- Kenny Lin, MD, MPH
Since July 2018, the U.S. Food and Drug Administration (FDA) has issued more than 20 recalls of the angiotensin-receptor blockers (ARBs) valsartan, irbesartan, and losartan because they contained potentially carcinogenic contaminants. As a result, there are now widespread shortages of these anti-hypertensive drugs. Although the FDA's internal analyses and published studies suggest that the excess cancer risk is small even with long-term use, and the FDA has posted a list of currently available ARBs that have been tested and found safe, identifying substitutes may be difficult. Many patients prescribed ARBs may already take other first-line anti-hypertensive drugs at maximum doses and/or be unable to tolerate angiotensin-converting enzyme (ACE) inhibitors due to cough.
One underutilized alternative is motivating patients with high blood pressure to make therapeutic lifestyle changes. In a Lown Right Care article in the March 15 issue of AFP, Drs. Ann Lindsay, Ajay Sharma, and Alan Glaseroff observed that "physicians ... often go straight to telling patients what to do without listening to what the patient thinks or is willing to do." Evidence suggests that patients are more likely adhere to treatment plans if physicians first get to know the patient's story and health goals, and that five key clinician behaviors are associated with better health outcomes: "(1) emphasizing patient ownership—work on patient goals; (2) partnering with patients on what they are willing and able to do; (3) identifying small steps to ensure success; (4) scheduling frequent follow-up visits to cheer successes or problem solve; and (5) showing care and concern for the patient."
A recent commentary in the Annals of Internal Medicine noted that the 2017 ACC/AHA hypertension guideline barely mentioned the value of lifestyle interventions for persons with hypertension or the barriers to providing them in primary care settings:
Practices that are not structured and staffed to systematically assess patient lifestyle factors, support behavior modification counseling, and provide follow-up will face obstacles to implementation. Clinicians in these practices also must be supported by relevant competencies; professional guidelines; routine feedback; and on-site training in practice change, such as academic detailing and practice facilitation. ... Ensuring that clinicians knowledgeable in behavior change theory and evidence-based lifestyle interventions are part of the primary care team is even more important.
Clinicians and patients may question if exercise programs have the same blood pressure-lowering benefits as medications. Although no randomized, controlled trials have directly compared exercise against medication, a systematic review and network meta-analysis of 391 trials found that in persons with hypertension, endurance or dynamic resistance exercise was equally effective for lowering systolic blood pressure as ACE inhibitors, ARBs, beta-blockers, and diuretics.
Sunday, April 28, 2019
Monday, April 22, 2019
Preventing lawn mower injuries with simple safety steps
- Jennifer Middleton, MD, MPH
Although lawn mowers don't seem to get a lot of press, over 80,000 persons in the United States are injured by them every year; children under the age of 19 make up a substantial minority of these injuries (estimates range from 4,000 to 13,000 children per year). Most injuries are lacerations or burns, but some lead to serious skin infections, and some are severe enough to require limb amputation. Lawn mower injuries are largely preventable with some simple safety measures. With spring weather upon us in the U.S., it's worth discussing lawn mower safety with patients, especially parents of young children and teens.
Young children (ages 1-3 years) and adolescents are the most likely youth to be injured by a lawn mower; young children are more likely to be accidentally struck when a lawn mower is put into reverse or hit by objects discharged into the air by a lawn mower in use, such as sticks, stones, or toys; teenagers are less likely to follow standard safety measures when operating a lawn mower themselves. The American Academy of Orthopedic Surgeons advises parents to forbid children from playing on a lawn as it is being mowed; they also discourage children from riding on riding lawn mowers with adults. The American Academy of Pediatrics recommends that children be at least 12 years of age before independently operating a push lawn mower and 16 years of age before using a riding lawn mower. Checking and clearing the lawn of debris prior to mowing, ensuring that children are playing elsewhere while mowing, and wearing closed-toed shoes, hearing protection, and eye protection are crucial safety actions for all operators of lawn mowers.
