- Kenny Lin, MD, MPH
Previous AFP Community Blog posts discussed the 2013 American College of Cardiology/American Heart Association cholesterol treatment guideline, provided additional perspectives on its 7.5% 10-year CVD event risk threshold for starting a statin, and noted that existing cardiovascular risk calculators tend to overestimate risk by significant margins. The ACC/AHA guideline has remained controversial in primary care. The American Academy of Family Physicians gave it a partial endorsement with qualifications (disclosure: I am a member of the AAFP Commission that made this recommendation), and a 2014 guideline from the U.S. Departments of Veterans Affairs and Defense recommended higher thresholds for considering (6%) or starting (12%) statins.
Two weeks ago, the U.S. Preventive Services Task Force weighed in with a new recommendation statement on the use of statins for primary prevention of cardiovascular events. The recommendations are similar to those from the ACC/AHA; the USPSTF recommends initiating low- to moderate-dose statins in adults aged 40 to 75 years with at least one CVD risk factor (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater ("B" recommendation). They recommend shared decision making and selective statin prescribing for similar adults with a 7.5% to 10% CVD risk ("C" recommendation).
The USPSTF's higher risk thresholds for statin therapy compensate for uncertainty regarding the accuracy of CVD risk calculators, and the "C" recommendation recognizes that in persons at lower risk, the benefits of statins are less likely to outweigh the harms, which include liver enzyme abnormalities and muscle toxicity and a small increased risk of new-onset type 2 diabetes.
Although a prior USPSTF statement had recommended screening for lipid disorders in adults as early as 20 years of age, a new systematic review found no direct evidence on the benefits and harms of screening for or treatment of dyslipidemia in adults aged 21 to 39 years. So when should family physicians start checking cholesterol levels in asymptomatic adults, if statins don't become a treatment option until age 40? This is an area to exercise one's clinical judgment on a case-by-case basis, keeping in mind that healthy lifestyle counseling is more likely to be beneficial in adults with CVD risk factors than in adults without known risks.
Tuesday, November 29, 2016
Monday, November 21, 2016
Efforts underway to restrain rising prescription drug costs
- Mara Lambert
In a recent blog post, AAFP President-Elect Michael Munger, MD, addressed an all-too-familiar scenario physicians are encountering in their practices: when medications become too expensive, patients stop taking them. Over the past several years, Americans have faced exorbitant price increases on common treatments such as inhalers for asthma and insulin for diabetes. A Reuters report from this past April found that the prices of four of the top-10 most widely used drugs in the United States increased by more than 100% over the past five years, while six others rose by more than 50%. When steep price hikes for Daraprim and EpiPen made headlines during the past year, the public was justifiably concerned.
Pharmaceutical companies attribute price increases to the cost of researching, developing, and approving new drugs; however, there is a lack of transparency about how these prices are set. Medical societies and other organizations are now upping their efforts to remove the secrecy surrounding drug pricing with the ultimate goal of easing the burden on consumers.
In July, the American College of Physicians released a position paper that outlined various ways to reduce the increasing costs of prescription drugs. Then earlier this month, the American Medical Association announced the TruthinRx campaign to “uncover the truth behind prescription drug pricing.” The campaign’s mission is to improve transparency and restore affordability to medications by educating lawmakers and the public. Website visitors can send a pre-populated e-mail message to their senators and representatives asking them to support calls for increased transparency from pharmaceutical companies and health insurers.
In a similar vein, the Campaign for Sustainable Rx Pricing (CSRxP) is a nonpartisan coalition of physicians, employers, hospitals, nurses, patients, and payers striving to increase awareness of drug pricing and to promote transparency and competition. AAFP leadership met with CSRxP representatives in October to discuss their mutual concerns about drug costs.
The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 6043) of 2016 and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 3056) of 2016 are two current bills endorsed by CSRxP. The FAIR Act would require drug companies to disclose price increases greater than 10% and to provide supporting explanations for the increases, whereas the CREATES Act would close a loophole that prevents generic drug companies from accessing samples of branded drugs for research purposes, hence stifling competition.
