). Doi: 10.1177/10600280221118402
Key clinical point: This real-world analysis confirms the benefits of anticalcitonin gene-related peptide (anti-CGRP) drugs, erenumab, galcanezumab, and fremanezumab, in drug-resistant chronic migraine; however, intensified erenumab regimen showed limited benefits.
Major finding: At week 12, all patients treated with erenumab (P < .001), galcanezumab (P < .001), or fremanezumab (P = .028) achieved a significant reduction in mean monthly migraine headache days, with treatment-associated toxicity being higher with erenumab vs galcanezumab and fremanezumab (P = .04). An intensified erenumab regimen demonstrated similar efficacy but with more severe grade 3/4 toxicity (140 vs 70 mg: 14.8% vs 0%; P = .038).
Study details: This was a retrospective study including 104 patients with drug-resistant chronic migraine who had failed >3 conventional migraine preventive treatments and received erenumab, galcanezumab, or fremanezumab.
Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest.
Source: Cantarelli L et al. Efficacy and safety of erenumab, galcanezumab, and fremanezumab in the treatment of drug-resistant chronic migraine: Experience in real clinical practice. Ann Pharmacother. 2022 (Aug 18). Doi: 10.1177/10600280221118402
Key clinical point: This real-world analysis confirms the benefits of anticalcitonin gene-related peptide (anti-CGRP) drugs, erenumab, galcanezumab, and fremanezumab, in drug-resistant chronic migraine; however, intensified erenumab regimen showed limited benefits.
Major finding: At week 12, all patients treated with erenumab (P < .001), galcanezumab (P < .001), or fremanezumab (P = .028) achieved a significant reduction in mean monthly migraine headache days, with treatment-associated toxicity being higher with erenumab vs galcanezumab and fremanezumab (P = .04). An intensified erenumab regimen demonstrated similar efficacy but with more severe grade 3/4 toxicity (140 vs 70 mg: 14.8% vs 0%; P = .038).
Study details: This was a retrospective study including 104 patients with drug-resistant chronic migraine who had failed >3 conventional migraine preventive treatments and received erenumab, galcanezumab, or fremanezumab.
Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest.
Source: Cantarelli L et al. Efficacy and safety of erenumab, galcanezumab, and fremanezumab in the treatment of drug-resistant chronic migraine: Experience in real clinical practice. Ann Pharmacother. 2022 (Aug 18). Doi: 10.1177/10600280221118402
Erenumab is safe and well tolerated across age groups in chronic or episodic migraine
Key clinical point: Erenumab vs placebo demonstrated a similar safety profile across all age groups of patients with chronic or episodic migraine, with no increase in adverse events because of age.
Major finding: Incidence of treatment-emergent adverse events was similar with 70 and 140 mg erenumab vs placebo across age groups: <40 (44.2% and 43.7% vs 44.4%, respectively), 40-49 (42.1% and 42.9% vs 49.2%, respectively), 50-59 (43.5% and 50.6% vs 41.6%, respectively), and ≥60 (39.5% and 48.6% vs 59.4%, respectively) years. The age-stratified incidence of treatment-emergent serious adverse events was low with both erenumab doses, with none reported among patients aged ≥60 years.
Study details: Findings are from a pooled and age-stratified analysis of five phase 2 and 3 randomized controlled trials including 3345 patients with chronic or episodic migraine with or without aura who were randomly assigned to receive erenumab (70 or 140 mg) or placebo.
Disclosures: This study was funded by Novartis Pharma AG, Switzerland. Erenumab was co-developed by Novartis and Amgen. Six authors declared being current or former employees or stockholders of Novartis or Amgen. C Lampl declared receiving honoraria from Novartis.
Source: Lampl C et al. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: A pooled analysis of placebo-controlled trials. J Headache Pain. 2022;23:104 (Aug 18). Doi: 10.1186/s10194-022-01470-4
Key clinical point: Erenumab vs placebo demonstrated a similar safety profile across all age groups of patients with chronic or episodic migraine, with no increase in adverse events because of age.
Major finding: Incidence of treatment-emergent adverse events was similar with 70 and 140 mg erenumab vs placebo across age groups: <40 (44.2% and 43.7% vs 44.4%, respectively), 40-49 (42.1% and 42.9% vs 49.2%, respectively), 50-59 (43.5% and 50.6% vs 41.6%, respectively), and ≥60 (39.5% and 48.6% vs 59.4%, respectively) years. The age-stratified incidence of treatment-emergent serious adverse events was low with both erenumab doses, with none reported among patients aged ≥60 years.
Study details: Findings are from a pooled and age-stratified analysis of five phase 2 and 3 randomized controlled trials including 3345 patients with chronic or episodic migraine with or without aura who were randomly assigned to receive erenumab (70 or 140 mg) or placebo.
Disclosures: This study was funded by Novartis Pharma AG, Switzerland. Erenumab was co-developed by Novartis and Amgen. Six authors declared being current or former employees or stockholders of Novartis or Amgen. C Lampl declared receiving honoraria from Novartis.