Adults sustain the largest numbers of injuries, however, and need to follow appropriate safety measures for themselves as well. The American Society for the Surgery of the Hand advises keeping blades in good condition and avoiding alcohol prior to or during mowing. They also discourage putting hands or feet into the mower to clear debris, lifting the mower from the bottom, and tampering with safety devices and guards. The mower's engine should be turned off, and the blades should stop moving, before crossing a gravel path, removing the grass catcher, or walking away from the mower.
With these simple safety steps, mowing the lawn can be an enjoyable and healthy activity. Pushing a lawn mower is beneficial aerobic exercise, which qualifies as an activity requiring at least 4 METs of functional capacity. Certainly many homeowners enjoy the calm rhythm of lawn mowing, too. You can find more safety tips for spring and summer activities in this 2018 post by Dr. Lin and a previous AFP article on prevention of unintended childhood injury.
Although lawn mowers don't seem to get a lot of press, over 80,000 persons in the United States are injured by them every year; children under the age of 19 make up a substantial minority of these injuries (estimates range from 4,000 to 13,000 children per year). Most injuries are lacerations or burns, but some lead to serious skin infections, and some are severe enough to require limb amputation. Lawn mower injuries are largely preventable with some simple safety measures. With spring weather upon us in the U.S., it's worth discussing lawn mower safety with patients, especially parents of young children and teens.
Young children (ages 1-3 years) and adolescents are the most likely youth to be injured by a lawn mower; young children are more likely to be accidentally struck when a lawn mower is put into reverse or hit by objects discharged into the air by a lawn mower in use, such as sticks, stones, or toys; teenagers are less likely to follow standard safety measures when operating a lawn mower themselves. The American Academy of Orthopedic Surgeons advises parents to forbid children from playing on a lawn as it is being mowed; they also discourage children from riding on riding lawn mowers with adults. The American Academy of Pediatrics recommends that children be at least 12 years of age before independently operating a push lawn mower and 16 years of age before using a riding lawn mower. Checking and clearing the lawn of debris prior to mowing, ensuring that children are playing elsewhere while mowing, and wearing closed-toed shoes, hearing protection, and eye protection are crucial safety actions for all operators of lawn mowers.
Adults sustain the largest numbers of injuries, however, and need to follow appropriate safety measures for themselves as well. The American Society for the Surgery of the Hand advises keeping blades in good condition and avoiding alcohol prior to or during mowing. They also discourage putting hands or feet into the mower to clear debris, lifting the mower from the bottom, and tampering with safety devices and guards. The mower's engine should be turned off, and the blades should stop moving, before crossing a gravel path, removing the grass catcher, or walking away from the mower.
With these simple safety steps, mowing the lawn can be an enjoyable and healthy activity. Pushing a lawn mower is beneficial aerobic exercise, which qualifies as an activity requiring at least 4 METs of functional capacity. Certainly many homeowners enjoy the calm rhythm of lawn mowing, too. You can find more safety tips for spring and summer activities in this 2018 post by Dr. Lin and a previous AFP article on prevention of unintended childhood injury.
Monday, April 15, 2019
Migraine prevention - what's changed?
- Michael J. Arnold, MD
Since getting a migraine headache every Friday during junior high school, I have always been interested in preventing migraines. In medical school, I realized that it was likely the nitrates in the hot dogs served on Fridays at the school cafeteria that were to blame – perhaps with a boost from adolescent hormones.
Powerful Placebo Effect
A recent study on migraine prevention in children opened my eyes to the power of the placebo effect. A 2017 National Institutes of Health-sponsored trial comparing topiramate (the only FDA approved drug for migraine prophylaxis in children) and amitriptyline was stopped early because placebo was more effective than either active drug. Although both medications were effective, placebo was even better, producing a 50% reduction in headache frequency in 61% of children assigned to that arm of the study.