These initiatives are a start. In the meantime, physicians should remain vigilant about asking patients whether they can afford their medications. In an AFP editorial from earlier this year, Steven R. Brown, MD, outlined five strategies for practicing high-value prescribing, including exercising skepticism and caution when prescribing new drugs, applying STEPS and knowing drug prices, prescribing generics and comparing value, restricting access to drug reps and office samples, and prescribing conservatively. Each of these actions can play a part in keeping costs down for patients and reducing health care spending at large.
In a recent blog post, AAFP President-Elect Michael Munger, MD, addressed an all-too-familiar scenario physicians are encountering in their practices: when medications become too expensive, patients stop taking them. Over the past several years, Americans have faced exorbitant price increases on common treatments such as inhalers for asthma and insulin for diabetes. A Reuters report from this past April found that the prices of four of the top-10 most widely used drugs in the United States increased by more than 100% over the past five years, while six others rose by more than 50%. When steep price hikes for Daraprim and EpiPen made headlines during the past year, the public was justifiably concerned.
Pharmaceutical companies attribute price increases to the cost of researching, developing, and approving new drugs; however, there is a lack of transparency about how these prices are set. Medical societies and other organizations are now upping their efforts to remove the secrecy surrounding drug pricing with the ultimate goal of easing the burden on consumers.
In July, the American College of Physicians released a position paper that outlined various ways to reduce the increasing costs of prescription drugs. Then earlier this month, the American Medical Association announced the TruthinRx campaign to “uncover the truth behind prescription drug pricing.” The campaign’s mission is to improve transparency and restore affordability to medications by educating lawmakers and the public. Website visitors can send a pre-populated e-mail message to their senators and representatives asking them to support calls for increased transparency from pharmaceutical companies and health insurers.
In a similar vein, the Campaign for Sustainable Rx Pricing (CSRxP) is a nonpartisan coalition of physicians, employers, hospitals, nurses, patients, and payers striving to increase awareness of drug pricing and to promote transparency and competition. AAFP leadership met with CSRxP representatives in October to discuss their mutual concerns about drug costs.
The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 6043) of 2016 and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 3056) of 2016 are two current bills endorsed by CSRxP. The FAIR Act would require drug companies to disclose price increases greater than 10% and to provide supporting explanations for the increases, whereas the CREATES Act would close a loophole that prevents generic drug companies from accessing samples of branded drugs for research purposes, hence stifling competition.
These initiatives are a start. In the meantime, physicians should remain vigilant about asking patients whether they can afford their medications. In an AFP editorial from earlier this year, Steven R. Brown, MD, outlined five strategies for practicing high-value prescribing, including exercising skepticism and caution when prescribing new drugs, applying STEPS and knowing drug prices, prescribing generics and comparing value, restricting access to drug reps and office samples, and prescribing conservatively. Each of these actions can play a part in keeping costs down for patients and reducing health care spending at large.
**
Mara Lambert is Senior Associate Editor of AFP.
Monday, November 14, 2016
Getting babies to sleep: strategies for fatigued parents
- Jennifer Middleton, MD, MPH
With a four-month-old of my own, I read the POEM on Getting an Infant to Sleep in the November 1 issue of AFP with more interest than I might have before becoming a parent. Prior studies have not found one sleep strategy to be superior to another. This latest study adds to the mix by finding that graduated extinction and sleep fading are not only effective but are well-tolerated by babies and parents alike.
Graduated extinction involves placing the infant down for bedtime while drowsy but still awake. Parents then wait a progressively increasing amount of time (2 minutes, then 4 minutes, then 6 minutes) before checking on the child. With sleep fading, parents progressively move bedtime later until the child falls asleep within 15 minutes of being laid down. The POEM study compared these two interventions in 6-month-olds with sleep difficulties to a control group and found that the time it took to fall asleep shortened with both methods. Infant and maternal stress also improved with both interventions. After 12 months, parent-child attachments were unaffected, and there was no change in the risk of emotional or behavioral problems.