Source: Lampl C et al. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: A pooled analysis of placebo-controlled trials. J Headache Pain. 2022;23:104 (Aug 18). Doi: 10.1186/s10194-022-01470-4
Key clinical point: Erenumab vs placebo demonstrated a similar safety profile across all age groups of patients with chronic or episodic migraine, with no increase in adverse events because of age.
Major finding: Incidence of treatment-emergent adverse events was similar with 70 and 140 mg erenumab vs placebo across age groups: <40 (44.2% and 43.7% vs 44.4%, respectively), 40-49 (42.1% and 42.9% vs 49.2%, respectively), 50-59 (43.5% and 50.6% vs 41.6%, respectively), and ≥60 (39.5% and 48.6% vs 59.4%, respectively) years. The age-stratified incidence of treatment-emergent serious adverse events was low with both erenumab doses, with none reported among patients aged ≥60 years.
Study details: Findings are from a pooled and age-stratified analysis of five phase 2 and 3 randomized controlled trials including 3345 patients with chronic or episodic migraine with or without aura who were randomly assigned to receive erenumab (70 or 140 mg) or placebo.
Disclosures: This study was funded by Novartis Pharma AG, Switzerland. Erenumab was co-developed by Novartis and Amgen. Six authors declared being current or former employees or stockholders of Novartis or Amgen. C Lampl declared receiving honoraria from Novartis.
Source: Lampl C et al. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: A pooled analysis of placebo-controlled trials. J Headache Pain. 2022;23:104 (Aug 18). Doi: 10.1186/s10194-022-01470-4
Eptinezumab reduces headache days with acute medication use in patients with chronic migraine
Key clinical point: Eptinezumab vs placebo significantly reduced the number of headache days with acute headache medication (AHM) use in patients with chronic migraine (CM), with the effect being greatest among those with medication-overuse headache and ≥50% response.
Major finding: Eptinezumab vs placebo resulted in a greater percentage-point reductions in the number of headache days with AHM use in the overall cohort of patients with CM (percentage-point reduction −25.1% vs −17.0%) and in patients with CM and medication-overuse headache who experienced ≥50% response (percentage-point reduction −38.3% vs −31.5%) over 24 weeks.
Study details: Findings are from a post hoc analysis of a phase 3 study, PROMISE-2, including 1072 patients with CM, of which 40.2% were diagnosed with medication-overuse headache and were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.
Disclosures: This study was funded by Lundbeck Seattle BioPharmaceuticals, Inc., USA. Four authors declared being current or former employees of Lundbeck or a subsidiary company or a company contracted by Lundbeck or owning stocks or stock options in Alder/Lundbeck. Several authors reported ties with Lundbeck or other sources.
Source: Cowan RP et al. Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: Subanalysis of the PROMISE‑2 study. J Headache Pain. 2022;23:115 (Sep 6). Doi: 10.1186/s10194-022-01482-0
Key clinical point: Eptinezumab vs placebo significantly reduced the number of headache days with acute headache medication (AHM) use in patients with chronic migraine (CM), with the effect being greatest among those with medication-overuse headache and ≥50% response.
Major finding: Eptinezumab vs placebo resulted in a greater percentage-point reductions in the number of headache days with AHM use in the overall cohort of patients with CM (percentage-point reduction −25.1% vs −17.0%) and in patients with CM and medication-overuse headache who experienced ≥50% response (percentage-point reduction −38.3% vs −31.5%) over 24 weeks.
Study details: Findings are from a post hoc analysis of a phase 3 study, PROMISE-2, including 1072 patients with CM, of which 40.2% were diagnosed with medication-overuse headache and were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.
Disclosures: This study was funded by Lundbeck Seattle BioPharmaceuticals, Inc., USA. Four authors declared being current or former employees of Lundbeck or a subsidiary company or a company contracted by Lundbeck or owning stocks or stock options in Alder/Lundbeck. Several authors reported ties with Lundbeck or other sources.
Source: Cowan RP et al. Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: Subanalysis of the PROMISE‑2 study. J Headache Pain. 2022;23:115 (Sep 6). Doi: 10.1186/s10194-022-01482-0
Key clinical point: Eptinezumab vs placebo significantly reduced the number of headache days with acute headache medication (AHM) use in patients with chronic migraine (CM), with the effect being greatest among those with medication-overuse headache and ≥50% response.
Major finding: Eptinezumab vs placebo resulted in a greater percentage-point reductions in the number of headache days with AHM use in the overall cohort of patients with CM (percentage-point reduction −25.1% vs −17.0%) and in patients with CM and medication-overuse headache who experienced ≥50% response (percentage-point reduction −38.3% vs −31.5%) over 24 weeks.
Study details: Findings are from a post hoc analysis of a phase 3 study, PROMISE-2, including 1072 patients with CM, of which 40.2% were diagnosed with medication-overuse headache and were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.
Disclosures: This study was funded by Lundbeck Seattle BioPharmaceuticals, Inc., USA. Four authors declared being current or former employees of Lundbeck or a subsidiary company or a company contracted by Lundbeck or owning stocks or stock options in Alder/Lundbeck. Several authors reported ties with Lundbeck or other sources.
Source: Cowan RP et al. Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: Subanalysis of the PROMISE‑2 study. J Headache Pain. 2022;23:115 (Sep 6). Doi: 10.1186/s10194-022-01482-0