In adult studies, the placebo effect is nearly as strong. Between 20 and 50% of patients achieve a 50% reduction in headache frequency with placebo, and few medications do much better. While a portion of this is likely due to the waxing course of migraine, the placebo response rate tends to be over 20% even for patients with more than 15 migraines per month. The best medications, including topiramate, valproate, and some beta blockers, help 25% more people than placebo halve their migraine frequency, leading to a Number Needed to Treat (NNT) of four. Amitriptyline works 9% better than placebo, with a NNT of 12.
Complementary Therapy
If matching placebo gives at least a 25% response rate, could it be worth trying a safe herbal medication with some evidence of being better? Herbal medications such as feverfew, 6.25 mg three times daily, riboflavin 400 mg daily and magnesium 600 mg daily have limited evidence of being better than placebo with only mild side effects. Another small trial suggested that nightly melatonin was better at reducing migraines than amitriptyline and placebo, with the only common side effect being fatigue. Acupuncture has a NNT of 10 for halving the number of migraines when compared to sham acupuncture, but only 4 when compared to usual care.
A complementary therapy to avoid is butterbur (petasites), which has the best evidence for benefit but can be hepatotoxic. Without FDA regulation of the supplement industry, use is not recommended in the United States.
New Injections for Migraine Prevention
You may have heard of erenumab, a monthly injected medication for migraine prevention comprised of antibodies focused on the calcium gene related peptide system. Erenumab is joined by similar medications fremanezumab and galcanezumab, all of which are priced at $575 per monthly injection, compared to the $150 retail price for 60 tabs of topiramate at 50 mg. These injections have evidence of benefit over placebo with NNTs of either 5 or 6 to reduce headache frequency by 50%.
The American Headache Association recommends trying at least two other medication classes before prescribing these injections, but most studies of these drugs specifically excluded patients who had failed multiple previous medications. A single trial did study erenumab in patients who had failed two medications, and the 50% headache frequency reduction was met in 14% with placebo and 30% with erenumab, leading to a NNT of 7.
Short term side effects were rare and minor (injection site reactions and constipation). However, none of these trials followed patients for longer than three months. These medicines may be valuable for selected patients, but much is yet to be proven. An article in the January 1, 2019 issue of AFP covers migraine prophylaxis in more depth.
**
Dr. Arnold is AFP's 2019-20 Jay Siwek Medical Editing Fellow. The views expressed in this blog post are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, Uniformed Services University of the Health Sciences, Department of Defense, or the U.S. Government.
Since getting a migraine headache every Friday during junior high school, I have always been interested in preventing migraines. In medical school, I realized that it was likely the nitrates in the hot dogs served on Fridays at the school cafeteria that were to blame – perhaps with a boost from adolescent hormones.
Powerful Placebo Effect
A recent study on migraine prevention in children opened my eyes to the power of the placebo effect. A 2017 National Institutes of Health-sponsored trial comparing topiramate (the only FDA approved drug for migraine prophylaxis in children) and amitriptyline was stopped early because placebo was more effective than either active drug. Although both medications were effective, placebo was even better, producing a 50% reduction in headache frequency in 61% of children assigned to that arm of the study.
In adult studies, the placebo effect is nearly as strong. Between 20 and 50% of patients achieve a 50% reduction in headache frequency with placebo, and few medications do much better. While a portion of this is likely due to the waxing course of migraine, the placebo response rate tends to be over 20% even for patients with more than 15 migraines per month. The best medications, including topiramate, valproate, and some beta blockers, help 25% more people than placebo halve their migraine frequency, leading to a Number Needed to Treat (NNT) of four. Amitriptyline works 9% better than placebo, with a NNT of 12.
Complementary Therapy
If matching placebo gives at least a 25% response rate, could it be worth trying a safe herbal medication with some evidence of being better? Herbal medications such as feverfew, 6.25 mg three times daily, riboflavin 400 mg daily and magnesium 600 mg daily have limited evidence of being better than placebo with only mild side effects. Another small trial suggested that nightly melatonin was better at reducing migraines than amitriptyline and placebo, with the only common side effect being fatigue. Acupuncture has a NNT of 10 for halving the number of migraines when compared to sham acupuncture, but only 4 when compared to usual care.