An AFP article from 2015 includes graduated extinction among other recommended strategies from the American Academy of Sleep Medicine such as unmodified extinction ("cry it out") and scheduled awakenings (awakening babies 15 minutes prior to expected overnight awakenings). "Camping out" has also been shown to be equivalent to graduated extinction. With camping out, parents initially sit close by as the baby falls asleep and then gradually, over several nights, move further away from the crib until they are outside of the baby's room.
Once infants are old enough to consider implementing a sleep strategy (usually around 4-6 months of age), having several to suggest allows family physicians to work with parents to find an agreeable starting point. I especially appreciate being able to reassure families that, whatever they do, most babies will be sleeping through the night by 1 year of age. There's an AFP By Topic on Sleep Disorders in Children if you'd like to read more.
Monday, November 7, 2016
300 posts and still going strong
- Kenny Lin, MD, MPH
Today's post is the 300th for the AFP Community Blog, which I began writing in August 2010. Fellow medical editor Jennifer Middleton, MD, MPH because our second regular contributor in April 2013. In recognition of this milestone, I thought I would revisit some earlier wayposts - namely, our 100th, 150th, 200th, and 250th posts - and provide updates.
#100 - The spiritual assessment: unnecessary or essential? (9/20/12)
While one reader opined that spiritual concerns have "little to do with improving the health of our patients," another countered, "I do not think this article goes far enough in promoting this type of spiritual health assessment." ... Some readers expressed concerns that physicians might seek to impose their religious beliefs on vulnerable patients, while another suggested that "many physicians seem to have more fear of [discussing] spiritual issues than the patients do."
The debate continues about how best to incorporate the spiritual assessment into clinical practice. Earlier this year, the National Cancer Institute's Physician Data Query (PDQ) database published a comprehensive review of spirituality in cancer care that included a list of standardized assessment measures and suggested options for assisting patients with spiritual concerns.
#150 - Preventing recurrent kidney stones (11/4/13)
Researchers examined 28 studies regarding prevention of recurrent nephrolithiasis ... and found that water works fine for preventing the second episode after an initial event. But after the second episode, water by itself didn't do as well. Participants with multiple stone episodes who added a thiazide diuretic, a citrate, or allopurinol to their 2 liters of water a day, though, had fewer recurrences.
A 2016 study in a University of Minnesota–affiliated health system found that counseling and shared decision making were documented in less than half of outpatient visits for patients who underwent LDCT for lung cancer screening after publication of the USPSTF guidelines. Although we don't know if this experience is representative of national practice, it certainly isn't good news.
#250: SPRINT and lower systolic BP goals (11/23/15)
Aggressively adjusting medication doses based on what may be inaccurate office BP readings could potentially cause patients significant harm. Most of the time, the JNC 8 guidelines are likely to be more applicable to the patients in our offices than SPRINT's narrowly defined parameters.
No new hypertension guidelines have been issued since the publication of the SPRINT trial, but in August 2016, a majority of cardiologists at the European Society of Cardiology meeting gave a "thumbs down" to lowering blood pressure targets based on the trial's results. An article published in Circulation explained how the measurement technique used in SPRINT would have led to blood pressure readings 5-10 mm Hg lower than in clinical practice.
Today's post is the 300th for the AFP Community Blog, which I began writing in August 2010. Fellow medical editor Jennifer Middleton, MD, MPH because our second regular contributor in April 2013. In recognition of this milestone, I thought I would revisit some earlier wayposts - namely, our 100th, 150th, 200th, and 250th posts - and provide updates.
#100 - The spiritual assessment: unnecessary or essential? (9/20/12)
While one reader opined that spiritual concerns have "little to do with improving the health of our patients," another countered, "I do not think this article goes far enough in promoting this type of spiritual health assessment." ... Some readers expressed concerns that physicians might seek to impose their religious beliefs on vulnerable patients, while another suggested that "many physicians seem to have more fear of [discussing] spiritual issues than the patients do."
The debate continues about how best to incorporate the spiritual assessment into clinical practice. Earlier this year, the National Cancer Institute's Physician Data Query (PDQ) database published a comprehensive review of spirituality in cancer care that included a list of standardized assessment measures and suggested options for assisting patients with spiritual concerns.