A complementary therapy to avoid is butterbur (petasites), which has the best evidence for benefit but can be hepatotoxic. Without FDA regulation of the supplement industry, use is not recommended in the United States.
New Injections for Migraine Prevention
You may have heard of erenumab, a monthly injected medication for migraine prevention comprised of antibodies focused on the calcium gene related peptide system. Erenumab is joined by similar medications fremanezumab and galcanezumab, all of which are priced at $575 per monthly injection, compared to the $150 retail price for 60 tabs of topiramate at 50 mg. These injections have evidence of benefit over placebo with NNTs of either 5 or 6 to reduce headache frequency by 50%.
The American Headache Association recommends trying at least two other medication classes before prescribing these injections, but most studies of these drugs specifically excluded patients who had failed multiple previous medications. A single trial did study erenumab in patients who had failed two medications, and the 50% headache frequency reduction was met in 14% with placebo and 30% with erenumab, leading to a NNT of 7.
Short term side effects were rare and minor (injection site reactions and constipation). However, none of these trials followed patients for longer than three months. These medicines may be valuable for selected patients, but much is yet to be proven. An article in the January 1, 2019 issue of AFP covers migraine prophylaxis in more depth.
**
Dr. Arnold is AFP's 2019-20 Jay Siwek Medical Editing Fellow. The views expressed in this blog post are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, Uniformed Services University of the Health Sciences, Department of Defense, or the U.S. Government.
Monday, April 8, 2019
Reimagining advance care planning for patients with serious illness
- Kenny Lin, MD, MPH
It is difficult to overstate the damage done by the fictional political term "death panel," which claimed that a 2009 legislative proposal to pay physicians for providing counseling to Medicare patients about advance directives and end-of-life care options amounted to a group of federal bureaucrats deciding whether an older or disabled person would be permitted to live or die. Not until 2016 did the Centers for Medicare & Medicaid Services (CMS) create Current Procedural Terminology (CPT) codes that allowed billing for advance care planning services, and clinicians have been slow to use them. According to a recent study in JAMA Internal Medicine, only about 2% of Medicare fee-for-service beneficiaries age 65 years or older had advance care planning visits. As expected, geriatricians and palliative medicine specialists were more likely to use the codes than other physicians. Even so, two-thirds of hospice and palliative medicine specialists did not use the codes at all in 2017, which suggested that billing did not reflect actual counseling practices.
Other articles have documented the challenges of incorporating patients' values and preferences into care plans when they are already experiencing serious illness. An analysis of recorded clinician-family conferences about critically ill patients found that in more than half, "there was no deliberation about how to apply patients' values and preferences in the current clinical situation," and in 1 out of every 4 discussions, the patient's values and preferences were not even mentioned. Similarly, a medical oncologist reflected in Health Affairs about the care team's failure to manage expectations of a patient with advanced (and ultimately fatal) lung cancer who, "because she was looking for rescue," declined to discuss goals of care as an outpatient even as treatments proved ineffective and her health deteriorated:
I'm not sure how well we managed Wendy's care at the end of her life. On the one hand, she achieved her short-term goal of attending the family gathering. On the other hand, she spent nearly the entire last month of her life hospitalized. She died in an intensive care unit, intubated, on a ventilator, and unable to say goodbye to love ones. She was not enrolled in hospice. We don't know whether we met Wendy's goals of care because we never managed to define them.
Two editorials in the March 1 issue of AFP addressed how family physicians can prepare patients better for end-of-life decisions by "thinking about [advance care planning] as an iterative and integrative process," rather than as a document to be filled out and then filed away. Primary care teams can use the Serious Illness Conversation Guide to assess patients' understanding of their illness, explore what matters most to them, and communicate goals of care to family members and subspecialists. Lack of training and time constraints remain barriers, however. Innovative residency curricula on advance care planning, such as this medical-legal partnership described in Family Medicine, may improve physicians' comfort level with these conversations. Having Medicare and private insurers pay for advance care planning discussions is a helpful first step, but as Drs. Joanna Paladino and Erik Fromme observed, "clinicians cannot improve the care of people with serious illness alone—to be successful, they need health system changes that support better conversations over the continuum of care."
It is difficult to overstate the damage done by the fictional political term "death panel," which claimed that a 2009 legislative proposal to pay physicians for providing counseling to Medicare patients about advance directives and end-of-life care options amounted to a group of federal bureaucrats deciding whether an older or disabled person would be permitted to live or die. Not until 2016 did the Centers for Medicare & Medicaid Services (CMS) create Current Procedural Terminology (CPT) codes that allowed billing for advance care planning services, and clinicians have been slow to use them. According to a recent study in JAMA Internal Medicine, only about 2% of Medicare fee-for-service beneficiaries age 65 years or older had advance care planning visits. As expected, geriatricians and palliative medicine specialists were more likely to use the codes than other physicians. Even so, two-thirds of hospice and palliative medicine specialists did not use the codes at all in 2017, which suggested that billing did not reflect actual counseling practices.
Other articles have documented the challenges of incorporating patients' values and preferences into care plans when they are already experiencing serious illness. An analysis of recorded clinician-family conferences about critically ill patients found that in more than half, "there was no deliberation about how to apply patients' values and preferences in the current clinical situation," and in 1 out of every 4 discussions, the patient's values and preferences were not even mentioned. Similarly, a medical oncologist reflected in Health Affairs about the care team's failure to manage expectations of a patient with advanced (and ultimately fatal) lung cancer who, "because she was looking for rescue," declined to discuss goals of care as an outpatient even as treatments proved ineffective and her health deteriorated:
I'm not sure how well we managed Wendy's care at the end of her life. On the one hand, she achieved her short-term goal of attending the family gathering. On the other hand, she spent nearly the entire last month of her life hospitalized. She died in an intensive care unit, intubated, on a ventilator, and unable to say goodbye to love ones. She was not enrolled in hospice. We don't know whether we met Wendy's goals of care because we never managed to define them.
Two editorials in the March 1 issue of AFP addressed how family physicians can prepare patients better for end-of-life decisions by "thinking about [advance care planning] as an iterative and integrative process," rather than as a document to be filled out and then filed away. Primary care teams can use the Serious Illness Conversation Guide to assess patients' understanding of their illness, explore what matters most to them, and communicate goals of care to family members and subspecialists. Lack of training and time constraints remain barriers, however. Innovative residency curricula on advance care planning, such as this medical-legal partnership described in Family Medicine, may improve physicians' comfort level with these conversations. Having Medicare and private insurers pay for advance care planning discussions is a helpful first step, but as Drs. Joanna Paladino and Erik Fromme observed, "clinicians cannot improve the care of people with serious illness alone—to be successful, they need health system changes that support better conversations over the continuum of care."
Monday, April 1, 2019
Introducing Dr. Mike Arnold, the first Jay Siwek Medical Editing Fellow
- Jennifer Middleton, MD, MPH
It's my pleasure to introduce the first Jay Siwek Medical Editing Fellow at AFP, Dr. Mike Arnold, whose fellowship year began on March 1. Here are some highlights from a recent interview I had the privilege to conduct with Dr. Arnold:
Tell us a little about yourself and your background.
I’m a bit of a late-comer to medicine. The Navy paid for my college in exchange for weekly marching and four years of service after graduation. They sent me to submarines, and I stayed for eight years. My medical training was through Uniformed Services University (USU), the only medical school where students are paid a salary to attend. In my opinion, NYU’s tuition-free plan is only starting to catch up to that hidden gem. In the thirteen years since graduation, I’ve been stationed as far away as Naples, Italy and the Pacific island of Guam. I recently served as residency faculty at the Naval Hospital in Jacksonville, Florida where I was trained. I’ve been able to practice in tents, ships and run-down gymnasiums. The Navy returned me to USU as faculty last year, where I am blown away by the intelligence and enthusiasm of our medical students.
What got you interested in medical editing and writing?