#150 - Preventing recurrent kidney stones (11/4/13)
Researchers examined 28 studies regarding prevention of recurrent nephrolithiasis ... and found that water works fine for preventing the second episode after an initial event. But after the second episode, water by itself didn't do as well. Participants with multiple stone episodes who added a thiazide diuretic, a citrate, or allopurinol to their 2 liters of water a day, though, had fewer recurrences.
A related POEM in the January 15, 2015 issue of AFP discussed a randomized controlled trial that concluded that ultrasonography is the best initial imaging test for kidney stones in the emergency department (ED), reducing overall radiation exposure compared to initial computed tomography (CT) without differences in rates of return to the ED, pain scores, or complications.
#200 - Lung cancer screening (11/18/14)
Shared decision-making is increasingly recommended by screening guidelines, but I worry that these difficult discussions may not actually take place, even if family physicians are paid to initiate them with patients eligible for LDCT [low-dose computed tomography] screening. Will clinicians merely go through the motions and just order the test?
#200 - Lung cancer screening (11/18/14)
Shared decision-making is increasingly recommended by screening guidelines, but I worry that these difficult discussions may not actually take place, even if family physicians are paid to initiate them with patients eligible for LDCT [low-dose computed tomography] screening. Will clinicians merely go through the motions and just order the test?
A 2016 study in a University of Minnesota–affiliated health system found that counseling and shared decision making were documented in less than half of outpatient visits for patients who underwent LDCT for lung cancer screening after publication of the USPSTF guidelines. Although we don't know if this experience is representative of national practice, it certainly isn't good news.
#250: SPRINT and lower systolic BP goals (11/23/15)
Aggressively adjusting medication doses based on what may be inaccurate office BP readings could potentially cause patients significant harm. Most of the time, the JNC 8 guidelines are likely to be more applicable to the patients in our offices than SPRINT's narrowly defined parameters.
No new hypertension guidelines have been issued since the publication of the SPRINT trial, but in August 2016, a majority of cardiologists at the European Society of Cardiology meeting gave a "thumbs down" to lowering blood pressure targets based on the trial's results. An article published in Circulation explained how the measurement technique used in SPRINT would have led to blood pressure readings 5-10 mm Hg lower than in clinical practice.
Monday, October 31, 2016
Aspirin for primary prevention: who and when?
- Jennifer Middleton, MD, MPH
It seems that the pendulum on aspirin use for primary cardiovascular disease (CVD) prevention has swung back and forth over the last few years. Dr. Lin wrote about the debate regarding aspirin's risks and benefits on the blog when the United States Preventive Services Task Force (USPSTF) had last updated their guidelines in 2011; at that time, the evidence was mixed regarding the net benefit for aspirin. Fast forward to 2016, and the current issue of AFP reviews the latest USPSTF recommendation: aspirin likely benefits adults aged 50-59 who meet certain criteria.
The USPSTF now recommends that adults aged 50-59 with at least a 10% 10-year-CVD risk, without risk factors for serious bleeding, and with the willingness to take aspirin for at least 10 years take aspirin to reduce the risk of both CVD and colorectal cancer. This is a B recommendation (USPSTF recommends this service, net benefit is moderate to substantial). The data they reviewed is less convincing for adults of other ages; aspirin use for adults aged 60-69 has a C recommendation (selectively offer or provide this service, net benefit is small), while aspirin use for those under 50 and over 70 are both I recommendations (current evidence is insufficient to assess balance of harms and benefits).
Increasingly, recommendations about preventive care becoming less general and more personalized. Calculating CVD risk is already commonplace in assessing which patients might benefit from statins (though the controversies surrounding the most recent 10-year-risk calculator continue). Screening mammography may benefit only high-risk women under the age of 50. The benefit of colorectal cancer screening for those aged 76-85 is likely limited to patients without limited life expectancy and/or multiple co-morbid conditions. Keeping track of who needs what preventive service and when is more complex when sweeping generalizations ("everybody over age 50 should take an aspirin/get colorectal cancer screening/have an annual mammogram") no longer apply.