The journals. Military family physicians have a tradition of packing a large stack of journals when going on deployment. We also love apps because they lighten our load. We often fall behind at our stateside hospitals, but during deployment we read voraciously. Being stationed overseas with limited specialists leads to the same. I believe that this is why you see so many journal authors with military rank. We have come to read, appreciate and depend on them, so we aspire to contribute.
What are you hoping to get out of the fellowship?
I have learned so much about writing articles from editors. I relish trying to assemble evidence to help colleagues in their daily work. Everything I have written has been vastly improved by peer reviewers and editors, the best of whom are able to say “I see what you were trying to do there, but this sentence is very confusing.” I want to get that skill: the ability to partner with authors to improve an article without taking over or losing the author’s voice. I also want to see what the secret formula is for selecting topics to keep thousands of colleagues up to date in the broadest medical specialty.
Is there anything else you'd like AFP readers to know about you?
Just that I try to be well rounded. I’m an intermittent scuba diver, skier, marathon runner, swimmer, biker and sailor. I am getting older and question how long before I have to take things off that list. I spent two years as a Ford engineer designing a V6 engine upgrade and still like to tinker. I’ve been married for twenty years and we have a nineteen year-old college sophomore who is passionately pursuing economics.
Michael J. Arnold, MD
CDR, MC, USN
Uniformed Services University
Dr. Arnold's most recent article, "Interventional Radiology: Indications and Best Practices," was published in the May 1 issue of AFP.
It's my pleasure to introduce the first Jay Siwek Medical Editing Fellow at AFP, Dr. Mike Arnold, whose fellowship year began on March 1. Here are some highlights from a recent interview I had the privilege to conduct with Dr. Arnold:
Tell us a little about yourself and your background.
I’m a bit of a late-comer to medicine. The Navy paid for my college in exchange for weekly marching and four years of service after graduation. They sent me to submarines, and I stayed for eight years. My medical training was through Uniformed Services University (USU), the only medical school where students are paid a salary to attend. In my opinion, NYU’s tuition-free plan is only starting to catch up to that hidden gem. In the thirteen years since graduation, I’ve been stationed as far away as Naples, Italy and the Pacific island of Guam. I recently served as residency faculty at the Naval Hospital in Jacksonville, Florida where I was trained. I’ve been able to practice in tents, ships and run-down gymnasiums. The Navy returned me to USU as faculty last year, where I am blown away by the intelligence and enthusiasm of our medical students.
What got you interested in medical editing and writing?
The journals. Military family physicians have a tradition of packing a large stack of journals when going on deployment. We also love apps because they lighten our load. We often fall behind at our stateside hospitals, but during deployment we read voraciously. Being stationed overseas with limited specialists leads to the same. I believe that this is why you see so many journal authors with military rank. We have come to read, appreciate and depend on them, so we aspire to contribute.
What are you hoping to get out of the fellowship?
I have learned so much about writing articles from editors. I relish trying to assemble evidence to help colleagues in their daily work. Everything I have written has been vastly improved by peer reviewers and editors, the best of whom are able to say “I see what you were trying to do there, but this sentence is very confusing.” I want to get that skill: the ability to partner with authors to improve an article without taking over or losing the author’s voice. I also want to see what the secret formula is for selecting topics to keep thousands of colleagues up to date in the broadest medical specialty.
Is there anything else you'd like AFP readers to know about you?
Just that I try to be well rounded. I’m an intermittent scuba diver, skier, marathon runner, swimmer, biker and sailor. I am getting older and question how long before I have to take things off that list. I spent two years as a Ford engineer designing a V6 engine upgrade and still like to tinker. I’ve been married for twenty years and we have a nineteen year-old college sophomore who is passionately pursuing economics.
Michael J. Arnold, MD
CDR, MC, USN
Uniformed Services University
Dr. Arnold's most recent article, "Interventional Radiology: Indications and Best Practices," was published in the May 1 issue of AFP.
The views expressed in this article are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, Uniformed Services University of the Health Sciences, Department of Defense, or the U.S. Government.
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