Apps such as the Agency for Healthcare Research and Quality Electronic Preventive Services Selector (AHRQ ePSS) can provide a quick, convenient way to search for relevant recommendations at the point-of-care with patients. The AHRQ ePSS app is free and provides a search tool that displays current USPSTF recommendations stratified by age, gender, tobacco history, and sexual activity. Pre-visit planning can help make preventive care a whole-office endeavor as can using Electronic Health Records (EHR) to identify those patients who may be overdue for services via registries or other population health tools. Regardless of the system used, having a systematic way to identify which patients might benefit from preventive services can leave more time for physicians to provide counseling about these increasingly complex recommendations.
It seems that the pendulum on aspirin use for primary cardiovascular disease (CVD) prevention has swung back and forth over the last few years. Dr. Lin wrote about the debate regarding aspirin's risks and benefits on the blog when the United States Preventive Services Task Force (USPSTF) had last updated their guidelines in 2011; at that time, the evidence was mixed regarding the net benefit for aspirin. Fast forward to 2016, and the current issue of AFP reviews the latest USPSTF recommendation: aspirin likely benefits adults aged 50-59 who meet certain criteria.
The USPSTF now recommends that adults aged 50-59 with at least a 10% 10-year-CVD risk, without risk factors for serious bleeding, and with the willingness to take aspirin for at least 10 years take aspirin to reduce the risk of both CVD and colorectal cancer. This is a B recommendation (USPSTF recommends this service, net benefit is moderate to substantial). The data they reviewed is less convincing for adults of other ages; aspirin use for adults aged 60-69 has a C recommendation (selectively offer or provide this service, net benefit is small), while aspirin use for those under 50 and over 70 are both I recommendations (current evidence is insufficient to assess balance of harms and benefits).
Increasingly, recommendations about preventive care becoming less general and more personalized. Calculating CVD risk is already commonplace in assessing which patients might benefit from statins (though the controversies surrounding the most recent 10-year-risk calculator continue). Screening mammography may benefit only high-risk women under the age of 50. The benefit of colorectal cancer screening for those aged 76-85 is likely limited to patients without limited life expectancy and/or multiple co-morbid conditions. Keeping track of who needs what preventive service and when is more complex when sweeping generalizations ("everybody over age 50 should take an aspirin/get colorectal cancer screening/have an annual mammogram") no longer apply.
Apps such as the Agency for Healthcare Research and Quality Electronic Preventive Services Selector (AHRQ ePSS) can provide a quick, convenient way to search for relevant recommendations at the point-of-care with patients. The AHRQ ePSS app is free and provides a search tool that displays current USPSTF recommendations stratified by age, gender, tobacco history, and sexual activity. Pre-visit planning can help make preventive care a whole-office endeavor as can using Electronic Health Records (EHR) to identify those patients who may be overdue for services via registries or other population health tools. Regardless of the system used, having a systematic way to identify which patients might benefit from preventive services can leave more time for physicians to provide counseling about these increasingly complex recommendations.
Monday, October 24, 2016
Underperforming big ideas in diabetes and breast cancer
- Kenny Lin, MD, MPH
Management of type 2 diabetes and screening for breast cancer make up a large portion of most family physicians' practices, including my own. Care and prevention for these patients is based on straightforward underlying theories of disease causation and behavior. Patients with type 2 diabetes have high blood glucose levels; treatment involves normalizing blood glucose through lifestyle modification and medication. Small, nonpalpable breast cancers eventually become large, symptomatic tumors. Smaller tumors are more likely to be curable, so undergoing regular screening mammography is preferable to not doing so.
But what if these underlying theories are wrong?
In a recent editorial in JAMA, Drs. Michael Joyner, Nigel Paneth, and John Ioannidis explored how the "big idea" or narrative that investments in genetics and information technology will lead to a revolution in health care has captured a large share of biomedical research funding and journal publications. They then illustrated how this big idea has "underperformed," as central assumptions of precision/personalized medicine have not been borne out in studies and tens of billions of dollars invested into electronic health records since 2009 have not made patient care measurably better or patient data more accessible to researchers.
Is tight glycemic control for patients with type 2 diabetes mellitus an underperforming clinical big idea? In an analysis in Circulation: Cardiovascular Quality and Outcomes, Drs. Rene Rodriguez-Gutierrez and Victor Montori compared clinical policy statements and practice guidelines for patients with type 2 diabetes between 2006 and 2015 with evidence from randomized controlled trials. Despite little or no evidence that tight glycemic control (hemoglobin A1c <6.5 or 7.0%) improves microvascular or macrovascular outcomes compared to less strict hemoglobin A1c goals, the majority of guidelines continued to endorse tight control for one or both of those outcomes. (In contrast, AFP editorials and articles have long asserted that "Physicians should not let well-intentioned but misguided concern for glucose levels distract them from attending to other interventions that more profoundly affect mortality [in patients with type 2 diabetes]: smoking cessation, blood pressure control, metformin therapy, and lipid reduction.")
And do small breast tumors detected by mammograms become large, lethal ones? Sometimes, but not as often as most patients and physicians think, according to an observational study in the New England Journal of Medicine that concluded: "Women [with tumors detected on mammography] were more likely to have breast cancer that was overdiagnosed than to have earlier detection of a tumor that was destined to become large." This study also concluded that most of the reduction in breast cancer mortality over the past 40 years could be attributed to improved systemic therapy rather than earlier tumor detection. In an AFP editorial on counseling women about breast cancer screening, Dr. Mark Ebell and I discussed the benefits and harms of mammography in younger women and noted that for every additional breast cancer death prevented by starting at age 40, two women will be overdiagnosed with (and overtreated for) breast tumors that never would have become clinically apparent.
Management of type 2 diabetes and screening for breast cancer make up a large portion of most family physicians' practices, including my own. Care and prevention for these patients is based on straightforward underlying theories of disease causation and behavior. Patients with type 2 diabetes have high blood glucose levels; treatment involves normalizing blood glucose through lifestyle modification and medication. Small, nonpalpable breast cancers eventually become large, symptomatic tumors. Smaller tumors are more likely to be curable, so undergoing regular screening mammography is preferable to not doing so.
But what if these underlying theories are wrong?
In a recent editorial in JAMA, Drs. Michael Joyner, Nigel Paneth, and John Ioannidis explored how the "big idea" or narrative that investments in genetics and information technology will lead to a revolution in health care has captured a large share of biomedical research funding and journal publications. They then illustrated how this big idea has "underperformed," as central assumptions of precision/personalized medicine have not been borne out in studies and tens of billions of dollars invested into electronic health records since 2009 have not made patient care measurably better or patient data more accessible to researchers.
Is tight glycemic control for patients with type 2 diabetes mellitus an underperforming clinical big idea? In an analysis in Circulation: Cardiovascular Quality and Outcomes, Drs. Rene Rodriguez-Gutierrez and Victor Montori compared clinical policy statements and practice guidelines for patients with type 2 diabetes between 2006 and 2015 with evidence from randomized controlled trials. Despite little or no evidence that tight glycemic control (hemoglobin A1c <6.5 or 7.0%) improves microvascular or macrovascular outcomes compared to less strict hemoglobin A1c goals, the majority of guidelines continued to endorse tight control for one or both of those outcomes. (In contrast, AFP editorials and articles have long asserted that "Physicians should not let well-intentioned but misguided concern for glucose levels distract them from attending to other interventions that more profoundly affect mortality [in patients with type 2 diabetes]: smoking cessation, blood pressure control, metformin therapy, and lipid reduction.")
And do small breast tumors detected by mammograms become large, lethal ones? Sometimes, but not as often as most patients and physicians think, according to an observational study in the New England Journal of Medicine that concluded: "Women [with tumors detected on mammography] were more likely to have breast cancer that was overdiagnosed than to have earlier detection of a tumor that was destined to become large." This study also concluded that most of the reduction in breast cancer mortality over the past 40 years could be attributed to improved systemic therapy rather than earlier tumor detection. In an AFP editorial on counseling women about breast cancer screening, Dr. Mark Ebell and I discussed the benefits and harms of mammography in younger women and noted that for every additional breast cancer death prevented by starting at age 40, two women will be overdiagnosed with (and overtreated for) breast tumors that never would have become clinically apparent.
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